Pharmaceutical reference substances and impurities ... - Kriticos.eu
Pharmaceutical reference substances and impurities ... - Kriticos.eu
Pharmaceutical reference substances and impurities ... - Kriticos.eu
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<strong>Pharmac<strong>eu</strong>tical</strong><br />
<strong>reference</strong> <strong>substances</strong><br />
<strong>and</strong> <strong>impurities</strong> - 2008
List of LGC St<strong>and</strong>ards offices<br />
France<br />
LGC St<strong>and</strong>ards<br />
6, Rue Kastler<br />
B.P. 83076<br />
67123 Molsheim<br />
France<br />
Tel: +33 (0)3 88 04 82 82<br />
Fax: +33 (0)3 88 04 82 90<br />
Email: fr@lgcst<strong>and</strong>ards.com<br />
Countries served<br />
- Algeria<br />
- Belgium<br />
- France<br />
- Ivory Coast<br />
- Jordan<br />
- Lebanon<br />
- Libya<br />
- Madagascar<br />
- Morocco<br />
- Senegal<br />
- Syria<br />
- Tanzania<br />
- Tunisia<br />
Germany<br />
LGC St<strong>and</strong>ards GmbH<br />
Mercatorstrasse 51<br />
46485 Wesel<br />
Germany<br />
Tel: +49 (0)281 9887 0<br />
Fax: +49 (0)281 9887 199<br />
Email: de@lgcst<strong>and</strong>ards.com<br />
Countries served<br />
- Austria<br />
- China (Hong Kong,<br />
Singapore)<br />
- Croatia<br />
- Cyprus<br />
- Egypt<br />
- Germany<br />
- Greece<br />
- Hungary<br />
- Iran<br />
- Israel<br />
- Japan<br />
- Korea<br />
- Macau<br />
- Netherl<strong>and</strong>s<br />
- Romania<br />
- Slovenia<br />
- Switzerl<strong>and</strong><br />
- Thail<strong>and</strong><br />
- Turkey<br />
India<br />
LGC St<strong>and</strong>ards<br />
P.O. Box 8061<br />
No.142, 3 rd Floor, 5 th Cross<br />
Rajmahal Vilas Extension<br />
Bangalore 560 080<br />
India<br />
Tel: +91 (0)80 2361 1256<br />
Fax: +91 (0)80 2361 3859<br />
Email:in@lgcst<strong>and</strong>ards.com<br />
Countries served<br />
- Bangladesh<br />
- India<br />
- Malaysia<br />
- Nepal<br />
- Pakistan<br />
Italy<br />
LGC St<strong>and</strong>ards s.r.l.<br />
Via Venezia, 23<br />
20099 Sesto San Giovanni<br />
Milan<br />
Italy<br />
Tel: +39 02 2412 6830<br />
Fax: +39 02 2412 6831<br />
Email:it@lgcst<strong>and</strong>ards.com<br />
Countries served<br />
- Italy<br />
Pol<strong>and</strong><br />
LGC St<strong>and</strong>ards<br />
ul. M. Konopnickiej 1<br />
Dziekanów Lesny<br />
05-092 Lomianki<br />
Pol<strong>and</strong><br />
Tel: +48 (0)22 751 31 40<br />
Fax: +48 (0)22 751 58 45<br />
Email:pl@lgcst<strong>and</strong>ards.com<br />
Countries served<br />
- Belorussia<br />
- Bulgaria<br />
- Czech Republic<br />
- Lithuania<br />
- Pol<strong>and</strong><br />
- Russia<br />
- Slovakia<br />
- Ukraine<br />
Spain<br />
LGC St<strong>and</strong>ards<br />
C/Salvador Espriu 59, 2º<br />
planta<br />
08005 Barcelona<br />
Spain<br />
Tel: +34 93 308 4181<br />
Fax: +34 93 307 3612<br />
Email:es@lgcst<strong>and</strong>ards.com<br />
Countries served<br />
- Andorra<br />
- Portugal<br />
- Spain<br />
- Latin America<br />
Sweden<br />
LGC St<strong>and</strong>ards<br />
Box 1737<br />
SE-501 17 Borås<br />
Sweden<br />
Tel: +46 (0)33 20 90 60<br />
Fax: +46 (0)33 20 90 79<br />
Email:se@lgcst<strong>and</strong>ards.com<br />
Countries served<br />
- Denmark<br />
- Estonia<br />
- Finl<strong>and</strong><br />
- Icel<strong>and</strong><br />
- Latvia<br />
- Norway<br />
- Sweden<br />
United Kingdom<br />
(Head office)<br />
LGC St<strong>and</strong>ards<br />
Queens Road<br />
Teddington<br />
Middlesex<br />
TW11 0LY<br />
United Kingdom<br />
Tel: +44 (0)20 8943 8480<br />
Fax: +44 (0)20 8943 7554<br />
Email:<br />
uksales@lgcst<strong>and</strong>ards.com<br />
Countries served<br />
- Australia<br />
- Brunei<br />
- Canada<br />
- Channel Isl<strong>and</strong>s<br />
- Irel<strong>and</strong><br />
- Kenya<br />
- Kuwait<br />
- Malta<br />
- New Zeal<strong>and</strong><br />
- Philippines<br />
- Saudi Arabia<br />
- South Africa<br />
- United Arab Emirates<br />
- United Kingdom<br />
Your LGC St<strong>and</strong>ards account number<br />
Your contact at LGC St<strong>and</strong>ards is<br />
Name:<br />
Tel:<br />
Fax:<br />
Email:<br />
www.lgcst<strong>and</strong>ards.com<br />
For countries not listed above, please contact our head office.
Introduction<br />
St<strong>and</strong>ards<br />
Excellence through measurement
Europe’s most<br />
comprehensive source<br />
of <strong>reference</strong> materials<br />
LGC St<strong>and</strong>ards combination of expertise in analytical<br />
science <strong>and</strong> experience in international st<strong>and</strong>ards offers<br />
laboratories throughout Europe the ideal solution<br />
to sourcing high quality certified <strong>reference</strong> materials.<br />
Our expert technical support staff provide unrivalled<br />
knowledge in the use of certified <strong>reference</strong> materials<br />
across a broad range of analytical activities.<br />
• Partnership with the world’s key producers of RMs<br />
• Expert local customer service <strong>and</strong> technical support<br />
• Supply of all major pharmacopeia <strong>and</strong> RMs<br />
• Assistance in finding the right materials to suit your<br />
need<br />
• Over 25,000 <strong>reference</strong> materials in our range<br />
Environmental<br />
Food <strong>and</strong> agriculture<br />
Matrix materials<br />
Clinical <strong>and</strong> forensic<br />
ATCC cultures <strong>and</strong> bioproducts<br />
Pure materials<br />
<strong>Pharmac<strong>eu</strong>tical</strong><br />
Phytochemicals<br />
Chromatography<br />
High purity solvents<br />
For further information or to receive any one of our<br />
catalogues please contact your local office or visit<br />
our website.<br />
Industrial materials<br />
www.lgcst<strong>and</strong>ards.com
Contents<br />
Contents<br />
Introduction<br />
Introduction 1<br />
Publications <strong>and</strong> subscriptions 5<br />
United States Pharmacopeia <strong>and</strong> National Formulary 9<br />
ATCC microbiological products 61<br />
European Pharmacopoeia 63<br />
ATCC microbiological products 114<br />
Certified liquids for viscosity measurements 116<br />
International commission on pharmac<strong>eu</strong>tical enzymes 117<br />
European Pharmacopoeia reagents 118<br />
British Pharmacopoeia 123<br />
ATCC microbiological products 136<br />
Pharmacopée Française 138<br />
Pharmacopoeia Helvetica 140<br />
International Pharmacopeia 141<br />
Institute of Dyes <strong>and</strong> Organic products 147<br />
Refractive index CRMs 150<br />
<strong>Pharmac<strong>eu</strong>tical</strong> <strong>impurities</strong> 151<br />
Background 153<br />
Certificate of Analysis 155<br />
List of products 159<br />
Physical St<strong>and</strong>ards 333<br />
High purity solvents 387<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 1
Introduction<br />
Introduction<br />
About LGC St<strong>and</strong>ards<br />
LGC St<strong>and</strong>ards has successfully established a global reputation for the production of <strong>impurities</strong> <strong>and</strong> working<br />
st<strong>and</strong>ards, <strong>and</strong> as a single source for the supply of pharmacopeia <strong>reference</strong> materials. Our menu of custom<br />
services, including custom synthesis of <strong>impurities</strong> <strong>and</strong> metabolites, characterisation, certification, packaging<br />
<strong>and</strong> distribution, adds value to the scientific support we provide to our pharmac<strong>eu</strong>tical customers.<br />
Our relationships with the world’s leading pharmacopoeias <strong>and</strong> their range of Chemical Reference<br />
Substances (CRS) <strong>and</strong> Reference St<strong>and</strong>ards (RS), combined with in-house production of certified <strong>reference</strong><br />
materials <strong>and</strong> pharmac<strong>eu</strong>tical <strong>impurities</strong>, enable us to meet our customers’ specific needs. LGC St<strong>and</strong>ards<br />
is also the exclusive European distributor for ATCC ® cultures <strong>and</strong> bio products.<br />
LGC St<strong>and</strong>ards’ extensive network of sales offices <strong>and</strong> distribution centres mean we offer the widest range<br />
of <strong>reference</strong> materials from one single source for rapid delivery. Our staff can provide scientific <strong>and</strong> technical<br />
guidance, including shipping <strong>and</strong> customs advice, in the local language.<br />
Our range of products also includes <strong>reference</strong> materials for clinical <strong>and</strong> forensic applications, phytochemicals,<br />
environmental analysis, physical properties determination, <strong>and</strong> food <strong>and</strong> beverage analysis.<br />
For more information about our range of services, or to receive any of our catalogues, please refer to<br />
our website www.lgcst<strong>and</strong>ards.com or contact your local office.<br />
About LGC<br />
LGC St<strong>and</strong>ards is part of LGC. LGC, whose Research <strong>and</strong> Technology Division acts as the designated<br />
UK National Measurement Institute (NMI) for Chemical <strong>and</strong> Biochemical measurement, has a long history<br />
in the development <strong>and</strong> validation of analytical methods <strong>and</strong> the production of <strong>reference</strong> materials.<br />
Many of the analytical methods, which cover the food, environment, industrial, clinical <strong>and</strong> pharmac<strong>eu</strong>tical<br />
sectors, are accredited to ISO/IEC 17025 (Requirements for the competency of testing <strong>and</strong> calibration<br />
laboratories). Full details of the accreditation schedule can be found on the UKAS website www.ukas.com.<br />
LGC’s Research <strong>and</strong> Technology Division is accredited to ISO Guide 34 (General Requirements for the<br />
competence of <strong>reference</strong> materials producers) for the production of <strong>reference</strong> materials. The measurement<br />
capabilities used to produce certified <strong>reference</strong> materials in its capacity as the UK NMI are verified through<br />
participation on key comparison studies organised by the Consultative Committee for the Amount of<br />
Substance (CCQM) of the International Weights <strong>and</strong> Measures Organisation (BIPM). The certificates<br />
are recognised by other National Measurement Institutes, under the Mutual Recognition Arrangement.<br />
In its role as the NMI, LGC serves on the International Organisation for St<strong>and</strong>ardisation (ISO) Committee<br />
for Reference Materials (REMCO), which aims to carry out <strong>and</strong> encourage a broad international effort for<br />
the harmonization, production <strong>and</strong> application of certified <strong>reference</strong> materials (CRM’s).<br />
About the catalogue<br />
The 2008 edition of the LGC St<strong>and</strong>ards catalogue ‘<strong>Pharmac<strong>eu</strong>tical</strong> <strong>reference</strong> <strong>substances</strong> <strong>and</strong> <strong>impurities</strong>’,<br />
replaces the ‘<strong>Pharmac<strong>eu</strong>tical</strong> <strong>reference</strong> <strong>substances</strong> <strong>and</strong> <strong>impurities</strong>’ 2006/2007 edition <strong>and</strong><br />
the three newsletter updates.<br />
The information provided in this catalogue as regards compendial articles is based on the ‘official’<br />
pharmacopoeial lists <strong>and</strong> is correct at the time of print. Original descriptions <strong>and</strong> spellings used by the<br />
producers are retained. In some cases additional information has been included to make the lists more<br />
convenient to use.<br />
The catalogue will be updated with three newsletters; these will be downloadable under<br />
www.lgcst<strong>and</strong>ards.com. You can also contact your local LGC St<strong>and</strong>ards office <strong>and</strong> ask to be<br />
provided with the newsletters once they are published.<br />
2 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
<strong>Pharmac<strong>eu</strong>tical</strong> <strong>reference</strong> <strong>substances</strong><br />
<strong>Pharmac<strong>eu</strong>tical</strong> <strong>reference</strong> <strong>substances</strong><br />
Certification<br />
The products described in this catalogue include pharmacopeial <strong>reference</strong> <strong>substances</strong> for use in<br />
pharmac<strong>eu</strong>tical analysis. Pharmacopeial CRSs <strong>and</strong> RSs should be distinguished from certified <strong>reference</strong><br />
materials (CRMs), which are produced in conformity with the ISO guides 30 to 35, <strong>and</strong> supplied with a<br />
detailed certification document.<br />
Pharmacopeial <strong>reference</strong> <strong>substances</strong> are produced for a specific purpose, <strong>and</strong> the manufacturers follow<br />
rigorous protocols to ensure the <strong>reference</strong> substance is fit for the intended purpose. The ‘certification’<br />
processes follow the basic requirements of the relevant ISO REMCO guides, but are modified by the<br />
pharmacopoeias to reflect the particular dem<strong>and</strong>s of the associated pharmac<strong>eu</strong>tical monograph.<br />
Details are given in the introduction to each section listing the various CRS collections in this catalogue.<br />
Shelf Life, storage <strong>and</strong> expiry dates<br />
Pharmacopeial CRSs <strong>and</strong> RSs should be purchased when required <strong>and</strong> not stored for a prolonged period.<br />
Pack sizes are designed to allow a limited number of replicate analyses, as required by Good Analytical<br />
Practice, but the opened pack should not be kept for future use. Please check all individual storage<br />
temperature requirements <strong>and</strong> note that the <strong>substances</strong> should be kept away from humidity <strong>and</strong> light<br />
(unless otherwise stated).<br />
Specific lot numbers or letters are allocated to all pharmacopeial <strong>reference</strong> <strong>substances</strong>, but no expiry<br />
dates are set. New lots are normally prepared well in advance of the expected "sell-out" of the current lot.<br />
When a substance is withdrawn from sale because the lot has depleted a final expiry date is given, by<br />
which any material from the outgoing lot held by users must be used. This means that for a period of time<br />
both lots are ‘official’. Lot information is provided by USP <strong>and</strong> EP in their literature <strong>and</strong> is available from<br />
LGC St<strong>and</strong>ards.<br />
If a material is withdrawn by the producer, then all stocks held by the users are no longer valid <strong>and</strong> have<br />
to be destroyed. Should this occur, LGC St<strong>and</strong>ards will inform all customers who have purchased the<br />
withdrawn substance. Please note that such a situation is outside LGC St<strong>and</strong>ards’ control <strong>and</strong> products<br />
are not refundable.<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 3
<strong>Pharmac<strong>eu</strong>tical</strong> <strong>reference</strong> <strong>substances</strong><br />
Impurity st<strong>and</strong>ards<br />
Impurities in a pharmac<strong>eu</strong>tical substance can change the effects <strong>and</strong> side effects of a drug significantly.<br />
Therefore, it is important to have an accurate detection of <strong>impurities</strong>. The pharmac<strong>eu</strong>tical monographs<br />
regulate the legal definition, the analysis <strong>and</strong> the limits of <strong>impurities</strong> of a given substance. An official range<br />
of impurity st<strong>and</strong>ards is available from the main pharmacopoeias where a CRS or RS is required in the<br />
monograph.<br />
Over 2200 other impurity st<strong>and</strong>ards are listed in the ‘pharmac<strong>eu</strong>tical <strong>impurities</strong>’ section of the catalogue.<br />
These materials are produced by LGC, whose Research & Technology Division acts as the designated<br />
UK National Measurement Institute for Chemical <strong>and</strong> Biochemical Measurements. They are produced at<br />
our facility in Luckenwalde near Berlin, Germany <strong>and</strong> are supplied with a certificate of analysis.<br />
Controlled <strong>substances</strong><br />
A number of the pharmac<strong>eu</strong>tical <strong>substances</strong>, such as narcotics <strong>and</strong> tranquillisers, described in this catalogue<br />
are Controlled Substances in their country of origin <strong>and</strong> are marked ‘Controlled Substance’ against the<br />
product description.<br />
The purchase, possession <strong>and</strong> use of Controlled Substances are subject to national <strong>and</strong> international<br />
regulations designed to limit their abuse. It is the responsibility of the customer to obtain any authorisation<br />
necessary to both purchase <strong>and</strong> possess Controlled Substances, complying with the laws of the importing<br />
country, before ordering.<br />
Customers wishing to obtain Controlled Substances must contact their LGC St<strong>and</strong>ards sales office before<br />
ordering, <strong>and</strong> clarify with the sales specialists the relevant national requirements, the associated charges<br />
<strong>and</strong> consequential delivery times. All orders for Controlled Substances must be provided in writing <strong>and</strong><br />
signed by an authorised person. The orders must be accompanied with the original import permit <strong>and</strong> / or<br />
possession permit.<br />
Use, safety <strong>and</strong> h<strong>and</strong>ling<br />
Please read any documents supplied with the product before opening or using it. Particular attention must<br />
be paid to instructions referring to pre-mixing, addition of diluent to lyophilised materials <strong>and</strong> to the minimum<br />
size of sample to be used.<br />
The latter point is particularly important as it has normally been set by the producer after considering fully<br />
the homogeneity testing data obtained as a part of the certification exercise. The use of smaller than<br />
recommended samples is one of the most common sources of error.<br />
Some pharmac<strong>eu</strong>tical <strong>substances</strong> are toxic <strong>and</strong> require special h<strong>and</strong>ling. Virtually all pharmac<strong>eu</strong>tical<br />
<strong>reference</strong> <strong>substances</strong> have a pharmacological <strong>and</strong>/or biological activity. We therefore recommend that all<br />
the products described in this catalogue should be h<strong>and</strong>led as if they were bio-active, toxic or infective,<br />
<strong>and</strong> that opened packs should only be h<strong>and</strong>led by trained laboratory personnel.<br />
All pharmac<strong>eu</strong>tical <strong>reference</strong> <strong>substances</strong> <strong>and</strong> st<strong>and</strong>ards are for laboratory analytical use only <strong>and</strong><br />
not for use in humans.<br />
General ordering information<br />
Prices <strong>and</strong> delivery procedures are described in the price list that accompanies this catalogue, or are<br />
available from your local LGC St<strong>and</strong>ards office. For products requiring special delivery procedures<br />
(cooled shipping, special licensing, Controlled Substances) additional charges may be applied.<br />
Please note that once delivered to the customer, <strong>reference</strong> <strong>substances</strong> are not returnable.<br />
Customers requiring assistance with the purchase, use or application of a particular <strong>reference</strong> substance<br />
should contact LGC St<strong>and</strong>ards where technical staff are available to advise on the use <strong>and</strong> suitability of<br />
the products.<br />
4 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
Publications<br />
<strong>and</strong> subscriptions<br />
St<strong>and</strong>ards<br />
Excellence through measurement
Reference materials<br />
for sports drugs,<br />
clinical analysis <strong>and</strong><br />
forensic toxicology<br />
LGC St<strong>and</strong>ards, Europe’s most comprehensive single<br />
source of <strong>reference</strong> materials, offers over 900 <strong>reference</strong><br />
materials suitable for use in forensic <strong>and</strong> sports drug<br />
testing, therap<strong>eu</strong>tic drug monitoring, clinical testing,<br />
forensic toxicology <strong>and</strong> employment drug testing.<br />
A wide selection of high quality st<strong>and</strong>ards in solution,<br />
including isotope labelled materials, is listed in our<br />
catalogue, ranging from primary st<strong>and</strong>ards of the highest<br />
metrological order to clinical controls for routine testing.<br />
A selection of the analytes is also available in matrices<br />
such as urine, blood, hair or serum. New materials are<br />
continually being developed <strong>and</strong> added to our product<br />
range.<br />
LGC St<strong>and</strong>ards’ partnerships with the world’s leading<br />
<strong>reference</strong> material producers, such as the National<br />
Measurement Institute of Australia (NMIA), the US<br />
National Institute of St<strong>and</strong>ards <strong>and</strong> Technology (NIST),<br />
the European Institute for Reference Materials <strong>and</strong><br />
Measurement (IRMM), SERO, Medichem <strong>and</strong> Cerilliant,<br />
combined with our high level of technical expertise,<br />
enable us to assist our customers in identifying the<br />
most appropriate materials available for their specific<br />
applications.<br />
For further information <strong>and</strong> advice please visit :<br />
Blood grouping<br />
Coagulation factors<br />
Drugs of abuse<br />
Enzymes<br />
Ethanol<br />
Hormones<br />
Metabolites <strong>and</strong><br />
substrates<br />
Micronutrients<br />
Proteins<br />
Sports drugs<br />
Steroids<br />
Trace elements<br />
Vitamins<br />
www.lgcst<strong>and</strong>ards.com
Publications <strong>and</strong> subscriptions<br />
Printed versions USP<br />
Publications <strong>and</strong> subscriptions<br />
Code Product Unit<br />
USP2310001<br />
1 year subscription:<br />
USP31-NF26 [2008 Print Subscription];<br />
(2008 book, Supplement 1 & 2)<br />
USP2PF0801 2008 Pharmacopoeial Forum Print unit<br />
Electronic versions USP<br />
USP2100000<br />
USP2310009<br />
1 year subscription:USP NF Online<br />
(3 electronic issues)<br />
-access to the USP-NF data on the website with passwords<br />
1 year subscription:<br />
USP31-NF26 CD-ROM [2008 Single-user subscription]<br />
unit<br />
per user<br />
USP2PF0021 Pharmacopoiea Forum Online 1-Year Subscription per user<br />
Printed versions EP<br />
PHEUR2008-2SE EP 2008 Book Subscription 6th Edition English (6.0-6.2) unit<br />
PHEUR2008-2SF EP 2008 Book Subscription 6th Edition French (6.0-6.2) unit<br />
PHPA2007E PHARMEUROPA 2007 - vol.19. 1-4 English(includes online access) unit<br />
PHPA2007F PHARMEUROPA 2007 - vol.19. 1-4 French(includes online access) unit<br />
Electronic versions EP, BP<br />
CD60-62-001E EP 6th Edition 2008 CD ROM Subscription(6.0-6.2) 1 user English unit<br />
CD60-62-001F EP 6th Edition 2008 CD ROM Subscription(6.0-6.2) 1 user French unit<br />
CD60-62-001B EP 6th Edition 2008 CD ROM Subscription(6.0-6.2) 1 user Bilingual unit<br />
ON60-62-PW ONLINE Subscription 6th Edition 2008(incl.Vol.6.0-6.2) Trilingual unit<br />
BP 2008<br />
British Pharmacopoeia 2008 Multimedia Package [2008 book(5 volumes),<br />
single-user CD-ROM, Password for one user for Online-access]<br />
unit<br />
unit<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 7
Publications <strong>and</strong> subscriptions<br />
We constantly add new products to our range, so<br />
please call us to find out about new products <strong>and</strong><br />
services <strong>and</strong> to make sure you are automatically<br />
kept up to date by subscribing to our free newsletter.<br />
Just send an email to<br />
pharma-news@lgcst<strong>and</strong>ards.com<br />
8 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
United States<br />
Pharmacopeia<br />
<strong>and</strong><br />
National<br />
Formulary<br />
St<strong>and</strong>ards<br />
Excellence through measurement
Phytochemical<br />
<strong>reference</strong> st<strong>and</strong>ards<br />
LGC St<strong>and</strong>ards, a range of over 30,000 <strong>reference</strong><br />
materials includes over 2,500 materials of natural<br />
origin.<br />
Our product range includes Certified Reference<br />
Materials from the US National Institute of St<strong>and</strong>ards<br />
<strong>and</strong> Technology (NIST) <strong>and</strong> LGC, as well as primary,<br />
secondary <strong>and</strong> working phytochemical st<strong>and</strong>ards<br />
produced by ChromaDex.<br />
Phytochemical or herbal st<strong>and</strong>ards have a wide range<br />
of application in the pharmac<strong>eu</strong>tical, dietary supplement<br />
<strong>and</strong> food industries, but are also of interest to<br />
medical, environmental <strong>and</strong> forensic laboratories,<br />
<strong>and</strong> to institutes for occupational health.<br />
Phytochemical <strong>reference</strong> st<strong>and</strong>ards to underpin analytical<br />
testing are available as pure active ingredients,<br />
as botanical materials <strong>and</strong> as extracted <strong>reference</strong><br />
materials, each supported by detailed certificates of<br />
analysis. Advice, <strong>reference</strong> to the American Herbal<br />
Pharmacopeia, assistance with developing analytical<br />
methods <strong>and</strong> custom isolation or purification are also<br />
available within the extensive range of services<br />
offered by LGC St<strong>and</strong>ards.<br />
Artichoke<br />
Belladonna<br />
Bilberry<br />
Black cohosh<br />
Carotinoids<br />
Cat´s claw<br />
Devil´s claw<br />
Echinacea<br />
Ginseng<br />
Kava kava<br />
Reishi mushroom<br />
Rosemary<br />
Salvia<br />
Soyasporins<br />
St. John´s wort<br />
Tribulus terrestris<br />
Valerian<br />
...<strong>and</strong> many more<br />
www.lgcst<strong>and</strong>ards.com
United States Pharmacopeia <strong>and</strong> National Formulary<br />
United States Pharmacopeia <strong>and</strong> National Formulary<br />
Background<br />
USP <strong>reference</strong> st<strong>and</strong>ards are highly purified <strong>substances</strong> that are provided specifically for use in the official<br />
test methods of the United States Pharmacopeia <strong>and</strong> National Formulary. When used as a part of the<br />
relevant official monograph they provide the means to verify the compliance of a material with USP-NF<br />
st<strong>and</strong>ards for identity, concentration, quality <strong>and</strong> purity.<br />
Official USP <strong>and</strong> NF Reference St<strong>and</strong>ards are made available as required for use in assays <strong>and</strong> tests<br />
appearing in the current edition of the USP-NF. They are collaboratively tested <strong>and</strong> approved for such use<br />
by the USP Reference St<strong>and</strong>ards Committee <strong>and</strong> released only under the authority of the USP Board of<br />
Trustees.<br />
The range of USP <strong>reference</strong> st<strong>and</strong>ards includes:<br />
1. Official USP <strong>and</strong> NF Reference St<strong>and</strong>ards.<br />
2. Former USP <strong>and</strong> NF Reference St<strong>and</strong>ards, not required in the current USP or NF,<br />
but for whichsufficient dem<strong>and</strong> remains.<br />
3. Food Chemicals Codex (FCC) <strong>reference</strong> st<strong>and</strong>ards, specified in the current edition<br />
of the Food Chemicals Codex.<br />
4. Authentic Substances (AS), which are highly purified samples of chemicals, that are<br />
collaboratively tested <strong>and</strong> made available as a service to analysts.<br />
The list in this catalogue includes all amendments <strong>and</strong> new products made official by USP<br />
to November 2007.<br />
Production <strong>and</strong> certification<br />
The development of USP <strong>reference</strong> st<strong>and</strong>ards is a multi-step process that makes much use of voluntary<br />
cooperation from the pharmac<strong>eu</strong>tical industry, government agencies including the United States Food <strong>and</strong><br />
Drug Administration (FDA), <strong>and</strong> both USP in-house scientific staff <strong>and</strong> the members of the Committee of<br />
Revision.<br />
The following steps are adhered to, <strong>and</strong> the process takes from one to two years.<br />
1. Preparation <strong>and</strong> purification of c<strong>and</strong>idate material.<br />
2. Testing <strong>and</strong> characterisation through a collaborative study (ring test).<br />
3. Initial scientific <strong>and</strong> statistical review. Further analytical work is often required, <strong>and</strong> at this stage<br />
it is possible that the c<strong>and</strong>idate material is rejected <strong>and</strong> the procedure restarted.<br />
4. Preparation of a USP Reference St<strong>and</strong>ards Committee letter, containing the data from the<br />
collaborative study for use by the Reference St<strong>and</strong>ards Committee. This document is USP’s<br />
internal equivalent of a certification report. Approval of the document must be unanimous or further<br />
analytical work will be requested, or the whole cycle restarted.<br />
5. Packaging <strong>and</strong> final quality control testing for homogeneity, integrity of the package, etc.<br />
USP generally does not provide certificates of analysis for USP <strong>reference</strong> st<strong>and</strong>ards (as outlined in their<br />
Document Disclosure Policy). USP <strong>reference</strong> st<strong>and</strong>ards are solely for use in the official tests <strong>and</strong> methods<br />
of the current official compendia. When h<strong>and</strong>led in accordance with labelled instructions <strong>and</strong> monographs,<br />
they are considered as a value of 100.0% for compendial purposes, unless otherwise stated. In response<br />
to requests from LGC St<strong>and</strong>ards, USP began listing the labelled purity values for <strong>reference</strong> st<strong>and</strong>ards <strong>and</strong><br />
authentic <strong>substances</strong>. Each value is followed by a code to indicate the basis of the assignment. For example,<br />
a <strong>reference</strong> st<strong>and</strong>ard with a labelled purity of 0.998 mg/mg calculated on the "as is" basis, will be listed as<br />
"0.998 mg/mg (ai)". From now on, the values will be included for new lots released since January 1, 2004<br />
<strong>and</strong> they will be included for all lots as they are released in the future. Below is a list of the basis codes<br />
<strong>and</strong> their meaning:<br />
(ai) as is<br />
(dr) dried<br />
(an) anhydrous<br />
(fb) free base.<br />
It must be noted that any other use of a USP <strong>reference</strong> st<strong>and</strong>ard in non-official procedures becomes the<br />
responsibility of the user.<br />
Proper use<br />
A full description of the background to, proper use of <strong>and</strong> lot control procedures for USP-NF <strong>reference</strong><br />
st<strong>and</strong>ards is given in General Chapter of the current USP-NF publication. Analysts are strongly advised<br />
to review this section on a regular basis. More information on USP publications <strong>and</strong> subscriptions is given in<br />
the ‘Publications <strong>and</strong> subscriptions’ section of this catalogue.<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 11
United States Pharmacopeia <strong>and</strong> National Formulary<br />
Shelf life <strong>and</strong> expiry dates<br />
USP <strong>reference</strong> st<strong>and</strong>ards are not labeled with an expiry date. The official lot number system provides greater<br />
flexibility than a simple expiry date system. USP <strong>reference</strong> st<strong>and</strong>ards stocks are regularly <strong>and</strong> rigorously<br />
checked. Under normal circumstances a new lot is made official <strong>and</strong> held for future use, before the old lot<br />
is sold out. The old lot remains official for a period of time so that in-house <strong>reference</strong> <strong>substances</strong> can be<br />
recertified against the out-going <strong>and</strong> incoming lots <strong>and</strong> also to prevent unnecessary waste.<br />
The official lot number index is printed six times a year in Pharmacopeial Forum (PF) so that the official<br />
status of all lots can be verified. The PF list shows the lot identification code for the current lot as well as any<br />
previous lot still official under the column headed “previous lot / date". Any lot shown in this column is official<br />
until the end of the month indicated in brackets. For example M0D211 (03/07) means lot M0D211 is official<br />
until 31 March 2007. No information or "NONE" in the column means that only the current lot may officially<br />
be used.<br />
It is the responsibility of each analyst to ensure that his particular supply of USP <strong>reference</strong> substance is<br />
current.<br />
Validation of secondary st<strong>and</strong>ards against USP <strong>reference</strong> <strong>substances</strong><br />
Our customers regularly share with us their experiences of FDA inspectors, <strong>and</strong> we would like to pass these<br />
on to all our customers:<br />
All secondary in-house working st<strong>and</strong>ards have to be validated against the CURRENT lot of the USP<br />
<strong>reference</strong> st<strong>and</strong>ard, so we advise you to check that you have current lot numbers.<br />
As your supplier of choice, LGC St<strong>and</strong>ards can provide lists of current lot numbers of USP <strong>reference</strong><br />
st<strong>and</strong>ards, so call us to receive these today. We can provide the same service for EP chemical <strong>reference</strong><br />
<strong>substances</strong>, which are listed in the EP chapter of this catalogue. Please take this opportunity to subscribe to<br />
this free service by contacting your local LGC St<strong>and</strong>ards office.<br />
Replacement lots <strong>and</strong> back orders<br />
Because of the rigorous nature of the approval process <strong>and</strong> the time taken, it is not always possible for USP<br />
to have a new lot available before an existing lot is depleted. USP provides LGC St<strong>and</strong>ards with regular<br />
information about the projected availability of back-ordered USP RS. Please contact LGC St<strong>and</strong>ards for any<br />
enquiry.<br />
Storage conditions<br />
The USP-NF states that “generally, <strong>reference</strong> st<strong>and</strong>ards should be stored in their original sealed containers<br />
away from heat <strong>and</strong> protected from light. Avoid humid storage areas in particular”. In addition, the USP-NF<br />
recommends in its General Notices, that “where no specific storage directions or limitations are provided in<br />
the individual monograph, it is to be understood that conditions of storage include protection from moisture,<br />
freezing <strong>and</strong> excessive heat”.<br />
Controlled Substances<br />
The USP list contains <strong>substances</strong> subject to Controlled Substance Regulations Schedules I, II, III, IV <strong>and</strong><br />
V. Special ordering procedures apply, please contact LGC St<strong>and</strong>ards for details <strong>and</strong> costs.<br />
Restricted Reference St<strong>and</strong>ards<br />
The United States Government restricts the export of chemicals appearing on the US Munition list, the<br />
Commerce Control list or in the Chemical Weapons Convention Annex on chemicals. Listed below are<br />
USP <strong>reference</strong> st<strong>and</strong>ards that are now currently restricted <strong>and</strong> may not be exported to any country outside<br />
the U.S.A.<br />
USP1106001 Chlorambucil<br />
USP1157002 Cyclophosphamide<br />
USP1376505 Mechlorethamine Hydrochloride<br />
USP1379300 Melphalan Hydrochloride<br />
USP1598008 3-Quinuclidinyl Benzilate<br />
USP1706009 Uracil Mustard<br />
Currently, LGC St<strong>and</strong>ards is in discussion with USP to get the small amounts, in which USP <strong>reference</strong><br />
st<strong>and</strong>ards are supplied, exempted from the above mentioned regulations.<br />
12 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
United States Pharmacopeia <strong>and</strong> National Formulary<br />
Code Product Unit<br />
USP1000601 Acebutolol HCl 125 mg<br />
New USP1000612<br />
Acebutolol Related Compound A<br />
N-(3-acetyl-4-hydroxyphenyl)butanamide (AS)<br />
USP1001003 Acenocoumarol 200 mg<br />
USP1001502 Acepromazine Maleate 250 mg<br />
USP1002505 Acesulfame Potassium 200 mg<br />
USP1003009 Acetaminophen 400 mg<br />
USP1004001 Acetanilide Melting Point St<strong>and</strong>ard (Approximately 114°C) 500 mg<br />
USP1005004 Acetazolamide 2 g<br />
USP1005706 Glacial Acetic Acid (AS) 3x1.5 mL<br />
USP1006007 Acetohexamide 250 mg<br />
USP1006506 Acetohydroxamic Acid 200 mg<br />
USP1006801 Acetone 3x1.5 mL<br />
USP1007000 Acetophenazine Maleate 200 mg<br />
USP1008501 Acetylcholine Chloride 200 mg<br />
USP1009005 Acetylcysteine 200 mg<br />
USP1009901 Acetyltributyl Citrate 500 mg<br />
USP1009923 Acetyltriethyl Citrate 500 mg<br />
USP1011007 Acitretin 200 mg<br />
USP1011018 Acitretin Related Compound A<br />
20 mg<br />
(2Z,4E,6E,8E)-9-(4-methoxy-2,3,6-trimethylphenyl)-3,7-dimethylnona-2,4,6,8-tetraenoic acid<br />
USP1011029<br />
Acitretin Related Compound B<br />
ethyl(all-E)-9-(4-methoxy-2,3,6-trimethylphenyl)-3,7-dimethylnona-2,4,6,8-tetraenoate<br />
USP1012065 Acyclovir 300 mg<br />
USP1012076<br />
Acyclovir Related Compound A<br />
2-[(2-amino-6-oxo-1,6-dihydro-9H-purin-9-yl)methoxy]ethyl acetate (AS)<br />
USP1012134 Ademetionine Disulfate Tosylate 500 mg<br />
USP1012101 Adenine 200 mg<br />
USP1012123 Adenosine 200 mg<br />
USP1012190 Adipic Acid 100 mg<br />
USP1012145 Agigenin 25 mg<br />
USP1012203 Agnuside 25 mg<br />
USP1012495 Beta Alanine 100 mg<br />
USP1012509 L-Alanine 200 mg<br />
USP1012553 Albendazole 200 mg<br />
USP1012600 Albuterol 200 mg<br />
USP1012633 Albuterol Sulfate 200 mg<br />
USP1012757 Alclometasone Dipropionate 300 mg<br />
USP1012768 Alcohol 5x1.2 mL<br />
USP1012772 Dehydrated Alcohol 5x1.2 mL<br />
USP1012699 Alcohol Determination-Acetonitrile 5x5 mL<br />
USP1012688 Alcohol Determination-Alcohol 5x5 mL<br />
USP1012780 Alendronate Sodium 200 mg<br />
USP1012906 Alfentanil HCl Controlled Substance CII 500 mg<br />
USP1012939 Allantoin 200 mg<br />
USP1012950 Alliin 25 mg<br />
USP1013002 Allopurinol 250 mg<br />
USP1013024<br />
New USP1013013<br />
New USP1013035<br />
Allopurinol Related Compound A<br />
3-Amino-4-carboxamidopyrazole Hemisulfate<br />
Allopurinol Related Compound B<br />
5-(formylamino)-1H-pyrazole-4-carboxamide<br />
Allopurinol Related Compound C<br />
5-(4H-1,2,4-triazol-4-yl)-1H-pyrazole-4-carboxamide<br />
20 mg<br />
20 mg<br />
50 mg<br />
50 mg<br />
25 mg<br />
25 mg<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 13
United States Pharmacopeia <strong>and</strong> National Formulary<br />
Code Product Unit<br />
New USP1013046<br />
New USP1013068<br />
New USP1013079<br />
Allopurinol Related Compound D<br />
ethyl 5-amino-1H-pyrazole-4-carboxylate<br />
Allopurinol Related Compound E<br />
ethyl 5-(formylamino)-1H-pyrazole-4-carboxylate<br />
Allopurinol Related Compound F<br />
ethyl-(E/Z)-5-(2-carbethoxy-2-cyanoethenyl)amino-1H-pyrazole-4-carboxylate<br />
USP1013057 S-Allyl-L-Cysteine 25 mg<br />
USP1014005 Alphaprodine HCl Controlled Substance CII 250 mg<br />
USP1015008 Alprazolam Controlled Substance CIV 200 mg<br />
USP1016000 Alprostadil 25 mg<br />
USP1017105 Altretamine 500 mg<br />
USP1017364 Aluminum Sulfate (AS) 2 g<br />
USP1017502 Dried Aluminum Hydroxide Gel 200 mg<br />
USP1018505 Amantadine HCl 200 mg<br />
USP1019202 Amcinonide 200 mg<br />
USP1019417 Amifostine Disulfide 25 mg<br />
USP1019508 Amikacin 300 mg<br />
USP1019701 Amiloride HCl 500 mg<br />
USP1019712<br />
Amiloride Related Compound A<br />
Methyl 3,5-diamino-6-chloropyrazine-2-carboxylate (AS)<br />
USP1019756 Aminobenzoate Potassium 200 mg<br />
USP1019767 Aminobenzoate Sodium 200 mg<br />
USP1019803<br />
Aminobenzoic Acid<br />
p-aminobenzoic acid<br />
35 mg<br />
25 mg<br />
25 mg<br />
30 mg<br />
200 mg<br />
USP1020008 Aminobutanol 500 mg<br />
USP1021000 Aminocaproic Acid 200 mg<br />
USP1021204 4-Aminophenol 100 mg<br />
USP1022808 2-Amino-5-chlorobenzophenone 25 mg<br />
USP1025205 Aminoglutethimide 200 mg<br />
USP1025307 m-Aminoglutethimide 100 mg<br />
USP1025351 Aminohippuric Acid 200 mg<br />
New USP1025602 Amino Methacrylate Copolymer 1.5 g<br />
USP1025806 2-[3-Amino-5-(n-methylacetamido)-2,4,6-triiodobenzamido]-2-deoxy-d-glucose 25 mg<br />
USP1025908 Aminopentamide Sulfate 200 mg<br />
USP1026004 m-Aminophenol 300 mg<br />
USP1026401 Aminosalicylic Acid 125 mg<br />
USP1026605 3-Amino-2,4,6-triiodobenzoic Acid 50 mg<br />
USP1027007 5-Amino-2,4,6-triiodo-N-methylisophthalamic Acid 50 mg<br />
USP1027302 Amiodarone HCl 200 mg<br />
USP1028000 Amitraz 200 mg<br />
USP1029002 Amitriptyline HCl 200 mg<br />
New USP1029013<br />
New USP1029024<br />
Amitriptyline Related Compound A<br />
Dibenzosuberone<br />
Amitriptyline Related Compound B<br />
5-[3-(dimethylamino)propyl]-10,11-dihydro-5H-dibenzo[a,d]-cyclohepten-5-ol<br />
USP1029501 Amlodipine Besylate 350 mg<br />
USP1029909 Ammonio Methacrylate Copolymer Type A 100 mg<br />
USP1029910 Ammonio Methacrylate Copolymer Type B 100 mg<br />
USP1029942 Ammonium Carbonate (AS) 2 g<br />
USP1029953 Ammonium Chloride 200 mg<br />
USP1029986 Ammonium Phosphate Dibasic (AS) 1 g<br />
USP1030001 Amobarbital Controlled Substance CII 200 mg<br />
USP1031004 Amodiaquine HCl 500 mg<br />
30 mg<br />
25 mg<br />
14 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
United States Pharmacopeia <strong>and</strong> National Formulary<br />
Code Product Unit<br />
USP1031401 Amoxapine 200 mg<br />
USP1031503 Amoxicillin 200 mg<br />
USP1032007 Amphotericin B 125 mg<br />
USP1033000 Ampicillin 200 mg<br />
USP1033203 Ampicillin Sodium 125 mg<br />
USP1033407 Ampicillin Trihydrate 200 mg<br />
USP1034002 Amprolium 200 mg<br />
USP1034308 Amrinone 500 mg<br />
USP1034320<br />
USP1034341<br />
USP1034363<br />
Amrinone Related Compound A<br />
5-carboxamide[3,4'-bipyridin]-6(1H)-one<br />
Amrinone Related Compound B<br />
N-(1,6-dihydro-6-oxo-(3,4'-bipyridine)-5-yl)-2-hydroxypropanamide<br />
Amrinone Related Compound C<br />
1,6-dihydro-6-oxo-(3,4'-bipyridine)-5-carbonitrile<br />
100 mg<br />
100 mg<br />
USP1034909 Anecortave Acetate 200 mg<br />
USP1034910<br />
Anecortave Acetate Related Compound A<br />
9(11)-dehydrocortisol<br />
USP1035005 Anethole (AS) 2 mL<br />
USP1036008 Anileridine HCl Controlled Substance CII 250 mg<br />
USP1036507 3-Anilino-2-(3,4,5-trimethoxybenzyl)acrylonitrile (AS) 25 mg<br />
USP1037011 Anisole 3x1.2 mL<br />
USP1038003 Antazoline Phosphate 200 mg<br />
USP1039006 Anthralin 200 mg<br />
USP1040005 Antipyrine 200 mg<br />
USP1040708 Apigenin-7-glucoside 30 mg<br />
USP1041008 Apomorphine HCl 250 mg<br />
USP1041609 Apraclonidine HCl 100 mg<br />
USP1042102 L-Arabinitol 500 mg<br />
USP1042500 L-Arginine 200 mg<br />
USP1042601 Arginine HCl 125 mg<br />
USP1042703 Arsanilic Acid 25 mg<br />
USP1043003 Ascorbic Acid (Vitamin C) 1 g<br />
USP1043105 Ascorbyl Palmitate (AS) 2 g<br />
USP1043502 Asparagine Anhydrous 200 mg<br />
USP1043513 Asparagine Monohydrate 200 mg<br />
USP1043706 Aspartame 200 mg<br />
USP1043728<br />
Aspartame Related Compound A<br />
5-Benzyl-3,6-dioxo-2-piperazineacetic Acid<br />
USP1043750 Aspartame Acesulfame 200 mg<br />
USP1043819 Aspartic Acid 100 mg<br />
USP1044006 Aspirin 500 mg<br />
USP1044301 Astemizole 200 mg<br />
USP1044403 Atenolol 200 mg<br />
USP1044651 Atovaquone 200 mg<br />
USP1044662<br />
Atovaquone Related Compound A<br />
cis-2-[4-(4-chlorophenyl)cyclohexyl]-3-hydroxy-1,4-naphthoquinone<br />
USP1044800 Atracurium Besylate 100 mg<br />
USP1045009 Atropine Sulfate 500 mg<br />
USP1045337 Avobenzone 500 mg<br />
USP1045508 Aurothioglucose 100 mg<br />
USP1045600<br />
Azaerythromycin A<br />
9-Deoxo-9a-aza-9a-homoerythromycin A<br />
50 mg<br />
20 mg<br />
25 mg<br />
25 mg<br />
100 mg<br />
USP1045756 Azaperone 200 mg<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 15
United States Pharmacopeia <strong>and</strong> National Formulary<br />
Code Product Unit<br />
USP1045803 Azatadine Maleate 200 mg<br />
USP1046001 Azathioprine 200 mg<br />
USP1046056 Azithromycin 100 mg<br />
New USP1046067 Azithromycin Identity 75 mg<br />
New USP1046090 Azithromycin N-Oxide 15 mg<br />
USP1046147 Azo-Aminoglutethimide 100 mg<br />
USP1046205 Aztreonam 200 mg<br />
USP1046307 Aztreonam E-Isomer 50 mg<br />
USP1046409 Open Ring Aztreonam 25 mg<br />
USP1047300 Bacampicillin HCl 200 mg<br />
USP1047503 Bacitracin (Susceptibility disk st<strong>and</strong>ard) 1 g<br />
USP1048007 Bacitracin Zinc 200 mg<br />
USP1048200 Baclofen 500 mg<br />
USP1048222<br />
Baclofen Related Compound A<br />
4-(4-Chlorophenyl)-2-pyrrolidinone<br />
USP1048506 Beclomethasone Dipropionate 200 mg<br />
New USP1048572 Bemotrizinol 200 mg<br />
USP1048619 Benazepril HCl 125 mg<br />
USP1048620<br />
USP1048630<br />
USP1048641<br />
USP1048652<br />
New USP1048663<br />
USP1048674<br />
USP1048685<br />
Benazapril Related Compound A<br />
(3R)-3-[[(1R)-1-(ethoxycarbonyl)-3-phenylpropyl]amino]-2,3,4,5-tetrahydro-2-oxo-1H-<br />
1-benazapine-1-acetic acid, monohydrochloride<br />
Benazepril Related Compound B<br />
(3S)-3-[[(1R)-1-(ethoxycarbonyl)-3-phenylpropyl]amino]-2,3,4,5-tetrahydro-2-oxo-1H-<br />
1-benazapine-1-acetic acid, monohydrochloride<br />
Benazepril Related Compound C<br />
(3S)-3-[[(1S)-1-(carboxy)-3-phenylpropyl]amino]-2,3,4,5-tetrahydro-2-oxo-1H-1-benazepine]-<br />
1-acetic acid<br />
Benazepril Related Compound D<br />
3-(1-Ethoxycarbonyl-3-cyclohexyl-(1S)-propyl)amino-2,3,4,5-tetrahydro-2-oxo-1H-1-(3S)-<br />
benzazepine-1-acetic acid monohydrochloride<br />
Benazapril Related Compound E<br />
3-amino-2,3,4,5-tetrahydro-2-oxo-1H-1-(3S)-benzazepine-1-acetic acid, monohydrochloride<br />
Benazepril Related Compound F<br />
3-Amino-2,3,4,5-tetrahydro-2-oxo-1H-1-(3S)-benzazepine-1-acetic acid, tert-butyl ester<br />
Benazepril Related Compound G<br />
3-(1-Ethoxycarbonyl-3-phenyl-(1S)-propyl)amino-2,3,4,5-tetrahydro-2-oxo-1H-1-(3S)-<br />
benzazepine-1-acetic acid, ethyl ester<br />
USP1049000 Bendroflumethiazide 200 mg<br />
USP1050009 Benoxinate HCl 200 mg<br />
New USP1050905 Benzaldehyde Controlled Substance 1 mL<br />
USP1051001 Benzalkonium Chloride 5 mL<br />
USP1051500 Benzethonium Chloride 500 mg<br />
USP1054000 Benzocaine 500 mg<br />
USP1055002 Benzoic Acid 300 mg<br />
USP1056005 Benzonatate 1 g<br />
USP1056504 1,4-Benzoquinone 200 mg<br />
USP1057507<br />
Benzothiadiazine Related Compound A<br />
4-Amino-6-chloro-1,3-benzenedisulfonamide<br />
50 mg<br />
15 mg<br />
15 mg<br />
50 mg<br />
15 mg<br />
25 mg<br />
15 mg<br />
15 mg<br />
100 mg<br />
USP1059003 Benzphetamine HCl Controlled Substance CIII (AS) 200 mg<br />
USP1061005 Benztropine Mesylate 200 mg<br />
USP1061901 Benzyl Alcohol 500 mg<br />
USP1062008 Benzyl Benzoate 5 g<br />
USP1064003 1-Benzyl-3-methyl-5-aminopyrazole HCl 25 mg<br />
USP1065006 Bephenium Hydroxynaphthoate 500 mg<br />
USP1065210 Berberine Chloride 50 mg<br />
16 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
United States Pharmacopeia <strong>and</strong> National Formulary<br />
Code Product Unit<br />
USP1065618 Betahistine HCl 200 mg<br />
USP1065709 Betaine HCl 200 mg<br />
USP1066009 Betamethasone 200 mg<br />
USP1067001 Betamethasone Acetate 500 mg<br />
USP1067307 Betamethasone Benzoate 200 mg<br />
USP1067704 Betamethasone Dipropionate 125 mg<br />
USP1068004 Betamethasone Sodium Phosphate 500 mg<br />
USP1069007 Betamethasone Valerate 200 mg<br />
USP1069018<br />
Betamethasone Valerate Related Compound A<br />
Betamethasone 21-valerate (AS)<br />
USP1069903 Betaxolol HCl 200 mg<br />
USP1070006 Betazole HCl 200 mg<br />
USP1071009 Bethanechol Chloride 200 mg<br />
USP1071202 Bicalutamide 200 mg<br />
USP1071213<br />
New USP1071224<br />
Bicalutamide Related Compound A<br />
N-[4-cyano-3-(trifluoromethyl)phenyl]-3-[(4-fluorophenyl)sulfinyl]-2-hydroxy-2-methylpropanamide<br />
Bicalutamide Related Compound B<br />
(RS)-N-[4-cyano-3-(trifluoromethyl)phenyl]-3-(3-fluorophenylsulfonyl)-2-hydroxy-<br />
2-methylpropanamide<br />
USP1071304 Bile Salts 10 g<br />
USP1071439 Positive Bioreaction 3 strips<br />
USP1071508 Biotin 200 mg<br />
USP1072001 Biperiden 200 mg<br />
USP1073004 Biperiden HCl 200 mg<br />
USP1074007 Bisacodyl 125 mg<br />
USP1074700 2,5-Bis-(D-arabino-1,2,3,4-tetrahydroxybutyl)pyrazine 25 mg<br />
USP1075203 Bis(2-ethylhexyl)maleate 2 mL<br />
USP1075509 p-Bis(di-n-propyl)carbamylbenzenesulfonamide 50 mg<br />
USP1075531 Bismuth Citrate 100 mg<br />
USP1075600 Bismuth Subcarbonate (AS) 1 g<br />
USP1075622 Bismuth Subgallate (AS) 2 g<br />
USP1075644 Bismuth Subnitrate (AS) 1.5 g<br />
USP1075553 Bismuth Subsalicylate 100 mg<br />
USP1075677 Bisoctrizole 200 mg<br />
USP1075688<br />
Bisoctrizole Related Compound A<br />
2-(2H-Benzotriazol-2-yl)-4-(1,1,3,3-tetramethylbutyl) phenol<br />
USP1075699 Bisoctrizole Resolution Mixture 50 mg<br />
USP1075757 Bisoprolol Fumarate 200 mg<br />
USP1076206 Powdered Black Cohosh Extract 1.5 g<br />
USP1076308 Bleomycin Sulfate 15 mg<br />
USP1076341 Boric Acid (AS) 1 g<br />
USP1076352 Bretylium Tosylate 200 mg<br />
USP1076363 Brinzolamide 200 mg<br />
USP1076374<br />
USP1076385<br />
Brinzolamide Related Compound A<br />
(S)-(-)-4-ethylamino-2,3-dihydro-2-(3-methoxypropyl)-4H-thieno-[3,2,e]-thiazine-<br />
6-sulfonamide-1,1-dioxide<br />
Brinzolamide Related Compound B<br />
(R)-4-amino-2,3-dihydro-2-(3-methoxypropyl)-4H-thieno-[3,2,e]-thiazine-6-sulfonamide-<br />
1,1-dioxide ethanedioate<br />
USP1076465 Bromazepam Controlled Substance CIV (AS) 100 mg<br />
USP1076501 Bromocriptine Mesylate 150 mg<br />
USP1077005 Bromodiphenhydramine HCl 200 mg<br />
USP1077708 8-Bromotheophylline 400 mg<br />
50 mg<br />
25 mg<br />
10 mg<br />
25 mg<br />
50 mg<br />
50 mg<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 17
United States Pharmacopeia <strong>and</strong> National Formulary<br />
Code Product Unit<br />
USP1078008 Brompheniramine Maleate 125 mg<br />
USP1078201 Budesonide 200 mg<br />
USP1078303 Bumetanide 250 mg<br />
USP1078325<br />
USP1078336<br />
Bumetanide Related Compound A<br />
3-Amino-4-phenoxy-5-sulfamoylbenzoic Acid<br />
Bumetanide Related Compound B<br />
3-Nitro-4-phenoxy-5-sulfamoylbenzoic Acid<br />
USP1078507 Bupivacaine HCl 1 g<br />
USP1078518<br />
USP1078529<br />
Bupivacaine Related Compound A<br />
6-(butylamino)-N-(2,6-dimethylphenyl)hexanamide (AS)<br />
Bupivacaine Related Compound B<br />
(2RS)-N-(2,6-dimethylphenyl)piperidine-2-carboxamide (AS)<br />
USP1078700 Buprenorphine HCl Controlled Substance CIII 50 mg<br />
USP1078711<br />
Buprenorphine Related Compound A<br />
21-[3-(1-propenyl)]7-alpha-[(S)-1-hydroxy-1,2,2-trimethylpropyl]-6,14-endo-ethano-<br />
6,7,8,14-tetrahydrooripavine Controlled Substance CII<br />
USP1078733 Bupropion HCl 200 mg<br />
USP1078744<br />
USP1078755<br />
USP1078766<br />
USP1078799<br />
Bupropion HCl Related Compound A<br />
2-(tert-butylamino)-4'-chloropropiophenone hydrochloride<br />
Bupropion HCl Related Compound B<br />
2-(tert-butylamino)-3'-bromopropiophenone hydrochloride<br />
Bupropion HCl Related Compound C<br />
1-(3-chlorophenyl)-2-hydroxy-1-propanone<br />
Bupropion HCl Related Compound F<br />
1-(3-chlorophenyl)-1-hydroxy-2-propanone<br />
USP1078802 Buspirone HCl 200 mg<br />
USP1079000 Butabarbital Controlled Substance CIII 200 mg<br />
USP1080000 Butacaine Sulfate 600 mg<br />
USP1081002 Butalbital Controlled Substance CIII 200 mg<br />
USP1081501 Butamben 200 mg<br />
USP1081807 1-Butanol 3x1.2 mL<br />
USP1081829 2-Butanol 3x1.2 mL<br />
USP1082300 Butoconazole Nitrate 200 mg<br />
USP1082504 Butorphanol Tartrate Controlled Substance CIV 500 mg<br />
USP1082606 Butyl Acetate 3x1.2 mL<br />
USP1082708 Butylated Hydroxytoluene (AS) 500 mg<br />
USP1082800 Monotertiary-butyl-p-benzoquinone (FCC) 100 mg<br />
USP1082901 Butyl 3-(butylamino)-4-phenoxy-5-sulfamoylbenzoate 25 mg<br />
USP1083008 2-tert-Butyl-4-hydroxyanisole 200 mg<br />
USP1083100 3-tert-Butyl-4-hydroxyanisole 200 mg<br />
New USP1083303 tert-Butylmethyl ether 3x1.2 mL<br />
USP1084000 Butylparaben 200 mg<br />
USP1085003 Caffeine 200 mg<br />
USP1086006 Caffeine Melting Point St<strong>and</strong>ard (Approximately 236°C) 1 g<br />
USP1086108 Calcifediol 75 mg<br />
USP1086301 Calcitriol 10 mg<br />
USP1086312 Calcitriol Solution 5 mL<br />
USP1086334 Calcium Acetate (AS) 1 g<br />
USP1086356 Calcium Ascorbate 200 mg<br />
USP1086403 Calcium Carbonate (AS) 1 g<br />
USP1086436 Calcium Chloride (AS) 1 g<br />
USP1086800 Calcium Gluceptate 200 mg<br />
USP1086855 Calcium Hydroxide (AS) 1 g<br />
USP1086888 Calcium Lactate 1 g<br />
10 mg<br />
25 mg<br />
50 mg<br />
50 mg<br />
50 mg<br />
15 mg<br />
15 mg<br />
40 mg<br />
30 mg<br />
18 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
United States Pharmacopeia <strong>and</strong> National Formulary<br />
Code Product Unit<br />
USP1086902 Calcium Lactobionate 200 mg<br />
USP1086935 Calcium Levulinate (AS) 1 g<br />
USP1087009 Calcium Pantothenate (Vitamin B 5) 200 mg<br />
USP1087031 Tribasic Calcium Phosphate (AS) 1 g<br />
USP1087202 Calcium Saccharate 200 mg<br />
USP1087359 Calcium Stearate (AS) 2 g<br />
USP1087406 Calcium Sulfate (AS) 1 g<br />
USP1087508 Camphor 1 g<br />
USP1087701 C<strong>and</strong>elilla Wax 250 mg<br />
USP1088001 C<strong>and</strong>icidin 200 mg<br />
New USP1090706 Capecitabine 200 mg<br />
New USP1090717<br />
New USP1090728<br />
New USP1090739<br />
Capecitabine Related Compound A<br />
5'-deoxy-5-fluorocytidine<br />
Capecitabine Related Compound B<br />
5'-deoxy-5-fluorouridine<br />
Capecitabine Related Compound C<br />
2',3'-O-carbonyl-5'-deoxy-5-fluoro-N4-(pentyloxycarbonyl) cytidine<br />
USP1091006 Capreomycin Sulfate 250 mg<br />
USP1091040 Caprylic Acid 300 mg<br />
USP1091505 Caprylocaproyl Polyoxylglycerides 200 mg<br />
USP1091108 Capsaicin 100 mg<br />
USP1091200 Captopril 200 mg<br />
USP1091221 Captopril Disulfide 100 mg<br />
USP1092009 Carbachol 200 mg<br />
USP1093001 Carbamazepine 100 mg<br />
New USP1093012<br />
New USP1093023<br />
Carbamazepine Related Compound A<br />
10,11-dihydrocarbamazepine<br />
Carbamazepine Related Compound B<br />
Iminostilbene<br />
USP1093205 Carbarsone 200 mg<br />
USP1093500 Carbenicillin Indanyl Sodium 300 mg<br />
USP1094004 Carbenicillin Monosodium Monohydrate 200 mg<br />
USP1095506 Carbidopa 400 mg<br />
USP1095517<br />
Carbidopa Related Compound A<br />
3-O-Methylcarbidopa<br />
USP1096000 Carbinoxamine Maleate 200 mg<br />
USP1096407 Carboplatin 100 mg<br />
USP1096509 Carboprost Tromethamine 25 mg<br />
USP1096531 Carboxymethylcellulose Calcium (AS) 1.5 g<br />
USP1096553 Carboxymethylcellulose Sodium 1.5 g<br />
USP1096600 Carisoprodol 1 g<br />
USP1096699 Carprofen (AS) 200 mg<br />
USP1096702<br />
Carprofen Related Compound A<br />
Carbazole<br />
USP1096757 Carteolol HCl 200 mg<br />
USP1096779 Casticin 25 mg<br />
USP1096804<br />
Cathinone HCl<br />
alpha-Aminopropiophenone HCl Controlled Substance CI<br />
USP1096906 Cefaclor 400 mg<br />
USP1096917 Cefaclor, Delta-3-Isomer 30 mg<br />
USP1097104 Cefadroxil 125 mg<br />
USP1097308 Cefam<strong>and</strong>ole Lithium 200 mg<br />
USP1097400 Cefam<strong>and</strong>ole Nafate 200 mg<br />
20 mg<br />
20 mg<br />
20 mg<br />
50 mg<br />
50 mg<br />
25 mg<br />
50 mg<br />
50 mg<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 19
United States Pharmacopeia <strong>and</strong> National Formulary<br />
Code Product Unit<br />
USP1097603 Cefazolin 400 mg<br />
USP1097636 Cefepime HCl 500 mg<br />
USP1097647 Cefepime HCl System Suitability 25 mg<br />
USP1097658 Cefixime 500 mg<br />
USP1097771 Cefmenoxime HCl 350 mg<br />
USP1097782 Cefmetazole 200 mg<br />
USP1097750 Cefonicid Sodium 1 g<br />
USP1097705 Cefoperazone Dihydrate 200 mg<br />
USP1097807 Ceforanide 200 mg<br />
USP1097909 Cefotaxime Sodium 250 mg<br />
USP1097975 Cefotetan 500 mg<br />
USP1098005 Cefotiam HCl 325 mg<br />
USP1098107 Cefoxitin 500 mg<br />
USP1098118 Cefpiramide 300 mg<br />
USP1098027 Cefpodoxime Proxetil 350 mg<br />
USP1098049 Cefprozil (E)-Isomer 50 mg<br />
USP1098050 Cefprozil (Z)-Isomer 200 mg<br />
USP1098129 Ceftazidime, Delta-3-Isomer 15 mg<br />
USP1098130 Ceftazidime Pentahydrate 300 mg<br />
USP1098173 Ceftizoxime 350 mg<br />
USP1098184 Ceftriaxone Sodium 350 mg<br />
USP1098195 Ceftriaxone Sodium E-Isomer 25 mg<br />
USP1098209 Cefuroxime Sodium 200 mg<br />
USP1098220 Cefuroxime Axetil 500 mg<br />
USP1098231 Cefuroxime Axetil Delta-3-Isomers 10 mg<br />
USP1098300 Cellulose Acetate 125 mg<br />
USP1098322 Cellaburate (Cellulose Acetate Butyrate) 350 mg<br />
USP1098355 Cellacefate (Cellulose Acetate Phthalate) 125 mg<br />
USP1098388 Microcystalline Cellulose (AS) 1 g<br />
USP1098402 Powdered Cellulose (AS) 1 g<br />
USP1098708 Cephaeline HBr 200 mg<br />
USP1099008 Cephalexin 400 mg<br />
USP1102000 Cephalothin Sodium 200 mg<br />
USP1102408 Cephapirin Benzathine 100 mg<br />
USP1102500 Cephapirin Sodium 500 mg<br />
USP1102805 Cephradine 200 mg<br />
New USP1102929 Cetirizine Hydrochloride 250 mg<br />
New USP1102930<br />
Cetirizine Related Compound A<br />
(RS)-2-[2-[4-[(4-chlorophenyl)phenylmethyl]piperazin-1-yl]ethoxy]acetic acid ethyl ester<br />
New USP1102974 Cetrimonium Bromide 1 g<br />
USP1103003 Cetyl Alcohol 100 mg<br />
USP1103105 Cetyl Palmitate 50 mg<br />
USP1104006 Cetylpyridinium Chloride 500 mg<br />
USP1105009 Powdered Chaste Tree Extract 1.5 g<br />
USP1107004 Chloramphenicol 200 mg<br />
USP1107300 Chloramphenicol Palmitate 200 mg<br />
USP1107401 Chloramphenicol Palmitate Nonpolymorph A 200 mg<br />
USP1107503 Chloramphenicol Palmitate Polymorph A 100 mg<br />
USP1109000 Chlordiazepoxide Controlled Substance CIV 200 mg<br />
USP1110009 Chlordiazepoxide HCl Controlled Substance CIV 200 mg<br />
20 mg<br />
20 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
United States Pharmacopeia <strong>and</strong> National Formulary<br />
Code Product Unit<br />
USP1110020<br />
Chlordiazepoxide Related Compound A<br />
7-Chloro-1,3-dihydro-5-phenyl-2H-1,4-benzodiazepin-2-one 4-Oxide<br />
USP1111001 Chlorhexidine 200 mg<br />
USP1111103 Chlorhexidine Acetate 500 mg<br />
USP1111307 Chlorhexidine Related Compounds 50 mg<br />
USP1112503 Chlorobutanol 200 mg<br />
USP1115545 Chlorogenic Acid 50 mg<br />
USP1115556 β-Chlorogenin 20 mg<br />
USP1117008 Chloroprocaine HCl 200 mg<br />
USP1118000 Chloroquine Phosphate 500 mg<br />
USP1121005 Chlorothiazide 200 mg<br />
USP1122700 Chloroxylenol 125 mg<br />
USP1122722<br />
Chloroxylenol Related Compound A<br />
2-chloro-3,5-dimethylphenol<br />
USP1123000 Chlorpheniramine Maleate 125 mg<br />
USP1123102<br />
Chlorpheniramine Maleate Extended-Release Tablets<br />
Drug Release Calibrator, Single Unit<br />
25 mg<br />
25 mg<br />
60 tablets<br />
USP1124003 Chlorphenoxamine HCl 200 mg<br />
USP1125006 Chlorpromazine HCl 200 mg<br />
USP1126009 Chlorpropamide 200 mg<br />
USP1129007 Chlortetracycline HCl 200 mg<br />
USP1130006 Chlorthalidone 200 mg<br />
USP1119309<br />
Chlorthalidone Related Compound A<br />
4'-Chloro-3'-sulfamoyl-2-benzophenone Carboxylic Acid<br />
USP1130505 Chlorzoxazone 500 mg<br />
USP1130527<br />
Chlorzoxazone Related Compound A<br />
2-Amino-4-chlorophenol<br />
USP1131009 Cholecalciferol (Vitamin D 3) 5x30 mg<br />
USP1131803 Delta-4,6-cholestadienol 30 mg<br />
USP1132001 Cholesteryl Caprylate 200 mg<br />
USP1133004 Cholestyramine Resin 500 mg<br />
USP1133503 Cholic Acid (AS) 2 g<br />
USP1133536 Choline Bitartrate 200 mg<br />
USP1133547 Choline Chloride 200 mg<br />
USP1133570 Chondroitin Sulfate Sodium 300 mg<br />
USP1133638 Chromium Picolinate 100 mg<br />
USP1134007 Chymotrypsin 300 mg<br />
USP1134018 Ciclopirox 50 mg<br />
USP1134029<br />
Ciclopirox Related Compound A<br />
3-Cyclohexyl-4,5-dihydro-5-methyl-5-isoxayzolyl acetic acid<br />
USP1134030 Ciclopirox Olamine 125 mg<br />
USP1134040<br />
Ciclopirox Related Compound B<br />
6-Cyclohexyl-4-methyl-2-pyrone<br />
USP1134051 Cilistatin Ammonium Salt 100 mg<br />
USP1134062 Cimetidine 200 mg<br />
USP1134073 Cimetidine HCl 200 mg<br />
USP1134109 Cinoxacin 200 mg<br />
New USP1134153 Cilostazol 200 mg<br />
New USP1134164<br />
New USP1134175<br />
Cilostazol Related Compound A<br />
6-hydroxy-3,4-dihydro-1H-quinolin-2-one<br />
Cilostazol Related Compound B<br />
6-[4-(1-Cyclohexyl-1H-tetrazol-5-yl)-butoxy]-1H-quinolin-2-one<br />
15 mg<br />
50 mg<br />
25 mg<br />
25 mg<br />
50 mg<br />
50 mg<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 21
United States Pharmacopeia <strong>and</strong> National Formulary<br />
Code Product Unit<br />
New USP1134186<br />
Cilostazol Related Compound C<br />
1-(4-(5-Cyclohexyl-1H-tetrazol-1-yl)butyl)-6-(4-(1-cyclohexyl-1H-tetrazol-5-yl)butoxy)-<br />
3,4-dihydroquinolin-2(1H)-one<br />
USP1134233 Citalopram HBr 200 mg<br />
New USP1134244<br />
USP1134255<br />
New USP1134266<br />
USP1134277<br />
USP1134288<br />
USP1134299<br />
New USP1134222<br />
Citalopram Related Compound A<br />
1-(3-(dimethyl)propyl)-1-(4'-fluorophenyl)-1,3-dihydroisobenzofuran-5-carboxamide<br />
Citalopram Related Compound B<br />
1-[3-(dimethylamino)propyl]-1-(4-fluorophenyl)-3-hydroxy-1,3-dihydroisobenzofuran-<br />
5-carbonitrile oxylate<br />
Citalopram Related Compound C<br />
3-[3-(dimethylamino)-1-propyl](4-fluorophenyl)-6-cyano-1(3H)-isobenzofuranone oxalate<br />
Citalopram Related Compound D<br />
1-(4'-fluorophenyl)-1-(3-(methylamino)propyl)-1,3-dihydroisobenzofuran-5-carbonitrile<br />
hydrochloride<br />
Citalopram Related Compound E<br />
1-(3-dimethylaminopropyl)-1-(4-fluorophenyl)-1,3-dihydroisobenzofuran-5-carbonitrile-Noxide<br />
hydrochloride<br />
Citalopram Related Compound F<br />
dimethyl-(1-methyl-3,3-diphenyl-allyl)-amine hydrochloride<br />
Citalopram Related Compound H<br />
1-(4'-fluorophenyl)-1-(3-dimethylaminopropyl)-5-bromophthalane hydrobromide<br />
50 mg<br />
25 mg<br />
25 mg<br />
25 mg<br />
15 mg<br />
25 mg<br />
200 mg<br />
USP1134313 Ciprofloxacin 200 mg<br />
USP1134324 Ciprofloxacin Ethylenediamine Analog 25 mg<br />
USP1134335 Ciprofloxacin HCl 400 mg<br />
USP1134346<br />
Ciprofloxacin Related Compound A<br />
7-Chloro-1-cyclopropyl-4-oxo-6-(piperazin-1-yl)-1,4-dihydroquinoline-3-carboxylic acid<br />
hydrochloride salt (AS)<br />
USP1134357 Cisplatin 100 mg<br />
USP1134368 Citric Acid 200 mg<br />
New USP1134200 Cladribine 200 mg<br />
USP1134211<br />
Cladribine Related Compound A<br />
2-methoxy-2'-deoxyadenosine<br />
USP1134379 Clarithromycin 75 mg<br />
USP1134380<br />
Clarithromycin Related Compound A<br />
6,11-di-O-methylerythromycin A<br />
USP1134390 Clarithromycin Identity 100 mg<br />
USP1134404 Clavam-2-carboxylate Potassium 4 µg<br />
USP1134426 Clavulanate Lithium 200 mg<br />
New USP1134459 Ciprofloxacin Formamide 125 mg<br />
USP1134506 Clemastine Fumarate 250 mg<br />
USP1135000 Clidinium Bromide 2 g<br />
USP1135021<br />
Clidinium Bromide Related Compound A<br />
3-Hydroxy-1-methylquinuclidinium Bromide<br />
25 mg<br />
25 mg<br />
20 mg<br />
50 mg<br />
250 mg<br />
USP1136002 Clindamycin HCl 200 mg<br />
USP1137005 Clindamycin Palmitate HCl 500 mg<br />
USP1138008 Clindamycin Phosphate 125 mg<br />
USP1138201 Clioquinol 500 mg<br />
USP1138405 Clobetasol Propionate 200 mg<br />
USP1138427<br />
Clobetasol Propionate Related Compound A<br />
9-alpha-fluoro-11-beta-hydroxy-16-beta-methyl-3-oxo-<strong>and</strong>rosta-1,4-diene-17(R)-spiro-2'-<br />
[4'-chloro-5'-ethylfuran-3'(2'H)-one]<br />
USP1138507 Clocortolone Pivalate 200 mg<br />
USP1138904 Clofazimine 200 mg<br />
USP1139000 Clofibrate 1 g<br />
USP1140000 Clomiphene Citrate 500 mg<br />
USP1140101<br />
Clomiphene Related Compound A<br />
(E,Z)-2-[4-(1,2-diphenylethenyl)phenoxy]-N,N-diethylethanamine hydrochloride<br />
50 mg<br />
100 mg<br />
22 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
United States Pharmacopeia <strong>and</strong> National Formulary<br />
Code Product Unit<br />
USP1140247 Clomipramine HCl 200 mg<br />
USP1140305 Clonazepam Controlled Substance CIV 200 mg<br />
USP1140327<br />
USP1140338<br />
USP1140349<br />
Clonazepam Related Compound A<br />
3-Amino-4-(2-chlorophenyl)-6-nitrocarbostyril<br />
Clonazepam Related Compound B<br />
2-Amino-2'-chloro-5-nitrobenzophenone<br />
Clonazepam Related Compound C<br />
2-Bromo-2'-(2-chlorobenzoyl)-4'-nitroacetanilide<br />
USP1140393 Clonidine 200 mg<br />
USP1140407 Clonidine HCl 200 mg<br />
USP1140418<br />
USP1140429<br />
Clonidine Related Compound A<br />
Acetylclonidine<br />
Clonidine Related Compound B<br />
2-[(E)-2,6-Dichlorophenylimino]-1-(1-{2-[(E)-2,6-dichlorophenylimino]-imidazolidin-1-yl}-<br />
ethyl)-imidazolidine<br />
USP1140430 Clopidogrel Bisulfate 125 mg<br />
USP1140586<br />
USP1140597<br />
USP1140600<br />
Clopidogrel Related Compound A<br />
(S)-(o-chlorophenyl)-6,7-dihydrothieno[3,2-c]pyridine-5-(4H)-<br />
acetic acid, hydrochloride<br />
Clopidogrel Related Compound B<br />
(Methyl(+/-)-(o-chlorophenyl)-4,5-dihydrothienol[2,3-c]pyridine-6(7H)-acetate, hydrochloride<br />
Clopidogrel Related Compound C<br />
methyl(-)-(R)-(o-chlorophenyl)-6,7-dihydrothieno[3,2-c]pyridine-5(4H)-acetate, hydrogen<br />
sulfate<br />
USP1140509 Clorazepate Dipotassium Controlled Substance CIV 125 mg<br />
USP1140702 Clorsulon 200 mg<br />
USP1141002 Clotrimazole 200 mg<br />
USP1141024<br />
Clotrimazole Related Compound A<br />
(o-chlorophenyl)diphenylmethanol<br />
USP1141909 Cloxacillin Benzathine 200 mg<br />
USP1142005 Cloxacillin Sodium 200 mg<br />
USP1142107 Clozapine 100 mg<br />
USP1143008 Cocaine HCl Controlled Substance CII 250 mg<br />
USP1143802 Codeine N-Oxide Controlled Substance CI 50 mg<br />
USP1144000 Codeine Phosphate Controlled Substance CII 100 mg<br />
USP1145003 Codeine Sulfate Controlled Substance CII 250 mg<br />
USP1145207 Cod Liver Oil 1 g<br />
USP1146006 Colchicine 300 mg<br />
USP1146505 Colestipol HCl 200 mg<br />
USP1147009 Colistimethate Sodium 200 mg<br />
USP1148001 Colistin Sulfate 200 mg<br />
USP1148500 Copovidone 100 mg<br />
USP1148806 Corn Oil (AS) 1 g<br />
USP1149004 Corticotropin 5 vials<br />
USP1150003 Cortisone Acetate 150 mg<br />
USP1150207 Cottonseed Oil (AS) 1 g<br />
USP1150353 Creatinine 100 mg<br />
USP1150502 Cromolyn Sodium 500 mg<br />
USP1150513<br />
Cromolyn Sodium Related Compound A<br />
1,3-Bis-(2-acetyl-3-hydroxyphenoxy)-2-propanol (AS)<br />
USP1150706 Crospovidone 200 mg<br />
USP1151006 Crotamiton 200 mg<br />
USP1151709 Cumene 3x1.2 mL<br />
USP1152009 Cyanocobalamin (Vitamin B 12) 1.5 g<br />
USP1152701 Cycl<strong>and</strong>elate 200 mg<br />
25 mg<br />
25 mg<br />
25 mg<br />
25 mg<br />
25 mg<br />
20 mg<br />
20 mg<br />
20 mg<br />
25 mg<br />
25 mg<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 23
United States Pharmacopeia <strong>and</strong> National Formulary<br />
Code Product Unit<br />
USP1154004 Cyclizine HCl 200 mg<br />
USP1154503 Cyclobenzaprine HCl 200 mg<br />
USP1154558 Alpha Cyclodextrin 50 mg<br />
USP1154569 Beta Cyclodextrin 250 mg<br />
New USP1154605 Cyclohexylmethanol 2x1mL<br />
USP1154707 Cyclomethicone 4 200 mg<br />
USP1154809 Cyclomethicone 5 200 mg<br />
USP1154900 Cyclomethicone 6 200 mg<br />
USP1156000 Cyclopentolate HCl 300 mg<br />
USP1157501 2-Cyclopropylmethylamino-5-chlorobenzophenone 50 mg<br />
USP1158005 Cycloserine 250 mg<br />
USP1158504 Cyclosporine 50 mg<br />
USP1158650 Cyclosporine Resolution Mixture 25 mg<br />
USP1159008 Cyclothiazide (AS) 200 mg<br />
USP1161000 Cyproheptadine HCl 500 mg<br />
New USP1161010<br />
Cyproheptadine Related Compound A<br />
5H-dibenzo[a,d]cycloheptene (AS)<br />
USP1161509 L-Cysteine HCl 200 mg<br />
USP1162002 Cytarabine 250 mg<br />
USP1162148 Cytosine 100 mg<br />
USP1162308 Dacarbazine 125 mg<br />
USP1162320<br />
USP1162330<br />
Dacarbazine Related Compound A<br />
5-aminoimidazole-4-carboxamide HCl<br />
Dacarbazine Related Compound B<br />
2-azahypoxanthine<br />
USP1162400 Dactinomycin 50 mg<br />
USP1162501 Danazol 200 mg<br />
New USP1163140 Dantrolene 200 mg<br />
New USP1163151 Dantrolene Sodium 100 mg<br />
New USP1163162<br />
New USP1163173<br />
New USP1163184<br />
Dantrolene Related Compound A<br />
5-(4-nitrophenyl)-2-furaldehyde azine<br />
Dantrolene Related Compound B<br />
5-(4-nitrophenyl)-2-furaldehyde-(2-carboxymethyl)semicarbazone<br />
Dantrolene Related Compound C<br />
(5-(4-nitrophenyl)-2-furancarboxyaldehyde<br />
USP1164008 Dapsone 125 mg<br />
USP1164700 Daunorubicin HCl 200 mg<br />
USP1165000 Decamethonium Bromide 250 mg<br />
USP1166003 Deferoxamine Mesylate 500 mg<br />
New USP1165408 Decoquinate 200 mg<br />
USP1166309 Dehydroacetic Acid 200 mg<br />
USP1166400 Dehydrocarteolol HCl 100 mg<br />
USP1166502 Dehydrocholic Acid 200 mg<br />
USP1169001 Demecarium Bromide 250 mg<br />
USP1170000 Demeclocycline HCl 200 mg<br />
USP1046089 N-Demethylazithromycin 15 mg<br />
USP1171003 Denatonium Benzoate 200 mg<br />
USP1171251 2-Deoxy-D-Glucose (AS) 100 mg<br />
USP1171706 Desacetyl Diltiazem HCl 50 mg<br />
USP1171900 Desflurane 0.5 mL<br />
USP1171910<br />
Desflurane Related Compound A<br />
bis-(1,2,2,2-tetrafluoroethyl) ether<br />
40 mg<br />
50 mg<br />
50 mg<br />
50 mg<br />
50 mg<br />
50 mg<br />
0.1 mL<br />
USP1172006 Desipramine HCl 125 mg<br />
24 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
United States Pharmacopeia <strong>and</strong> National Formulary<br />
Code Product Unit<br />
USP1173009 Deslanoside 100 mg<br />
USP1173235 Desogestrel 50 mg<br />
USP1173246<br />
USP1173257<br />
USP1173268<br />
Desogestrel Related Compound A<br />
13-Ethyl-11-methylene-18,19-dinor-5alpha, 17alpha-preg-3-en-20-yl-17-ol,<br />
desogestrel delta-3 isomer<br />
Desogestrel Related Compound B<br />
3-Hydroxy-desogestrel<br />
Desogestrel Related Compound C<br />
3-Keto-desogestrel<br />
USP1046078 Desosaminylazithromycin 15 mg<br />
USP1173508 Desoximetasone 200 mg<br />
USP1174001 Desoxycorticosterone Acetate 200 mg<br />
USP1175004 Desoxycorticosterone Pivalate 125 mg<br />
USP1176007 Dexamethasone 125 mg<br />
USP1176506 Dexamethasone Acetate 200 mg<br />
USP1177000 Dexamethasone Phosphate 200 mg<br />
USP1178002 Dexbrompheniramine Maleate 200 mg<br />
USP1179005 Dexchlorpheniramine Maleate 300 mg<br />
USP1179504 Dexpanthenol 500 mg<br />
USP1179628 Dextran 1 50 mg<br />
USP1179650 Dextran T-10 200 mg<br />
USP1179708 Dextran 40 50 mg<br />
USP1179720 Dextran 40 System Suitability 200 mg<br />
USP1179741 Dextran 70 50 mg<br />
USP1179763 Dextran 70 System Suitability 200 mg<br />
USP1179800 Dextran Vo Marker 100 mg<br />
USP1179854 Dextran 4 Calibration 100 mg<br />
USP1179865 Dextran 10 Calibration 100 mg<br />
USP1179876 Dextran 40 Calibration 100 mg<br />
USP1179887 Dextran 70 Calibration 100 mg<br />
USP1179898 Dextran 250 Calibration 100 mg<br />
USP1180004 Dextroamphetamine Sulfate Controlled Substance CII 500 mg<br />
USP1180503 Dextromethorphan 2 g<br />
USP1181007 Dextromethorphan HBr 500 mg<br />
USP1181302 Dextrose 500 mg<br />
USP1181506 Diacetylated Monoglycerides 200 mg<br />
USP1182000 Diacetylfluorescein 200 mg<br />
USP1183002 Diacetylmorphine HCl (Heroin HCl) (AS) Controlled Substance CI 25 mg<br />
USP1184005 Diatrizoic Acid 100 mg<br />
USP1184027<br />
Diatrizoic Acid Related Compound A<br />
5-Acetamido-3-amino-2,4,6-triiodobenzoic Acid<br />
USP1185008 Diazepam Controlled Substance CIV 100 mg<br />
USP1185020<br />
USP1023403<br />
Diazepam Related Compound A<br />
2-Methyl-amino-5-chlorobenzophenone<br />
Diazepam Related Compound B<br />
3-Amino-6-chloro-1-methyl-4-phenylcarbostyril<br />
USP1186000 Diazoxide 200 mg<br />
USP1187003 Dibucaine HCl 200 mg<br />
USP1187080 Dibutyl Phthalate 200 mg<br />
USP1187091 Dibutyl Sebacate (AS) 1 mL<br />
USP1187207 Dichloralphenazone Controlled Substance CIV 200 mg<br />
USP1187954 2,4-Dichlorophenol 100 mg<br />
USP1188006 Dichlorphenamide 200 mg<br />
15 mg<br />
15 mg<br />
25 mg<br />
50 mg<br />
25 mg<br />
25 mg<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 25
United States Pharmacopeia <strong>and</strong> National Formulary<br />
Code Product Unit<br />
USP1188301<br />
Dichlorvos<br />
2,2-dichlorovinyl dimethyl phosphate (AS)<br />
150 mg<br />
New USP1188709 Diclofenac Potassium 200 mg<br />
USP1188800 Diclofenac Sodium 200 mg<br />
USP1188811<br />
Diclofenac Related Compound A<br />
N-(2,6-dichlorophenyl)indolin-2-one<br />
USP1189009 Dicloxacillin Sodium 500 mg<br />
USP1190008 Dicumarol 200 mg<br />
New USP1190904 Dicyclohexyl 2x2 mL<br />
USP1191000 Dicyclomine HCl 125 mg<br />
New USP1191204 Didanosine 200 mg<br />
New USP1191215 Didanosine System Suitability Mixture 10 mg<br />
New USP1191226<br />
New USP1191237<br />
Didanosine Related Compound A<br />
Hypoxanthine<br />
Didanosine Related Compound B<br />
2',3'-dideoxyadenosine<br />
USP1192003 Dienestrol 125 mg<br />
USP1192808 Diethanolamine 3 mL<br />
USP1193006 Diethylcarbamazine Citrate 200 mg<br />
USP1193301 Diethylene Glycol Monoethyl Ether 0.5 mL<br />
USP1193505 Diethyl Phthalate 200 mg<br />
USP1194009 Diethylpropion HCl Controlled Substance CIV 200 mg<br />
USP1195001 Diethylstilbestrol 200 mg<br />
USP1197007 Diethyltoluamide 3 g<br />
USP1197302 Diflorasone Diacetate 200 mg<br />
USP1197506 Diflunisal 200 mg<br />
USP1198000 Digitalis 3 g<br />
USP1199002 Digitoxin 200 mg<br />
USP1200000 Digoxin 250 mg<br />
USP1200600 Dihydrocapsaicin 25 mg<br />
USP1200804 Dihydrocodeine Bitartrate Controlled Substance CII 200 mg<br />
USP1201002 17α-Dihydroequilin 50 mg<br />
USP1202005 Dihydroergotamine Mesylate 250 mg<br />
USP1203008 Dihydrostreptomycin Sulfate 200 mg<br />
USP1204000 Dihydrotachysterol 4x30 mg<br />
USP1204102 Dihydroxyacetone 250 mg<br />
USP1204805 Diloxanide Furoate 200 mg<br />
USP1205003 Diltiazem HCl 200 mg<br />
New USP1205014<br />
Diltiazem Related Compound A (AS)<br />
trans-diltiazem hydrochloride<br />
USP1206006 Dimenhydrinate 100 mg<br />
USP1208001 Dimethisoquin HCl 2 g<br />
USP1211006 Dimethyl Sulfoxide 3 g<br />
USP1213001 Dinoprost Tromethamine 50 mg<br />
USP1213103 Dinoprostone 50 mg<br />
USP1214004 Dioxybenzone 150 mg<br />
USP1217909 Diphenhydramine Citrate 125 mg<br />
USP1218005 Diphenhydramine HCl 200 mg<br />
USP1219008 Diphenoxylate HCl Controlled Substance CII 200 mg<br />
USP1220302 Dipivefrin HCl 200 mg<br />
USP1220506 Dipyridamole 200 mg<br />
USP1220700 Dirithromycin 200 mg<br />
25 mg<br />
25 mg<br />
25 mg<br />
25 mg<br />
26 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
United States Pharmacopeia <strong>and</strong> National Formulary<br />
Code Product Unit<br />
USP1221000 Disodium Guanylate (FCC) 300 mg<br />
USP1222002 Disodium Inosinate (FCC) 500 mg<br />
USP1222501 Disopyramide Phosphate 200 mg<br />
USP1223005 2,4-Disulfamyl-5-trifluoromethylaniline 125 mg<br />
USP1224008 Disulfiram 200 mg<br />
USP1224507 Dobutamine HCl 600 mg<br />
New USP1224664 Docosyl Ferulate 50 mg<br />
USP1224700 Docusate Calcium 500 mg<br />
USP1224802 Docusate Sodium 500 mg<br />
USP1224904 Docusate Potassium 100 mg<br />
USP1224959 Dolasetron Mesylate 200 mg<br />
USP1224960<br />
Dolasetron Mesylate Related Compound A<br />
Hexahydro-8-hydroxy-2,6-methano-2H-quinolizin-3(4H)-one HCl<br />
USP1225204 Dopamine HCl 200 mg<br />
USP1225281 Dorzolamide HCl 200 mg<br />
USP1225292<br />
Dorzolamide Hydrochloride Related Compound A<br />
(4R,6R)-4-(ethylamino)-5,6-dihydro-6-methyl-4H-thieno<br />
[2,3-b]thiopyran-2-sulfonamide 7,7-dioxide, monohydrochloride<br />
USP1225000 Doxapram HCl 200 mg<br />
USP1225419 Doxazosin Mesylate 200 mg<br />
USP1225500 Doxepin HCl 500 mg<br />
New USP1225511<br />
New USP1225522<br />
New USP1225533<br />
Doxepin Related Compound A<br />
dibenzo[b,e]oxepin-11(6H)-one<br />
Doxepin Related Compound B<br />
(11RS)-11-[3-(dimethylamino)propyl]-6,11-dihydrodibenzo[b,e]oxepin-11-ol<br />
Doxepin Related Compound C<br />
(E-3-(dibenzo[b,e]oxepin-11(6H)-ylidene)-N-methylpropan-1-amine HCl<br />
USP1225703 Doxorubicin HCl 50 mg<br />
USP1226003 Doxycycline Hyclate 200 mg<br />
USP1227006 Doxylamine Succinate 300 mg<br />
USP1229001 Droperidol 250 mg<br />
New USP1229409 Drospirenone 200 mg<br />
USP1230000 Dyclonine HCl 200 mg<br />
USP1231003 Dydrogesterone 200 mg<br />
USP1231502 Dyphylline 200 mg<br />
USP1231706 Powdered Echinacea Angustifolia Extract 1 g<br />
USP1231728 Powdered Echinacea Purpurea Extract 1 g<br />
USP1231808 Econazole Nitrate 200 mg<br />
USP1232006 Edetate Calcium Disodium 200 mg<br />
USP1233009 Edetate Disodium 200 mg<br />
USP1233508 Edetic Acid 200 mg<br />
USP1234001 Edrophonium Chloride 200 mg<br />
USP1234668 El<strong>eu</strong>theroside B (Syringin) 15 mg<br />
USP1234680 El<strong>eu</strong>theroside E (Syringaresinol diglucoside) 15 mg<br />
USP1234704 Powdered El<strong>eu</strong>thero Extract 1.5 g<br />
USP1234806 Emedastine Difumarate 100 mg<br />
USP1235004 Emetine HCl 300 mg<br />
USP1235274 Enalaprilat 300 mg<br />
USP1235300 Enalapril Maleate 200 mg<br />
USP1235503 Endotoxin unit<br />
USP1235809 Enflurane 1 mL<br />
USP1235900 Enrofloxacin (AS) 200 mg<br />
USP1236007 Ephedrine Sulfate Controlled Substance 200 mg<br />
25 mg<br />
20 mg<br />
50 mg<br />
50 mg<br />
25 mg<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 27
United States Pharmacopeia <strong>and</strong> National Formulary<br />
Code Product Unit<br />
USP1236506 4-Epianhydrotetracycline HCl 50 mg<br />
USP1236801 Epilactose 200 mg<br />
USP1237000 Epinephrine Bitartrate 200 mg<br />
USP1237509 Epitetracycline HCl (AS) 200 mg<br />
USP1238002 Equilin 25 mg<br />
USP1239005 Ergocalciferol (Vitamin D 2) 5x30 mg<br />
USP1239504 Ergoloid Mesylates 300 mg<br />
USP1240004 Ergonovine Maleate Controlled Substance 100 mg<br />
USP1241007 Ergosterol 50 mg<br />
USP1241506 Ergotamine Tartrate Controlled Substance 150 mg<br />
USP1241550 Ergotaminine 100 mg<br />
USP1241903 Erythritol 200 mg<br />
USP1242000 Erythromycin 250 mg<br />
USP1242010 Erythromycin B 100 mg<br />
USP1242021 Erythromycin C 50 mg<br />
USP1242032<br />
Erythromycin Related Compound N<br />
N-Demethylerythromycin A<br />
USP1243002 Erythromycin Estolate 200 mg<br />
USP1245008 Erythromycin Ethylsuccinate 200 mg<br />
USP1246000 Erytromycin Gluceptate 200 mg<br />
USP1247003 Erythromycin Lactobionate 200 mg<br />
USP1248006 Erythromycin Stearate 200 mg<br />
USP1249009 Erythrosine Sodium 100 mg<br />
USP1249202 Escin 350 mg<br />
New USP1249789 Esomeprazole Magnesium 10 mg<br />
USP1250008 Estradiol 500 mg<br />
USP1251000 Estradiol Benzoate (AS) 250 mg<br />
USP1252003 Estradiol Cypionate 200 mg<br />
USP1254009 Estradiol Valerate 100 mg<br />
USP1254508 Estriol 100 mg<br />
USP1255001 Estrone 200 mg<br />
USP1255500 Estropipate 500 mg<br />
USP1256004 Ethacrynic Acid 200 mg<br />
USP1257007 Ethambutol HCl 200 mg<br />
USP1258305 Ethchlorvynol Contolled Substance CIV 0.7 mL<br />
USP1260001 Ethinyl Estradiol 150 mg<br />
USP1260012<br />
Ethinyl Estradiol Related Compound A<br />
6-Keto-ethinyl estradiol<br />
USP1261004 Ethionamide 200 mg<br />
USP1262801 Ethopabate 125 mg<br />
USP1262823<br />
Ethopabate Related Compound A<br />
Methyl-4-acetamido-2-hydroxybenzoate<br />
USP1264002 Ethosuximide 500 mg<br />
USP1264501 Ethotoin 200 mg<br />
USP1265005 Ethoxzolamide 200 mg<br />
USP1265402 Ethyl Acetate 3x1.2 mL<br />
New USP1265457 Ethylbenzene 3x0.5 mL<br />
USP1265504 Ethylcellulose 1 g<br />
New USP1265606 Ethyl Formate 3x1.2 mL<br />
USP1266008 Ethyl Maltol (FCC) 1 g<br />
USP1266507 Ethylnorepinephrine HCl 200 mg<br />
USP1267000 Ethylparaben 200 mg<br />
50 mg<br />
20 mg<br />
25 mg<br />
28 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
United States Pharmacopeia <strong>and</strong> National Formulary<br />
Code Product Unit<br />
USP1267500 Ethyl Vanillin 200 mg<br />
USP1268003 Ethynodiol Diacetate 200 mg<br />
USP1268502 Etidronate Disodium 200 mg<br />
USP1268513<br />
Etidronate Disodium Related Compound A<br />
Sodium phosphite dibasic pentahydrate<br />
300 mg<br />
USP1268604 Etidronic Acid Monohydrate 1 g<br />
USP1268706 Etodolac 400 mg<br />
USP1268728<br />
Etodolac Related Compound A<br />
(+/-)-8-ethyl-1-methyl-1,3,4,9-tetrahydropyrano[3,4-b]-indole-1-acetic acid<br />
USP1268808 Etoposide 300 mg<br />
USP1268852 Etoposide Resolution Mixture 30 mg<br />
USP1268965 Eugenol (AS) 500 mg<br />
USP1269200 Famotidine 125 mg<br />
New USP1269221<br />
Famotidine Related Compound B<br />
3,5-bis[2-[[[2-[(diaminomethylene)amino]thiazol-4-yl]methyl]sulphany]ethyl]-4H-<br />
1,2,4,6-thiatriazine1,1-dioxide (AS)<br />
USP1269389 Felodipine 200 mg<br />
USP1269390<br />
Felodipine Related Compound A<br />
ethyl methyl 4-(2,3-dichlorophenyl)-2,6-dimethylpyridine-3,5-dicarboxylate<br />
USP1269403 Fenbendazole 100 mg<br />
USP1269414<br />
USP1269425<br />
Fenbendazole Related Compound A<br />
Methyl(1H-benzimidazole-2-yl)carbamate<br />
Fenbendazole Related Compound B<br />
Methyl[5(6)-chlorobenzimidazole-2-yl]carbamate<br />
USP1269447 Fenofibrate 200 mg<br />
USP1269458 Fenoldopam Mesylate 200 mg<br />
USP1269469<br />
USP1269470<br />
Fenoldopam Related Compound A<br />
N-Methyl-6-chloro-2,3,4,5-tetrahydro-1-(4-hydroxyphenyl)-1H-3-benzazepine-7,8-diol HCl<br />
Fenoldopam Related Compound B<br />
1H-3-Benzazapine-7,8-diol, 2,3,4,5-tetrahydro-1-(4-hydroxyphenyl)-, methanesulfonate<br />
USP1269505 Fenoprofen Calcium 500 mg<br />
USP1269550 Fenoprofen Sodium 500 mg<br />
USP1269607<br />
USP1269618<br />
USP1269629<br />
Fenofibrate Related Compound A<br />
(4-chlorophenyl)(4-hydroxyphenyl) methanone<br />
Fenofibrate Related Compound B<br />
2-(4-(4-chlorobenzoyl)phenoxy)-2-methylpropanoic acid<br />
Fenofibrate Related Compound C<br />
1-methylethyl 2-[[2-[4-(4-chlorobenzoyl)phenoxy]-2-methylpropanoyl]oxy]-<br />
2-methylpropanoate<br />
USP1270005 Fentanyl Citrate Controlled Substance CII 100 mg<br />
USP1270355 Ferrous Sulfate (AS) 1.5 g<br />
USP1270377 Fexofenadine HCl 200 mg<br />
USP1270388<br />
USP1270399<br />
USP1270446<br />
Fexofenadine Related Compound A<br />
4-[1-oxy-4-[4-(hydroxydiphenylmethyl)-1-piperidinyl]butyl]-alpha,alpha-dimethyl<br />
benzeneacetic acid<br />
Fexofenadine Related Compound B<br />
3-[1-hydroxy-4-[4-(hydroxydiphenylmethyl)-1-piperidinyl]butyl]-alpha,alpha-dimethyl<br />
benzeneacetic acid hydrochloride<br />
Fexofenadine Related Compound C<br />
(+)-4-[1-hydroxy-4-[4-(hydroxydiphenylmethyl)-1-piperidinyl]-butyl]-isopropylbenzene (AS)<br />
USP1270402 Finasteride 200 mg<br />
USP1270800 Flecainide Acetate 200 mg<br />
USP1270821<br />
Flecainide Related Compound A<br />
3-[2,5-bis(2,2,2-trifluoroethoxy) phenyl]-1,5,6,7,8,8a-hexahydroimidazo-[1,5a]pyridine HCl<br />
USP1271008 Floxuridine 250 mg<br />
USP1271700 Fluconazole 200 mg<br />
25 mg<br />
25 mg<br />
25 mg<br />
30 mg<br />
30 mg<br />
20 mg<br />
20 mg<br />
25 mg<br />
25 mg<br />
25 mg<br />
25 mg<br />
25 mg<br />
15 mg<br />
75 mg<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 29
United States Pharmacopeia <strong>and</strong> National Formulary<br />
Code Product Unit<br />
USP1271711<br />
USP1271722<br />
USP1271733<br />
Fluconazole Related Compound A<br />
2-[2-fluoro-4-(1H-1,2,4-triazol-1-yl)phenyl]-1,3-bis(1H-1,2,4-triazol-1-yl)-propan-2-ol<br />
Fluconazole Related Compound B<br />
2-(4-fluorophenyl)-1,3-bis(1H-1,2,4-triazol-1-yl)-propan-2-ol<br />
Fluconazole Related Compound C<br />
1,1'-(1,3-phenylene)di(1H-1,2,4-triazole)<br />
USP1272000 Flucytosine 200 mg<br />
USP1272204 Fludarabine Phosphate 300 mg<br />
USP1272907 Fludeoxyglucose 100 mg<br />
USP1272918<br />
Fludeoxyglucose Related Compound A<br />
4,7,13,16,21,24-hexaoxa-1,10-diazabicyclo[8.8.8.]hexacosane<br />
USP1273003 Fludrocortisone Acetate 250 mg<br />
USP1273808 Flumazenil 200 mg<br />
USP1273819<br />
USP1273820<br />
Flumazenil Related Compound A<br />
8-fluoro-5,6-dihydro-5-methyl-6-oxo-4H-imidazol-[1,5-alpha]<br />
[1,4]benzodiazepine-3-carboxylic acid<br />
Flumazenil Related Compound B<br />
Ethyl 8-hydroxy-5,6-dihydro-5-methyl-6-oxo-4H-imidazol-[1,5-alpha]<br />
[1,4]benzodiazepine-3-carboxylate<br />
USP1274006 Flumethasone Pivalate 200 mg<br />
USP1274505 Flunisolide 200 mg<br />
USP1274607 Flunixin Meglumine 300 mg<br />
USP1275009 Fluocinolone Acetonide 100 mg<br />
USP1276001 Fluocinonide 100 mg<br />
USP1277004 Fluorescein 200 mg<br />
USP1277252 Fluoride Dentifrice: Sodium Fluoride/Silica 4.5 oz<br />
USP1277274 Fluoride Dentifrice: Sodium Fluoride/Sodium Bicarbonate Powder 4 oz<br />
USP1277300 Fluoride Dentifrice: Sodium Monofluorophosphate - Calcium Carbonate 4.6 oz<br />
USP1277354 Fluoride Dentifrice: Sodium Monofluorophosphate/Dicalcium Phosphate 4.6 oz<br />
USP1277401 Fluoride Dentifrice: Sodium Monofluorophosphate (1000 ppm)/Silica 5.25 oz<br />
USP1277423 Fluoride Dentifrice: Sodium Monofluorophosphate (1500 ppm)/Silica 5.25 oz<br />
USP1277456 Fluoride Dentifrice: Stannous Fluoride-Silica 4 oz<br />
USP1278007 Fluorometholone 200 mg<br />
USP1278109 Fluorometholone Acetate 200 mg<br />
USP1278302 Fluoroquinolonic Acid 50 mg<br />
USP1279000 Fluorouracil 250 mg<br />
USP1279804 Fluoxetine HCl 200 mg<br />
USP1279815<br />
USP1279826<br />
USP1279837<br />
Fluoxetine Related Compound A<br />
N-methyl-3-phenyl-3-[(alpha,alpha,alpha-(trifluoro-m-tolyl)oxy]propylamine HCl<br />
Fluoxetine Related Compound B<br />
N-methyl-3-phenylpropylamine Controlled Substance<br />
Fluoxetine Related Compound C<br />
N-Methyl-N-[3-phenyl-3-(4-trifluoromethyl-phenoxy)-propyl] succinamic acid<br />
USP1280009 Fluoxymesterone Controlled Substance CIII 200 mg<br />
USP1280803 Fluphenazine Decanoate Dihydrochloride 500 mg<br />
USP1281001 Fluphenazine Enanthate Dihydrochloride 125 mg<br />
USP1282004 Fluphenazine HCl 125 mg<br />
USP1284000 Flur<strong>and</strong>renolide 100 mg<br />
USP1285002 Flurazepam HCL Controlled Substance CIV 200 mg<br />
USP1285308<br />
USP1285603<br />
Flurazepam Related Compound C<br />
5-chloro-2-(2-diethylaminoethyl(amino)-2'-fluorobenzophenone HCl<br />
Flurazepam Related Compound F<br />
7-chloro-5-(2-fluorophenyl)-1,3-dihydro-2H-1,4-benzodiazepine-2-one)<br />
USP1285750 Flurbiprofen 200 mg<br />
10 mg<br />
10 mg<br />
10 mg<br />
15 mg<br />
20 mg<br />
20 mg<br />
15 mg<br />
5 mL<br />
15 mg<br />
50 mg<br />
50 mg<br />
30 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
United States Pharmacopeia <strong>and</strong> National Formulary<br />
Code Product Unit<br />
USP1285760<br />
Flurbiprofen Related Compound A<br />
2-(4-Biphenylyl)propionic Acid<br />
100 mg<br />
USP1285807 Flurbiprofen Sodium 200 mg<br />
USP1285851 Flutamide 200 mg<br />
USP1285862 o-Flutamide 50 mg<br />
USP1285873 Fluticasone Propionate 100 mg<br />
New USP1285840 Fluticasone Propionate Related Compounds Mixture 25 mg<br />
USP1285884 Fluticasone Propionate Resolution Mixture 25 mg<br />
New USP1285910 Fluticasone Propionate Nasal Spray Resolution Mixture 25 mg<br />
USP1285895<br />
Fluticasone Propionate System Suitability Mixture<br />
Fluticasone Propionate <strong>and</strong> Fluticasone Propionate Related Compounds B, C <strong>and</strong> D<br />
USP1285931 Fluvastatin Sodium 350 mg<br />
USP1285942<br />
USP1285964<br />
Fluvastatin for System Suitability<br />
Fluvastatin sodium <strong>and</strong> fluvastatin sodium anti-isomer ([R*,R*-E](+/-)-7-[3-(4-fluorophenyl)-<br />
1-(methylethyl)-1H-indol-2-yl]-3,5-dihydroxy-6-heptenoic acid monosodium salt<br />
Fluvastatin Related Compound B<br />
[R*,S*-E](+/-)-7-[3-(4-fluorophenyl)-1-methylethyl-1H-indol-2-yl]-3,5-dihydroxy-6-heptenoic<br />
acid 1,1-dimethylethyl ester<br />
USP1285909 Fluvoxamine Maleate 200 mg<br />
USP1286005 Folic Acid (Vitamin M or Vitamin Bc) 500 mg<br />
USP1286027<br />
Folic Acid Related Compound A<br />
Calcium Formyltetrahydrofolate<br />
USP1286060 Formononetin 50 mg<br />
USP1286300 10-Formylfolic Acid 25 mg<br />
New USP1283404 Fosinopril Sodium 200 mg<br />
New USP1283415<br />
New USP1283426<br />
New USP1283437<br />
New USP1283448<br />
New USP1283459<br />
New USP1283460<br />
New USP1283470<br />
New USP1283481<br />
Fosinopril Related Compound A<br />
(4S)-4-cyclohexyl-[(4-phenylbutyl)phosphinyl]-acetyl-L-proline<br />
Fosinopril Related Compound B<br />
((4S)-4-Cyclohexyl-1-[(R)-[(S)-1-hydroxy-2-methylpropoxy](4-phenylbutyl)phosphinyl]acetyl-<br />
D-proline propionate (ester), hemibarium salt, sesquihydrate)<br />
Fosinopril Related Compound C<br />
(4S)-4-cyclohexyl-1-[(RS)-1-hydroxy-2-methylpropoxy](4-phenylbutyl)phosphinyl]-acetyl-Lproline<br />
propionate (ester),sodium salt<br />
Fosinopril Related Compound D<br />
(4R)-4-cyclohexyl-1-[(R)-[(S]-1-hydroxy-2-methylpropoxy](4-phenylbutyl)phosphinyl]acetyl-Lproline<br />
propionate (ester), sodium salt<br />
Fosinopril Related Compound E<br />
(4S)-4-phenyl-1-[(R)-[(S)-1-hydroxy-2-methyl-propoxy](4-phenylbutyl]phospinyl]acetyl-Lproline<br />
propionate (ester), sodium salt<br />
Fosinopril Related Compound F<br />
(4S)-4-cyclohexyl-1-[(R)-[(S)-1-hydroxypropoxy](4-phenylbutyl)phospinyl]acetyl-L-proline<br />
propionate (ester),sodium salt<br />
Fosinopril Related Compound G<br />
(4-phenylbutyl)phosphinyl acetic acid, disodium salt<br />
Fosinopril Related Compound H<br />
4-phenylbutyl phosphonic acid<br />
USP1286366 Fosphenytoin Sodium 250 mg<br />
USP1286504 Fructose 125 mg<br />
USP1286606 L-Fucose (AS) 200 mg<br />
USP1286708 Fumaric Acid 200 mg<br />
USP1286800 Furazolidone 200 mg<br />
USP1287008 Furosemide 125 mg<br />
USP1287020<br />
USP1287030<br />
Furosemide Related Compound A<br />
2-Chloro-4-N-furfurylamino-5-sulfamoylbenzoic Acid<br />
Furosemide Related Compound B<br />
4-Chloro-5-sulfamoylanthranilic Acid<br />
25 mg<br />
25 mg<br />
15 mg<br />
50 mg<br />
25 mg<br />
15 mg<br />
15 mg<br />
15 mg<br />
15 mg<br />
15 mg<br />
15 mg<br />
25 mg<br />
50 mg<br />
100 mg<br />
USP1287303 Gabapentin 250 mg<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 31
United States Pharmacopeia <strong>and</strong> National Formulary<br />
Code Product Unit<br />
USP1287325<br />
USP1287347<br />
USP1287358<br />
USP1287369<br />
Gabapentin Related Compound A<br />
3,3-pentamethylene-5-butyrolactam<br />
Gabapentin Related Compound B<br />
(1-cyanocyclohexyl)acetic acid<br />
Gabapentin Related Compound D<br />
(1-(3-oxo-2-aza-spiro[4,5]dec-2-ylmethyl)-cyclohexyl)acetic acid<br />
Gabapentin Related Compound E<br />
carboxymethyl-cyclohexanecarboxylic Acid<br />
USP1287507 Gadodiamide 500 mg<br />
USP1287518<br />
USP1287529<br />
Gadodiamide Related Compound A<br />
gadolinium sodium diethylenetriamine pentaacetic acid monomethylamide<br />
Gadodiamide Related Compound B<br />
gadolinium disodium diethylenetriamine pentaacetic Acid<br />
USP1287609 Gadopentetate Monomeglumine 500 mg<br />
USP1287631 Gadoteridol 500 mg<br />
USP1287642<br />
USP1287653<br />
USP1287664<br />
Gadoteridol Related Compound A<br />
10-(2-hydroxypropyl)-1,4,7,10-tetraazacyclodedodecane-1,4,7-triaacetic Acid<br />
Gadoteridol Related Compound B<br />
1,4,7,10-Tetraazacyclododecane-1,4,7-triacetic acid, monogadolinium salt<br />
Gadoteridol Related Compound C<br />
1,4,7,10-Tetraaza-11-oxo-bicylco[8.2.2]tetradecan-4,7-diacetic Acid<br />
USP1287675 Gadoversetamide 200 mg<br />
USP1287686<br />
Gadoversetamide Related Compound A<br />
Hydrogen[8,11,14-tris(carboxymethyl)-6-oxo-2-oxa-5,8,11,14-tetraazahexadecan-16-oato<br />
(4-)]gadolinium<br />
50 mg<br />
30 mg<br />
20 mg<br />
25 mg<br />
50 mg<br />
50 mg<br />
50 mg<br />
50 mg<br />
50 mg<br />
200 mg<br />
USP1287711 Galactitol 500 mg<br />
New USP1287722 Galactosamine HCl 300 mg<br />
USP1287700 Galactose 200 mg<br />
USP1288000 Gallamine Triethiodide 200 mg<br />
USP1288306 Ganciclovir 200 mg<br />
USP1288317<br />
Ganciclovir Related Compound A<br />
(RS)-2-Amino-9-(2,3-dihydroxy-propoxymethyl)-1,9-dihydropurin-6-one<br />
USP1288463 Gemcitabine Hydrochloride 200 mg<br />
USP1288500 Gemfibrozil 200 mg<br />
USP1288510<br />
Gemfibrozil Related Compound A<br />
2,2-dimethyl-5-[2,5-dimethyl-4-propene-1-yl)phenoxy]valeric acid<br />
USP1289003 Gentamicin Sulfate 200 mg<br />
USP1290002 Gentian Violet 650 mg<br />
USP1291005 Gibberellic Acid (FCC) 200 mg<br />
New USP1291446<br />
Ginger Constituent Mixture<br />
6-gingerol <strong>and</strong> 6-shogaol<br />
15 mg<br />
20 mg<br />
0.2 mg<br />
New USP1291548 Ginkgolic Acids 10 mg<br />
New USP1291559 Ginkgo Terpene Lactones 50 mg<br />
USP1291504 Powdered Ginger 500 mg<br />
New USP1291683 Powdered American Ginseng Extract 1.5 g<br />
USP1291708 Powdered Asian Ginseng Extract 1.5 g<br />
USP1292008 Gitoxin 50 mg<br />
USP1292303 Glimepiride 200 mg<br />
USP1292314<br />
USP1292325<br />
USP1292336<br />
USP1292347<br />
Glimepiride Related Compound A<br />
Glimepiride cis-isomer<br />
Glimepiride Related Compound B<br />
Glimepiride Sulfonamide<br />
Glimepiride Related Compound C<br />
Glimepiride urethane<br />
Glimepiride Related Compound D<br />
Glimepiride-3-isomer<br />
20 mg<br />
20 mg<br />
20 mg<br />
20 mg<br />
32 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
United States Pharmacopeia <strong>and</strong> National Formulary<br />
Code Product Unit<br />
USP1292507 Glipizide 125 mg<br />
USP1292609<br />
New USP1292610<br />
New USP1292631<br />
Glipizide Related Compound A<br />
N-{2-[(4-aminosulfonyl)phenyl]ethyl}-5-methyl-pyrazinecarboxamide<br />
Glipizide Related Compound B<br />
6-methyl-N-[2-(4-sulphamoylphenyl)ethyl]pyrazine-2-carboxamide<br />
Glipizide Related Compound C<br />
1-cyclohexyl-3-[[4-[2-[[(6-methylpyrazin-2-yl)carbonyl]amino]ethyl]phenyl]sulfonyl]urea<br />
USP1294207 Glucosamine HCl 200 mg<br />
USP1294976 Glutamic Acid 200 mg<br />
USP1294808 Glutamine 100 mg<br />
USP1294848 gamma-Glutamyl-S-allyl-L-cysteine 25 mg<br />
USP1295006 Glutethimide Controlled Substance CII 500 mg<br />
USP1295505 Glyburide 200 mg<br />
USP1295516<br />
USP1295527<br />
Glyburide Related Compound A<br />
5-chloro-2-methoxy-N-[2-(4-sulfamoylphenyl)ethyl]benzamide<br />
Glyburide Related Compound B<br />
methyl-[[4-[2-[5(-chloro-2-methoxybenzoyl)-amino]ethyl]phenyl]sulfonyl]carbamate (AS)<br />
USP1295607 Glycerin 2 mL<br />
USP1295709 Glyceryl Behenate 200 mg<br />
New USP1295724 Glyceryl Distearate 500 mg<br />
New USP1295731 Glyceryl Monolinoleate 500 mg<br />
New USP1295742 Glyceryl Monooleate 90% 250 mg<br />
USP1295800 Glycine 200 mg<br />
USP1296009 Glycopyrrolate 200 mg<br />
USP1295888 Glycyrrhizic Acid 25 mg<br />
New USP1296756 Gonadorelin Acetate 50 mg<br />
New USP1296767<br />
Gonadorelin Acetate Related Compound A<br />
Gonadorelin free acid trifluoroacetate salt<br />
USP1297001 Human Chorionic Gonadotropin - 5,760 USP units per package vial<br />
USP1298004 Gramicidin 200 mg<br />
USP1299007 Griseofulvin 200 mg<br />
USP1299200 Griseofulvin Permeability Diameter 2 g<br />
USP1300004 Guaiacol 1 g<br />
USP1301007 Guaifenesin 200 mg<br />
USP1301404 Guanabenz Acetate 200 mg<br />
USP1301608 Guanadrel Sulfate 200 mg<br />
USP1301801 Guanethidine Monosulfate 200 mg<br />
USP1302000 Guanethidine Sulfate 500 mg<br />
USP1302101 Guanfacine HCl 125 mg<br />
USP1302305 Halazepam Controlled Substance CIV 200 mg<br />
USP1302509 Halcinonide 200 mg<br />
USP1303002 Haloperidol 200 mg<br />
USP1303013<br />
Haloperidol Related Compound A<br />
4,4-Bis[(4-p-chlorophenyl)-4-hydroxy-piperidino]butyrophenone<br />
USP1303501 Halothane 1 mL<br />
USP1304005 Heparin Sodium 10x1 mL<br />
New USP1304209 Heptane 3x1.2 mL<br />
USP1305008 Hexachlorophene 500 mg<br />
USP1305303 Hexacosanol 100 mg<br />
USP1305507 2E,4E-Hexadienoic Acid Isobutylamide 25 mg<br />
USP1307003 Hexobarbital Controlled Substance CIII 500 mg<br />
USP1308006 Hexylcaine HCl 1 g<br />
USP1308200 Hexylene Glycol 125 mg<br />
25 mg<br />
15 mg<br />
15 mg<br />
25 mg<br />
25 mg<br />
10 mg<br />
15 mg<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 33
United States Pharmacopeia <strong>and</strong> National Formulary<br />
Code Product Unit<br />
USP1308307 Hexylresorcinol 200 mg<br />
USP1308505 L-Histidine 200 mg<br />
USP1309009 Histamine Dihydrochloride 250 mg<br />
USP1310008 Homatropine HBr 200 mg<br />
USP1311000 Homatropine Methylbromide 250 mg<br />
USP1311306 Homopolymer Polypropylene 3 strips<br />
USP1311408 Homosalate 500 mg<br />
USP1313006 Hydralazine HCl 200 mg<br />
USP1313210 Hydrastine 10 mg<br />
USP1314009 Hydrochlorothiazide 200 mg<br />
USP1315001 Hydrocodone Bitartrate Controlled Substance CII 100 mg<br />
USP1315012<br />
Hydrocodone Bitartrate Related Compound A<br />
Morphinan-6-one, 4-hydroxy-3-methoxy-17-methyl Controlled Substance CII<br />
USP1316004 Hydrocortisone 200 mg<br />
USP1317007 Hydrocortisone Acetate 200 mg<br />
USP1317302 Hydrocortisone Butyrate 200 mg<br />
USP1318000 Hydrocortisone Cypionate 200 mg<br />
USP1319002 Hydrocortisone Hemisuccinate 200 mg<br />
USP1320001 Hydrocortisone Phosphate Triethylamine 200 mg<br />
USP1321004 Hydrocortisone Valerate 200 mg<br />
USP1322007 Hydroflumethiazide 200 mg<br />
USP1323000 Hydromorphone HCl Controlled Substance CII 50 mg<br />
USP1324002 Hydroquinone 500 mg<br />
USP1325005 Hydroxyamphetamine HBr 200 mg<br />
USP1327000 Hydroxychloroquine Sulfate 200 mg<br />
USP1329006 Hydroxyprogesterone Caproate 200 mg<br />
USP1329709 Hydroxypropyl Betadex 200 mg<br />
USP1329800 Hydroxypropyl Cellulose 200 mg<br />
USP1332000 Hydroxyurea 200 mg<br />
USP1333003 Hydroxyzine HCl 500 mg<br />
USP1333058<br />
Hydroxyzine Related Compound A<br />
p-Chlorobenzhydrylpiperazine<br />
USP1334006 Hydroxyzine Pamoate 500 mg<br />
USP1335009 Hyoscyamine Sulfate 125 mg<br />
USP1335010<br />
Hyoscyamine Related Compound A<br />
Norhyoscyamine Sulfate<br />
USP1335202 Hyperoside 50 mg<br />
USP1330005 Hypromellose (Hydroxypropyl Methylcellulose) 250 mg<br />
USP1335279 Hypromellose Acetate Succinate 100 mg<br />
USP1335304 Hypromellose Phthalate 100 mg<br />
USP1335508 Ibuprofen 750 mg<br />
USP1335541<br />
Ibuprofen Related Compound C<br />
4-isobutylacetophenone<br />
70 mg<br />
25 mg<br />
10 mg<br />
3x0.2 mL<br />
USP1335701 Idarubicin HCl 50 mg<br />
USP1336001 Idoxuridine 250 mg<br />
USP1336205 Ifosfamide 500 mg<br />
USP1336500 Imidazole 200 mg<br />
USP1336806 Imidurea 200 mg<br />
USP1337004 Iminodibenzyl 25 mg<br />
USP1337809 Imipenem Monohydrate 100 mg<br />
USP1338007 Imipramine HCl 200 mg<br />
USP1338801 Indapamide 250 mg<br />
34 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
United States Pharmacopeia <strong>and</strong> National Formulary<br />
Code Product Unit<br />
USP1338812<br />
Indapamide Related Compound A<br />
4-Chloro-N-(2-methyl-indol-1-yl)-3-sulfamoylbenzamide (AS)<br />
USP1339000 Indigotindisulfonate Sodium 500 mg<br />
USP1339178 Indinavir 100 mg<br />
USP1339189 Indinavir System Suitability 100 mg<br />
USP1340009 Indocyanine Green 200 mg<br />
USP1341001 Indomethacin 200 mg<br />
USP1342004 Insulin 100 mg<br />
USP1342106 Insulin Human 100 mg<br />
USP1342208 Insulin (Beef) 100 mg<br />
USP1342300 Insulin (Pork) 100 mg<br />
USP1342321 Insulin Lispro 5.97 mg<br />
USP1343007 Iodipamide 200 mg<br />
USP1343517 Iodixanol 200 mg<br />
USP1343540<br />
USP1343550<br />
USP1343561<br />
Iodixanol Related Compound C<br />
5-Acetyl[3-[[3,5-bis[[2,3-dihydroxypropyl)<br />
amino]carbonyl]-2,4,6-triiodophenyl]amino]-2-hydroxypropyl]amino]-N,N'-bis-<br />
(2,3-dihydroxypropyl)-2,4,6-triiodo-1,3-benzenedicarboxamide<br />
Iodixanol Related Compound D<br />
5-[Acetyl(2-hydroxy-3-methylpropyl)amino]-N,N'-bis(2,3-dihydroxypropyl)<br />
2,4,6-triiodo-1,3-benzenedicarboxamide<br />
Iodixanol Related Compound E<br />
5-[[3-[[3-[[(2,3-Dihydoxypropyl)amino]carbonyl]-5-[[amino]carbonyl]-<br />
2,4,6-triiodophenyl](acetylimino)]-2-hydroxypropyl]-(acetylimino)]-N,N'-<br />
bis(2,3-dihydoxypropyl)-2,4,6-triiodo-1,3-benzenedicarboxamide<br />
USP1344305 o-Iodohippuric Acid 100 mg<br />
USP1344509 Iodoquinol 100 mg<br />
USP1344600 Iohexol 200 mg<br />
USP1344622<br />
USP1344644<br />
USP1344666<br />
Iohexol Related Compound A<br />
5-(acetylamino)-N,N'-bis(2,3-dihydroxypropyl)-2,4,6-triiodo-1,3-benzenedicarboxamide<br />
Iohexol Related Compound B<br />
5-amino-N,N'-bis(2,3-dihydroxypropyl)-2,4,6-triiodo-1,3-benzenedicarboxamide<br />
Iohexol Related Compound C<br />
N,N'-bis(2,3-dihydroxypropyl)-5-nitro-1,3-benzenedicarboxamide<br />
50 mg<br />
25 mg<br />
50 mg<br />
25 mg<br />
100 mg<br />
50 mg<br />
100 mg<br />
USP1344702 Iopamidol 200 mg<br />
USP1344724<br />
USP1344735<br />
Iopamidol Related Compound A<br />
N,N'Bis-(1,3-dihydroxy-2-propyl)5-amino-2,4,6-triiodoiso-phthalamide<br />
Iopamidol Related Compound B<br />
5-Glycolamido-N,N'-bis[2-hydroxy-1-(hydroxymethyl)ethyl]-2,4,6-triiodoisophthalamide<br />
50 mg<br />
100 mg<br />
USP1344804 Iopromide 400 mg<br />
USP1344826<br />
USP1344837<br />
Iopromide Related Compound A<br />
5-Amino-N,N'-bis(2,3-dihydroxypropyl)-2,4,6-triiodo-N-methyl-1,3-benzenedicarboxamide<br />
Iopromide Related Compound B<br />
5-(Acetylamino)-N,N'-bis(2,3-dihydroxypropyl)-2,4,6-triiodo-N-methyl-<br />
1,3-benzenedicarboxamide<br />
USP1345002 Iothalamic Acid 200 mg<br />
USP1345104 Ioversol 200 mg<br />
USP1345115<br />
USP1345126<br />
Ioversol Related Compound A<br />
5-Amino-N,N'-bis(2,3-dihydroxypropyl)-2,4,6-triiodoisophthalamide<br />
Ioversol Related Compound B<br />
N,N'-bis(2,3-dihydroxypropyl)-5-[(N-(2-hydroxyethyl)-carbonyl)methoxy]-<br />
2,4,6-triiodoisophthalamide<br />
USP1345159 Ioxaglic Acid 100 mg<br />
USP1345206 Ioxilan 400 mg<br />
USP1345228<br />
Ioxilan Related Compound A<br />
5-amino-2,4,6-triiodo-3 N-(2-hydroxyethyl)carbamoyl benzoic Acid<br />
50 mg<br />
50 mg<br />
50 mg<br />
50 mg<br />
100 mg<br />
USP1347008 Ipodate Sodium 200 mg<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 35
United States Pharmacopeia <strong>and</strong> National Formulary<br />
Code Product Unit<br />
New USP1347507 Ipratropium Bromide 100 mg<br />
New USP1347518<br />
New USP1347529<br />
New USP1347530<br />
Ipratropium Bromide Related Compound A<br />
endo-3-Hydroxy-8-isopropyl-8-methyl-8-azoniabicyclo[3.2.1]octane bromide<br />
Ipratropium Bromide Related Compound B<br />
(1R,3r,5S,8s)-3-[[(2RS)-3-hydroxy-2-phenylpropanoyl]oxy]-8-methyl-8-<br />
(1-methylethyl)-8-azoniabicyclo[3.2.1]octane, bromide<br />
Ipratropium Bromide Related Compound C<br />
(2-RS)-3-hydroxy-2-phenylpropanoic acid<br />
New USP1347700 Irbesartan 200 mg<br />
USP1347711<br />
Irbesartan Related Compound A<br />
1-pentanoylaminocyclopentanecarboxylic acid[2'-(1H-tetrazol-5-yl)-<br />
biphenyl-4-ylmethyl]-amide<br />
USP1347755 Isoamyl Methoxycinnamate 750 mg<br />
USP1347802 Isobutyl acetate 3x1.2 mL<br />
USP1348000 Isocarboxazid 200 mg<br />
USP1348500 Isoetharine HCl 250 mg<br />
USP1348907 Isoflupredone Acetate 200 mg<br />
USP1349003 Isoflurane 1 mL<br />
USP1349014<br />
USP1349025<br />
Isoflurane Related Compound A<br />
1-chloro-2,2,2-trifluoroethyl chlorodifluoromethyl ether<br />
Isoflurane Related Compound B<br />
2,2,2-Trifluoroethyldifluoromethyl ether<br />
10 mg<br />
10 mg<br />
15 mg<br />
25 mg<br />
0.1 mL<br />
0.1 mL<br />
USP1349502 L-Isol<strong>eu</strong>cine 200 mg<br />
USP1349604 Isomalathion 50 mg<br />
USP1349626 Isomalt 200 mg<br />
USP1349659 Isometheptene Mucate 200 mg<br />
USP1349706 Isoniazid 200 mg<br />
USP1350002 Isopropamide Iodide 200 mg<br />
USP1350104 Isopropyl Acetate 3x1.2 mL<br />
USP1350308 Isopropyl Alcohol (AS) 3x1.5 mL<br />
USP1350400 Isopropyl Myristate 500 mg<br />
USP1350603 Isopropyl Palmitate 500 mg<br />
USP1351005 Isoproterenol HCl 125 mg<br />
USP1352008 Isosorbide (75% solution) 1 g<br />
USP1353000 Diluted Isosorbide Dinitrate 500 mg<br />
New USP1353102 Diluted Isosorbide Mononitrate 350 mg<br />
New USP1353113<br />
Diluted Isosorbide Mononitrate Related Compound A<br />
1,4;3,6-dianhydro-D-glucitol 2-nitrate<br />
100 mg<br />
USP1353500 Isotretinoin 200 mg<br />
USP1354003 Isoxsuprine HCl 200 mg<br />
USP1354207 Isradipine 200 mg<br />
USP1354218<br />
Isradipine Related Compound A<br />
Isopropyl methyl 4-(4-benzofurazanyl)-2,6-dimethyl-3,5-pyridinecarboxylate<br />
USP1354309 Ivermectin 200 mg<br />
USP1355006 Kanamycin Sulfate 200 mg<br />
USP1355709 Powdered Kava Extract 1 g<br />
USP1355753 Kawain 200 mg<br />
USP1356009 Ketamine HCl Controlled Substance CIII 250 mg<br />
USP1356020<br />
Ketamine Related Compound A<br />
1-[(2-Chlorophenyl)(methylimino)methyl]cylcopentanol<br />
USP1356508 Ketoconazole 200 mg<br />
USP1356632 Ketoprofen 200 mg<br />
USP1356643<br />
Ketoprofen Related Compound A<br />
alpha-Methyl-3-(4-methylbenzoyl) benzeneacetic Acid (AS)<br />
25 mg<br />
50 mg<br />
25 mg<br />
36 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
United States Pharmacopeia <strong>and</strong> National Formulary<br />
Code Product Unit<br />
USP1356665 Ketorolac Tromethamine 200 mg<br />
USP1356654 Labetalol HCl 200 mg<br />
USP1356698 Lactase 200 mg<br />
USP1356734 Lactic Acid (AS) 3x1.5 mL<br />
USP1356676 Anhydrous Lactose 100 mg<br />
USP1356687 Lactitol 500 mg<br />
USP1356701 Lactose Monohydrate 500 mg<br />
USP1356803 Lactulose 1 g<br />
USP1356836 Lamivudine 200 mg<br />
USP1356847 Lamivudine Resolution Mixture A 10 mg<br />
USP1356858 Lamivudine Resolution Mixture B 10 mg<br />
USP1356880 Lanolin 20 g<br />
USP1356905 Lanolin Alcohols 5 g<br />
USP1356916 Lansoprazole 150 mg<br />
USP1356927<br />
Lansoprazole Related Compound A<br />
2-[[[3-methyl-4-(2,2,2-triflouroethoxy)-2-pyridyl]methyl]sulfonyl]benzimidazole<br />
USP1356950 Lauroyl Polyoxylglycerides 500 mg<br />
USP1356971 Letrozole 200 mg<br />
USP1356982<br />
Letrozole Related Compound A<br />
4,4'-(1H-1,3,4-triazol-1-ylmethylene)dibenzonitrile<br />
USP1357001 L-L<strong>eu</strong>cine 200 mg<br />
USP1358004 L<strong>eu</strong>covorin Calcium 500 mg<br />
USP1358503 L<strong>eu</strong>prolide Acetate 200 mg<br />
New USP1358784 Levalbuterol HCl 200 mg<br />
New USP1358795<br />
New USP1358809<br />
New USP1358810<br />
New USP1358820<br />
New USP1358831<br />
New USP1358842<br />
New USP1358853<br />
Levalbuterol Related Compound A<br />
4-(2-tert-butylamino-ethyl)-2-hydroxymethyl-phenol<br />
Levalbuterol Related Compound B<br />
alpha-[{(1,1-Dimethylethyl)amino}methyl[-4-hydroxy-3-methyl-benzenemethanol<br />
Levalbuterol Related Compound C<br />
alpha-[{(1,1-Dimethylethyl)amino}methyl]-4-hydroxy-3-(methoxymethyl)-benzenemethanol<br />
Levalbuterol Related Compound D<br />
5-[2-{(1,1-dimethylethyl)amino}-1-hydroxyethyl]-2-hydroxy-benzaldehyde benzenesulfonic<br />
acid salt<br />
Levalbuterol Related Compound E<br />
alpha-[{(1,1-Dimethylethyl)amino}methyl]-3-(ethoxy-methyl)-4-hydroxy-benzenemethanol<br />
Levalbuterol Related Compound F<br />
alpha-[{(1,1-Dimethylethyl)amino}methyl}-4-(phenylmethoxy)-1,3-benzenedimethanol<br />
Levalbuterol Related Compound G<br />
alpha[{(1,1-Dimethylethyl)amino}methyl]-4,5-dihydroxy-1,3-benzenedimethanol<br />
USP1359302 Levamisole HCl 125 mg<br />
USP1359506 Levmetamfetamine Controlled Substance CII 75 mg<br />
USP1359801 Levobunolol HCl 200 mg<br />
USP1359903 Levocarnitine 400 mg<br />
USP1359925<br />
Levocarnitine Related Compound A<br />
3-carboxy-N,N,N-trimethyl-2-propen-1-aminium chloride<br />
25 mg<br />
25 mg<br />
30 mg<br />
20 mg<br />
30 mg<br />
30 mg<br />
30 mg<br />
30 mg<br />
20 mg<br />
100 mg<br />
USP1361009 Levodopa 200 mg<br />
USP1361010<br />
USP1420006<br />
Levodopa Related Compound A<br />
3-(3,4,6-Trihydroxyphenyl)-alanine<br />
Levodopa Related Compound B<br />
3-Methoxytyrosine<br />
USP1362500 Levonordefrin 200 mg<br />
USP1363004 Levopropoxyphene Napsylate 300 mg<br />
USP1364007 Levorphanol Tartrate Controlled Substance CII 500 mg<br />
USP1365000 Levothyroxine 500 mg<br />
USP1366002 Lidocaine 250 mg<br />
50 mg<br />
50 mg<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 37
United States Pharmacopeia <strong>and</strong> National Formulary<br />
Code Product Unit<br />
USP1367005 Lincomycin HCl 200 mg<br />
USP1367504 Lindane 200 mg<br />
USP1367708 Linoleoyl Polyoxylglycerides 100 mg<br />
USP1368008 Liothyronine 250 mg<br />
USP1368609 Lisinopril 300 mg<br />
USP1369000 Lithium Carbonate 300 mg<br />
USP1370000 Loperamide HCl 200 mg<br />
USP1370203 Loracarbef 200 mg<br />
USP1370225 Loracarbef L-Isomer 25 mg<br />
USP1370270 Loratadine 200 mg<br />
USP1370280<br />
USP1370291<br />
Loratadine Related Compound A<br />
8-chloro-6,11-dihydro-11(4-piperidinylidene)-5H-benzo[5,6]cyclohepta [1,2-b]pyridine<br />
Loratadine Related Compound B<br />
8-chloro-6,11-dihydro-11(N-methyl-4-piperidinylidene)-5H-benzo[5,6]cyclohepta<br />
[1,2-b]pyridine<br />
USP1370305 Lorazepam Controlled Substance CIV 200 mg<br />
USP1370327<br />
USP1370338<br />
USP1370349<br />
USP1370350<br />
USP1370360<br />
Lorazepam Related Compound A<br />
7-Chloro-5-(o-chlorophenyl)-1,3-dihydro-3-acetoxy-2H-1,4-benzodiazepine-2-one<br />
Controlled Substance<br />
Lorazepam Related Compound B<br />
2-Amino-2',5-dichlorobenzophenone<br />
Lorazepam Related Compound C<br />
6-Chloro-4-(o-chlorophenyl)-2-quinazolinecarboxaldehyde<br />
Lorazepam Related Compound D<br />
6-Chloro-4-(o-chlorophenyl)-2-quinazolinecarboxylic Acid<br />
Lorazepam Related Compound E<br />
6-Chloro-4-(o-chlorophenyl)-2-quinazoline Methanol<br />
USP1370462 Losartan Potassium 250 mg<br />
USP1370600 Lovastatin 125 mg<br />
USP1370611<br />
Lovastatin Related Compound A<br />
Dihydro-lovastatin<br />
USP1370702 Loxapine Succinate 125 mg<br />
USP1370804 Lutein 1 mL<br />
USP1370906 Lynestrenol 20 mg<br />
USP1371002 Lysergic Acid Diethylamide Tartrate (AS) (LSD) Controlled Substance CI 10 mg<br />
USP1371501 L-Lysine Acetate 200 mg<br />
USP1372005 L-Lysine HCl 200 mg<br />
USP1373008 Mafenide Acetate 400 mg<br />
USP1286209<br />
Mafenide Related Compound A<br />
4-Formylbenzenesulfonamide<br />
USP1374000 Magaldrate 200 mg<br />
USP1374226 Magnesium Carbonate (AS) 2 g<br />
USP1374248 Magnesium Chloride (AS) 1 g<br />
USP1374260 Magnesium Hydroxide (AS) 1 g<br />
USP1374292 Magnesium Phosphate (AS) 2 g<br />
USP1374306 Magnesium Salicylate 200 mg<br />
USP1374340 Magnesium Stearate (AS) 5 g<br />
USP1374361 Magnesium Sulfate (AS) 1 g<br />
USP1374408 Malathion 500 mg<br />
USP1374500 Maleic Acid 300 mg<br />
USP1374601 Malic Acid 200 mg<br />
USP1374907 Maltitol 200 mg<br />
USP1375003 Maltol (FCC) 4 g<br />
USP1375025 Maltose Monohydrate 500 mg<br />
15 mg<br />
15 mg<br />
25 mg<br />
25 mg<br />
25 mg<br />
25 mg<br />
25 mg<br />
10 mg<br />
50 mg<br />
38 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
United States Pharmacopeia <strong>and</strong> National Formulary<br />
Code Product Unit<br />
USP1375058 M<strong>and</strong>elic Acid 500 mg<br />
USP1375069 Mangafodipir Trisodium 200 mg<br />
USP1375070<br />
USP1375080<br />
USP1375091<br />
Mangafodipir Related Comound A<br />
Manganese (II) dipyridoxyl monophosphate sodium salt<br />
Mangafodipir Related Comound B<br />
Manganese (II) dipyridoxyl diphosphate mono-overalkylated sodium salt<br />
Mangafodipir Related Comound C<br />
Manganese (III) dipyridoxyl diphosphate sodium salt<br />
USP1375127 Manganese Chloride (AS) 1 g<br />
USP1375149 Manganese Sulfate (AS) 1 g<br />
USP1375105 Mannitol 200 mg<br />
New USP1375182 Mannose 300 mg<br />
USP1375207 Maprotiline HCl 200 mg<br />
USP1375309 Mazindol Controlled Substance CIV 350 mg<br />
USP1375502 Mebendazole 200 mg<br />
USP1375706 Mebrofenin 100 mg<br />
USP1376006 Mecamylamine HCl 200 mg<br />
USP1376017<br />
Mecamylamine Related Compound A<br />
N,1,7,7-tetramethyl bicyclo[2.2.1]heptan-2-amine hydrochloride<br />
USP1377009 Meclizine HCl 500 mg<br />
USP1377508 Meclocycline Sulfosalicylate 300 mg<br />
USP1377803 Meclofenamate Sodium 500 mg<br />
USP1378001 Medroxyprogesterone Acetate 200 mg<br />
USP1378012<br />
Medroxyprogesterone Acetate Related Compound A<br />
4,5-beta-Dihydromedroxyprogesterone acetate<br />
USP1379004 Medrysone 500 mg<br />
USP1379605 Mefenamic Acid 200 mg<br />
USP1379059 Mefloquine Hydrochloride 100 mg<br />
USP1379060<br />
Mefloquine Related Compound A<br />
threo-mefloquine<br />
USP1379106 Megestrol Acetate 500 mg<br />
USP1379140 Meglumine (AS) 500 mg<br />
New USP1379183<br />
Melamine<br />
2,4,6-Triamino-1,3,5-triazine<br />
15 mg<br />
15 mg<br />
15 mg<br />
10 mg<br />
25 mg<br />
20 mg<br />
250 mg<br />
USP1380105 Melatonin (AS) 100 mg<br />
USP1379254 Melengestrol Acetate 125 mg<br />
USP1379265<br />
USP1379276<br />
Melengestrol Acetate Related Compound A<br />
17-hydroxy-16-methylenepregna-4-ene-3,20-dione 17-acetate<br />
Melengestrol Acetate Related Compound B<br />
6,16-dimethylene-17-hydroxypregna-4-ene-3,20-dione 17-acetate<br />
USP1379401 Meloxicam 400 mg<br />
USP1379412<br />
USP1379423<br />
USP1379434<br />
USP1379445<br />
Meloxicam Related Compound A<br />
4-Hydroxy-2-methyl-2H-1,2-benzothiazine-3-carboxylic acid ethyl ester 1,1-dioxide<br />
Meloxicam Related Compound B<br />
2-Amino-5-methyl-thiazole<br />
Meloxicam Related Compound C<br />
Isopropyl 4-hydroxy-2-methyl-2H-1,2-benzothiazine-3-carboxylate-1,1-dioxide<br />
Meloxicam Related Compound D<br />
4-Methoxy-2-methyl-(5-methyl-1,3-thiazol-2yl)-<br />
2H-1,2-benzothiazine-3-carboxamide-1,1-dioxide<br />
USP1381006 Menadione (Vitamin K 3) 200 mg<br />
USP1381709 Menthol 250 mg<br />
USP1381742 Menthyl Anthranilate 500 mg<br />
USP1382009 Mepenzolate Bromide 200 mg<br />
USP1383001 Meperidine HCl Controlled Substance CII 200 mg<br />
25 mg<br />
25 mg<br />
25 mg<br />
25 mg<br />
30 mg<br />
30 mg<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 39
United States Pharmacopeia <strong>and</strong> National Formulary<br />
Code Product Unit<br />
USP1385007 Mephenytoin 250 mg<br />
USP1386000 Mephobarbital Controlled Substance CIV 250 mg<br />
USP1387002 Mepivacaine HCl 200 mg<br />
USP1388005 Meprednisone 200 mg<br />
USP1389008 Meprobamate Controlled Substance CIV 200 mg<br />
USP1390007 Meprylcaine HCl 200 mg<br />
USP1391000 3-Mercapto-2-methylpropanoic Acid 1,2-Diphenylethylamine Salt 75 mg<br />
USP1392002 Mercaptopurine 500 mg<br />
USP1392454 Meropenem 300 mg<br />
USP1392705 Mesalamine 200 mg<br />
USP1393005 Mesoridazine Besylate 250 mg<br />
USP1394008 Mestranol 200 mg<br />
USP1395500 Metaproterenol Sulfate 200 mg<br />
USP1396003 Metaraminol Bitartrate 200 mg<br />
USP1396309 Metformin HCl 200 mg<br />
USP1396310<br />
USP1396331<br />
USP1396342<br />
Metformin Related Compound A<br />
1-Cyanoguanidine<br />
Metformin Related Compound B<br />
1-Methylbiguanide hydrochloride<br />
Metformin Related Compound C<br />
N,N-Dimethyl-[1,3,5]triazine-2,4,6-triamine<br />
USP1396364 Methacholine Chloride (AS) 500 mg<br />
USP1396400 Methacrylic Acid Copolymer Type A 200 mg<br />
USP1396502 Methacrylic Acid Copolymer Type B 200 mg<br />
USP1396604 Methacrylic Acid Copolymer Type C 200 mg<br />
USP1397006 Methacycline HCl 200 mg<br />
USP1398009 Methadone HCl Controlled Substance CII 200 mg<br />
USP1399001 Methamphetamine HCl Controlled Substance CII 125 mg<br />
USP1401001 Methantheline Bromide 200 mg<br />
USP1402004 Methapyrilene Fumarate 200 mg<br />
USP1404000 Methaqualone Controlled Substance CI 500 mg<br />
USP1405002 Metharbital Controlled Substance CIII 200 mg<br />
USP1406005 Methazolamide 500 mg<br />
USP1408000 Methdilazine HCl 200 mg<br />
USP1409003 Methenamine 500 mg<br />
USP1409502 Methenamine Hippurate 200 mg<br />
USP1409604 Methenamine M<strong>and</strong>elate 200 mg<br />
USP1410002 Methicillin Sodium (AS) 500 mg<br />
USP1411005 Methimazole 200 mg<br />
USP1411504 L-Methionine 200 mg<br />
USP1412008 Methocarbamol 200 mg<br />
USP1413000 Methohexital Controlled Substance CIV 500 mg<br />
USP1414003 Methotrexate 500 mg<br />
USP1415006 Methotrimeprazine 125 mg<br />
USP1416009 Methoxamine HCl 200 mg<br />
USP1417001 Methoxsalen 500 mg<br />
USP1418004 Methoxyflurane 1 mL<br />
USP1419007 Methoxyphenamine HCl 250 mg<br />
USP1421009 Methscopolamine Bromide 200 mg<br />
USP1422001 Methsuximide 500 mg<br />
USP1424007 Methyclothiazide 200 mg<br />
50 mg<br />
25 mg<br />
25 mg<br />
40 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
United States Pharmacopeia <strong>and</strong> National Formulary<br />
Code Product Unit<br />
USP1424018<br />
Methyclothiazide Related Compound A<br />
4-amino-6-chloro-N-3-methyl-m-benzenedisulfonamide<br />
100 mg<br />
USP1424051 Methyl Acetate 3x1.2 mL<br />
USP1424109 Methyl Alcohol 3x1.5 mL<br />
USP1424153 3-Methyl-1-butanol 3x1.2 mL<br />
USP1424211 Methylbenzethonium Chloride 500 mg<br />
USP1424222 Methyl Benzylidene Camphor 200 mg<br />
USP1424233 Methyl Caprate 300 mg<br />
USP1424244 Methyl Caproate 300 mg<br />
USP1424255 Methyl Caprylate 300 mg<br />
USP1424506 Methylcellulose (AS) 1 g<br />
USP1425000 4-Methyl-2,5-dimethoxyamphetamine HCl (STP) (AS) Controlled Substance CI 25 mg<br />
USP1426002 Methyldopa 500 mg<br />
USP1427005 Methyldopate HCl 200 mg<br />
USP1428008 Methylene Blue 250 mg<br />
USP1429000 Methylenedioxy-3,4-amphetamine HCl (MDA) (AS) Controlled Substance CI 25 mg<br />
USP1430000 Methylergonovine Maleate 50 mg<br />
New USP1430101 Methyl Ethyl Ketone 3x1.2 mL<br />
New USP1430203 Methyl Isobutyl Ketone 3x1.2 mL<br />
USP1430305 Methyl Laurate 500 mg<br />
USP1430327 Methyl Linoleate 5x50 mg<br />
USP1430349 Methyl Linolenate 5x50 mg<br />
USP1430509 3-O-Methylmethyldopa 50 mg<br />
USP1431002 Methyl 5-methyl-3-isoxazolecarboxylate 25 mg<br />
USP1431501 Methyl Myristate 300 mg<br />
USP1431556 Methyl Oleate 500 mg<br />
USP1431603 Methyl Palmitate 300 mg<br />
USP1431625 Methyl Palmitoleate 300 mg<br />
USP1432005 Methylparaben 125 mg<br />
USP1433008 Methylphenidate HCl Controlled Substance CII 125 mg<br />
USP1434011 Methylphenidate HCl Erythro Isomer Solution Controlled Substance CII 0.5 mL<br />
USP1434022<br />
Methylphenidate Related Compound A<br />
alpha-Phenyl-2-piperidineacetic Acid HCl<br />
USP1435003 Methylprednisolone 200 mg<br />
USP1436006 Methylprednisolone Acetate 200 mg<br />
USP1437009 Methylprednisolone Hemisuccinate 200 mg<br />
USP1437053 2-Methyl-1-propanol 3x1.2 mL<br />
USP1437450 Methyl Salicylate (AS) 2 mL<br />
USP1437508 Methyl Stearate 300 mg<br />
New USP1437600 Methylsulfonylmethane 200 mg<br />
USP1438001 Methyltestosterone Controlled Substance CIII 200 mg<br />
USP1440003 Methysergide Maleate 350 mg<br />
USP1440808 Metoclopramide HCl 500 mg<br />
USP1441200 Metolazone 200 mg<br />
USP1441232<br />
USP1441243<br />
USP1441254<br />
USP1441265<br />
Metoprolol Related Compound A<br />
(+/-)1-(ethylamino)-3-[4-(2-methoxyethyl)phenoxy]-propan-2-ol<br />
Metoprolol Related Compound B<br />
(+/-)1-Chloro-2-hydroxy-3-[4-(2-methoxyethyl)phenoxy]propane<br />
Metoprolol Related Compound C<br />
(+/-)4-[2-Hydroxy-3-(1-methylethyl)aminopropoxy]benzaldehyde<br />
Metoprolol Related Compound D<br />
(+/-)N,N-bis-[2-hydroxy-3-[4-(2-methoxyethyl)phenoxy]propyl]<br />
(1-methylethyl)amine hydrochloride<br />
50 mg<br />
20 mg<br />
50 mg<br />
20 mg<br />
50 mg<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 41
United States Pharmacopeia <strong>and</strong> National Formulary<br />
Code Product Unit<br />
USP1441287 Metoprolol Fumarate 200 mg<br />
USP1441298 Metoprolol Succinate 200 mg<br />
USP1441301 Metoprolol Tartrate 200 mg<br />
USP1441505 Metrizamide 500 mg<br />
USP1442009 Metronidazole 100 mg<br />
New USP1442100 Metronidazole Benzoate 100 mg<br />
USP1443001 Metyrapone 200 mg<br />
USP1443205 Metyrosine 200 mg<br />
USP1443250 Mexiletine HCl 200 mg<br />
USP1443307 Mezlocillin Sodium 350 mg<br />
USP1443409 Miconazole 200 mg<br />
USP1443500 Miconazole Nitrate 200 mg<br />
USP1443850 Powdered Milk Thistle Extract 250 mg<br />
USP1443908 Milrinone 500 mg<br />
USP1443919<br />
Milrinone Related Compound A<br />
1,6-Dihydro-2-methyl-6-oxo(3,4'-bipyridine)-5-carboxamide<br />
USP1444004 Minocycline HCl 200 mg<br />
USP1444208 Minoxidil 125 mg<br />
USP1444279 Mirtazapine 350 mg<br />
USP1444707 Mitomycin 50 mg<br />
USP1445007 Mitotane 500 mg<br />
USP1445200 Mitoxantrone HCl 400 mg<br />
USP1445211 Mitoxantrone System Suitability Mixture 0.3 mg<br />
USP1445404 Modafinil Controlled Substance CIV 200 mg<br />
New USP1445346<br />
New USP1445368<br />
New USP1445379<br />
New USP1445380<br />
Modafinil Related Compound A<br />
2-[(diphenylmethyl)sulfinyl]acetic acid<br />
Modafinil Related Compound C<br />
2-[(diphenylmethyl)sulfenyl]acetamide<br />
Modafinil Related Compound D<br />
Bis (diphenylmethyl)ether<br />
Modafinil Related Compound E<br />
Bis(diphenylmethyl)disulfide<br />
50 mg<br />
500 mg<br />
500 mg<br />
USP1445459 Molindone HCl 500 mg<br />
USP1445470 Mometasone Furoate 200 mg<br />
USP1445481 Monensin Sodium 200 mg<br />
USP1445506 Monobenzone 200 mg<br />
USP1445925 Monoethanolamine 1 mL<br />
USP1446000 Monoglycerides 125 mg<br />
USP1446600 Monosodium Glutamate (AS) 1 g<br />
USP1446804 Monostearyl Maleate 100 mg<br />
USP1446906 Morantel Tartrate 100 mg<br />
USP1446950 Moricizine HCl 250 mg<br />
USP1447002 Morphine Monohydrate (AS) Controlled Substance CII 50 mg<br />
USP1448005 Morphine Sulfate Controlled Substance CII 500 mg<br />
USP1448901 Mupirocin 50 mg<br />
USP1448912 Mupirocin Calcium 200 mg<br />
USP1448923 Mupirocin Lithium 100 mg<br />
USP1448990 Myristic Acid 200 mg<br />
USP1449008 Myristyl Alcohol 1 g<br />
USP1449518 Nabumetone 200 mg<br />
USP1449530<br />
Nabumetone Related Compound A<br />
1-(6-methoxy-2-naphthyl)-but-1-en-3-one<br />
USP1449700 Nadolol 200 mg<br />
20 mg<br />
20 mg<br />
15 mg<br />
42 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
United States Pharmacopeia <strong>and</strong> National Formulary<br />
Code Product Unit<br />
USP1450007 Nafcillin Sodium 200 mg<br />
USP1450404 Naftifine HCl 200 mg<br />
USP1451000 Nalidixic Acid 200 mg<br />
USP1452002 Nalorphine HCl Controlled Substance CIII 250 mg<br />
USP1453005 Naloxone 125 mg<br />
USP1453504 Naltrexone 200 mg<br />
USP1453526<br />
Naltrexone Related Compound A<br />
N-(3-butenyl)-noroxymorphone HCl Controlled Substance CII<br />
USP1454008 N<strong>and</strong>rolone Controlled Substance CIII 50 mg<br />
USP1455000 N<strong>and</strong>rolone Decanoate Controlled Substance CIII 250 mg<br />
USP1456003 N<strong>and</strong>rolone Phenpropionate Controlled Substance CIII 250 mg<br />
USP1457006 Naphazoline HCl 200 mg<br />
USP1457301 Naproxen 200 mg<br />
USP1457403 Naproxen Sodium 200 mg<br />
USP1457469 Naratriptan HCl 125 mg<br />
USP1457491 Naratriptan Resolution Mixture 20 mg<br />
USP1457505 Natamycin 200 mg<br />
New USP1457844 Near IR System Suitability unit<br />
USP1457902 Nefazodone HCl 200 mg<br />
USP1457913<br />
USP1457924<br />
Nefazodone Related Compound A<br />
1-(3-chlorophenyl)-4-(3-chloropropyl)-piperazine hydrochloride<br />
Nefazodone Related Compound B<br />
2-[3-[4-(4-chlorophenyl)-1-piperazinyl]propyl]-5-ethyl-2,4-dihydro-4-(2-phenoxyethyl)-3H-<br />
1,2,4-triazol-3-one hydrochloride<br />
USP1458009 Neomycin Sulfate 200 mg<br />
USP1459001 Neostigmine Bromide 200 mg<br />
USP1460000 Neostigmine Methylsulfate 200 mg<br />
USP1460204 Neotame 200 mg<br />
USP1460215<br />
Neotame Related Compound A<br />
N-[N-(3-3-dimethylbutyl)-L-alpha-aspartyl]-L-phenylalanine<br />
USP1460500 Netilmicin Sulfate 500 mg<br />
USP1460703 Nevirapine Anhydrous 100 mg<br />
USP1460714 Nevirapine Hemihydrate 100 mg<br />
USP1460725<br />
USP1460736<br />
Nevirapine Related Compound A<br />
5,11-Dihydro-6H-11-ethyl-4-methyl-dipyrido[3,2-b2',3'-e][1,4]diazepin-6-one<br />
Nevirapine Related Compound B<br />
5,11-Dihydro-4-methyl-6H-dipyrido[3,2-b:2',3'-e][1,4]diazepin-6-one<br />
USP1461003 Niacin 200 mg<br />
USP1462006 Niacinamide (Vitamin B 3) 500 mg<br />
USP1463304 Nicotine Bitartrate Dihydrate 500 mg<br />
USP1463508 Nifedipine 125 mg<br />
USP1463600 Nifedipine Nitrophenylpyridine Analog 25 mg<br />
USP1463701 Nifedipine Nitrosophenylpyridine Analog 25 mg<br />
USP1463858 Nimodipine 125 mg<br />
USP1463870<br />
USP1463869<br />
Nimodipine Related Compound A<br />
2-methoxyethyl 1-methylethyl 2,6-dimethyl-4-(3-nitrophenyl)pyridine-3,5-dicarboxylate<br />
Nimodipine Related Compound B<br />
bis(2-methoxyethyl) 2,6-dimethyl-4-(3-nitrophenyl)<br />
-1,4-dihydropyridine-3,5-dicarboxylate (AS)<br />
USP1464001 Nitrofurantoin 500 mg<br />
USP1021703<br />
Nitrofurantoin Related Compound A<br />
N-(Aminocarbonyl)-N-[([5-nitro-2-furanyl]-methylene)-amino]-glycine<br />
USP1465004 Nitrofurazone 200 mg<br />
USP1465503 Nitrofurfural Diacetate 100 mg<br />
30 mg<br />
25 mg<br />
25 mg<br />
15 mg<br />
15 mg<br />
15 mg<br />
50 mg<br />
50 mg<br />
25 mg<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 43
United States Pharmacopeia <strong>and</strong> National Formulary<br />
Code Product Unit<br />
USP1466007<br />
Nitrofurazone Related Compound A<br />
5-Nitro-2-furfuraldazine<br />
500 mg<br />
USP1466506 Diluted Nitroglycerin 5 ampules<br />
USP1467804 Nizatidine 200 mg<br />
USP1467950 Nonoxynol 9 0.5 mL<br />
USP1468002 Nonoxynol 10 200 mg<br />
USP1468400<br />
Nordazepam Controlled Substance CIV<br />
7-Chloro-1,3-dihydro-5-phenyl-2H-1,4-benzodiazepin-2-one<br />
USP1468501 Norepinephrine Bitartrate 125 mg<br />
USP1469005 Norethindrone 200 mg<br />
USP1470004 Norethindrone Acetate 100 mg<br />
USP1471007 Norethynodrel 200 mg<br />
USP1471506 Norfloxacin 200 mg<br />
USP1471914 Norgestimate 200 mg<br />
USP1471925<br />
USP1471958<br />
Norgestimate Related Compound A<br />
Levonorgestrel Acetate<br />
Deacetylnorgestimate<br />
(E)- <strong>and</strong> (Z)-17-deacetyl norgestimate mixture<br />
USP1472000 Norgestrel 125 mg<br />
USP1473002 Noroxymorphone HCl Controlled Substance CII 50 mg<br />
USP1473206 Norphenylephrine Hydrochloride 25 mg<br />
USP1474005 Nortriptyline HCl 200 mg<br />
USP1474504 Noscapine 500 mg<br />
USP1475008 Novobiocin 200 mg<br />
USP1476000 Nylidrin HCl 200 mg<br />
USP1477003 Nystatin 200 mg<br />
USP1477900 Octinoxate (Octyl Methoxycinnamate) 500 mg<br />
USP1477943 Octisalate (Octyl Salicylate) 400 mg<br />
USP1477411 Octocrylene 500 mg<br />
USP1477502 Octoxynol 9 200 mg<br />
USP1477808 Octyldodecanol 200 mg<br />
USP1478108 Ofloxacin 200 mg<br />
USP1478119<br />
Ofloxacin Related Compound A<br />
(RS)-9-fluoro-2,3-dihydro-3-methyl-7-oxo-10-(piperazin-1-yl)-7H-pyrido[1,2,3-de]-<br />
1,4-benzoxazine-6-carboxylic acid<br />
USP1478130 Oleic Acid 1 g<br />
USP1478152 Oleoyl Polyoxylglycerides 100 mg<br />
USP1478254 Olive Oil (AS) 1 g<br />
USP1478505 Omeprazole 200 mg<br />
USP1478516<br />
Omeprazole Related Compound A<br />
Omeprazole Sulfone (AS)<br />
New USP1478549 Omeprazole Magnesium 10 mg<br />
USP1478571 Ondansetron 300 mg<br />
USP1478582 Ondansetron HCl 300 mg<br />
USP1478593<br />
USP1478618<br />
USP1478629<br />
Ondansetron Related Compound A<br />
3[(Dimethylamino)methyl]-1,2,3,9-tetrahydro-9-methyl<br />
-4H-carbazol-4-one hydrochloride<br />
Ondansetron Related Compound C<br />
1,2,3,9-Tetrahydro-9-methyl-4H-carbazol-4-one<br />
Ondansetron Related Compound D<br />
1,2,3,9-Tetrahydro-9-methyl-3-methylene-4H-carbazol-4-one<br />
USP1478630 Ondansetron Resolution Mixture 50 mg<br />
New USP1478800 Orlistat 10 mg<br />
50 mg<br />
25 mg<br />
25 mg<br />
25 mg<br />
15 mg<br />
50 mg<br />
30 mg<br />
30 mg<br />
44 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
United States Pharmacopeia <strong>and</strong> National Formulary<br />
Code Product Unit<br />
New USP1478811<br />
New USP1478822<br />
New USP1478833<br />
Orlistat Related Compound A<br />
(3S,4S)3-hexyl-4-[(R)-2-hydroxytridecyl]-2-oxetanone<br />
Orlistat Related Compound B<br />
diisopropyl bicarbamate<br />
Orlistat Related Compound C<br />
Triphenylphosphine oxide<br />
USP1479009 Orphenadrine Citrate 200 mg<br />
USP1479010<br />
Orphenadrine Related Compound A<br />
(RS)-N,N-dimethyl-2-[(3-methylphenyl)-phenylmethoxy]ethanamine citrate (AS)<br />
USP1481000 Oxacillin Sodium 200 mg<br />
USP1482003 Ox<strong>and</strong>rolone Controlled Substance CIII 50 mg<br />
USP1482014<br />
USP1482025<br />
USP1482036<br />
Ox<strong>and</strong>rolone Related Compound A<br />
17beta-hydroxy-17alpha-methyl-2-oxa-5alpha-<strong>and</strong>rost-7-en-3-one<br />
Controlled Substance CIII<br />
Ox<strong>and</strong>rolone Related Compound B<br />
17 beta-hydroxy-17-alpha-methyl-4-oxa-5 alpha-<strong>and</strong>rosta-3-one<br />
Controlled Substance CIII<br />
Ox<strong>and</strong>rolone Related Compound C<br />
17,17-dimethyl-18-nor-2-oxa-5alpha-<strong>and</strong>rost-13-en-3-one<br />
Controlled Substance CIII<br />
USP1482207 Oxaprozin 200 mg<br />
USP1483006 Oxazepam Controlled Substance CIV 200 mg<br />
USP1483301 Oxfendazole 200 mg<br />
USP1483505 Oxprenolol HCl 200 mg<br />
USP1484009 Oxtriphylline 500 mg<br />
USP1485001 Oxybenzone 150 mg<br />
USP1485103 Oxybutynin Chloride 200 mg<br />
USP1485114<br />
USP1485125<br />
USP1485136<br />
Oxybutynin Related Compound A<br />
Phenylcyclohexylglycolic Acid<br />
Oxybutynin Related Compound B<br />
Cyclohexyl m<strong>and</strong>elic acid methyl ester<br />
Oxybutynin Related Compound C<br />
4-(Ethylmethylamino)but-2-ynyl(+/-)-2-cyclohexyl-2-hydroxy-2-phenylacetate hydrochloride<br />
25 mg<br />
10 mg<br />
25 mg<br />
50 mg<br />
20 mg<br />
20 mg<br />
20 mg<br />
100 mg<br />
USP1485191 Oxycodone Controlled Substance CII 200 mg<br />
USP1486004 Oxymetazoline HCl 200 mg<br />
USP1487007 Oxymetholone Controlled Substance CIII 200 mg<br />
USP1488000 Oxymorphone Controlled Substance CII 500 mg<br />
USP1490103 Oxyquinoline Sulfate 200 mg<br />
USP1491004 Oxytetracycline 200 mg<br />
USP1491015 Oxytetracycline HCl (AS) 200 mg<br />
USP1491300 Oxytocin 5 vials<br />
USP1491332 Paclitaxel 200 mg<br />
USP1491343<br />
USP1491354<br />
Paclitaxel Related Compound A<br />
Cephalomannine<br />
Paclitaxel Related Compound B<br />
10-Deacetyl-7-epipaclitaxel<br />
USP1491503 Padimate O 300 mg<br />
USP1492040 Palm Oil (AS) 1 g<br />
USP1492007 Palmitic Acid 500 mg<br />
USP1492801 Pamidronate Disodium 100 mg<br />
USP1493000 Pamoic Acid 250 mg<br />
USP1494057 Pancreatin Amylase <strong>and</strong> Protease 2 g<br />
USP1494079 Pancreatin Lipase 2 g<br />
USP1494217 Pancuronium Bromide 200 mg<br />
USP1494501 Panthenol, Racemic 200 mg<br />
20 mg<br />
20 mg<br />
20 mg<br />
20 mg<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 45
United States Pharmacopeia <strong>and</strong> National Formulary<br />
Code Product Unit<br />
USP1494807 Pantolactone 500 mg<br />
USP1495005 Papain 1 g<br />
USP1496008 Papaverine HCl 200 mg<br />
USP1496802 Parachlorophenol 500 mg<br />
New USP1496904 Paraffin 1 g<br />
USP1497000 Paramethadione 500 mg<br />
USP1498003 Paramethasone Acetate 200 mg<br />
USP1498706 Parbendazole 200 mg<br />
USP1499006 Pargyline HCl 200 mg<br />
USP1499403 Paricalcitol 10 mg<br />
New USP1499414 Paricalcitol Solution 3 mL<br />
USP1500003 Paromomycin Sulfate 125 mg<br />
USP1500218 Paroxetine HCl 350 mg<br />
USP1500230<br />
USP1500240<br />
USP1500251<br />
USP1500262<br />
USP1500273<br />
USP1500284<br />
Paroxetine Related Compound B<br />
trans-4-phenyl-3-([(3,4-methylenedioxy)phenoxymethyl]piperidine HCl<br />
Paroxetine Related Compound C<br />
(+)-trans-Paroxetine HCl<br />
Paroxetine Related Compound D<br />
cis-Paroxetine HCl (AS)<br />
Paroxetine Related Compound E Mixture<br />
1-Methyl-4-(p-fluorophenyl)-1,2,3,6-tetrahydropyridine in Paroxetine Hydrochloride Matrix<br />
Paroxetine Related Compound F<br />
trans(-)-1-methyl-3-[(1,3-benzodioxol-5-yloxy)Methyl]-4-(4-fluorophenyl)piperidine<br />
Paroxetine Related Compound G<br />
(+/-)trans-3-[(1,3-benzodioxol-5-yloxy)methyl]-4-(4''-fluorophenyl-4'-phenyl)piperidine HCl<br />
15 mg<br />
15 mg<br />
10 mg<br />
25 mg<br />
10 mg<br />
0.4 mg<br />
USP1500353 Paroxetine System Suitability Mixture A 50 mg<br />
USP1500400 Parthenolide 25 mg<br />
USP1500502 Particle Count Set unit<br />
USP1500557 Peanut Oil (AS) 1 g<br />
USP1500808 Penbutolol Sulfate 200 mg<br />
USP1501006 Penicillamine 200 mg<br />
USP1501108 Penicillamine Disulfide 200 mg<br />
USP1502009 Penicillin G Benzathine 200 mg<br />
USP1502508 Penicillin G Potassium 200 mg<br />
USP1502552 Penicillin G Procaine 200 mg<br />
USP1502701 Pencillin G Sodium 150 mg<br />
USP1504489 Penicillin V 200 mg<br />
USP1504503 Penicillin V Potassium 200 mg<br />
New USP1504933 Pentane 3x1.2 mL<br />
USP1504955 1-Pentanol 3x1.2 mL<br />
USP1505007 Pentazocine Controlled Substance CIV 500 mg<br />
USP1505506 Pentetic Acid 100 mg<br />
USP1507002 Pentobarbital Controlled Substance CII 200 mg<br />
USP1508901 Pentoxifylline 200 mg<br />
USP1510007 Pepsin 5 g<br />
USP1510801 Perflubron 0.5 mL<br />
USP1510845 Pergolide Mesylate 200 mg<br />
USP1510867 Pergolide Sulfoxide 50 mg<br />
USP1511000 Perphenazine 200 mg<br />
USP1511203 Perphenazine Sulfoxide 100 mg<br />
USP1513005 Phenacetin 500 mg<br />
USP1514008 Phenacetin Melting Point St<strong>and</strong>ard (Approximately 135°C) 500 mg<br />
USP1515000 Phenazopyridine HCl 200 mg<br />
46 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
United States Pharmacopeia <strong>and</strong> National Formulary<br />
Code Product Unit<br />
USP1516003 Phencyclidine HCl (AS) Controlled Substance CII 25 mg<br />
USP1516502 Phendimetrazine Tartrate Controlled Substance CIII 350 mg<br />
USP1517006 Phenelzine Sulfate 200 mg<br />
USP1517301 D-Phenethicillin Potassium 200 mg<br />
USP1517607 L-Phenethicillin Potassium 200 mg<br />
USP1520000 Phenformin HCl 200 mg<br />
USP1522006 Phenindione 250 mg<br />
USP1522301 Pheniramine Maleate 100 mg<br />
USP1523009 Phenmetrazine HCl Controlled Substance CII 200 mg<br />
USP1524001 Phenobarbital Controlled Substance CIV 200 mg<br />
USP1524806 Phenol 500 mg<br />
USP1524908 Phenolphthalein 250 mg<br />
USP1525004 Phenolsulfonphthalein 100 mg<br />
USP1525707 Phenothiazine (AS) 500 mg<br />
USP1526007 Phenoxybenzamine HCl 250 mg<br />
USP1526200<br />
Phenoxyethanol<br />
2-Phenoxyethanol<br />
500 mg<br />
USP1528002 Phensuximide 500 mg<br />
USP1528501 Phentermine HCl Controlled Substance CIV 200 mg<br />
USP1529005 Phentolamine HCl 300 mg<br />
USP1530004 Phentolamine Mesylate 200 mg<br />
USP1530503 L-Phenylalanine 200 mg<br />
USP1530809 Phenylbenzimidazole Sulfonic Acid 200 mg<br />
USP1531007 Phenylbutazone 250 mg<br />
USP1533002 Phenylephrine HCl 125 mg<br />
USP1533250 Phenylethyl Alcohol 1 mL<br />
USP1533308 5-Phenylhydantoin 100 mg<br />
USP1533851 Phenylpropanediol 100 mg<br />
USP1533909 Phenylpropanolamine Bitartrate Controlled Substance 100 mg<br />
USP1534005 Phenylpropanolamine HCl Controlled Substance 250 mg<br />
USP1534402 Phenyltoloxamine Citrate 100 mg<br />
USP1534413<br />
Phenyltoloxamine Related Compound A<br />
2-(2-benzylphenoxy)ethylmethylamine hydrochloride<br />
USP1535008 Phenytoin 200 mg<br />
USP1535019<br />
USP1535020<br />
Phenytoin Related Compound A<br />
2,2-Diphenylglycine<br />
Phenytoin Related Compound B<br />
alpha-((aminocarbonyl)amino)-alpha-phenyl benzeneacetic acid<br />
USP1535507 Phenytoin Sodium 200 mg<br />
USP1535700 Phosphated Riboflavin 100 mg<br />
USP1535802 Phosphoric Acid (AS) 3x1.5 mL<br />
USP1537003 Physostigmine Salicylate 200 mg<br />
USP1538006 Phytonadione (Vitamin K 1) 500 mg<br />
USP1538505 Pilocarpine 300 mg<br />
USP1538902 Pilocarpine HCl 200 mg<br />
USP1539009 Pilocarpine Nitrate 200 mg<br />
USP1539508 Pimozide 200 mg<br />
USP1539701 Pindolol 200 mg<br />
USP1541000 Piperacetazine 250 mg<br />
USP1541500 Piperacillin 500 mg<br />
USP1541703 Piperazine Adipate 200 mg<br />
USP1541805 Piperazine Citrate 200 mg<br />
50 mg<br />
50 mg<br />
50 mg<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 47
United States Pharmacopeia <strong>and</strong> National Formulary<br />
Code Product Unit<br />
USP1541907 Piperazine Dihydrochloride 200 mg<br />
USP1542003 Piperazine Phosphate 200 mg<br />
USP1543006 Piperidolate HCl 200 mg<br />
USP1544304 Pirbuterol Acetate 200 mg<br />
USP1544508 Piroxicam 200 mg<br />
USP1545205 Plicamycin 50 mg<br />
USP1545409 Polacrilex Resin 100 mg<br />
USP1545500 Polacrilin Potassium 200 mg<br />
USP1546106 Poloxalene 500 mg<br />
USP1546300 Polydimethylsiloxane 500 mg<br />
USP1546401 Polyethylene Glycol 200 1 g<br />
USP1546423 Polyethylene Glycol 300 1 g<br />
USP1546445 Polyethylene Glycol 400 1 g<br />
USP1546467 Polyethylene Glycol 600 1 g<br />
USP1546489 Polyethylene Glycol 1000 1 g<br />
USP1546503 Polyethylene Glycol 1500 1 g<br />
USP1546525 Polyethylene Glycol 3000 1 g<br />
USP1546547 Polyethylene Glycol 3350 1 g<br />
USP1546569 Polyethylene Glycol 4000 1 g<br />
USP1546580 Polyethylene Glycol 6000 1 g<br />
USP1546605 Polyethylene Glycol 8000 1 g<br />
USP1546627 Polyethylene Glycol 10000 1 g<br />
USP1546649 Polyethylene Glycol 12000 1 g<br />
USP1546650 Polyethylene Glycol 20000 1 g<br />
USP1546660 Polyethylene Glycol 35000 1 g<br />
USP1546707 Polyethylene, High Density 3 strips<br />
USP1546809 Polyethylene, Low Density 3 strips<br />
USP1546853 Polyethylene Oxide 100 mg<br />
USP1546900 Polyethylene Terephthalate (PET) 3 strips<br />
USP1546922 Polyethylene Terephthalate G (PETG) 3 strips<br />
USP1546966 Polyisobutylene 1 g<br />
USP1547007 Polymyxin B Sulfate 200 mg<br />
USP1547200 Polyoxyl 35 Castor Oil 1 g<br />
USP1547302 Polyoxyl 10 Oleyl Ether 1 mL<br />
USP1547346 Polyoxyl 2 Stearyl Ether (AS) 1 g<br />
New USP1372606 Polyoxyl 10 Stearyl Ether 1 g<br />
USP1547368 Polyoxyl 20 Stearyl Ether (AS) 1 g<br />
USP1547404 Polyoxyl 50 Stearate 200 mg<br />
USP1547801 Polyoxyl 20 Cetostearyl Ether 100 mg<br />
USP1547903 Polyoxyl 40 Stearate 200 mg<br />
USP1372402 Polyoxyl Lauryl Ether 500 mg<br />
USP1372504 Polyoxyl Oleate 500 mg<br />
USP1547925 Polysorbate 20 (AS) 2 g<br />
USP1547936 Polysorbate 40 (AS) 2 g<br />
USP1547947 Polysorbate 60 (AS) 2 g<br />
USP1547969 Polysorbate 80 (AS) 2 g<br />
USP1548101 Potassium Benzoate (AS) 1 g<br />
USP1548134 Potassium Bicarbonate (AS) 1 g<br />
USP1548167 Potassium Carbonate (AS) 1 g<br />
USP1548190 Potassium Chloride (AS) 1 g<br />
USP1548225 Potassium Citrate (AS) 1 g<br />
48 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
United States Pharmacopeia <strong>and</strong> National Formulary<br />
Code Product Unit<br />
USP1548280 Potassium Iodide (AS) 1 g<br />
USP1548349 Potassium Nitrate (AS) 5 g<br />
USP1548407 Potassium Sorbate (AS) 1 g<br />
USP1549807 Potassium Acetate (AS) 500 mg<br />
USP1549840 Potassium Bitartrate (AS) 3 g<br />
USP1550001 Potassium Gluconate 200 mg<br />
USP1551004 Potassium Guaiacolsulfonate 500 mg<br />
USP1551128 Dibasic Potassium Phosphate (AS) 5 g<br />
USP1551139 Monobasic Potassium Phosphate (AS) 5 g<br />
USP1551140 Potassium Sodium Tartrate (AS) 2 g<br />
USP1551150 Potassium Sucrose Octasulfate 300 mg<br />
USP1551300 Potassium Trichloroammineplatinate 20 mg<br />
USP1551503 Povidone 100 mg<br />
USP1553000 Pralidoxime Chloride 200 mg<br />
USP1554002 Pramoxine HCl 500 mg<br />
New USP1554192 Pravastatin 1,1,3,3-Tetramethylbutylamine 200 mg<br />
New USP1554206 Pravastatin Sodium 50 mg<br />
New USP1554217<br />
New USP1554228<br />
Pravastatin Related Compound A<br />
Sodium(3R,5R)-3,5-dihydroxy-7-[(1S,2S,3S,8S,8aR)-3-hydroxy-2methyl-8-[[(2S)-<br />
2-methylbutanoyl]oxy]-1,2,3,7,8,8a-hexahydronaphthalen-1-yl]heptanoate<br />
Pravastatin Related Compound B<br />
sodium (3R,5R)-3,5-dihydroxy-7-[(1S,2S,6R,8S,8aR)-6-hydroxy-2-methyl-8-[[(2S)-<br />
2-methylbutanoyl]oxy]1,2,6,7,8,8a-hexahydronaphthalen-1-yl]heptanoate<br />
USP1554501 Prazepam Controlled Substance CIV 500 mg<br />
USP1554603 Praziquantel 200 mg<br />
USP1554658<br />
USP1554669<br />
USP1554670<br />
Praziquantel Related Compound A<br />
2-benzoyl-1,2,3,6,7,11b-hexahydro-4 H-pyrazino[2,1-a]isoquinolin-4-one<br />
Praziquantel Related Compound B<br />
2-(cyclohexylcarbonyl)-2,3,6,7-tetrahydro-4H-pyrazino[2,1-a]isoquinolin-4-one<br />
Praziquantel Related Compound C<br />
2-(N-formylhexahydrohippuroyl-1,2,3,4-tetrahydroisoquinolin-1-one<br />
USP1554705 Prazosin HCl 500 mg<br />
USP1554909 Prednicarbate 200 mg<br />
USP1554910<br />
New USP1554920<br />
New USP1554931<br />
Prednicarbate Related Compound A<br />
1,2-dihydroprednicarbate<br />
Prednicarbate Related Compound B<br />
prednisolone-17-ethylcarbonate<br />
Prednicarbate Related Compound C<br />
prednisolone-21-propionate<br />
USP1555005 Prednisolone 200 mg<br />
USP1556008 Prednisolone Acetate 200 mg<br />
USP1556507 Prednisolone Hemisuccinate 125 mg<br />
USP1557000 Prednisolone Sodium Phosphate 100 mg<br />
USP1558003 Prednisolone Tebutate 200 mg<br />
USP1559006 Prednisone 250 mg<br />
USP1559505<br />
Prednisone Tablets<br />
Dissolution calibrator tablets,Disintegrating<br />
15 mg<br />
20 mg<br />
50 mg<br />
50 mg<br />
50 mg<br />
20 mg<br />
20 mg<br />
20 mg<br />
30 tablets<br />
USP1560990 Prilocaine 200 mg<br />
USP1561008 Prilocaine HCl 200 mg<br />
USP1561019<br />
USP1561020<br />
Prilocaine Related Compound A<br />
o-toluidine hydrochloride<br />
Prilocaine Related Compound B<br />
(RS)-N-(4-methylphenyl)-2-(propylamino)propanamide<br />
100 mg<br />
USP1561507 Primaquine Phosphate 200 mg<br />
USP1562000 Primidone 200 mg<br />
50 mg<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 49
United States Pharmacopeia <strong>and</strong> National Formulary<br />
Code Product Unit<br />
USP1563003 Probenecid 200 mg<br />
USP1563309 Probucol 200 mg<br />
USP1563320<br />
USP1563331<br />
USP1563342<br />
Probucol Related Compound A<br />
2,2',6,6'-tetra-tert-butyldiphenoquinone<br />
Probucol Related Compound B<br />
4,4'-dithio-bis(2,6-di-tert-butylphenol)<br />
Probucol Related Compound C<br />
4-[(3,5-di-tert-butyl-2-hydroxyphenylthio)isopropylidenethio]-2,6-di-tert-butylphenol<br />
USP1563502 Procainamide HCl 200 mg<br />
USP1564006 Procaine HCl 200 mg<br />
USP1565009 Procarbazine HCl 200 mg<br />
USP1566001 Prochlorperazine Maleate 200 mg<br />
USP1567004 Procyclidine HCl 200 mg<br />
USP1568007 Progesterone 200 mg<br />
USP1568506 L-Proline 200 mg<br />
USP1569000 Promazine HCI 200 mg<br />
USP1570009 Promethazine HCl 500 mg<br />
USP1570304 Propafenone HCl 200 mg<br />
New USP1570406 1-Propanol 3x1.2 mL<br />
USP1570428 2-Propanol 3x1.2 mL<br />
USP1570508 Propantheline Bromide 200 mg<br />
USP1329505<br />
Propantheline Bromide Related Compound A<br />
9-Hydroxypropantheline Bromide<br />
USP1571001 Proparacaine HCl 200 mg<br />
USP1572208 Propionic Acid (AS) 3x1.5 mL<br />
USP1572503 Propofol 200 mg<br />
USP1572525<br />
USP1572536<br />
USP1572547<br />
USP1572558<br />
Propofol Resolution Mixture<br />
Propofol;2,6-diisopropylphenyl isopropylether, <strong>and</strong> 2-isopropyl-6-n-propylphenol<br />
Propofol Related Compound A<br />
3,3',5,5'-Tetraisopropyldiphenol<br />
Propofol Related Compound B<br />
2,6-diisopropylbenzoquinone<br />
Propofol Related Compound C<br />
2,6-diisopropylphenyl isopropylether<br />
25 mg<br />
25 mg<br />
25 mg<br />
50 mg<br />
100 mg<br />
USP1573007 Propoxycaine HCl 200 mg<br />
USP1574000 Propoxyphene HCl Controlled Substance CII 1 g<br />
USP1575002 Propoxyphene Napsylate Controlled Substance CII 1 g<br />
USP1575206<br />
USP1008002<br />
Propoxyphene Related Compound A<br />
alpha-d-4-dimethylamino-1,2-diphenyl-3-methyl-2-butanol HCl<br />
Propoxyphene Related Compound B<br />
alpha-d-2-Acetoxy-4-dimethylamino-1,2-diphenyl-3-methylbutane<br />
USP1576005 Propranolol HCl 200 mg<br />
New USP1576402 Propyl Acetate 3x1.2 mL<br />
USP1576504 Propylene Carbonate 200 mg<br />
USP1576708 Propylene Glycol 1 mL<br />
USP1576800 Propyl Gallate 200 mg<br />
USP1577008 Propylparaben 200 mg<br />
USP1578000 Propylthiouracil 200 mg<br />
USP1578500 Prostagl<strong>and</strong>in A1 25 mg<br />
USP1578554<br />
Prostagl<strong>and</strong>in B1<br />
(13E,15S,)-15-Hydroxy-9-oxoprosta-8(12),13-dien-1-oic Acid<br />
USP1580002 Protriptyline HCl 200 mg<br />
USP1581005 Ps<strong>eu</strong>doephedrine HCl Controlled Substance 125 mg<br />
USP1581504 Ps<strong>eu</strong>doephedrine Sulfate Controlled Substance 200 mg<br />
25 mg<br />
50 mg<br />
50 mg<br />
50 mg<br />
50 mg<br />
25 mg<br />
50 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
United States Pharmacopeia <strong>and</strong> National Formulary<br />
Code Product Unit<br />
New USP1583805 Pyg<strong>eu</strong>m Extract 150 mg<br />
USP1584003 Pyrantel Pamoate 1 g<br />
USP1585006 Pyrazinamide 200 mg<br />
USP1586009 Pyridostigmine Bromide 200 mg<br />
USP1587001 Pyridoxine HCl (Vitamin B 6) 200 mg<br />
USP1588004 Pyrilamine Maleate 200 mg<br />
USP1589007 Pyrimethamine 200 mg<br />
USP1592001 Pyrvinium Pamoate 500 mg<br />
USP1592205 Quazepam Controlled Substance CIV 200 mg<br />
USP1592227<br />
Quazepam Related Compount A<br />
7-Chloro-1-(2,2,2-trifluoroethyl)-5-(2-fluorophenyl)-1,3-dihydro-<br />
2H-1,4-benzodiazepine-2-one<br />
USP1592409 Quercetin 500 mg<br />
USP1593004 Quinacrine HCl 200 mg<br />
New USP1593401 Quinapril HCl 400 mg<br />
USP1593412<br />
USP1593423<br />
Quinapril Related Compound A<br />
Ethyl[3S-[2(R*),3a,11a beta]]-1,3,4,6,11,11a-hexahydro-3-methyl-1,4-dioxo-alpha-<br />
(2-phenylethyl)-2H-pyrazino[1,2-b]isoquinoline-2-acetate<br />
Quinapril Related Compound B<br />
3-Isoquinolinecarboxylic acid, 2-[2-[(1-carboxy-3-phenylpropyl)amino]-1-oxopropyl]-<br />
1,2,3,4-tetrahydro-,[3S-[2[R*(R*)],3R*]]-)<br />
USP1594007 Quinethazone 1.5 g<br />
USP1594506 Quinic Acid 200 mg<br />
USP1595000 Quinidine Gluconate 200 mg<br />
USP1595509 Quinidine Sulfate 500 mg<br />
USP1596807 Quinine HCl Dihydrate 1 g<br />
USP1597005 Quinine Sulfate 500 mg<br />
USP1597504 Quininone 50 mg<br />
USP1598303 Ramipril 200 mg<br />
USP1598314<br />
USP1598323<br />
USP1598338<br />
USP1598347<br />
Ramipril Related Compound A<br />
(2S,3aS,6aS)-1[(S)2-[[(S)1-(methoxycarbonyl)-3-phenylpropyl]amino]-1-oxopropyl]-<br />
octahydrocyclopenta[b]pyrrole-2-carboxylic acid<br />
Ramipril Related Compound B<br />
Ramipril Isopropylester<br />
Ramipril Related Compound C<br />
Hexahydroramipil HCl<br />
Ramipril Related Compound D<br />
Ramipril Diketopiperazine<br />
USP1598405 Ranitidine HCl 200 mg<br />
USP1598450 Ranitidine Resolution Mixture 20 mg<br />
USP1598507<br />
USP1598609<br />
USP1598700<br />
Ranitidine Related Compound A<br />
5-[[(2-aminoethyl)thio]methyl]-N,N-dimethyl-2-furanmethanamine hemifumarate<br />
Ranitidine Related Compound B<br />
N,N'-bis[2-[[[5-[(dimethylamino)methyl]-2-furanyl]methyl]thio]ethyl]-2-nitro-1,1-ethenediamine<br />
Ranitidine Related Compound C<br />
N-[2-[[[5-[(dimethylamino)methyl]-2-furanyl]methyl]sulfinyl]ethyl]-N-methyl-2-nitro-<br />
1,1-ethenediamine<br />
USP1599000 Rauwolfia Serpentina 15 g<br />
USP1599500 Powdered Red Clover Extract 500 mg<br />
USP1600813 Repaglinide 200 mg<br />
USP1600824<br />
USP1600835<br />
USP1600846<br />
Repaglinide Related Compound A<br />
(S)-3-Methyl-1-[2-(1-piperidinyl)phenyl]butylamine, N-acetyl-L-glutamate Salt<br />
Repaglinide Related Compound B<br />
3-Ethoxy-4-ethoxycarbonyl-phenylacetic Acid<br />
Repaglinide Related Compound C<br />
(S)-2-Ethoxy-4-[2-[[2-phenyl-1-[2-(1-piperidinyl)phenyl]ethyl]amino]-2-oxoethyl]benzoic Acid<br />
30 mg<br />
50 mg<br />
50 mg<br />
20 mg<br />
20 mg<br />
20 mg<br />
20 mg<br />
50 mg<br />
50 mg<br />
50 mg<br />
50 mg<br />
50 mg<br />
25 mg<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 51
United States Pharmacopeia <strong>and</strong> National Formulary<br />
Code Product Unit<br />
USP1601000 Reserpine 200 mg<br />
USP1601102 Residual Solvent Mixture - Class 1 3x1.2 mL<br />
USP1601146 Residual Solvent Class 1 - Benzene 3x1.2 mL<br />
USP1601168 Residual Solvent Class 1 - Carbon Tetrachloride 3x1.2 mL<br />
USP1601180 Residual Solvent Class 1 - 1,2-Dichloroethane 3x1.2 mL<br />
USP1601204 Residual Solvent Class 1 - 1,1-Dichloroethene 3x1.2 mL<br />
USP1601226 Residual Solvent Class 1 - 1,1,1-Trichloroethane 3x1.2 mL<br />
USP1601281 Residual Solvent Class 2 - Mixture A 3x1.2 mL<br />
USP1601292 Residual Solvent Class 2 - Mixture B 3x1.2 mL<br />
USP1601306 Residual Solvent Class 2 - Mixture C 3x1.2 mL<br />
USP1601340 Residual Solvent Class 2 - Acetonitrile 3x1.2 mL<br />
USP1601361 Residual Solvent Class 2 - Chlorobenzene 3x1.2 mL<br />
USP1601383 Residual Solvent Class 2 - Chloroform 3x1.2 mL<br />
USP1601408 Residual Solvent Class 2 - Cyclohexane 3x1.2 mL<br />
USP1601420 Residual Solvent Class 2 - 1,2-Dichloroethene 3x1.2 mL<br />
USP1601441 Residual Solvent Class 2 - Methylene Chloride 3x1.2 mL<br />
USP1601463 Residual Solvent Class 2 - 1,2-Dimethoxyethane 3x1.2 mL<br />
USP1601485 Residual Solvent Class 2 - N,N-Dimethylacetamide 3x1.2 mL<br />
USP1601500 Residual Solvent Class 2 - N,N-Dimethylformamide 3x1.2 mL<br />
USP1601521 Residual Solvent Class 2 - 1,4-Dioxane 3x1.2 mL<br />
USP1601543 Residual Solvent Class 2 - 2-Ethoxyethanol 3x1.2 mL<br />
USP1601565 Residual Solvent Class 2 - Ethylene Glycol 3x1.2 mL<br />
USP1601587 Residual Solvent Class 2 - Formamide 3x1.2 mL<br />
USP1601601 Residual Solvent Class 2 - Hexane 3x1.2 mL<br />
USP1601623 Residual Solvent Class 2 - Methanol 3x1.2 mL<br />
USP1601645 Residual Solvent Class 2 - 2-Methoxyethanol 3x1.2 mL<br />
USP1601667 Residual Solvent Class 2 - Methylbutylketone 3x1.2 mL<br />
USP1601689 Residual Solvent Classe 2 - Methylcyclohexane 3x1.2 mL<br />
USP1601703 Residual Solvent Classe 2 - N-Methylpyrrolidone 3x1.2 mL<br />
USP1601725 Residual Solvent Class 2 - Nitromethane 3x1.2 mL<br />
USP1601747 Residual Solvent Class 2 - Pyridine 3x1.2 mL<br />
USP1601769 Residual Solvent Class 2 - Sulfolane 3x1.2 mL<br />
USP1601770 Residual Solvent Class 2 - Tetrahydrofuran 3x1.2 mL<br />
USP1601780 Residual Solvent Class 2 - Tetralin 3x1.2 mL<br />
USP1601805 Residual Solvent Class 2 - Toluene 3x1.2 mL<br />
USP1601827 Residual Solvent Class 2 - Trichloroethylene 3x1.2 mL<br />
USP1601849 Residual Solvent Class 2 - Xylenes 3x1.2 mL<br />
USP1602003 Resorcinol 200 mg<br />
USP1602706 Ribavirin 200 mg<br />
USP1603006 Riboflavin (Vitamin B 2) 500 mg<br />
New USP1603108 Ribose 300 mg<br />
USP1603800 Rifabutin 50 mg<br />
USP1604009 Rifampin 300 mg<br />
USP1604202 Rifampin Quinone 50 mg<br />
USP1604508 Rimantadine HCl 300 mg<br />
USP1604600 Rimexolone 100 mg<br />
New USP1604654 Risperidone 200 mg<br />
New USP1604665 Risperidone System Suitability Mixture 10 mg<br />
USP1604701 Ritodrine HCl 200 mg<br />
USP1604803 Ritonavir 200 mg<br />
USP1604814 Ritonavir Related Compounds Mixture 50 mg<br />
52 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
United States Pharmacopeia <strong>and</strong> National Formulary<br />
Code Product Unit<br />
USP1605500 Ropivacaine HCl 200 mg<br />
USP1605512<br />
USP1605523<br />
Ropivacaine Related Compound A<br />
2,6-dimethylaniline hydrochloride<br />
Ropivacaine Related Compound B<br />
(R)-(+)-1-Propylpiperidine-2-carboxylic acid (2,6-dimethylphenyl)-<br />
amide hydrochloride monohydrate<br />
USP1606208 Roxarsone 200 mg<br />
USP1606503 Rutin 100 mg<br />
USP1607007 Saccharin 200 mg<br />
New USP1607029 Saccharin Calcium 100 mg<br />
USP1607040 Saccharin Sodium 100 mg<br />
USP1608000 Salicylamide 200 mg<br />
USP1609002 Salicylic Acid 125 mg<br />
USP1609013<br />
USP1609024<br />
USP1609501<br />
Salicylic Acid Related Compound A<br />
4-hydroxybenzoic acid<br />
Salicylic Acid Related Compound B<br />
4-hydroxyisophthalic acid<br />
Salicylic Acid Tablets<br />
Dissolution Calibrator, Non-disintegrating<br />
25 mg<br />
50 mg<br />
100 mg<br />
100 mg<br />
30 tablets<br />
USP1609807 Salsalate 125 mg<br />
USP1609829 Saquinavir Mesylate 200 mg<br />
USP1609831<br />
Saquinavir Related Compound A<br />
N-tert-butyl-decahydro-2-[2(R)-hydroxy-4-phenyl-3(S)-[[N-(2-quinolylcarbonyl)-Dasparaginyl]amino]butyl]-(4aS,8aS)-isoquinoline-3(S)-carboxamide<br />
USP1610001 Scopolamine HBr 250 mg<br />
USP1610090 Scopoletin 20 mg<br />
USP1611004 Secobarbital Controlled Substance CII 200 mg<br />
USP1611900 Selegiline HCl 200 mg<br />
USP1611955 Selenomethionine 100 mg<br />
USP1612007 Sennosides 500 mg<br />
USP1612404 Sesame Oil (AS) 2x1 mL<br />
USP1612415<br />
USP1612426<br />
Sesame Oil Related Compound A<br />
1,2-dilinoleoyl-3-oleoyl-rac-glycerol<br />
Sesame Oil Related Compound B<br />
1,2-dilinoleoyl-3-palmitoyl-rac-glycerol, PLL<br />
25 mg<br />
3x6 mg<br />
3x6 mg<br />
USP1612506 L-Serine 200 mg<br />
USP1612540 Sevoflurane 1 mL<br />
USP1612550<br />
USP1612572<br />
USP1612594<br />
Sevoflurane Related Compound A<br />
1,1,3,3,3-Pentafluoroisopropenyl fluoromethyl ether<br />
Sevoflurane Related Compound B<br />
1,1,1,3,3,3-hexafluoro-2-methoxypropane<br />
Sevoflurane Related Compound C<br />
1,1,1,3,3,3-hexafluoro-2-propanol<br />
0.2 mL<br />
0.2 mL<br />
0.2 mL<br />
USP1612608 Silver Sulfadiazine 200 mg<br />
USP1612630 Silybin 50 mg<br />
USP1612641 Silydianin 20 mg<br />
USP1612652 Simethicone 50 g<br />
USP1612700 Simvastatin 200 mg<br />
USP1612801 Sisomicin Sulfate 500 mg<br />
USP1612947 Beta-Sitosterol 300 mg<br />
USP1613407 Sodium Acetate (AS) 1 g<br />
USP1613509 Sodium Ascorbate 200 mg<br />
USP1613564 Sodium Benzoate 1 g<br />
USP1613655 Sodium Bicarbonate (AS) 3 g<br />
USP1613600 Sodium Butyrate 25 mg<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 53
United States Pharmacopeia <strong>and</strong> National Formulary<br />
Code Product Unit<br />
USP1613757 Sodium Carbonate Anhydrous (AS) 1 g<br />
USP1613804 Sodium Chloride (AS) 1 g<br />
USP1613859 Sodium Citrate (AS) 1 g<br />
USP1614002 Sodium Fluoride 1 g<br />
USP1614308 Sodium Lactate 200 mg<br />
USP1614363 Sodium Lauryl Sulfate (AS) 1 g<br />
USP1614396 Sodium Metabisulfite (AS) 1 g<br />
USP1614454 Sodium Nitrite (AS) 1 g<br />
USP1614501 Sodium Nitroprusside 500 mg<br />
USP1614603 Sodium Propionate 200 mg<br />
USP1614636 Sodium Salicylate 500 mg<br />
USP1614669 Sodium Starch Glycolate Type A 400 mg<br />
USP1614670 Sodium Starch Glycolate Type B 400 mg<br />
USP1614705 Sodium Stearyl Fumarate 200 mg<br />
USP1614807 Sodium Sulfate Anhydrous (AS) 1 g<br />
USP1615107 Sodium Thiosulfate (AS) 1 g<br />
USP1615708 Somatropin unit<br />
USP1615956 Sorbic Acid (AS) 1 g<br />
USP1616008 1,4-Sorbitan 300 mg<br />
USP1617000 Sorbitol 125 mg<br />
USP1617408 Sotalol HCl 300 mg<br />
USP1617419<br />
USP1617420<br />
USP1617430<br />
Sotalol Related Compound A<br />
N-[4-[[(1-Methylethyl)amino]acetyl]phenyl]methanesulfonamide monohydrochloride<br />
Sotalol Related Compound B<br />
N(4-Formylphenyl)methanesulfonamide<br />
Sotalol Related Compound C<br />
N-[4-[2-[(1-Methylethyl)amino]ethyl]phenyl]methanesulfonamide HCl<br />
USP1618003 Spectinomycin HCl 200 mg<br />
USP1619006 Spironolactone 125 mg<br />
USP1619017<br />
Spironolactone Related Compound A<br />
Canrenone (3-Oxo-17-alpha-pregna-4,6-diene-21,17-carbolactone) (AS)<br />
50 mg<br />
50 mg<br />
50 mg<br />
100 mg<br />
USP1619505 Squalane 500 mg<br />
USP1620005 Stanozolol Controlled Substance CIII 200 mg<br />
USP1620209 Stavudine 250 mg<br />
USP1620220 Stavudine System Suitability Mixture 20 mg<br />
USP1621008 Stearic Acid 500 mg<br />
USP1621507 Stearoyl Polyoxyglycerides 100 mg<br />
USP1622000 Stearyl Alcohol 125 mg<br />
USP1623003 Streptomycin Sulfate 200 mg<br />
USP1623502 Succinylcholine Chloride 500 mg<br />
USP1623604 Succinylmonocholine Chloride 150 mg<br />
USP1623626 Sucralose 400 mg<br />
USP1623637 Sucrose 100 mg<br />
New USP1623615 Sucrose Octaacetate 500 mg<br />
USP1623648 Sufentanil Citrate Controlled Substance CII 25 mg<br />
USP1623670 Sulbactam 250 mg<br />
USP1623681 Sulconazole Nitrate 200 mg<br />
USP1623706 Sulfabenzamide 200 mg<br />
USP1623808 Sulfacetamide 300 mg<br />
USP1624006 Sulfacetamide Sodium 500 mg<br />
USP1624505 Sulfachlorpyridazine 200 mg<br />
USP1625009 Sulfadiazine 200 mg<br />
54 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
United States Pharmacopeia <strong>and</strong> National Formulary<br />
Code Product Unit<br />
USP1626001 Sulfadimethoxine 200 mg<br />
USP1626500 Sulfadoxine 200 mg<br />
USP1628007 Sulfamerazine 500 mg<br />
USP1629000 Sulfamethazine 1 g<br />
USP1630009 Sulfamethizole 200 mg<br />
USP1631001 Sulfamethoxazole 200 mg<br />
USP1631500 Sulfamethoxazole N 4-glucoside 25 mg<br />
USP1632004 Sulfanilamide 5 g<br />
USP1633007 Sulfanilamide Melting Point St<strong>and</strong>ard (Approximately 165°C) 500 mg<br />
USP1633506 Sulfanilic Acid 200 mg<br />
USP1634000 Sulfapyridine 200 mg<br />
USP1635002 Sulfapyridine Melting Point St<strong>and</strong>ard (Approximately 191°C) 1 g<br />
USP1635206 Sulfaquinoxaline 200 mg<br />
USP1635228<br />
Sulfaquinoxaline Related Compound A<br />
N1-N2-diquinoxalin-2-ylsulfanilamide<br />
USP1636005 Sulfasalazine 125 mg<br />
USP1636504 Sulfathiazole 350 mg<br />
USP1637008 Sulfinpyrazone 200 mg<br />
USP1638000 Sulfisoxazole 200 mg<br />
USP1639003 Sulfisoxazole Acetyl 200 mg<br />
USP1642008 Sulindac 200 mg<br />
USP1642019<br />
Sulindac Related Compound A<br />
trans-sulindac<br />
USP1642100 Sulisobenzone 500 mg<br />
USP1642154 Sumatriptan 50 mg<br />
USP1642201 Sumatriptan Succinate 200 mg<br />
USP1642212<br />
USP1642223<br />
Sumatriptan Succinate Related Compound A<br />
[3-[2-(dimethylamino)ethyl]-2-[[3-[2-(dimethylamino)ethyl]-1H-indol-5-yl]methyl]-1H-indol-<br />
5-yl]-N-methylmethansulfonamide, succinate Salt<br />
Sumatriptan Succinate Related Compound C<br />
[3-[2-(dimethylamino)ethyl]-1-(hydroxymethyl)-1H-indol-5-yl]-<br />
N-methylmethanesulfonamide succinate salt<br />
USP1642256 Sumatriptan Succinate Related Impurities 25 mg<br />
USP1642507 Suprofen 200 mg<br />
USP1642700 Tacrine HCl 500 mg<br />
USP1642904 Tagatose 200 mg<br />
USP1643000 Talbutal Controlled Substance CIII 250 mg<br />
USP1643306 Tamoxifen Citrate 200 mg<br />
USP1643328 Tannic Acid (AS) 2 g<br />
USP1643340 Tartaric Acid (AS) 1 g<br />
USP1643361 Taurine 100 mg<br />
New USP1643383 Tazobactam 200 mg<br />
New USP1643394<br />
Tazobactam Related Compound A<br />
2-amino-3-methyl-3-sulfino-4-(1H-1,2,3-triazol-1-yl)butyric acid<br />
USP1643408 Temazepam Controlled Substance CIV 200 mg<br />
USP1643452 Terazosin HCl 200 mg<br />
USP1643463<br />
USP1643474<br />
USP1643485<br />
Terazosin Related Compound A<br />
1-(4-Amino-6,7-dimethoxy-2-quinazolinyl)piperazine dihydrochloride<br />
Terazosin Related Compound B<br />
1-(4-hydroxy-6,7-dimethoxy-2-quinazolinyl)-4-[(tetrahydro-2-furanyl)carbonyl]piperazine<br />
Terazosin Related Compound C<br />
1,4-bis(4-amino-6,7-dimethoxy-2-quinazolinyl)piperazine dihydrochloride<br />
USP1643500 Terbutaline Sulfate 125 mg<br />
25 mg<br />
20 mg<br />
15 mg<br />
50 mg<br />
20 mg<br />
50 mg<br />
50 mg<br />
25 mg<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 55
United States Pharmacopeia <strong>and</strong> National Formulary<br />
Code Product Unit<br />
USP1643510<br />
Terbutaline Related Compound A<br />
tert-butylamino-3,5-dihydroxyacetophenone sulfate<br />
USP1643703 Terconazole 200 mg<br />
USP1643805 Terfenadine 200 mg<br />
USP1643907<br />
USP1643929<br />
Terfenadine Related Compound A<br />
1-[4-(1,1-dimethylethyl)phenyl]-4-[4-(hydroxydiphenylmethyl)-1-piperidinyl]-1-butanone<br />
Terfenadine Related Compound B<br />
Terfenadine-N-oxide<br />
50 mg<br />
100 mg<br />
USP1644003 Terpin Hydrate 750 mg<br />
USP1645006 Testolactone Controlled Substance CIII 125 mg<br />
USP1646009 Testosterone Controlled Substance CIII 125 mg<br />
USP1647001 Testosterone Cypionate Controlled Substance CIII 200 mg<br />
USP1648004 Testosterone Enanthate Controlled Substance CIII 200 mg<br />
USP1649007 Testosterone Propionate Controlled Substance CIII 200 mg<br />
USP1650006 Tetracaine HCl 200 mg<br />
USP1651009 Tetracycline HCl 200 mg<br />
New USP1651621 Delta-9-Tetrahydrocannabinol Controlled Substance 1 mL<br />
New USP1090014 Exo-tetrahydrocannabinol Controlled Substance 1 mL<br />
USP1652001 Tetrahydrozoline HCl 200 mg<br />
USP1652500 Thalidomide 200 mg<br />
USP1653004 Theophylline 200 mg<br />
USP1655000 Thiabendazole 100 mg<br />
USP1656002 Thiamine HCl (Vitamin B 1 HCl) 500 mg<br />
USP1656308 Thiamylal Controlled Substance CIII 200 mg<br />
USP1657005 Thiethylperazine Malate 200 mg<br />
USP1658008 Thiethylperazine Maleate 200 mg<br />
USP1659000 Thimerosal 500 mg<br />
USP1660000 Thioguanine 200 mg<br />
USP1661002 Thiopental Controlled Substance CIII 250 mg<br />
USP1662504 Thioridazine 200 mg<br />
USP1663008 Thioridazine HCl 200 mg<br />
USP1663700 Thiostrepton 200 mg<br />
USP1664000 Thiotepa 500 mg<br />
USP1665003 Thiothixene 250 mg<br />
USP1666006 (E)-Thiothixene 100 mg<br />
USP1667100 Thonzonium Bromide 200 mg<br />
USP1667202 L-Threonine 200 mg<br />
USP1667213 Thymol 500 mg<br />
USP1667280 Tiagabine Hydrochloride 300 mg<br />
USP1667224<br />
USP1667235<br />
Tiagabine Related Compound A<br />
(R)-ethyl 1-[4,4-bis(3-methyl-2-thienyl)-3-butenyl]-3-piperidinecarboxylate, HCl<br />
Racemic Tiagabine Hydrochloride Mixture<br />
(S)-(+),(R)-(-)-1-[4,4-bis(3-methyl-2-thienyl)-3-butenyl]nipecotic acid, HCl<br />
USP1667355 Tiamulin 100 mg<br />
USP1667290 Tiamulin Fumarate 250 mg<br />
USP1667304 Ticarcillin Monosodium Monohydrate 350 mg<br />
USP1667337<br />
Tiamulin Related Compound A<br />
Tosyl pl<strong>eu</strong>romutilin<br />
USP1667359 Tiletamine HCl 200 mg<br />
USP1667370 Tilmicosin 400 mg<br />
USP1667406 Timolol Maleate 200 mg<br />
USP1667520 Tinidazole 200 mg<br />
50 mg<br />
15 mg<br />
25 mg<br />
50 mg<br />
56 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
United States Pharmacopeia <strong>and</strong> National Formulary<br />
Code Product Unit<br />
USP1667530<br />
USP1667541<br />
Tinidazole Related Compound A<br />
2-methyl-5-nitroimidazole<br />
Tinidazole Related Compound B<br />
(1-(2-ethyl-sulfonylethyl)-2-methyl-4-nitroimidazole)<br />
100 mg<br />
USP1667439 Tioconazole 200 mg<br />
USP1667450<br />
USP1667461<br />
USP1667472<br />
Tioconazole Related Compound A<br />
1-[2,4-Dichloro-beta-[(3-thenyl)-oxy]phenethyl]imidazole HCl<br />
Tioconazole Related Compound B<br />
1-[2,4-Dichloro-beta-[(2,5-dichloro-3-thenyl)oxy]phenethyl]imidazole HCl<br />
Tioconazole Related Compound C<br />
1-[2,4-Dichloro-beta-[(5-bromo-2-chloro-3-thenyl)-oxy]-phenethyl]imidazole HCl<br />
USP1667585 Titanium Dioxide (AS) 1 g<br />
New USP1667905 Tizanidine Hydrochloride 200 mg<br />
USP1667916<br />
USP1667924<br />
USP1667938<br />
Tizanidine Related Compound A<br />
4-amino-5-chloro-2,1,3-benzothiadiazole<br />
Tizanidine Related Compound B<br />
N-acetyltizanidine<br />
Tizanidine Related Compound C<br />
1-acetylimidazolidine-2-thione<br />
USP1667508 Tobramycin 350 mg<br />
USP1667552 Tocainide HCl 125 mg<br />
USP1667600 Alpha Tocopherol (Vitamin E Alcohol) 250 mg<br />
USP1667701 Alpha Tocopheryl Acetate (Vitamin E Acetate) 250 mg<br />
USP1667803 Alpha Tocopheryl Acid Succinate (Vitamin E Succinate) 250 mg<br />
USP1668001 Tolazamide 200 mg<br />
USP1669004 Tolazoline HCl 300 mg<br />
USP1670003 Tolbutamide 200 mg<br />
USP1670207 Tolcapone 200 mg<br />
USP1670218<br />
USP1670229<br />
Tolcapone Related Compound A<br />
4'-methyl-3,4-dihydroxybenzophenone<br />
Tolcapone Related Compound B<br />
4-hydroxy-3-methoxy-4'-methyl-5-nitrobenzophenone<br />
USP1670502 Tolmetin Sodium 500 mg<br />
USP1671006 Tolnaftate 200 mg<br />
USP1672010 o-Toluenesulfonamide 200 mg<br />
USP1672020 p-Toluenesulfonamide 200 mg<br />
New USP1672206 Topiramate 200 mg<br />
USP1672210<br />
Topiramate Related Compound A<br />
2,3,4,5-Bis-O-(1-methylethylidene)-beta-D-fructopyranose<br />
USP1672304 Torsemide 200 mg<br />
USP1672315<br />
USP1672326<br />
USP1672337<br />
Torsemide Related Compound A<br />
4-[(3-methylphenyl)amino]-3-pyridinesulfonamide<br />
Torsemide Related Compound B<br />
N-[(n-butylamino)carbonyl]-4-[(3-methylphenyl)amino]-3-pyridinesulfonamide<br />
Torsemide Related Compound C<br />
N-[(ethylamino)carbonyl]-4-[(3-methylphenyl)amino]-3-pyridinesulfonamide<br />
USP1672803 Transplatin 25 mg<br />
USP1673500 Trazodone HCl 200 mg<br />
New USP1673715 Trehalose 400 mg<br />
USP1673806 Trenbolone Controlled Substance CIII 50 mg<br />
USP1673828 Trenbolone Acetate Controlled Substance CIII 200 mg<br />
USP1674004 Tretinoin 5x30 mg<br />
USP1675007 Triacetin 1 g<br />
USP1676000 Triamcinolone 250 mg<br />
USP1677002 Triamcinolone Acetonide 500 mg<br />
20 mg<br />
25 mg<br />
25 mg<br />
25 mg<br />
50 mg<br />
50 mg<br />
50 mg<br />
25 mg<br />
25 mg<br />
25 mg<br />
75 mg<br />
75 mg<br />
75 mg<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 57
United States Pharmacopeia <strong>and</strong> National Formulary<br />
Code Product Unit<br />
USP1678005 Triamcinolone Diacetate 350 mg<br />
USP1679008 Triamcinolone Hexacetonide 200 mg<br />
USP1680007 Triamterene 200 mg<br />
USP1680506 Triazolam Controlled Substance CIV 200 mg<br />
USP1680608 Tributyl Citrate 500 mg<br />
USP1680801 Trichlorfon 200 mg<br />
USP1681000 Trichlormethiazide 200 mg<br />
USP1682206 Triclosan 200 mg<br />
USP1682217 Triclosan Related Compounds Mixture A 3x1.2 mL<br />
USP1683005 Tridihexethyl Chloride 200 mg<br />
USP1683504 Trientine HCl 125 mg<br />
USP1683606 Triethyl Citrate 500 mg<br />
USP1685000 Trifluoperazine HCl 200 mg<br />
USP1685500 2-[N-(2,2,2-Trifluoro-ethyl)amino-5]-chlorobenzophenone 25 mg<br />
USP1686003 Triflupromazine HCI 200 mg<br />
USP1686309 Trifluridine 200 mg<br />
USP1686310<br />
Trifluridine Related Compound A<br />
5-Carboxy-2'-deoxyuridine<br />
USP1687006 Trihexyphenidyl HCl 200 mg<br />
USP1689001 Trimeprazine Tartrate 200 mg<br />
USP1690000 Trimethadione 200 mg<br />
USP1692006 Trimethobenzamide HCl 500 mg<br />
USP1692505 Trimethoprim 300 mg<br />
New USP1692516<br />
New USP1692527<br />
Trimethoprim Related Compound A<br />
4-amino-5-(3,4,5-trimethoxybenzyl)pyrimidin-2-ol (AS)<br />
Trimethoprim Related Compound B<br />
(2,4-diaminopyrimidin-5-yl)(3,4,5-trimethoxyphenyl)methanone<br />
New USP1692709 Trimipramine Maleate 50 mg<br />
New USP1692710<br />
Trimipramine Related Compound A<br />
dehydro trimipramine<br />
USP1693009 Trioxsalen 200 mg<br />
USP1695004 Tripelennamine HCl 200 mg<br />
USP1696007 Triprolidine HCl 500 mg<br />
USP1696109 Triprolidine HCl Z-Isomer 100 mg<br />
USP1696200 Trisalicylic Acid 100 mg<br />
USP1696958 Trolamine 3 mL<br />
USP1697000 Trole<strong>and</strong>omycin 250 mg<br />
USP1698002 Tromethamine 125 mg<br />
USP1699005 Tropicamide 200 mg<br />
USP1700002 Trypsin Crystallized 300 mg<br />
USP1700501 L-Tryptophan 200 mg<br />
USP1702008 Tubocurarine Chloride 250 mg<br />
USP1703805 Tylosin 250 mg<br />
USP1703850 Tylosin Tartrate 100 mg<br />
USP1704003 Tyloxapol 600 mg<br />
USP1705006 L-Tyrosine 500 mg<br />
USP1705301 Ubidecarenone 200 mg<br />
USP1705312 Ubidecarenone for System Suitability 25 mg<br />
USP1705323<br />
Ubidecarenone Related Compound A<br />
Coenzyme Q 9<br />
USP1705505 Undecylenic Acid 200 mg<br />
USP1705800 Uracil Arabinoside 50 mg<br />
20 mg<br />
25 mg<br />
25 mg<br />
25 mg<br />
15 mg<br />
58 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
United States Pharmacopeia <strong>and</strong> National Formulary<br />
Code Product Unit<br />
USP1706698 Urea 200 mg<br />
USP1706701 Urea C 13 100 mg<br />
USP1707806 Ursodiol 125 mg<br />
USP1707908 Valerenic Acid 15 mg<br />
USP1708503 L-Valine 200 mg<br />
USP1708707 Valproic Acid 500 mg<br />
USP1708729<br />
USP1708718<br />
Valproic Acid Related Compound A<br />
Diallylacetic Acid<br />
Valproic Acid Related Compound B<br />
(2RS)-2-(1-methylethyl) pentanoic acid (AS)<br />
0.25 mL<br />
USP1708762 Valsartan 350 mg<br />
USP1708773<br />
New USP1708784<br />
USP1708795<br />
Valsartan Related Compound A<br />
(R)-N-Valeryl-N-([2'-(1-H-tetrazole)-5-yl)-biphenyl-4-yl]-methyl)-valine<br />
Valsartan Related Compound B<br />
(S)-N-butyryl-N-{[2'-(1-H-tetrazole-5-yl)-biphenyl-4-yl]-methyl}-valine<br />
Valsartan Related Compound C<br />
(S)-N-Valeryl-N-([2'-(1-H-tetrazole)-5-yl)-biphenyl-4-yl]-methyl)-valine benzyl ester<br />
USP1709007 Vancomycin HCl 4 vials<br />
USP1709018 Vancomycin B with Monodechlorovancomycin 350 mg<br />
USP1710006 Vanillin 200 mg<br />
USP1711009 Vanillin Melting Point St<strong>and</strong>ard (Approximately 82°C) 1 g<br />
USP1711155 Vecuronium Bromide 50 mg<br />
USP1711166<br />
New USP1711177<br />
New USP1711188<br />
New USP1711224<br />
Vecuronium Bromide Related Compound A<br />
3alpha, 17beta-diacetyl-oxy-2beta, 16beta-bispiperidinyl-5alpha-<strong>and</strong>rostan<br />
Vecuronium Bromide Related Compound B<br />
Piperidinium,1-[(2beta, 3alpha, 5alpha, 16beta, 17beta)-3-acetyloxy-17-hydroxy-<br />
2-(1-piperidinyl)<strong>and</strong>rostan-16-yl]-1-methyl bromide<br />
Vecuronium Bromide Related Compound C<br />
[Piperidinium,1-[(2beta,3alpha,5alpha,16beta,17beta)-3,17-dihydroxy-<br />
2-(1-piperidinyl)<strong>and</strong>rostan-16-yl]-1-methyl bromide]<br />
Vecuronium Bromide Related Compound F<br />
Piperidinium,1-[(2beta,3alpha,5alpha,16beta,17beta)-17-acetyloxy-3-hydroxy-<br />
2-(1-piperidinyl)<strong>and</strong>rostan-16-yl]-1-methyl bromide<br />
USP1711202 Verapamil HCl 200 mg<br />
USP1711304<br />
USP1711406<br />
USP1711428<br />
New USP1711439<br />
New USP1711440<br />
Verapamil Related Compound A<br />
3,4-Dimethoxy-alpha-[3-(methylamino)propyl]-alpha-(1-methylethyl)-benzeneacetonitrile<br />
monoHCl<br />
Verapamil Related Compound B<br />
alpha-[2-[[2-(3,4-dimethoxyphenyl)-ethyl]methylamino]ethyl]-3,4-dimethoxy-alpha-<br />
(1-methylethyl)-benzeneacetonitrile monohydrochloride<br />
Verapamil Related Compound D<br />
5,5'-[[2-(3,4)dimethoxyphenyl)ethyl]imino]bis[2-(3,4-dimethoxyphenyl)-<br />
2-(1-methylethyl)pentanenitrile]hydrochloride<br />
Verapamil Related Compound E<br />
3,4-dimethoxybenzaldehyde<br />
Verapamil Related Compound F<br />
3,4-Dimethoxybenzyl alcohol<br />
50 mg<br />
10 mg<br />
10 mg<br />
10 mg<br />
25 mg<br />
15 mg<br />
15 mg<br />
15 mg<br />
50 mg<br />
50 mg<br />
50 mg<br />
50 mg<br />
150 mg<br />
USP1711461 Verteporfin 200 mg<br />
USP1711472<br />
Verteporfin Related Compound A<br />
(+/-)18-Ethenyl-4,4a-dihydro-3,4-bis(methoxycarbonyl)-4a,8,14,19-tetramethyl-23H,25Hbenzo[b]prophine-9,13-dipropanoic<br />
Acid<br />
USP1711508 Vidarabine 200 mg<br />
USP1713004 Vinblastine Sulfate 50 mg<br />
USP1714007 Vincristine Sulfate 50 mg<br />
USP1714506 Vinorelbine Tartrate 200 mg<br />
USP1714528<br />
Vinorelbine Related Compound A<br />
4-O-Deacetylvinorelbine Tartrate<br />
USP1715000 Viomycin Sulfate 200 mg<br />
50 mg<br />
25 mg<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 59
United States Pharmacopeia <strong>and</strong> National Formulary<br />
Code Product Unit<br />
USP1716002 Vitamin A unit<br />
USP1717504 Vitamin D Assay System Suitability 1.5 g<br />
USP1717708 Vitexin 30 mg<br />
USP1719000 Warfarin 200 mg<br />
USP1719102<br />
Warfarin Related Compound A<br />
3-(o-hydroxyphenyl)-5-phenyl-2-cyclohexen-1-one<br />
USP1720000 Xanthanoic Acid 100 mg<br />
USP1720203 Xanthone 100 mg<br />
USP1720407 Xylazine 200 mg<br />
USP1720429 Xylazine HCl 200 mg<br />
USP1720600 Xylitol 1 g<br />
USP1721002 Xylometazoline HCl 125 mg<br />
USP1722005 Xylose 1 g<br />
USP1724000 Yohimbine HCl 200 mg<br />
USP1724306 Zalcitabine 200 mg<br />
USP1724317<br />
Zalcitabine Related Compound A<br />
2',3'-Didehydro-2',3'-dideoxycytidine<br />
USP1724500 Zidovudine 400 mg<br />
USP1724521<br />
USP1724532<br />
Zidovudine Related Compound B<br />
3'-chloro-3'-deoxythymidine<br />
Zidovudine Related Compound C<br />
Thymine<br />
50 mg<br />
50 mg<br />
25 mg<br />
100 mg<br />
USP1724656 Zil<strong>eu</strong>ton 150 mg<br />
USP1724667<br />
USP1724678<br />
USP1724689<br />
Zil<strong>eu</strong>ton Related Compound A<br />
N-(1-Benzo[b]thien-2-ylethyl)urea<br />
Zil<strong>eu</strong>ton Related Compound B<br />
2-(Benzo[b]thien-2-oyl)benzo[b]thiophene<br />
Zil<strong>eu</strong>ton Related Compound C<br />
1-Benzo[b]thien-2-ylethanone<br />
USP1724747 Zinc Oxide (AS) 2 g<br />
USP1724769 Zinc Sulfate (AS) 1 g<br />
USP1724805 Zolazepam HCl 500 mg<br />
50 mg<br />
50 mg<br />
50 mg<br />
60 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
ATCC microbiology products<br />
ATCC microbiology products<br />
As a scientist you know the importance of using the best materials to support your quality control programme.<br />
As Europe’s only officially authorized distributor of ATCC ® cultures, LGC St<strong>and</strong>ards can supply all ATCC<br />
organisms specified in the pharmacopoeia.<br />
ATCC maintains the highest st<strong>and</strong>ards for its biological materials, employing stringent quality control procedures<br />
to produce cultures which are well characterized <strong>and</strong> have low passage numbers. Long-term subculturing of<br />
biological materials can have adverse effects on the culture population, including genetic drift, unwanted selection,<br />
contamination, <strong>and</strong> varied cell responses. ATCC quality control cultures sold by LGC St<strong>and</strong>ards are never<br />
subcultured or transferred in any way from ATCC’s strains <strong>and</strong> our European stock-holding means orders<br />
are usually filled within 3 - 5 working days.<br />
So whether it is quality control strains, genomic DNA, media or growth supplements, antibiotics for selection,<br />
or a huge selection of organisms, take the time <strong>and</strong> guesswork out of ordering your microbiology supplies with<br />
authentic, high-quality ATCC materials - exclusively from LGC St<strong>and</strong>ards.<br />
Code Product Unit<br />
USP27 - Chondroitin sulfate sodium Monograph<br />
ATCC-11437 Clostridium sporogenes amp.<br />
USP27 - Oil- <strong>and</strong> water-soluble vitamins with minerals tablets Monograph<br />
ATCC-7830 Lactobacillus delbrueckii ss. lactis (as L.Leichmannii) amp.<br />
ATCC-8014 Lactobacillus plantarum 17-5 amp.<br />
USP27 - Penicillamine Monograph<br />
ATCC-9341 Kocuria rhizophila amp.<br />
USP27 - Penicillin G Procaine <strong>and</strong> novobiocin sodium intramammary infusion......<br />
ATCC-12692 Staphylococcus aur<strong>eu</strong>s ss.aur<strong>eu</strong>s amp.<br />
USP27 - Sargraostim Monograph<br />
ATCC-CRL-2003 TF-1 Cells amp.<br />
USP27 - Tetracycline hydrochloride <strong>and</strong> novobiocin sodium tablets Monograph<br />
ATCC-10536 Escherichia coli amp.<br />
USP27 - Water-soluble vitamins capsules Monograph<br />
ATCC-8042 Pediococcus acidilactici amp.<br />
USP27 Antimicrobial effectiveness testing<br />
ATCC-16404 Aspergillus niger amp.<br />
ATCC-10231 C<strong>and</strong>ida albicans amp.<br />
ATCC-8739 Escherichia coli amp.<br />
ATCC-9027 Ps<strong>eu</strong>domonas aeruginosa amp.<br />
ATCC-6538 Staphylococcus aur<strong>eu</strong>s ss. aur<strong>eu</strong>s amp.<br />
USP27 Biological indicator for dry-heat sterilization, paper carrier<br />
ATCC-9372** Bacillus subtilis amp.<br />
USP27 Biological indicator for ethylene oxide sterilization, paper carrier<br />
ATCC-9372** Bacillus subtilis amp.<br />
USP27 Biological indicator for steam sterilization, paper carrier<br />
ATCC-7953** Bacillus stearothermophilus amp.<br />
ATCC-12980 Bacillus stearothermophilus amp.<br />
USP27 Biological indicator for steam sterilization, self contained<br />
ATCC-7953** Bacillus stearothermophilus amp.<br />
ATCC-12980 Bacillus stearothermophilus amp.<br />
USP27 Sterility tests<br />
ATCC-16404 Aspergillus niger amp.<br />
ATCC-6633 Bacillus subtilis amp.<br />
ATCC-8482 Bacteroides vulgatus amp.<br />
ATCC-10231 C<strong>and</strong>ida albicans amp.<br />
ATCC-11437 Clostridium sporogenes amp.<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 61
ATCC microbiology products<br />
Code Product Unit<br />
ATCC-19404 Clostridium sporogenes amp.<br />
ATCC-9341 Kocuria rhizophila amp.<br />
ATCC-9027 Ps<strong>eu</strong>domonas aeruginosa amp.<br />
ATCC-6538 Staphylococcus aur<strong>eu</strong>s ss. aur<strong>eu</strong>s amp.<br />
USP27 Antibiotics assays<br />
ATCC-6633 Bacillus subtilis amp.<br />
ATCC-4617 Bordetella bronchiseptica amp.<br />
ATCC-10541 Enterococcus hirae (as Streptococcus faecalis) amp.<br />
ATCC-10536 Escherichia coli amp.<br />
ATCC-10031 Klebsiella pn<strong>eu</strong>moniae ss. pn<strong>eu</strong>moniae amp.<br />
ATCC-9341 Kocuria rhizophila amp.<br />
ATCC-10240 Micrococcus lut<strong>eu</strong>s amp.<br />
ATCC-607 Mycobacterium smegmatis amp.<br />
ATCC-25619 Ps<strong>eu</strong>domonas aeruginosa amp.<br />
ATCC-2601 Saccharomyces cerevisiae amp.<br />
ATCC-9763 Saccharomyces cerevisiae amp.<br />
ATCC-9144 Staphylococcus aur<strong>eu</strong>s ss. aur<strong>eu</strong>s amp.<br />
ATCC-29737 Staphylococcus aur<strong>eu</strong>s ss. aur<strong>eu</strong>s amp.<br />
ATCC-12228 Staphylococcus epidermidis amp.<br />
USP27 Biological reactivity tests, in-vitro amp<br />
ATCC-CCL-1 L-929 mammalian fibroblasts NCTC Clone 929 amp.<br />
USP27 Calcium pantothenate assay<br />
ATCC-8014 Lactobacillus plantarum 17-5 amp.<br />
USP27 Dexpanthenol assay<br />
ATCC-8042 Pediococcus acidilactici amp.<br />
USP27 Vitamin B12 activity assay<br />
ATCC-7830 Lactobacillus delbrueckii ss. lactis (as L.Leichmannii) amp.<br />
USP27 Niacin or niacinamide assay<br />
ATCC-8014 Lactobacillus plantarum 17-5 amp.<br />
USP27 Analytical methodologies<br />
ATCC-VR-1448 Hybrid Moloney Amphotropic murine l<strong>eu</strong>kemia virus amp.<br />
ATCC-VR-1450 Hybrid Moloney Amphotropic murine l<strong>eu</strong>kemia virus amp.<br />
USP27 Sterilzation <strong>and</strong> sterility assurance of compendial articles<br />
ATCC-27142** Bacillus pumilus amp.<br />
ATCC-7953** Bacillus stearothermophilus amp.<br />
ATCC-9372** Bacillus subtilis amp.<br />
ATCC-19146 Brevendimonas diminuta (as Ps<strong>eu</strong>domonas diminuta) amp.<br />
ATCC-14756 Serratia marcescens amp.<br />
USP27 Microbial enumeration tests - Dietary supplements<br />
ATCC-16404 Aspergillus niger amp.<br />
ATCC-6633 Bacillus subtilis amp.<br />
ATCC-10231 C<strong>and</strong>ida albicans amp.<br />
ATCC-8739 Escherichia coli amp.<br />
ATCC-13311 Salmonella choleraesuis ss. choleraesuis serotype typhimurium (as Salmonella typhimurium) amp.<br />
ATCC-6538 Staphylococcus aur<strong>eu</strong>s ss. aur<strong>eu</strong>s amp.<br />
** = Alternative strain<br />
All care has been taken in compiling catalogue numbers, however users should consult the Pharmacopoeia directly to<br />
confirm the testing requirements <strong>and</strong> recommended organisms before ordering or undertaking the testing procedures<br />
as described in the Pharmacopoeia.<br />
62 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
European<br />
Pharmacopoeia<br />
Certified liquids<br />
for viscosity<br />
measurements<br />
International<br />
commission on<br />
pharmac<strong>eu</strong>tical<br />
enzymes<br />
European<br />
pharmacopoeia<br />
reagents<br />
St<strong>and</strong>ards<br />
Excellence through measurement
From Acebutolol<br />
to Zopiclone -<br />
2,100 pharmac<strong>eu</strong>tical<br />
<strong>impurities</strong><br />
LGC St<strong>and</strong>ards offers over 2,100 <strong>reference</strong> st<strong>and</strong>ards for<br />
pharmac<strong>eu</strong>tical <strong>impurities</strong> to support the pharmac<strong>eu</strong>tical<br />
industry worldwide. We have a technical support team<br />
<strong>and</strong> expert customer service to aid you with any specific<br />
query you may have.<br />
• Impurities linked to the European Pharmacopoeia<br />
(EP) wherever possible<br />
• Customised pharmac<strong>eu</strong>tical <strong>impurities</strong> created on<br />
request<br />
• Supply of mg or g quantities<br />
• Detailed certificates of analysis provided<br />
• Tailored certificates with additional documentation<br />
available<br />
• Assistance in finding the right material to suit your<br />
analyses<br />
For further information or to receive any one of our<br />
catalogues please contact your local office or visit<br />
our website.<br />
Acebutolol<br />
Clotrimazole<br />
Ethinylestradiol<br />
Flucloxacillin<br />
Ibuprofen<br />
Naproxen<br />
Omeprazole<br />
Piroxicam<br />
Sildenafil<br />
Testosterone<br />
Verapamil<br />
Zopiclone<br />
www.lgcst<strong>and</strong>ards.com
European Pharmacopoeia<br />
Background<br />
European Pharmacopoeia<br />
The European Pharmacopoeia (EP) Commission includes in its membership delegates from nations who<br />
have adopted the European Pharmacopoeia.<br />
The EP Commission is in charge of judging the suitability of monographs. Prior to release, a new monograph<br />
must be adopted by the EP Commission, <strong>and</strong> then published in the annual ‘Fascicule’. Member States then<br />
officially adopt the new monograph on 1 st January of the following year.<br />
To support the monographs of the European Pharmacopoeia, a collection of <strong>reference</strong> <strong>substances</strong> has<br />
been made available which includes:<br />
1. Current, official, European Pharmacopoeia Chemical Reference Substances (EP CRS) <strong>and</strong><br />
Biological Reference Preparations (BRP)<br />
2. Reference Spectra<br />
3. Other <strong>reference</strong> preparations, including Enzymes <strong>and</strong> Substrates from the<br />
International Commission on <strong>Pharmac<strong>eu</strong>tical</strong> Enzymes <strong>and</strong> Certified Viscosity St<strong>and</strong>ards<br />
from Van Swinden Laboratories.<br />
4. With supplement 4.3, the revised EP general method 2.2.6 replaces CRS <strong>reference</strong> liquids with<br />
certified <strong>reference</strong> materials available from suppliers of chemical reagents or materials certified<br />
for metrology. Ten liquid CRMs, certified by the Physical Chemistry Division of the Central Office<br />
of Measures (GUM), Warsaw in Pol<strong>and</strong>, cover the wide range of refractive index from 1,333<br />
(water) to 1,657 (1-bromonaphthalene). More detailed information is given in the chapter<br />
"Dyes <strong>and</strong> refractive index CRMs" of this catalogue.<br />
5. European Pharmacopoeia Reagents.<br />
New lists of EP CRS/BRP are published three times a year. The list in this catalogue is taken from<br />
EP list No. 49 of August 2007.<br />
Relationship with other pharmacopoeias in Europe<br />
Any <strong>reference</strong> substance, spectra or preparation required for a new EP monograph, is made available as<br />
soon as the monograph comes into force.<br />
Many of the member countries of the European Pharmacopoeia Commission have adopted the EP in full,<br />
<strong>and</strong> their monographs require only EP CRS/BRP. When an EP monograph is adopted by the pharmacopoeia<br />
of a member state of the Council of Europe then any <strong>reference</strong> material that may have been available from<br />
a national pharmacopoeia, e.g. BP or PF, will usually be discontinued in favour of the EP <strong>reference</strong><br />
substance. However, a number of member countries of the EP Commission maintain national<br />
pharmacopoeial monographs, especially for finished dosage forms, which require the use of separate<br />
<strong>reference</strong> <strong>substances</strong>.<br />
A separate chapter in this catalogue includes lists of the <strong>reference</strong> <strong>substances</strong> produced for the British,<br />
French, Swiss <strong>and</strong> International pharmacopoeia monographs. The International Pharmacopoeia (IP)<br />
<strong>reference</strong> <strong>substances</strong> are described in the section referring to the WHO (World Health Organization).<br />
Production <strong>and</strong> certification<br />
European Pharmacopoeia <strong>reference</strong> <strong>substances</strong> <strong>and</strong> preparations are selected <strong>and</strong> verified by the EP<br />
laboratories as being suitable for the use as prescribed in the relevant monograph of the European<br />
Pharmacopoeia.<br />
Since CRS <strong>and</strong> BRP are officially certified by the European Pharmacopoeia Commission, it should be<br />
noted that neither certificates of analysis nor data not relevant to the use of the products as defined by<br />
the EP monograph are provided with the <strong>reference</strong> product or substance.<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 65
European Pharmacopoeia<br />
Storage, shelf life <strong>and</strong> expiry dates<br />
European Pharmacopoeia CRS/BRP are subject to regular inspection <strong>and</strong> repeated analysis by EP scientific<br />
staff. Each EP CRS/BRP is, on receipt by the customer, fit for the intended use.<br />
No expiry date is indicated on the <strong>reference</strong> materials because the products or <strong>substances</strong> comply with<br />
the requirements of the corresponding monograph <strong>and</strong> are monitored regularly. When batches are to be<br />
changed, the EP CRS catalogue shows the date on which the lot will no longer be official.<br />
In specific cases for reasons related to filling or labeling, sub-batches are obtained from the same batch of<br />
bulk material. However, all the necessary precautions are taken in order to guarantee that the quality <strong>and</strong><br />
specifications of the sub-batches do not differ from one to another. The EP changed the labeling structure<br />
of the sub-batches recently. Sub-batches are now labeled for example as 2.1, 2.2, 2.3 instead of 2a, 2b, 2c.<br />
The EP is also currently over-labelling all its <strong>reference</strong> st<strong>and</strong>ards vials with a secondary label. This new<br />
secondary label is useful for customs purposes as it can be peeled off. It can also be stuck onto your<br />
laboratory book to prove the use of the <strong>reference</strong> st<strong>and</strong>ard. All the required information to perform the<br />
tests described in the European Pharmacopoeia monographs are stated on the primary label.<br />
EP recommends only sufficient material should be purchased for immediate use <strong>and</strong> that unopened vials<br />
should be stored in the dark unless otherwise stated. Whilst most EP CRS/BRP can be shipped at ambient<br />
temperature, certain items have to be maintained at controlled temperatures at all times <strong>and</strong> are subject to<br />
special shipping charges <strong>and</strong> storage conditions (details are available on request).<br />
Where no drying conditions are stated, the substance is to be used as received.<br />
Once opened, EP can no longer guarantee the stability of the material <strong>and</strong> any of the CRS/BRP not used<br />
should be disposed of <strong>and</strong> not kept for future use.<br />
Validation of secondary st<strong>and</strong>ards<br />
All secondary in-house working st<strong>and</strong>ards have to be validated against the CURRENT batch of the EP<br />
CRS/BRP, so we advise you to check that you have current batch numbers.<br />
As your supplier of choice, LGC St<strong>and</strong>ards can provide lists of current batch numbers of EP<br />
CRS/BRP, so call us to receive these today. We can provide the same service for USP <strong>reference</strong><br />
st<strong>and</strong>ards, which are listed in the USP chapter of this catalogue. Please take this opportunity to subscribe<br />
to this free service by contacting your local LGC St<strong>and</strong>ards office.<br />
Proper use<br />
EP discontinued their use code number system as of January 2006.<br />
For information on the use of the <strong>substances</strong> please refer to the monograph or contact your local<br />
LGC St<strong>and</strong>ards office.<br />
Opening<br />
For <strong>reference</strong> <strong>substances</strong> <strong>and</strong> preparations supplied in sealed glass ampoules the following technique is<br />
suitable for opening the ampoule: tap gently to collect the material at the lower end, score the ampoule with<br />
a file, heat a glass rod to white heat <strong>and</strong> apply firmly to the file mark. If the glass does not crack, deepen <strong>and</strong><br />
extend the file mark, <strong>and</strong> repeat the process. Eye <strong>and</strong> h<strong>and</strong> protection MUST be used.<br />
Many <strong>reference</strong> <strong>substances</strong> are supplied as lyophilised material in a septum vial. No attempt should be<br />
made to open the vial <strong>and</strong> weigh out the powder. It is important to strictly follow the monograph instructions,<br />
reconstitute the material in a buffer solvent <strong>and</strong> h<strong>and</strong>le the resultant solution volumetrically.<br />
Toxicity<br />
The potential toxicity of certain <strong>reference</strong> <strong>substances</strong> is such that special precautions should be taken to<br />
avoid contact.<br />
Such <strong>substances</strong> should be manipulated in a glove box. If this is not possible, gloves, eye protection <strong>and</strong><br />
a mask should be worn.<br />
Following the guidelines suggested by the EP does not replace the need to carry out a full hazard<br />
assessment.<br />
Biological <strong>and</strong> blood products should be regarded as potentially hazardous to health <strong>and</strong> therefore used<br />
<strong>and</strong> disposed of according to established laboratory safety procedures.<br />
Controlled Substances<br />
The EP list contains <strong>substances</strong> subject to Controlled Substance regulations schedules. Special ordering<br />
procedures apply, so please contact LGC St<strong>and</strong>ards for details <strong>and</strong> costs.<br />
66 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
European Pharmacopoeia<br />
Code Product Unit<br />
EPY0000055 Acamprosate calcium - Reference Spectrum unit<br />
EPY0000116<br />
Acamprosate impurity A<br />
3-aminopropane-1-sulphonic acid<br />
EPY0000500 Acarbose 94.7 mg<br />
EPY0000354 Acarbose for identification 10 mg<br />
EPY0000427 Acarbose for peak identification 40 mg<br />
EPA0040000 Acebutolol hydrochloride 50 mg<br />
EPY0000359<br />
EPY0000127<br />
EPY0000128<br />
Acebutolol impurity B<br />
N-[3-acetyl-4-[(2RS)-2-hydroxy-3-[(1-methylethyl)<br />
amino]propoxy]phenyl]acetamide (diacetolol)<br />
Acebutolol impurity C<br />
N-(3-acetyl-4-hydroxyphenyl)butanamide<br />
Acebutolol impurity I<br />
N-[3-acetyl-4-[(2RS)-3-(ethylamino)-2-hydroxypropoxy]phenyl)<br />
butanamide<br />
50 mg<br />
10 mg<br />
20 mg<br />
0.004 mg<br />
EPY0000056 Aceclofenac - Reference Spectrum unit<br />
EPY0000085<br />
New EPY0000086<br />
Aceclofenac impurity F<br />
benzyl[[[2-[(2,6-dichlorophenyl)amino]phenyl]acetyl]oxy]acetate<br />
Aceclofenac impurity H<br />
[[[[[[[2-[(2,6-dichlorophenyl)amino]phenyl]acetyl]oxy]acetyl]oxy]acetyl]oxy]acetic acid<br />
New EPY0000810 Acemetacin 100 mg<br />
New EPY0000811<br />
Acemetacin impurity A<br />
4-chlorobenzoic acid<br />
EPA0050000 Acenocoumarol 20 mg<br />
EPA0070000 Acesulfame potassium 50 mg<br />
EPA0070020<br />
Acesulfame potassium impurity B<br />
5-chloro-6-methyl-1,2,3-oxathiazin-4(3H)-one 2,2-dioxide<br />
EPA0100000 Acetazolamide 100 mg<br />
EPY0000002 Acetylcholine chloride 50 mg<br />
EPA0150000 Acetylcysteine 50 mg<br />
EPA0152000<br />
EPA0153000<br />
Acetylcysteine impurity C<br />
N,N'-diacetyl-L-cystine<br />
Acetylcysteine impurity D<br />
N,S-diacetyl-L-cysteine<br />
EPY0000565 β-Acetyldigoxin 30 mg<br />
EPY0000642 β-Acetyldigoxin for peak identification 10 mg<br />
EPA0200000 Acetylsalicylic acid 100 mg<br />
EPA0208000 N-Acetyltryptophan 125 mg<br />
EPA0202000 N-Acetyltyrosine 200 mg<br />
EPY0000693 Acholeplasma laidlawii BRP 1 mL<br />
EPA0220000 Aciclovir 75 mg<br />
EPA0221000<br />
Aciclovir impurity A<br />
2-[(2-amino-6-oxo-1,6-dihydro-9H-purin-9-yl)methoxy]ethyl acetate<br />
EPA0225000 Acitretin 100 mg<br />
EPY0000360 Acriflavinium monochloride 1 mg<br />
EPA0230000 Adenine 50 mg<br />
EPA0230200 Adenosine 50 mg<br />
EPY0000110 Adipic acid 50 mg<br />
EPA0300000 Adrenaline tartrate 200 mg<br />
New EPY0000740 Adrenaline impurity mixture 0.005 mg<br />
New EPY0000707 Adrenaline tartrate with impurity A 15 mg<br />
EPA0325000 Alanine 50 mg<br />
New EPY0000728 Agnus castus fruit st<strong>and</strong>ardised dry extract 200 mg<br />
EPA0325100 Albendazole 50 mg<br />
EPA0325200 Alcuronium chloride 100 mg<br />
20 mg<br />
10 mg<br />
10 mg<br />
10 mg<br />
10 mg<br />
10 mg<br />
15 mg<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 67
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Code Product Unit<br />
EPA0325450 Alfacalcidol 5 mg<br />
EPA0325451 Alfacalcidol - Reference Spectrum unit<br />
EPA1225000 Alfadex 150 mg<br />
EPA0325500 Alfentanil hydrochloride - Reference Spectrum unit<br />
EPA0325800 Alfuzosin hydrochloride 50 mg<br />
EPA0325801<br />
Alfuzosin impurity A<br />
N-[3-[(4-amino-6,7-dimethoxyquinazolin-2-yl)(methyl)-amino]propyl]<br />
furan-2-carboxamide<br />
New EPY0000832 Alfuzosin for system suitability 10 mg<br />
EPA0349000 Allantoin 60 mg<br />
EPA0350000 Allopurinol 50 mg<br />
EPA0350010<br />
EPA0350020<br />
EPA0350030<br />
EPA0350040<br />
EPA0350050<br />
Allopurinol impurity A<br />
5-amino-1H-pyrazole-4-carboxamide<br />
Allopurinol impurity B<br />
5-formylamino-1H-pyrazole-4-carboxamide<br />
Allopurinol impurity C<br />
N-(4H-1,2,4-triazol-4-yl)1H-pyrazole-4-carboxamide<br />
Allopurinol impurity D<br />
ethyl 5-amino-1H-pyrazole-4-carboxylate<br />
Allopurinol impurity E<br />
ethyl 5-(formylamino)-1H-pyrazole-4-carboxylate<br />
EPA0351000 Allylstrychnine bromide 10 mg<br />
EPY0000235 Almagate 25 mg<br />
EPY0000255 Almagate - Reference Spectrum unit<br />
EPA0357000 Alprazolam Controlled Substance 100 mg<br />
EPA0360000 Alprenolol hydrochloride 100 mg<br />
EPY0000054 Alprostadil 50 mg<br />
EPY0000606 Altizide 5 mg<br />
EPY0000687 Alverine citrate 5 mg<br />
EPY0000595 Alverine for peak identification 0.125 mg<br />
EPY0000607<br />
Alverine impurity D<br />
N-(3-cyclohexylpropyl)-N-ethyl-3-phenylpropan-1-amine<br />
EPA0363000 Amantadine hydrochloride 100 mg<br />
EPA0363700 Ambroxol hydrochloride 125 mg<br />
EPA0900000 Amfetamine sulphate - Reference Spectrum unit<br />
EPA0365000 Amidotrizoic acid dihydrate 100 mg<br />
EPA0368000 Amikacin 200 mg<br />
EPA0368010<br />
Amikacin Impurity A<br />
4-O-(3-amino-3-desoxy-alpha-D-glycopyranosyl)-6-O-(6-amino-6-desoxy-alpha-Dglucopyranosyl)-N1-[(2S)-4-amino-2-hydroxybutanoyl]-2-desoxy-L-streptamine<br />
10 mg<br />
10 mg<br />
10 mg<br />
10 mg<br />
10 mg<br />
20 mg<br />
10 mg<br />
2x10 mg<br />
EPA0365900 Amikacin sulphate 200 mg<br />
EPA0370000 Amiloride hydrochloride 100 mg<br />
EPY0000020<br />
Amiloride impurity A<br />
methyl-3,5-diamino-6-chloropyrazine-2-carboxylate<br />
EPY0000173 4-Aminobenzoic acid 60 mg<br />
EPA0420000 Aminocaproic acid 50 mg<br />
EPA0460000 7-Aminodesacetoxycephalosporanic acid 100 mg<br />
EPA0496000 Aminoglutethimide 125 mg<br />
EPA0496005<br />
EPA0496020<br />
Aminoglutethimide impurity A<br />
(3RS)-3-(3-aminophenyl)-3-ethylpiperidine-2,6-dione;<br />
(3-aminoglutethimide)<br />
Aminoglutethimide impurity D<br />
3,3'-[diazenediyldi(4,1-phenylene)]bis(3-ethylpiperidine-2,6-dione) (azoglutethimide)<br />
EPA0560000 5-Amino-2,4,6-tri-iodo-N-methylisophthalamic acid 20 mg<br />
EPA0575000 Amiodarone hydrochloride 100 mg<br />
10 mg<br />
20 mg<br />
10 mg<br />
68 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
European Pharmacopoeia<br />
Code Product Unit<br />
EPY0000129<br />
EPY0000130<br />
Amiodarone impurity D<br />
(2-butyl-benzofuran-3-yl)-(4-hydroxy-3,5-diiodophenyl)methanone<br />
Amiodarone impurity E<br />
(2-butyl-benzofuran-3-yl)-(4-hydroxyphenyl)methanone<br />
EPA0590000 Amisulpride 50 mg<br />
EPA0590004<br />
Amisulpride impurity B<br />
4-amino-N-[[(2RS )-1-ethylpyrrolidin-2-yl] methyl-5-(ethylsulphonyl)-2-hydroxybenzamine<br />
New EPY0000563 Amitriptyline hydrochloride 10 mg<br />
EPA0600000 Amitriptyline hydrochloride - Reference Spectrum unit<br />
EPY0000049 Amlodipine besilate 150 mg<br />
EPY0000302 Ammonio methacrylate copolymer (type A) - Reference Spectrum unit<br />
EPY0000303 Ammonio methacrylate copolymer (type B) - Reference Spectrum unit<br />
EPA0650000 Amobarbital Controlled Substance 500 mg<br />
EPA0700000 Amobarbital sodium Controlled Substance 500 mg<br />
EPA0800000 Amoxicillin trihydrate 100 mg<br />
EPY0000005 Amphotericin B 500 mg<br />
EPA1000000 Ampicillin (anhydrous) 250 mg<br />
EPA1100000 Ampicillin trihydrate 150 mg<br />
EPA1200000 Anhydrotetracycline hydrochloride 10 mg<br />
EPA1210000 Antazoline hydrochloride 50 mg<br />
EPY0000172 Apomorphine hydrochloride - Reference Spectrum unit<br />
EPA1220000 Alpha-apo-oxytetracycline 20 mg<br />
EPA1230000 Beta-apo-oxytetracycline 20 mg<br />
EPA1250000 Aprotinin solution BRP 0.5 mL<br />
EPA1269000 L-Arabinitol 10 mg<br />
New EPY0000806 Arbutin 100 mg<br />
EPA1270000 Arginine 50 mg<br />
EPY0000304 Arginine aspartate 20 mg<br />
EPA1271000 Arginine hydrochloride 50 mg<br />
EPY0000079 Articaine hydrochloride 100 mg<br />
EPY0000080<br />
EPY0000081<br />
Articaine impurity A<br />
methyl3-[[2-(propylamino)acetyl]amino]-4-methylthiophene-2-carboxylate<br />
Articaine impurity E<br />
methyl 4-methyl-3-[[(2RS)-2-[(1-methylethyl)amino]propanoyl]<br />
amino]thiophene-2-carboxylate<br />
EPA1300000 Ascorbic acid (Vitamin C) 100 mg<br />
New EPY0000800 Ascorbyl palmitate 10 mg<br />
EPA1315000 Ascorbyl palmitate - Reference Spectrum unit<br />
EPY0000305 Asparagine monohydrate 60 mg<br />
EPA1320000 Aspartame 40 mg<br />
EPA1321000<br />
Aspartame impurity A<br />
2-(5-benzyl-3,6-dioxopiperazin-2-yl)acetic acid (diketopiperazine)<br />
EPA1330000 Aspartic acid 50 mg<br />
EPA1335000 Astemizole 150 mg<br />
EPA1340000 Atenolol 100 mg<br />
EPA1341000 Atenolol for column validation 100 mg<br />
EPY0000424 Atracurium besilate 120 mg<br />
EPY0000503 Atracurium for impurity F identification 5 mg<br />
EPY0000504 Atracurium for peak identification 5 mg<br />
EPY0000231 Atropine - Reference Spectrum unit<br />
EPA1400000 Atropine sulphate 50 mg<br />
EPY0000230 Atropine for system suitability 0.4 mg<br />
EPY0000029 Azaperone 50 mg<br />
20 mg<br />
20 mg<br />
10 mg<br />
10 mg<br />
10 mg<br />
10 mg<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 69
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Code Product Unit<br />
EPA1500000 Azathioprine 100 mg<br />
EPY0000326 Azelastine hydrochloride 25 mg<br />
EPY0000327<br />
EPY0000328<br />
EPY0000329<br />
Azelastine impurity B<br />
1-benzoyl-2-[(4RS)-1-methylhexahydro-1H-azepin-4-yl]diazane<br />
Azelastine impurity D<br />
4-(4-chlorobenzyl)phthalazin-1(2H)-one<br />
Azelastine impurity E<br />
3-(4-chlorobenzilidene)isobenzofuran-1(3H)-one<br />
EPY0000306 Azithromycin 120 mg<br />
EPY0000637 Azithromycin for peak identification 15 mg<br />
EPY0000641 Azithromycin for system suitability 0.05 mg<br />
EPY0000307<br />
EPY0000308<br />
Azithromycin impurity A<br />
6-demethylazithromycin<br />
Azithromycin impurity B<br />
3-deoxyazithromycin<br />
5 mg<br />
5 mg<br />
5 mg<br />
10 mg<br />
0.04 mg<br />
EPY0000285 B19 virus DNA for NAT testing BRP 150 mg<br />
EPB0070000 Bacampicillin hydrochloride 120 mg<br />
EPB0100000 Bacitracin zinc 150 mg<br />
EPB0200000 Baclofen 50 mg<br />
EPB0200050<br />
Baclofen impurity A<br />
(RS)-4-amino-3-(4-chlorophenyl)butyric acid lactam<br />
EPB0250000 Bambuterol hydrochloride 100 mg<br />
EPB0300000 Barbital Controlled Substance 500 mg<br />
EPY0000295 Basic butylated methacrylate copolymer - Reference Spectrum unit<br />
EPB0305000 Beclometasone dipropionate anhydrous 150 mg<br />
EPY0000351 Beclometasone dipropionate monohydrate 10 mg<br />
EPY0000352 Beclometasone dipropionate for system suitability 10 mg<br />
EPY0000469 Beclometasone dipropionate for peak identification 10 mg<br />
EPB0400000 Bendroflumethiazide 100 mg<br />
EPY0000564<br />
Bendroflumethiazide impurity A<br />
4-amino-6-(trifluoromethyl)benzene-1,3-disulphonamide<br />
EPY0000044 Benfluorex hydrochloride 50 mg<br />
EPY0000043 Benfluorex hydrochloride for system suitability 360 mg<br />
EPB0470000 Benperidol 100 mg<br />
EPB0477000 Benserazide hydrochloride 50 mg<br />
EPB0477010<br />
Benserazide impurity A<br />
(RS)-2-amino-3-hydroxypropanohydrazide<br />
EPB0490000 Benzarone 10 mg<br />
EPB0500000 Benzathine benzylpenicillin 125 mg<br />
New EPY0000775 Benzbromarone 10 mg<br />
EPB0505000 Benzbromarone - Reference Spectrum unit<br />
EPB0550000 Benzethonium chloride 100 mg<br />
EPB0600000 Benzocaine 50 mg<br />
EPY0000647 Benzophenone 40 mg<br />
EPY0000167 Benzyl alcohol 50 mg<br />
EPB0670000 Benzyl benzoate - Reference Spectrum unit<br />
EPB0680000 S-Benzylmercaptoacetyltriglycin 10 mg<br />
EPB0700000 Benzylpenicillin potassium 50 mg<br />
EPB0900000 Benzylpenicillin sodium 200 mg<br />
EPB0950000 Betadex 200 mg<br />
EPY0000391 Betahistine dihydrochloride 50 mg<br />
EPB0990000 Betahistine mesilate 100 mg<br />
EPB1000000 Betamethasone 75 mg<br />
50 mg<br />
5 mg<br />
20 mg<br />
70 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
European Pharmacopoeia<br />
Code Product Unit<br />
EPB1030000 Betamethasone acetate 100 mg<br />
EPB1040000 Betamethasone diproprionate 100 mg<br />
EPB1045000 Betamethasone sodium phosphate 100 mg<br />
EPB1054000 Betamethasone-17-valerate 100 mg<br />
EPB1055000 Betamethasone-21-valerate 15 mg<br />
EPB1103000 Betaxolol hydrochloride 60 mg<br />
EPB1103100<br />
Betaxolol impurity A<br />
(RS)-3-(4-ethylphenoxy)-1-[(1-methylethyl)-amido]propan-2-ol<br />
EPB1115000 Bezafibrate 100 mg<br />
EPB1110000 Bifonazole 100 mg<br />
EPB1110004<br />
Bifonazole impurity B<br />
4-[(RS)-(biphenyl-4-yl)phenylmethyl]-1H-imidazole trifluoroacetate<br />
EPB1116000 Biotin (Vitamin H) 50 mg<br />
EPB1120000 Biperiden hydrochloride 60 mg<br />
EPB1121000<br />
Biperiden impurity A<br />
(1RS)-1-[(1SR,2SR,4SR)-bicyclo[2.2.1]hept-5-en-2-yl]-1-phenyl-3-<br />
(piperidin-1-yl)propan-1-ol (endo form)<br />
EPB1130000 1,3-bis(2-acetyl-3-hydroxyphenoxy)-2-propanol 50 mg<br />
EPB1140000 Bisacodyl 50 mg<br />
EPY0000608 Bisacodyl for peak identification 10 mg<br />
New EPY0000694 Bisacodyl for system suitability 5 mg<br />
EPB1141000 Bleomycin sulphate 7 mg<br />
EPY0000434 Boldine 30 mg<br />
EPB1142000 Bordetella pertussis mouse antiserum BRP 0.5 mg<br />
EPB1143000 Bromazepam Controlled Substance 60 mg<br />
EPY0000645 Bromazepam for system suitability Controlled Substance 10 mg<br />
EPB1145000 Bromhexine hydrochloride 100 mg<br />
EPY0000200<br />
Bromhexine impurity C<br />
N-(2-aminobenzyl)-N-methylcyclohexanamine<br />
EPB1150000 Bromocriptine mesilate 30 mg<br />
EPY0000677 Bromocriptine mesilate for system suitability 5 mg<br />
EPB1152000 Bromperidol 100 mg<br />
EPB1152050 Bromperidol decanoate 60 mg<br />
EPB1153000 Brompheniramine maleate 100 mg<br />
EPY0000468 Brotizolam Controlled Substance 10 mg<br />
EPY0000470<br />
Brotizolam impurity B<br />
2-bromo-4-(2-chlorophenyl)-6H-thieno[3,2-f][1,2,4]triazolo[4,3-a][1,4]diazepine<br />
(demethylbrotizolam)<br />
EPB1155000 Brucella melitensis Rev. 1 strain BRP 1 mg<br />
EPB1157300 Budesonide 110 mg<br />
EPB1156000 Bufexamac 100 mg<br />
EPB1157400 Buflomedil hydrochloride 100 mg<br />
EPB1157410<br />
Buflomedil impurity B<br />
4-(pyrrolidin-1-yl)-1-(4-hydroxy-2,6-dimethoxyphenyl)butan-1-one<br />
EPB1158000 Bumetanide 150 mg<br />
EPY0000309<br />
EPY0000310<br />
Bumetanide impurity A<br />
3-nitro-4-phenoxy-5-sulphamoylbenzoic acid<br />
Bumetanide impurity B<br />
3-amino-4-phenoxy-5-sulphamoylbenzoic acid<br />
EPB1160000 Bupivacaine hydrochloride 100 mg<br />
EPY0000088<br />
EPY0000089<br />
Bupivacaine impurity B<br />
(2RS)-N-(2,6-dimethylphenyl)piperidine-2-carboxamide<br />
Bupivacaine impurity E<br />
6-(butylamino)-N-(2,6-dimethylphenyl)hexanamide<br />
10 mg<br />
10 mg<br />
30 mg<br />
10 mg<br />
10 mg<br />
20 mg<br />
5 mg<br />
5 mg<br />
20 mg<br />
20 mg<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 71
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Code Product Unit<br />
EPB1160490 Buprenorphine - Reference Spectrum unit<br />
EPB1160500 Buprenorphine hydrochloride - Reference Spectrum unit<br />
EPB1168000 Buserelin 4.92 mg<br />
EPB1168020 D-His-Buserelin 0.5 mg<br />
EPY0000131 Buspirone hydrochloride 5 mg<br />
EPY0000471 Buspirone for system suitability 2 mg<br />
EPB1170000 Busulfan 50 mg<br />
EPB1217000 Butyl parahydroxybenzoate 50 mg<br />
EPB1212000 Butylhydroxyanisole 50 mg<br />
EPB1215000<br />
Butylhydroxytoluene<br />
Plastic additive 07<br />
EPY0000472 Cabergoline 100 mg<br />
EPC0100000 Caffeine 70 mg<br />
New EPY0000787 Caffeine for system suitability 20 mg<br />
EPC0166000 Calcifediol 5 mg<br />
EPC0166001 Calcifediol - Reference Spectrum unit<br />
EPY0000499 Calcipotriol (anhydrous) - Reference Spectrum unit<br />
EPY0000473 Calcipotriol monohydrate 5 mg<br />
EPY0000474 Calcipotriol monohydrate - Reference Spectrum unit<br />
EPC0200000 Calcitonin (salmon) 2x0.98 mg<br />
EPY0000632 Calcitonin-Gly 0.4 mL<br />
EPC0200010 N-acetyl-cys1-calcitonin 0.1 mg<br />
EPC0225000 Calcitriol 10 mg<br />
EPC0226000 Calcitriol - Reference Spectrum unit<br />
EPC0249000 Calcium ascorbate - Reference Spectrum unit<br />
EPC0250000 Calcium folinate 100 mg<br />
EPC0299000 Calcium glucoheptonate 60 mg<br />
EPC0300000 Calcium gluconate 100 mg<br />
EPC0340000 Calcium levulinate dihydrate 250 mg<br />
EPC0350000 Calcium oxalate monohydrate 500 mg<br />
EPC0400000 Calcium pantothenate 60 mg<br />
EPC0405000 Camphor (racemic) 50 mg<br />
EPC0410000 Canrenone 50 mg<br />
EPC0426000 Caprylic acid 200 mg<br />
EPY0000671 Capsaicin 50 mg<br />
EPC0430000 Captopril 10 mg<br />
EPY0000113 Carbachol 50 mg<br />
EPC0450000 Carbamazepine 200 mg<br />
EPY0000033 Carbamazepine impurity A<br />
10,11-dihydro-5H-dibenz[b,f]azepine-5-carboxamide<br />
(10,11-dihydrocarbamazepine)<br />
10 mg<br />
EPC0451000 Carbasalate calcium - Reference Spectrum unit<br />
EPC0455000 Carbenicillin sodium 50 mg<br />
EPC0460000 Carbidopa 50 mg<br />
EPC0465000 Carbimazole 100 mg<br />
EPC0470000 Carbocisteine 50 mg<br />
EPC0499900 Carbon dioxide - Reference Spectrum unit<br />
EPC0550000 Carboplatin - Reference Spectrum unit<br />
EPY0000475 Carboprost trometamol 40 mg<br />
EPY0000536 Carboprost trometamol - Reference Spectrum unit<br />
EPY0000035 Carisoprodol 50 mg<br />
50 mg<br />
72 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
European Pharmacopoeia<br />
Code Product Unit<br />
EPY0000036<br />
Carisoprodol impurity A<br />
(2RS)-2-(hydroxymethyl)-2-methylpentyl(1-methylethyl)carbamate<br />
EPC0580004 Carmustine - Reference Spectrum unit<br />
EPC0580010<br />
Carmustine impurity A<br />
1,3-bis(2-chloroethyl)urea<br />
EPY0000192 Carteolol hydrochloride - Reference Spectrum unit<br />
EPY0000193 Carteolol for system suitability 30 mg<br />
EPY0000075 Carvedilol - Reference Spectrum unit<br />
EPY0000103<br />
Carvedilol impurity C<br />
(2RS)-1-[benzyl[2-(2-methoxyphenoxy)ethyl]amino]-3-(9H-carbazol-4-yloxy) propan-2-ol<br />
EPC0600000 Casein BRP 100 g<br />
EPC0630000 Cefaclor 450 mg<br />
EPC0640000 Delta-3-Cefaclor 20 mg<br />
EPC0650000 Cefadroxil 250 mg<br />
EPC0675000 Cefalexin monohydrate 150 mg<br />
EPC0682000 Cefalotin sodium 100 mg<br />
EPY0000505 Cefalotin for impurity B identification 10 mg<br />
EPC0682300 Cefam<strong>and</strong>ole nafate 125 mg<br />
EPY0000240 Cefapirin sodium 100 mg<br />
EPC0682400 Cefatrizine propylene glycol 150 mg<br />
EPC0682410<br />
Cefatrizine impurity A<br />
7-amino-(6R,7R)-3-[(2H-1,2,3-triazol-4-yl)sulfanyl]-methyl-8-oxo-5-thia-<br />
1-azabicyclo[4.2.O]oct-2-ene-2-carboxylic acid(7-ACA triazole)<br />
EPC0682800 Cefazolin 150 mg<br />
EPY0000633 Cefepime dihydrochloride monohydrate 150 mg<br />
EPY0000634 Cefepime dihydrochloride monohydrate for system suitability 15 mg<br />
EPC0684000 Cefixime 200 mg<br />
EPC0684750 Cefoperazone dihydrate 100 mg<br />
EPC0684800 Cefoperazone sodium - Reference Spectrum unit<br />
EPY0000420 Cefotaxime acid 80 mg<br />
EPC0685000 Cefotaxime sodium 30 mg<br />
EPY0000506 Cefotaxime sodium for peak identification 10 mg<br />
EPC0688000 Cefoxitin sodium 250 mg<br />
EPC0690000 Cefradine 300 mg<br />
EPY0000568 Cefradine for peak identification 6 mg<br />
EPC0690500 Ceftazidime 200 mg<br />
EPC0690510<br />
Ceftazidime impurity A<br />
(6R,7R)-7-[[(Z)-2-(2-aminothiazol-4-yl)-2-[(1-carboxy-1<br />
-methylethoxy)imino]acetyl]amino]-8-oxo-3-[(1-pyridinio)-methyl]<br />
-5-thia-1-azabicyclo[4.2.O]oct-3-ene-2-carboxylate<br />
(delta-2-ceftazidime)<br />
EPC0691000 Ceftriaxone sodium 80 mg<br />
EPC0692000<br />
Ceftriaxone impurity A<br />
E-isomer<br />
EPC0694990 Cefuroxime axetil 60 mg<br />
EPC0695000 Cefuroxime sodium 150 mg<br />
EPY0000311 Celiprolol hydrochloirde 10 mg<br />
EPY0000312<br />
Celiprolol impurity I<br />
1-acetyl-1-(4-ethoxyphenyl)-3,3-diethylurea<br />
10 mg<br />
20 mg<br />
10 mg<br />
60 mg<br />
15 mg<br />
10 mg<br />
0.02 mg<br />
EPY0000239 Celiprolol for peak identification 20 mg<br />
EPC0698000 Cellulose acetate - Reference Spectrum unit<br />
EPC0698005 Cellulose acetate butyrate - Reference Spectrum unit<br />
EPC0698020 Cellulose acetate phthalate - Reference Spectrum unit<br />
EPC0700000 Cephaeline hydrochloride 10 mg<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 73
European Pharmacopoeia<br />
Code Product Unit<br />
EPC0980650 Cetirizine dihydrochloride 100 mg<br />
EPC0980651<br />
Cetirizine impurity A<br />
(RS)-1-[(4-chlorophenyl)phenylmethyl]piperazine<br />
EPC0984100 Cetostearyl isononanoate - Reference Spectrum unit<br />
EPC0990000 Cetyl alcohol 250 mg<br />
EPY0000073 Cetyl palmitate 15 60 mg<br />
EPY0000074 Cetyl palmitate 95 50 mg<br />
EPC1000000 Cetylpyridinium chloride 50 mg<br />
EPC1050000 Chenodeoxycholic acid 125 mg<br />
EPY0000104 Chitosan hydrochloride 30 mg<br />
EPC1100000 Chlorambucil 100 mg<br />
EPC1200000 Chloramphenicol 500 mg<br />
EPC1300000 Chloramphenicol dipalmitate 100 mg<br />
EPC1350000 Chloramphenicol disodium disuccinate 25 mg<br />
EPC1400000 Chloramphenicol palmitate isomer 100 mg<br />
EPC1425000 Chloramphenicol sodium succinate 1.5 g<br />
EPC1435000 Chlorcyclizine hydrochloride 100 mg<br />
EPC1450000 Chlordiazepoxide Controlled Substance 2x50 mg<br />
EPC1500000 Chlordiazepoxide hydrochloride Controlled Substance 100 mg<br />
EPY0000476<br />
Chlordiazepoxide impurity A<br />
7-chloro-5-phenyl-1,3-dihydro-2H-1,4-benzodiazepin-2-one 4-oxide<br />
EPC1510000 Chlorhexidine 50 mg<br />
EPC1520000 Chlorhexidine diacetate 10 mg<br />
EPC1540000 Chlorhexidine dihydrochloride 50 mg<br />
EPC1530000 Chlorhexidine for performance test 50 mg<br />
EPY0000569 Chlorogenic acid 20 mg<br />
EPC1600000 Chloromethylnitroimidazole 100 mg<br />
EPC1605000 (2-Chlorophenyl) diphenylmethanol 20 mg<br />
EPC2223030<br />
1-(4-Chlorophenyl)-1-phenylethanol<br />
Clemastine fumarate impurity C<br />
EPC1650000 Chloroquine sulphate 200 mg<br />
EPC1700000 Chlorothiazide 100 mg<br />
EPC1800000 Chlorphenamine maleate 100 mg<br />
New EPY0000436<br />
EPY0000437<br />
Chlorphenamine impurity A<br />
2-(4-chlorophenyl)-4-(dimethylamino)-2-[2-(dimethylamino)ethyl]butanenitrile<br />
Chlorphenamine impurity C<br />
(3RS)-3-(4-chlorophenyl)-N-methyl-3-(pyridin-2-yl)propan-1-amine<br />
10 mg<br />
10 mg<br />
20 mg<br />
0.01 mg<br />
EPC1900000 Chlorpromazine hydrochloride 200 mg<br />
EPY0000507<br />
EPY0000479<br />
EPY0000508<br />
Chlorpromazine impurity A<br />
3-(2-chloro-10H-phenothiazin-10-yl)-N,N-dimethylpropan-1- amine S-oxide (chlorpromazine<br />
sulphoxide)<br />
Chlorpromazine impurity D<br />
3-(2-chloro-10H-phenothiazin-10-yl)-N-methypropan-1-amine (demethylchlorpromazine)<br />
Chlorpromazine impurity E<br />
2-chloro-10H-phenothiazine<br />
EPC1905000 Chlorpropamide 100 mg<br />
EPC1905020<br />
Chlorpropamide impurity B<br />
1,3-Dipropylurea<br />
EPC1915000 Chlorprothixene hydrochloride 50 mg<br />
EPC1950000 Chlortalidone 50 mg<br />
New EPY0000779 Chlortalidone for peak identification 1 mg<br />
EPC1950020<br />
Chlortalidone impurity B<br />
2-(4-chloro-3-sulfamoylbenzoyl)benzoic acid<br />
EPC2000000 Chlortetracycline hydrochloride 100 mg<br />
10 mg<br />
10 mg<br />
10 mg<br />
10 mg<br />
50 mg<br />
10 mg<br />
74 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
European Pharmacopoeia<br />
Code Product Unit<br />
EPC2100000 Cholecalciferol 500 mg<br />
EPC2150000 Cholecalciferol for performance test 1 mL<br />
EPC2155000 Cholesterol 60 mg<br />
EPC2158000 Cholic acid 60 mg<br />
EPY0000280 Chondroitin sulphate sodium 250 mg<br />
EPY0000593 Chondroitin sulphate sodium (marine) 100 mg<br />
EPC2160000 Chymotrypsin BRP 100 mg<br />
EPY0000639 Cladribine 50 mg<br />
EPY0000609 Cladribine for peak identification 10 mg<br />
EPY0000610<br />
Cladribine impurity C<br />
2-chloro-7H-purin-6-amine<br />
New EPY0000758 Clozapine for peak identification 0.41 mg<br />
EPY0000040 Ciclopirox 100 mg<br />
EPC2162701<br />
EPC2162702<br />
Ciclopirox impurity A<br />
(RS)-2-(3-cyclohexyl-5-methyl-4,5-dihydroisoxazol-5-yl)<br />
acetic acid<br />
Ciclopirox impurity B<br />
6-cyclohexyl-4-methyl-2H-pyran-2-one<br />
EPC2162700 Ciclopirox olamine 150 mg<br />
EPC2163000 Ciclosporin 120 mg<br />
EPY0000361 Ciclosporin for system suitability 5 mg<br />
EPC2170000 Cilastatin sodium 10 mg<br />
EPC2174000 Cilazapril 50 mg<br />
EPC2174002<br />
EPC2174005<br />
Cilazapril impurity A<br />
1,1-dimethylethyl(1S,9S)-9-[[(S)-1-ethoxycarbonyl-3-phenylpropyl]amino]<br />
-10-oxo-octahydro-6H-pyridazino[1,2a][1,2]diazepine-1-caboxylate<br />
Cilazapril impurity D<br />
(1S,9S)-9-[[(R)-1-ethoxycarbonyl-3-phenylpropyl]amino]-10-oxo-octahydro-6Hpyridazino[1,2a][1,2]diazepine-1-carboxylic<br />
acid<br />
EPC2175000 Cimetidine 50 mg<br />
EPC2175500 Cimetidine hydrochloride 100 mg<br />
EPC2177000 Cinchocaine hydrochloride 60 mg<br />
EPY0000176 Cineole 180 mg<br />
EPC2180000 Cinnarizine 100 mg<br />
EPY0000362 Ciprofibrate 5 mg<br />
EPY0000363 Ciprofibrate for system suitability 5 mg<br />
EPY0000198 Ciprofloxacin 20 mg<br />
EPC2190000 Ciprofloxacin hydrochloride 100 mg<br />
EPY0000199 Ciprofloxacin hydrochloride for peak identification 10 mg<br />
EPC2190050<br />
Ciprofloxacin impurity A<br />
7-chloro-1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-quinoline-3-carboxylic acid<br />
(fluoroquinolonic acid)<br />
EPC2205000 Cisapride monohydrate 30 mg<br />
EPC2205100 Cisapride tartrate 100 mg<br />
EPC2210000 Cisplatin 150 mg<br />
EPA1202000 Citric acid (anhydrous) 50 mg<br />
EPC2219000 Citric acid monohydrate 50 mg<br />
EPY0000320 Clarithromycin 160 mg<br />
EPY0000321 Clarithromycin for peak identification 30 mg<br />
EPY0000269 Clazuril for system suitability 10 mg<br />
EPY0000262 Clazuril for veterinary use - Reference Spectrum unit<br />
EPC2221000 Clebopride malate 100 mg<br />
EPC2223000 Clemastine fumarate 100 mg<br />
EPC2248000 Clenbuterol hydrochloride 50 mg<br />
5 mg<br />
20 mg<br />
20 mg<br />
25 mg<br />
10 mg<br />
10 mg<br />
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European Pharmacopoeia<br />
Code Product Unit<br />
EPC2248010<br />
Clenbuterol impurity B<br />
1-(4-amino-3,5-dichlorophenyl)-2-[(1,1-dimethylethyl)amino]ethanone (clenbuterol ketone)<br />
EPC2250000 Clindamycin hydrochloride 200 mg<br />
EPC2269000 Clindamycin phosphate 250 mg<br />
EPY0000364 Clioquinol 5 mg<br />
EPY0000205 Clobazam - Reference Spectrum unit<br />
EPY0000241<br />
Clobazam impurity A<br />
7-chloro-5-phenyl-1,5-dihydro-1,5-dihydro-3H-1,5-benzodiazepine-2,4-dione<br />
EPY0000559 Clobetasol propionate 40 mg<br />
EPY0000570 Clobetasol for peak identification 2 mg<br />
EPY0000571<br />
Clobetasol impurity J<br />
(17R)-4'-chloro-5'-ethyl-9-fluoro-11ß-hydroxy-16ß-methylspiro[<strong>and</strong>rosta-1,4-diene-17,2'(3'H)-<br />
furan]-3,3'-dione (17 alpha-spiro compound)<br />
20 mg<br />
10 mg<br />
0.4 mg<br />
EPC2285000 Clobetasone butyrate 50 mg<br />
EPY0000313 Clofazimine 150 mg<br />
EPY0000358 Clofazimine for system suitability 10 mg<br />
EPC2300000 Clofibrate 0.5 mL<br />
EPC2320000 Clomifene citrate 50 mg<br />
EPC2332000 Clomifene citrate for performance test 50 mg<br />
EPC2360000 Clomipramine hydrochloride 100 mg<br />
EPY0000132<br />
EPY0000133<br />
EPY0000134<br />
Clomipramine impurity C<br />
3-(3-chloro-5H-dibenzo[b,f]azepin-5-yl)-N,N-dimethylpropan-1-amine<br />
Clomipramine impurity D<br />
3-(3,7-dichloro-10,11-dihydro-5H-dibenzo[b,f]azepin-5-yl)<br />
N,N-dimethylpropan-1-amine<br />
Clomipramine impurity F<br />
3-chloro-10,11-dihydro-5H-dibenzo[b,f]azepine<br />
EPC2385000 Clonazepam Controlled Substance 50 mg<br />
EPC2385010<br />
EPC2385015<br />
Clonazepam impurity A<br />
2-Amino-2'-chloro-5-nitrobenzophenone<br />
Clonazepam impurity B<br />
3-Amino-4-(2-chlorophenyl)-6-nitro-1H-quinolin-2-one<br />
EPY0000286 Clonazepam - Reference Spectrum unit<br />
EPC2400000 Clonidine hydrochloride 100 mg<br />
New EPY0000801<br />
Clonidine impurity B<br />
10 mg<br />
10 mg<br />
5 mg<br />
25 mg<br />
25 mg<br />
20 mg<br />
1-acetyl-2-[(2,6-dichlorophenyl)amino]-4,5-dihydro-1H-imidazole<br />
EPY0000392 Closantel sodium dihydrate 20 mg<br />
EPY0000393 Closantel for system suitability 20 mg<br />
EPC2424400<br />
EPC2424550<br />
EPC2424500<br />
EPC2425600<br />
Clostridia (multi-component) rabbit antiserum<br />
(for vaccines-vet.use) BRP<br />
Clostridium tetani guinea pig antiserum<br />
(for vaccines-human use) BRP<br />
Clostridium tetani guinea pig antiserum<br />
(for vaccines - vet.use) BRP<br />
Clostridium tetani rabbit antiserum<br />
(for vaccines - vet.use) BRP<br />
1 mg<br />
3x1 mL<br />
EPC2430000 Clotrimazole 100 mg<br />
New EPY0000818<br />
Clotrimazole impurity E<br />
(2-chlorophenyl)phenylmethanone (2-chlorobenzophenone)<br />
EPC2450000 Cloxacillin sodium 125 mg<br />
EPC2460000 Clozapine 60 mg<br />
New EPY0000758 Clozapine for peak identification 0.41 mg<br />
EPY0000162 Cocaine hydrochloride - Reference Spectrum unit<br />
EPC2480000 Cocoyl caprylocaprate 40 mg<br />
New EPY0000722 Codeine Controlled Substance 20 mg<br />
EPC2500000 Codeine - Reference Spectrum unit<br />
1 mg<br />
1 mg<br />
10 mg<br />
76 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
European Pharmacopoeia<br />
Code Product Unit<br />
EPY0000334<br />
Codeine impurity A<br />
7,8-didehydro-4,5α-epoxy-3,6α-dimethoxy-17-methylmorphinan (methylcodeine)<br />
Controlled Substance<br />
EPC2500100 Codeine hydrochloride dihydrate - Reference Spectrum unit<br />
EPC2510000 Codergocrine mesilate 60 mg<br />
EPC2580000 Colchicine 50 mg<br />
EPY0000209 Colchicine for system suitability 50 mg<br />
EPY0000374 Colestyramine 10 mg<br />
EPC2600000 Colistimethate sodium 100 mg<br />
EPY0000277 Colistin sulphate 25 mg<br />
EPC2700000 Colistin sulphate for microbiological assay 25 mg<br />
EPC2725000 Copovidone - Reference Spectrum unit<br />
EPC2800000 Cortisone acetate 250 mg<br />
EPY0000438 Coumarin 80 mg<br />
EPC2900000 Cotton wool.st<strong>and</strong>ard for neps 1000 mg<br />
EPC2950000 Crospovidone - Reference Spectrum unit<br />
EPC2970000 Crotamiton 100 mg<br />
EPC2970005<br />
Crotamiton impurity A<br />
N-ethyl-N-(2-methylphenyl)but-3-enamide<br />
EPC3000000 Cyanocobalamin 20 mg<br />
EPC3090000 Cyclizine hydrochloride 50 mg<br />
EPC3200000 Cyclobenzaprine hydrochloride 100 mg<br />
EPC3230000 Cyclohexa-1,4-dienylglycine 80 mg<br />
EPC3245000 Cyclopentolate hydrochloride 60 mg<br />
EPC3250000 Cyclophosphamide 50 mg<br />
EPC3280000 Cyproheptadine hydrochloride 30 mg<br />
EPC3283000 Cyproterone acetate 30 mg<br />
EPC3290000 Cysteine hydrochloride monohydrate 50 mg<br />
EPC3300000 Cystine 100 mg<br />
EPC3350000 Cytarabine 150 mg<br />
New EPY0000733 Dacarbazine 20 mg<br />
New EPY0000734<br />
New EPY0000735<br />
Dacarbazine impurity A<br />
2-azahypoxanthine<br />
Dacarbazine impurity B<br />
5-amino-1H-imidazole-carboxamide<br />
EPD0070000 Dalteparin sodium 250 mg<br />
EPY0000600 Danaparoid sodium 10 mg<br />
EPD0100000 Dapsone 100 mg<br />
EPD0125000 Daunorubicin hydrochloride 100 mg<br />
EPD0120000<br />
Daunorubicinone<br />
Daunorubicin aglycone<br />
EPD0160000 Deferoxamine mesilate 30 mg<br />
EPD0201000 Dehydrohexetidine 50 mg<br />
EPY0000611 Dembrexine hydrochloride monohydrate 10 mg<br />
EPD0300000 Demeclocycline hydrochloride 100 mg<br />
EPD0350000 N-Demethylerythromycin A 10 mg<br />
EPY0000228 Demethylflumazenil - Reference Spectrum unit<br />
EPD0406000 Deoxyminoxidil 0.25 mg<br />
EPD0406200 Deptropine citrate 60 mg<br />
EPD0430000 Dequalinium chloride 50 mg<br />
EPD0431000 Dequalinium chloride for performance test 50 mg<br />
EPD0480000 Desacetylvinblastine 2x1 mg<br />
10 mg<br />
30 mg<br />
10 mg<br />
10 mg<br />
10 mg<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 77
European Pharmacopoeia<br />
Code Product Unit<br />
New EPY0000807<br />
Desflurane impurity A<br />
1,1'-oxybis(1,2,2,2-tetrafluoroethane)<br />
EPD0500000 Desipramine hydrochloride 100 mg<br />
EPD0600000 Deslanoside 150 mg<br />
EPD0630000 Desmethylmetrifonate 30 mg<br />
EPD0650000 Desmopressin 0.98 mg<br />
EPY0000509 Desogestrel 50 mg<br />
EPY0000510 Desogestrel for system suitability 10 mg<br />
EPD0400000 Desoxycortone acetate 250 mg<br />
EPY0000001 Detomidine hydrochloride 100 mg<br />
EPD0660020<br />
Detomidine impurity B<br />
(RS)-(1-benzyl-1H-imidazol-5-yl)(2,3-dimethylphenyl)methanol<br />
EPD0700000 Dexamethasone 60 mg<br />
EPD0710000 Dexamethasone acetate 100 mg<br />
EPY0000538 Dexamethasone isonicotinate 10 mg<br />
EPY0000511 Dexamethasone isonicotinate for impurity C identification 10 mg<br />
EPD0718000 Dexamethasone pivalate 50 mg<br />
EPD0720000 Dexamethasone sodium phosphate 50 mg<br />
EPD0720800 Dexchlorpheniramine maleate 60 mg<br />
EPD0730000 Dexpanthenol 5 mg<br />
EPD0731000 Dextran 25 mg<br />
EPD0731005 Dextran 1 50 mg<br />
EPD0732000 Dextran Vo 10 mg<br />
EPD0733000 Dextran 4 for calibration 50 mg<br />
EPD0734000 Dextran 10 for calibration 50 mg<br />
EPD0735000 Dextran 40 for calibration 50 mg<br />
EPD0736000 Dextran 70 for calibration 50 mg<br />
EPD0737000 Dextran 250 for calibration 50 mg<br />
EPD0738000 Dextran 40 for performance test 50 mg<br />
EPD0739000 Dextran 60/70 for performance test 50 mg<br />
New EPY0000744 Dextranomer 50 mg<br />
EPD0740000 Dextromethorphan hydrobromide 100 mg<br />
EPY0000261<br />
Dextromethorphan impurity A<br />
ent-3-methoxymorphinan<br />
EPD0940000 Diazepam Controlled Substance 30 mg<br />
EPY0000596 Diazepam for system suitability Controlled Substance 0.5 mg<br />
EPD0950000 Diazoxide 50 mg<br />
EPD0970000 Dibenzocycloheptene 20 mg<br />
EPD1000000 Dibenzosuberone 100 mg<br />
EPY0000480 Dibrompropamidine diisetionate 10 mg<br />
EPY0000481 Dibrompropamidine for system suitability 20 mg<br />
EPD1010000 Dibutyl phthalate 1 mL<br />
EPY0000275 Dichlorodiaminocyclohexaneplatinum 10 mg<br />
EPY0000259 Diclazuril for system suitability 20 mg<br />
EPY0000264 Diclazuril for veterinary use - Reference Spectrum unit<br />
EPD1039990 Diclofenac potassium 100 mg<br />
EPD1040000<br />
Diclofenac impurity A<br />
1-(2,6-dichlorophenyl)-indolin-2-one<br />
1 mL<br />
20 mg<br />
5 mg<br />
0.005 mg<br />
EPD1050000 Dicloxacillin sodium 250 mg<br />
EPD1060000 Dicycloverine hydrochloride 100 mg<br />
EPY0000439 Didanosine 10 mg<br />
EPY0000440 Didanosine for system suitability 10 mg<br />
78 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
European Pharmacopoeia<br />
Code Product Unit<br />
EPY0000441<br />
EPY0000442<br />
Didanosine impurity A<br />
1,7-dihydro-6H-purin-6-one (hypoxanthine)<br />
Didanosine impurity G<br />
9-(2,3-dideoxy-β-D-glycero-pentofuranosyl)-9H-purin-6-amine<br />
(2',3'-dideoxyadenosine)<br />
EPD1200000 Dienestrol 150 mg<br />
EPD1250000 Diethanolamine fusidate 50 mg<br />
EPD1300000 Diethylcarbamazine citrate 250 mg<br />
EPY0000217 Diethylene glycol (monoethyl ether) - Reference Spectrum unit<br />
EPD1410000 Diethyl phthalate 1 mL<br />
EPD1500000 Diethylstilbestrol 100 mg<br />
EPD1600000 Diethylstilbestrol dimethyl ether 10 mg<br />
EPD1700000 Diethylstilbestrol monomethyl ether 10 mg<br />
EPD1750000 Diflunisal 30 mg<br />
EPD1800000 Digitoxin 250 mg<br />
EPY0000640 Digoxigenin 5 mg<br />
EPD1900000 Digoxin 30 mg<br />
EPY0000554 Digoxin for peak identification 10 mg<br />
EPY0000232 Dihydralazine for system suitability 10 mg<br />
EPD1940001 Dihydralazine sulphate (hydrated) - Reference Spectrum unit<br />
EPY0000216 Dihydrocodeine hydrogen tartrate - Reference Spectrum unit<br />
EPY0000053 17 alpha-dihydroequilin 10 mg<br />
EPD1945000 Dihydroergocristine mesilate 250 mg<br />
New EPY0000831 Dihydroergotamine for peak identification 10 mg<br />
EPD1950000 Dihydroergotamine mesilate 100 mg<br />
EPD1952000 Dihydroergotamine tartrate 150 mg<br />
EPD1954000 Dihydrostreptomycin sulphate (for LC assay) 25 mg<br />
EPY0000544 Dihydrotachysterol 10 mg<br />
EPY0000482 Dihydrotachysterol for system suitability 5 mg<br />
EPD1980000 Diltiazem hydrochloride 200 mg<br />
EPD1982000<br />
Diltiazem impurity A<br />
(2R,3S)-3-acetyloxy-5-[2-(dimethylamino)ethyl]-2-(4-methoxyphenyl)<br />
-2,3-dihydro-1,5-benzothiazepin-4(5H)-one<br />
EPD2000000 Dimenhydrinate 100 mg<br />
EPD2046000 (2,6-Dimethylphenoxy)acetone 50 mg<br />
EPY0000234 N,N-Dimethylacetamide - Reference Spectrum unit<br />
EPD2050000 Dimethyl sulfoxide 1 mL<br />
EPD2200000 Dimeticone 200 mg<br />
EPD2205000 Dimetindene maleate 50 mg<br />
EPD2255000 Dinoprost trometamol 60 mg<br />
EPD2250000 Dinoprostone 100 mg<br />
EPD2250015<br />
Dinoprostone impurity C<br />
(E)-7-[(1S,2R,3R)-3-hydroxy-2-[(E)-(3S)-3-hydroxyoct-1-enyl]-5-oxocyclopentyl]-hept-5-enoic<br />
acid (5-trans-PGE 2;(5E)-PGE 2)<br />
EPY0000094 Diosmin 50 mg<br />
EPY0000095 Diosmin for system suitability 5 mg<br />
EPD2600000 Diphenhydramine hydrochloride 100 mg<br />
EPY0000135<br />
Diphenhydramine impurity A<br />
2-(diphenylmethoxy)-N-methylethanamine<br />
EPD2630000 Diphenoxylate hydrochloride - Reference Spectrum unit<br />
EPY0000258 Diphtheria toxin BRP 1 mL<br />
EPD2700000 Diphtheria vaccine (absorbed) BRP 32 mg<br />
EPY0000376 Dipivefrine hydrochloride 100 mg<br />
10 mg<br />
10 mg<br />
10 mg<br />
10 mg<br />
10 mg<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 79
European Pharmacopoeia<br />
Code Product Unit<br />
EPY0000394 Dipivefrine for system suitability 10 mg<br />
EPD2750100 Dipotassium clorazepate - Reference Spectrum unit<br />
EPD2800000 Diprophylline 100 mg<br />
EPD2850000 Dipyridamole 50 mg<br />
New EPY0000802 Dipyridamole for peak identification 2 mg<br />
EPD2880000 Dirithromycin 100 mg<br />
EPD2900000 Disodium edetate 100 mg<br />
EPD2920000 Disopyramide 100 mg<br />
EPD2922000 Disopyramide phosphate 100 mg<br />
EPD2950000 Disulfiram 100 mg<br />
EPD2953000 Dithranol 125 mg<br />
EPD2953025<br />
EPD2953050<br />
Dithranol impurity C<br />
Dithranol-dimer<br />
4,4',5,5'-tetrahydroxy-9,9'-bianthracenyl-10,10'(9H,9'H)-dione<br />
Dithranol impurity D<br />
1-hydroxyanthracen-9(10H)-one<br />
EPD2954000 Dobutamine hydrochloride 100 mg<br />
EPD2954600 Docosahexaenoic acid ethyl ester 150 mg<br />
EPD2954500 Docusate sodium - Reference Spectrum unit<br />
EPY0000365 Dodecyl gallate 30 mg<br />
EPD2955000 Domperidone 150 mg<br />
EPD2957000 Domperidone maleate 150 mg<br />
EPD2960000 Dopamine hydrochloride 50 mg<br />
EPY0000612 Dopexamine dihydrochloride 10 mg<br />
EPY0000613<br />
EPY0000614<br />
New EPY0000727<br />
Dopexamine impurity B<br />
2-methoxy-4-[2-[[6-[(2-phenylethyl)hexyl]amino]ethyl]phenol<br />
Dopexamine impurity F<br />
4-Chloro-5-[2-[[6-[(2-phenylethyl)amino]hexyl]amino]ethyl]benzene-1,2-diol<br />
Dorzolamide impurity A<br />
(4R,6R)-4-(ethylamino)-6-methyl-5,6-dihydro-4H-thieno[2,3-b]thiopyran-2-sulphonamide<br />
7,7-dioxide<br />
New EPY0000726 Dorzolamide hydrochloride 50 mg<br />
New EPY0000750 Dorzolamide for system suitability 5 mg<br />
EPD2962000 Dosulepin hydrochloride 100 mg<br />
EPD2962005<br />
Dosulepin impurity A<br />
(E)-3-(6,11-dihydrodibenzo[b,e]thiepin-11-ylidene)-<br />
N,N'-dimethylpropan-1-amine S-oxide<br />
EPD2963000 Doxapram hydrochloride 50 mg<br />
EPY0000208<br />
Doxapram impurity B<br />
(4RS)-1-ethyl-4-[2-[(2-hydroxyethyl)amino]ethyl]-3,3-diphenylpyrolidin-2-one<br />
EPY0000553 Doxazosin mesilate 60 mg<br />
EPY0000551<br />
EPY0000552<br />
Doxazosin impurity D<br />
6,7-dimethoxyquinazoline-2,4(1H,3H)-dione<br />
Doxazosin impurity F<br />
2-chloro-6,7-dimethoxyquinazolin-4-amine<br />
EPD2964500 Doxepin hydrochloride - Reference Spectrum unit<br />
EPD2964510<br />
EPD2964520<br />
Doxepin impurity A<br />
dibenzo[b,e]oxepin-11(6H)-one<br />
Doxepin impurity B<br />
(11RS)-11-[3-(dimethylamino)propyl]-6,11-dihydrodibenzo[b,e]oxepin-11-ol<br />
EPD2975000 Doxorubicin hydrochloride 150 mg<br />
EPD3000000 Doxycycline hyclate 50 mg<br />
EPY0000163 Doxylamine hydrogen succinate - Reference Spectrum unit<br />
EPY0000160<br />
Doxylamine impurity A<br />
N,N-dimethyl-2-[1(RS)-1-phenyl-1-(pyridin-4-yl)ethoxy]ethanamine<br />
20 mg<br />
20 mg<br />
10 mg<br />
10 mg<br />
5 mg<br />
50 mg<br />
10 mg<br />
10 mg<br />
10 mg<br />
20 mg<br />
25 mg<br />
50 mg<br />
80 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
European Pharmacopoeia<br />
Code Product Unit<br />
EPD3100000 Droperidol 150 mg<br />
EPY0000249 Ebastine - Reference Spectrum unit<br />
EPY0000247<br />
EPY0000248<br />
Ebastine impurity C<br />
4-(diphenylmethoxy)piperidine<br />
Ebastine impurity D<br />
1-[4-(1,1-dimethylethyl)phenyl]-4-(4-hydroxypiperidin-1-yl)butan-1-one<br />
EPY0000270 Econazole - Reference Spectrum unit<br />
EPY0000254 Econazole for system suitability 20 mg<br />
EPE0050000 Econazole nitrate 100 mg<br />
EPY0000296 Econazole nitrate - Reference Spectrum unit<br />
EPE0085000 Eicosapentaenoic acid ethyl ester 150 mg<br />
EPY0000537 Emedastine difumarate 10 mg<br />
EPY0000512<br />
Emedastine impurity E<br />
1-(2-ethoxyethyl)-2-(hexahydro-1H-1,4-diazepin-1yl)benzimidazole<br />
EPE0100000 Emetine hydrochloride 100 mg<br />
EPE0110000 Enalapril for system suitability 20 mg<br />
EPE0109000 Enalapril maleate 50 mg<br />
EPY0000615 Enalaprilat dihydrate 100 mg<br />
EPY0000629 Enalaprilat for system suitability 10 mg<br />
EPY0000678<br />
Enalaprilat impurity G<br />
(2SR)-2[(3SR,8aRS)-3-methyl-1,4-dioxohexahydropyrrolo[1,2-a]pyrazin-2(1H)-<br />
4-phenylbutanoic acid<br />
10 mg<br />
10 mg<br />
10 mg<br />
0.005 mg<br />
EPY0000136 Enilconazole 60 mg<br />
EPY0000137<br />
Enilconazole impurity E<br />
(1RS)-1-(2,4-dichlorophenyl)-2-(-1H-imidazol-1-yl)ethanol<br />
EPE0150000 Endotoxin st<strong>and</strong>ard BRP 11 mg<br />
EPE0180000 Enoxaparin sodium 200 mg<br />
EPE0180500 Enoxolone 100 mg<br />
EPE0200000 Enterokinase BRP 500 mg<br />
EPE0305000 Ephedrine hydrochloride (racemic) Controlled Substance 50 mg<br />
EPE0300000 Ephedrine hydrochloride Controlled Substance 150 mg<br />
EPE0400000 4-Epianhydrotetracycline hydrochloride 10 mg<br />
EPE0430000 4-Epichlortetracycline hydrochloride 20 mg<br />
EPE0440000 4-Epidemeclocycline hydrochloride 20 mg<br />
EPE0500000 6-Epidoxycycline hydrochloride 50 mg<br />
EPE0530000 4-Epioxytetracycline 40 mg<br />
EPE0550000 Epirubicin hydrochloride 100 mg<br />
EPE0600000 4-Epitetracycline hydrochloride 20 mg<br />
EPY0000052 Equilin 15 mg<br />
EPE0850010 Eq influenza Subtype 1 Strain A/eq/Newmarket/77 Horse Antiserum BRP 3x1 mg<br />
EPE0850021 Eq influenza Subtype 2 American-like/Newmarket Horse Antiserum BRP 3x1 mg<br />
EPE0850022 Eq Influenza Subtype 2 European-like/Newmarket Horse Antiserum BRP 3x1 mg<br />
EPY0000712 Eq Influenza Subtype 2 American-like/South Africa Horse Antiserum BRP 1 mg<br />
EPE0900000 Ergocalciferol 500 mg<br />
EPE1000000 Ergometrine maleate Controlled Substance 50 mg<br />
EPE1100000 Ergosterol 20 mg<br />
EPE1200000 Ergotamine tartrate Controlled Substance 100 mg<br />
EPY0000051 Erysipelas ELISA coating antigen BRP 0.4 mg<br />
EPY0000177 Erythritol 1000 mg<br />
EPE1300000 Erythromycin 250 mg<br />
EPE1305000 Erythromycin A 250 mg<br />
EPE1310000 Erythromycin B 50 mg<br />
EPE1320000 Erythromycin C 50 mg<br />
20 mg<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 81
European Pharmacopoeia<br />
Code Product Unit<br />
EPE1400000 Erythromycin estolate 100 mg<br />
EPE1500000 Erythromycin ethylsuccinate 100 mg<br />
EPE1500800 Erythromycin stearate 50 mg<br />
EPE1515000 Erythropoietin BRP 37.5 mg<br />
EPY0000324 Esketamine hydrochloride - Reference Spectrum unit<br />
EPY0000338<br />
Esketamine impurity D<br />
(2R)-2-(2-chlorophenyl)-2-(methylamino)cyclohexanone<br />
Controlled Substance<br />
New EPY0000749 Essential oils 1000 mg<br />
EPE1600000 Estradiol benzoate 250 mg<br />
EPY0000201 Estradiol benzoate impurity E<br />
10 mg<br />
17alpha-hydroxyestra-1,3,5(10)-trien-3-yl benzoate<br />
EPY0000045 Estradiol butyrate 10 mg<br />
EPE1620000 Estradiol hemihydrate 100 mg<br />
EPY0000314 Estradiol for peak identification 10 mg<br />
EPY0000046 Estradiol valerate 50 mg<br />
EPE1680000 Estriol 50 mg<br />
EPE1680005<br />
Estriol impurity A<br />
9,11-didehydroestriol<br />
EPE1700000 Estrone 15 mg<br />
EPE1800000 Etacrynic acid 100 mg<br />
EPE1830000 Etamsylate 30 mg<br />
EPE1840000 Ethacridine lactate monohydrate 50 mg<br />
EPE1850000 Ethambutol hydrochloride 250 mg<br />
New EPY0000803 Ethambutol for system suitability 10 mg<br />
EPA1202800 Ethanol (anhydrous) - Reference Spectrum unit<br />
EPE1860100 Ethanol 96% - Reference Spectrum unit<br />
EPE1900000 Ethinylestradiol 100 mg<br />
EPE2000000 Ethionamide 100 mg<br />
EPE2150000 Ethosuximide 30 mg<br />
EPE2250000<br />
Ethosuximide impurity A<br />
2-Ethyl-2-methylsuccinic acid<br />
EPE2195000 Ethyl acetate - Reference Spectrum unit<br />
EPE2195900 Ethylcellulose - Reference Spectrum unit<br />
EPE2202000 1-N-Ethylgaramin sulphate 125 mg<br />
EPE2205500 1,1'-Ethylidenebistryptophan 5 mg<br />
EPY0000617 Ethyl indole-3-carboxylate 10 mg<br />
EPE2300000 Ethylmorphine hydrochloride - Reference Spectrum unit<br />
EPE2400000 Ethylnicotinamide 150 mg<br />
EPE2425000 Ethyl parahydroxybenzoate 50 mg<br />
EPE2450000 Etifenin 25 mg<br />
EPE2451000 Etilefrine hydrochloride 75 mg<br />
EPE2451010<br />
Etilefrine impurity A<br />
2-ethylamino-1-(3-hydroxyphenyl)ethanone (etilefrone)<br />
EPY0000572 Etidronate disodium 10 mg<br />
EPE2470000 Etodolac 60 mg<br />
EPE2470050<br />
Etodolac impurity H<br />
2-(7-ethylindol-3-yl)ethanol<br />
New EPY0000768 Etodolac for peak identification 10 mg<br />
EPE2499900 Etofenamate 40 mg<br />
EPE2499901 Etofenamate for peak identification 15 mg<br />
EPE2499914<br />
Etofenamate impurity G<br />
2-hydroxyethyl 2-[[3-(trifluoromethyl)phenyl]amino]-benzoate<br />
10 mg<br />
20 mg<br />
50 mg<br />
20 mg<br />
10 mg<br />
20 mg<br />
82 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
European Pharmacopoeia<br />
Code Product Unit<br />
EPE2500000 Etofylline 100 mg<br />
EPE2503000 Etomidate 100 mg<br />
EPE2503004<br />
Etomidate impurity B<br />
methyl-1-[(1RS)-1-phenylethyl]-1H-imidazole-5-carboxylate<br />
EPE2600000 Etoposide 150 mg<br />
EPE5000000 Eugenol 500 µL<br />
EPF0005000 Famotidine 100 mg<br />
EPY0000382 Famotidine for system suitability 10 mg<br />
EPF0006000<br />
EPF0007000<br />
EPY0000409<br />
Famotidine impurity A<br />
3-[[[2-[(diaminomethylene)amino]thiazol-4-yl]methyl]-thio]propanamide<br />
Famotidine impurity B<br />
3,5-bis[2-[[[2-[(diaminomethylene)amino] thiazol-4-yl]methyl]thio]-ethyl]-<br />
4H-1,2,4,6-thiatriazine1,1-dioxide<br />
Famotidine impurity D<br />
3-[[[2-[(diaminomethylene)amino]thiazol-4-yl]methyl]sulphanyl]propanamide<br />
EPY0000556 Febantel 110 mg<br />
EPY0000660 Febantel for system suitability 10 mg<br />
New EPY0000731 Felbinac 10 mg<br />
EPY0000732<br />
Felbinac impurity A<br />
4-acetyl biphenyl<br />
EPF0030000 Felodipine 120 mg<br />
EPY0000415 Felypressin 0.994 mg<br />
EPF0040000 Fenbendazole 150 mg<br />
EPF0040010<br />
EPF0040020<br />
Fenbendazole impurity A<br />
methyl(1H-benzimidazol-2-yl)carbamate<br />
Fenbendazole impurity B<br />
methyl[5(6)-chlorobenzimidazol-2-yl]carbamate<br />
EPF0041000 Fenbufen 100 mg<br />
EPF0048000 Fenofibrate 100 mg<br />
EPF0048005<br />
EPF0048010<br />
EPF0048035<br />
Fenofibrate impurity A<br />
(4-chlorophenyl)(4-hydroxyphenyl)methanone<br />
Fenofibrate impurity B<br />
2[4-(4-chlorobenzoyl)phenoxy]-2-methylpropanoic acid (fenofibric acid)<br />
Fenofibrate impurity G<br />
1-methylethyl 2-[[2-[4-(4-chlorobenzoyl)phenoxy]-2-methylpropanoyl]<br />
oxy]-2-methylpropanoate<br />
New EPY0000756 Fenoterol for peak identification 1.2 mg<br />
EPF0050000 Fenoterol hydrobromide 100 mg<br />
EPF0051000 Fenoterol hydrobromide - Reference Spectrum unit<br />
EPF0054990 Fentanyl - Reference Spectrum unit<br />
EPF0055000 Fentanyl citrate - Reference Spectrum unit<br />
EPF0060000 Fenticonazole nitrate 50 mg<br />
EPF0060040<br />
Fenticonazole impurity D<br />
(RS)-1-[2-(2,4-dichlorophenyl)-2-hydroxyethyl]-3-<br />
[4-(phenylsuphanyl)benzyl]imidazolium nitrate<br />
EPF0100000 Ferrous gluconate 1000 mg<br />
New EPY0000789 Fexofenadine hydrochloride 60 mg<br />
New EPY0000751<br />
New EPY0000752<br />
New EPY0000753<br />
Fexofenadine impurity A<br />
2-[4-[4-[4-(hydroxydiphenylmethyl)piperidin-1-yl]butanoyl]phenyl]-2-methylpropanoic acid<br />
Fexofenadine impurity B<br />
2-[3-[(1RS)-1-hydroxy-4-[4-(hydroxydiphenylmethyl)piperidin-1-yl]butyl]phenyl]-<br />
2-methylpropanoic acid<br />
Fexofenadine impurity C<br />
(1RS)-4-[4-(hydroxydiphenylmethyl)piperidin-1-yl]-1-[4-(1-methylethyl)phenyl]butan-1-ol<br />
25 mg<br />
10 mg<br />
10 mg<br />
10 mg<br />
20 mg<br />
20 mg<br />
20 mg<br />
20 mg<br />
10 mg<br />
25 mg<br />
20 mg<br />
5 mg<br />
0.01 mg<br />
EPY0000090 Finasteride 50 mg<br />
EPY0000091 Finasteride for system suitability 100 mg<br />
5 mg<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 83
European Pharmacopoeia<br />
Code Product Unit<br />
New EPY0000736 Flavoxate hydrochloride 10 mg<br />
New EPY0000737<br />
New EPY0000738<br />
Flavoxate impurity A<br />
3-methyl-4-oxo-2-phenyl-4H-1-benzopyran-8-carboxylic acid<br />
Flavoxate impurity B<br />
ethyl3-methyl-4-oxo-2-phenyl-4H-1-benzopyran-8-carboxylate<br />
EPF0120000 Flecainide acetate 200 mg<br />
EPF0120005<br />
EPF0120010<br />
Flecainide impurity A<br />
3-[2,5-bis(2,2,2-trifluoroethoxy)phenyl]-1,5,6,7,8,8a-hexahydroimidazo<br />
[1,5-a]pyridine<br />
Flecainide impurity B<br />
(piperidin-2-yl)methanamine<br />
EPY0000138 Flubendazole 25 mg<br />
EPY0000139 Flubendazole for system suitability 20 mg<br />
EPF0150000 Flucloxacillin sodium 250 mg<br />
EPY0000557 Fluconazole 50 mg<br />
EPY0000558 Fluconazole for peak identification 10 mg<br />
EPY0000573<br />
EPY0000574<br />
Fluconazole impurity B<br />
2-[2-fluro-4-(1H-1,2,4-triazol-1-yl)phenyl]-1,3-bis(1H-1,2,4-triazol-1-yl)propan-2-ol<br />
Fluconazole impurity C<br />
1,1´-(1,3-phenylene)di-1H-1,2,4-triazole<br />
EPF0175000 Flucytosine 100 mg<br />
EPY0000419 Fludarabine phosphate 100 mg<br />
EPF0180000 Fludrocortisone acetate 100 mg<br />
EPF0188000 Flumazenil - Reference Spectrum unit<br />
EPY0000335<br />
Flumazenil impurity B<br />
ethyl 8-hydroxy-5-methyl-6-oxo-5,6-dihydro-4H-imidazo[1,5-a][1,4]benzodiazepine-<br />
3-carboxylate<br />
EPF0189000 Flumequine 60 mg<br />
EPF0189020<br />
Flumequine impurity B<br />
ethyl(RS)-9-fluoro-5-methyl-1-oxo-6,7-dihydro-1H,5H-benzo[i,j]<br />
quinolizine-2-carboxylate (flumequine ethyl ester)<br />
10 mg<br />
10 mg<br />
50 mg<br />
25 mg<br />
10 mg<br />
5 mg<br />
5 mg<br />
0.1 mg<br />
EPF0188500 Flumetasone pivalate 100 mg<br />
EPF0189900 Flunarizine dihydrochloride 100 mg<br />
EPY0000265 Flunarizine dihydrochloride - Reference Spectrum unit<br />
EPY0000266 Flunarizine dihydrochloride for system suitability 20 mg<br />
EPF0190000 Flunitrazepam Controlled Substance 100 mg<br />
EPY0000169 Flunitrazepam - Reference Spectrum unit<br />
EPY0000443 Flunixin meglumine 10 mg<br />
EPY0000444<br />
EPY0000445<br />
Flunixin impurity B<br />
2-methyl-3-(trifluoromethyl)aniline<br />
Flunixin impurity C<br />
ethyl 2-chloropyridine-3-carboxylate<br />
EPF0200000 Fluocinolone acetonide 100 mg<br />
EPF0230000 Fluocortolone pivalate 100 mg<br />
New EPY0000796 Fluorescein 120 mg<br />
New EPY0000804<br />
Fluorescein impurity C<br />
2-(2,4-dihydroxybenzoyl)benzoic acid<br />
10 mg<br />
50 mg<br />
0.01 mg<br />
EPY0000454 Diacetylfluorescein 100 mg<br />
EPF0245000 Fluoresceine sodium - Reference Spectrum unit<br />
EPF0250000 Fluorouracil 50 mg<br />
New EPY0000762<br />
New EPY0000763<br />
New EPY0000764<br />
Fluorouracil impurity A<br />
pyrimidine-2,4,6(1H,3H,5H)-trione (barbituric acid)<br />
Fluorouracil impurity B<br />
dihydropyrimidine-2,4,5(3H)-trione (isobarbituric acid or 5-hydroxyuracil)<br />
Fluorouracil impurity C<br />
pyrimidine-2,4(1H,3H)-dione (uracil)<br />
10 mg<br />
10 mg<br />
10 mg<br />
84 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
European Pharmacopoeia<br />
Code Product Unit<br />
New EPY0000765<br />
Fluorouracil impurity F<br />
2-ethoxy-5-fluoropyrimidin-4(1H)-one (2-ethoxy-5-fluorouracil)<br />
New EPY0000791 Fluorouracil impurity mixture 0.0002 mg<br />
EPF0253000 Fluoxetine hydrochloride 250 mg<br />
EPF0253020<br />
EPF0253030<br />
Fluoxetine impurity B<br />
methyl (3-phenylpropyl)amine Controlled Substance<br />
Fluoxetine impurity C<br />
(RS)-methyl-[3-phenyl-3-(3-trifluoromethylphenoxy)-propyl]amine<br />
EPY0000064 Flupentixol dihydrochloride 120 mg<br />
EPY0000067<br />
EPY0000078<br />
Flupentixol impurity D<br />
2-[2-[4-[3-[(EZ)-2-(trifluoromethyl)-9H-thioxanthen-9-ylidene]propyl]<br />
piperazin-1-yl]ethoxy]ethanol<br />
Flupentixol impurity F<br />
2-[4-[(EZ)-3-[(9RS)-2-(trifluoromethyl)-9H-thioxanthen-9-yl)prop-2-enyl]-<br />
piperazin-1-yl]ethanol<br />
EPF0260000 Fluphenazine decanoate 60 mg<br />
EPY0000009 Fluphenazine enantate 100 mg<br />
EPF0280000 Fluphenazine dihydrochloride 50 mg<br />
New EPY0000708 Fluphenazine impurity mixture 0.07 mg<br />
EPY0000298 Fluphenazine octanoate 10 mg<br />
EPY0000299 Fluphenazine sulphoxide 10 mg<br />
EPY0000211 Flurazepam monohydrochloride - Reference Spectrum unit<br />
EPF0285200 Flurbiprofen 50 mg<br />
EPF0285202<br />
Flurbiprofen impurity A<br />
(2RS)-2-(biphenyl-4-yl)propanoic acid<br />
EPY0000236 Fluspirilene 20 mg<br />
EPY0000375<br />
Fluspirilene impurity C<br />
8-[4,4-bis((4-fluorophenyl)butyl]-3-(hydroxymethyl)-1-phenyl-1,3,8-triazaspiro[4.5]decan-<br />
4-one<br />
EPF0285600 Flutamide 50 mg<br />
EPF0285603<br />
Flutamide impurity C<br />
N-[4-nitro-3-(trifluoromethyl)phenyl]propanamide<br />
EPY0000284 Fluticasone propionate 100 mg<br />
EPY0000221<br />
Fluticasone impurity D<br />
S-methyl 6a,9a-difluoro-11b-hydroxy-16a-methyl-3-oxo-17a-propionyloxy-<strong>and</strong>rosta-<br />
1,4-diene-17β-carbothioate (S-methyl derivative)<br />
EPF0290000 Flutrimazole 100 mg<br />
EPF0290010<br />
EPY0000386<br />
Flutrimazole impurity B<br />
(RS)-(2-fluorophenyl)(4-fluorophenyl)phenylmethanol<br />
Foeniculin for peak identification<br />
Star anise oil<br />
10 mg<br />
5 mg<br />
5 mg<br />
15 mg<br />
25 mg<br />
20 mg<br />
10 mg<br />
20 mg<br />
10 mg<br />
60 mg<br />
100 mg<br />
EPF0300000 Folic acid 250 mg<br />
EPF0372000 Formoterol fumarate dihydrate 10 mg<br />
EPY0000339 Formoterol fumarate dihydrate for impurity I identification 10 mg<br />
EPY0000340 Formoterol fumarate for system suitability 10 mg<br />
EPF0380000<br />
Formylfolic acid<br />
10-Formylfolic acid<br />
EPF0389000 Foscarnet sodium hexahydrate 50 mg<br />
EPF0389004<br />
Foscarnet impurity B<br />
disodium(ethoxyoxydophosphanyl)formate<br />
EPF0399900 Fosfomycin calcium - Reference Spectrum unit<br />
EPF0399950 Fosfomycin sodium - Reference Spectrum unit<br />
EPF0400000 Fosfomycin trometamol 1500 mg<br />
EPF0450000 Framycetin sulphate 2x25 mg<br />
EPF0550000 Fructose 100 mg<br />
EPF0600000 Fumaric acid 100 mg<br />
30 mg<br />
10 mg<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 85
European Pharmacopoeia<br />
Code Product Unit<br />
EPF0700000 Furosemide 100 mg<br />
EPF0702000<br />
Furosemide impurity A<br />
2-chloro-4-(furfurylamino)-5-sulphamoylbenzoic acid<br />
EPF1000000 Fusidic acid - Reference Spectrum unit<br />
EPG0049000 Galactitol 50 mg<br />
EPG0050000 Galactose 60 mg<br />
EPG0100000 Gallamine triethiodide 100 mg<br />
EPG0150000 Gammacyclodextrin 50 mg<br />
EPY0000675 Gemcitabine hydrochloride 50 mg<br />
EPY0000676<br />
Gemcitabine impurity A<br />
4-aminopyrimidin-2(1H)-one (Cytosine)<br />
EPY0000513 Gemfibrozil 5 mg<br />
EPY0000514 Gemfibrozil for system suitability 0.196 mg<br />
EPG0200000 Gentamicin sulphate 2x25 mg<br />
EPG0300000 Gitoxin 30 mg<br />
EPG0325000 Glibenclamide 100 mg<br />
EPG0325010<br />
EPY0000242<br />
Glibenclamide impurity A<br />
4-[2-(5-Chloro-2-methoxybenzamido)ethyl]<br />
benzenesulphonamide<br />
Glibenclamide impurity B<br />
methyl [[4-[2-[(5-chloro-2-methoxybenzoyl)amino]ethyl]phenyl] sulphonyl]carbamate<br />
EPG0326000 Gliclazide 20 mg<br />
EPG0326004<br />
EPG0326012<br />
Gliclazide impurity B<br />
2-nitroso-octahydrocyclopenta[c]pyrrole<br />
Gliclazide impurity F<br />
1-(hexahydrocyclopenta[c]pyrrol-2-(1H)-yl-3-[(2-methylphenyl)sulphonyl]urea<br />
EPY0000515 Glimepiride 60 mg<br />
EPY0000516 Glimepiride for system suitability 0.012 mg<br />
EPG0340000 Glipizide 50 mg<br />
EPG0342000<br />
EPY0000523<br />
EPY0000643<br />
Glipizide impurity A<br />
4-[2-(5-methylpyrazine-2-carboxamido)ethyl]benzene sulphonamide<br />
Glipizide impurity C<br />
ethyl 2-[4-[(cyclohexylcarbamoyl)sulphamoyl]phenyl]ethyl]carbamate<br />
Glipizide impurity D<br />
6-methyl-N-[2-(4-sulphamoylphenyl)ethyl]pyrazine-2-carboxamide<br />
EPY0000191 Human glucagon 2x0.952 mg<br />
EPG0350500 Glucose 100 mg<br />
EPG0355000 Glutamic acid 50 mg<br />
EPY0000517 Glutathione 10 mg<br />
EPG0360000 Glutethimide Controlled Substance 50 mg<br />
EPG0400000 Glycerol (85 per cent) - Reference Spectrum unit<br />
EPG0400002 Glycerol dibehenate 2000 mg<br />
EPG0400004 Glycerol distearate 2000 mg<br />
New EPY0000794 Glycerol monocaprylate 400 mg<br />
New EPY0000795 Glycerol monocaprylocaprate 400 mg<br />
EPG0400006 Glycerol monolinoleate 2000 mg<br />
EPG0400007 Glycerol mono-oleate 2000 mg<br />
EPG0400008 Glycerol monostearate 40-55 2000 mg<br />
EPG0400101 Glyceryl trinitrate - Reference Spectrum unit<br />
EPG0400100 Glyceryl trinitrate solution 0.5 mL<br />
EPG0450000 Glycine 50 mg<br />
EPY0000433 Ammonium glycyrrhizate 70 mg<br />
EPG0460000 Glycyrrhizate (monoammonium) 300 mg<br />
EPG0525000 Gonadorelin 5.08 mg<br />
5 mg<br />
20 mg<br />
10 mg<br />
10 mg<br />
25 mg<br />
30 mg<br />
10 mg<br />
10 mg<br />
10 mg<br />
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European Pharmacopoeia<br />
Code Product Unit<br />
EPY0000125 Goserelin 4.93 mg<br />
EPY0000126 Gosereline - Reference Spectrum unit<br />
EPY0000019 4-D-Ser-goserelin 0.1 mg<br />
EPY0000194 Goserelin validation mixture 1 mg<br />
EPG0550000 Gramicidin 250 mg<br />
EPY0000396 Granisetron hydrochloride 120 mg<br />
EPY0000477<br />
EPY0000478<br />
EPY0000395<br />
Granisetron impurity A<br />
2-methyl-N-[(1R,3r,5S)-9-methyl-9-azabicyclo[3.3.1]non-3-yl]-2H-indazole-3-carboxamide<br />
Granisetron impurity B<br />
N-[(1R,3r,5S)-9-methyl-9-azabicyclo[3.3.1]non-3-yl]-1H-indazole-3-carboxamide<br />
Granisetron impurity E<br />
endo-3-amino-9-methyl-9-azabicyclo[3.3.1]nonane<br />
EPG0600000 Griseofulvin 50 mg<br />
EPY0000619 Guaiacol 2200 mg<br />
EPG0700000 Guaifenesin 100 mg<br />
EPY0000117 Halofantrine hydrochloride 125 mg<br />
EPY0000118<br />
Halofantrine impurity C<br />
[1,3-dichloro-6-(trifluoromethyl)phenantren-9-yl]methanol<br />
EPH0100000 Haloperidol 50 mg<br />
EPH0100100 Haloperidol decanoate 60 mg<br />
EPH0150000 Halothane - Reference Spectrum unit<br />
EPH0185000 Heparin Low-Molecular-Mass for assay BRP 5x1 mL<br />
EPH0190000 Heparin Low-Molecular-Mass for calibration CRS 25 mg<br />
EPH0200000 Heparin sodium BRP 2 mL<br />
EPH0205010 Hepatitis A vaccine (inactivated,absorbed) Type B BRP 3x0.5 mL<br />
EPY0000389 Hepatitis B vaccine (rDNA) BRP method A (thiomersal free) 2x0.5 mL<br />
EPH0210010 Hepatitis B vaccine (rDNA) BRP method B 2x1 mL<br />
EPH0215000 Hepatitis C Virus BRP 5x40 mg<br />
EPH0220000 Heptadecanol 600 mg<br />
EPY0000063 Heptaminol hydrochloride 150 mg<br />
EPY0000057<br />
Heptaminol impurity A<br />
(2RS)-6-methylhept-5-en-2-amine<br />
EPH0250000 alpha-Hexachlorocyclohexane 10 mg<br />
EPH0330000 Hexamidine diisetionate 50 mg<br />
EPH0325000 Hexetidine 100 mg<br />
EPH0400000 Hexobarbital 500 mg<br />
EPH0420000 Hexylresorcinol 100 mg<br />
EPH0500000 Hide Powder 500 mg<br />
EPH0600000 Histamine dihydrochloride 250 mg<br />
EPH0700000 Histamine phosphate 250 mg<br />
EPH0750000 Histidine 100 mg<br />
EPH0755000 Histidine hydrochloride monohydrate 100 mg<br />
EPH0800000 Homatropine hydrobromide 100 mg<br />
EPH0830000 Homatropine methylbromide 25 mg<br />
EPH0837000 L-Homocycsteine thiolactone hydrochloride - Reference Spectrum unit<br />
EPH0900000 Human albumin for electrophoresis BRP 1000 mg<br />
EPY0000219 Human anti-D immunoglobulin BPR unit<br />
EPY0000667 Human coagulation factor VII concentrate BRP 2x26 mg<br />
EPH0920000 Human coagulation factor VIII concentrate BRP 5x34 mg<br />
EPH0920500 Human coagulation factor IX concentrate BRP 5x30 mg<br />
EPH0950000 Human hepatisis A immunoglobulin BRP 3x10 mg<br />
EPH0990000 Human immunoglobulin BRP 15800 mg<br />
1 mg<br />
1 mg<br />
10 mg<br />
10 mg<br />
20 mg<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 87
European Pharmacopoeia<br />
Code Product Unit<br />
EPH1000000 Human immunoglobulin for electrophoresis BRP 96 mg<br />
EPY0000488 Human immunoglobulin (molecular size) BRP 3x700 mg<br />
EPH1005000 Human Plasma Pools for NAT Validation 3502 mg<br />
EPH1100000 Human rabies immunoglobulin BRP 3x170 mg<br />
EPH1110000 Human tetanus immunoglobulin BRP 87 mg<br />
EPY0000502 Human vaccinia immunoglobulin 3x1 mL<br />
EPH1115000 Hyaluronidase BRP 50 mg<br />
EPH1120000 Hydralazine hydrochloride 20 mg<br />
EPH1200000 Hydrochlorothiazide 150 mg<br />
EPY0000646<br />
Hydrocodone hydrogen tartrate 2.5-hydrate<br />
Controlled Substance<br />
EPY0000710 Hydrocodone for peak identification Controlled Substance 10 mg<br />
EPH1300000 Hydrocortisone 100 mg<br />
EPH1400000 Hydrocortisone acetate 125 mg<br />
EPH1425000 Hydrocortisone hydrogen succinate 100 mg<br />
EPH1426000 Hydrogenated wool fat 250 mg<br />
EPY0000446 Hydromorphone Hydrochloride Controlled Substance 10 mg<br />
EPB0650000 Hydrous benzoyl peroxide - Reference Spectrum unit<br />
EPH1428000 Hydroxocobalamin 10 mg<br />
EPY0000119 Hydroxycarbamide 175 mg<br />
EPH1429400 Hydroxyethyl salicylate 125 mg<br />
EPH1429700 4-Hydroxyphenoxymethylpenicillin 20 mg<br />
EPH1430000 D-alpha-(4-Hydroxy-phenyl)glycine 50 mg<br />
EPY0000186 Hydroxypropylbetadex 10 mg<br />
EPH1435000 Hydroxyzine hydrochloride 600 mg<br />
EPY0000011 Hymecromone 100 mg<br />
EPY0000012<br />
EPY0000013<br />
Hymecromone impurity A<br />
Resorcinol<br />
Hymecromone impurity B<br />
7-hydroxy-2-methyl-4H-1-benzopyran-4-one<br />
EPY0000483 Hyoscine 10 mg<br />
EPY0000484<br />
Hyoscine impurity A<br />
(1R,2R,4S,5S,7s)-3-oxa-9-azatricyclo[3.3.1.02,4]non-7-yl (2S)-3-hydroxy-<br />
2-phenylpropanoate (norhyoscine)<br />
EPH1450000 Hyoscine butylbromide 20 mg<br />
EPY0000447<br />
Hyoscine butylbromide impurity E<br />
(1R,2R,4S,5S,7S)-9-butyl-7-[[(2S)-3-hydroxy-2-phenylpropanoyl]oxy]-3-oxa-9-azoni<br />
atricyclo[3.3.1.02,4]nonane<br />
EPH1500000 Hyoscine hydrobromide 50 mg<br />
EPY0000448<br />
Hyoscine hydrobromide impurity B<br />
(1R,2R,4S,5S,7s)-3-oxa-9-azatricyclo[3.3.1.02,4]non-7-yl(2S)-<br />
3-hydroxy-2-phenylpropanoate<br />
EPH1600000 Hyoscyamine sulphate 100 mg<br />
EPY0000449<br />
Hyoscyamine impurity E<br />
(1R,3s,5S)-8-azabicyclo[3.2.1] oct-3-yl(2S)-3-hydroxy-2-phenylpropanoate<br />
EPH5000000 Hypromellose phthalate - Reference Spectrum unit<br />
EPI0020000 Ibuprofen 160 mg<br />
EPB1220000<br />
EPY0000140<br />
Ibuprofen impurity B<br />
(2RS)-2-(4-Butylphenyl)propionic acid (0,06% solution in Acetonitrile)<br />
Ibuprofen impurity F<br />
3-[4-(2-methylpropyl)phenyl]propanoic acid<br />
10 mg<br />
25 mg<br />
25 mg<br />
10 mg<br />
10 mg<br />
10 mg<br />
10 mg<br />
1.15 mL<br />
EPI0050000 Idoxuridine 50 mg<br />
EPI0060000 Ifosfamide 50 mg<br />
EPI0060100 Ifosfamide - Reference Spectrum unit<br />
5 mg<br />
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European Pharmacopoeia<br />
Code Product Unit<br />
EPI0060002<br />
EPI0060004<br />
EPI0060010<br />
EPI0060012<br />
Ifosfamide impurity A<br />
3-[(2-chloroethyl)amino]propyl dihydrogen phosphate<br />
Ifosfamide impurity B<br />
bis[3-[(2-chloroethyl)amino]propyl]dihydrogen diphosphate<br />
Ifosfamide impurity E<br />
3-chloro-N-(2-chloroethyl)propan-1-amine<br />
Ifosfamide impurity F<br />
(RS)-2-chloro-3-(2-chloroethyl)-1,3,2-oxazaphosphinane 2-oxide<br />
EPI0086000 Imidazole 100 mg<br />
EPI0090000 Imipenem 100 mg<br />
EPI0100000 Imipramine hydrochloride 50 mg<br />
EPY0000540 Immunoglobulin panel for anti-D antibodies test BRP 2000 mg<br />
EPI0150000 Indapamide 150 mg<br />
EPI0150020<br />
Indapamide impurity B<br />
4-chloro-3-sulphamoyl-N-(2-methyl-1H-indol-1-yl)benzamide<br />
New EPY0000788 Indinavir 100 mg<br />
New EPY0000880 Indinavir sulphate - Reference Spectrum unit<br />
New EPY0000746 Indinavir for system suitability 20 mg<br />
EPI0200000 Indometacin 50 mg<br />
EPY0000349 Insulin aspart 3.89 mg<br />
EPI0305000 Insulin (bovine) 7.99 mg<br />
EPI0310000 Insulin (human) 7.03 mg<br />
EPY0000348 Insulin lispro 5.93 mg<br />
EPI0320000 Insulin (porcine) 8.61mg<br />
EPI0320300 Interferon alfa-2a unit<br />
EPI0320301 Interferon alfa-2b 0.2 mL<br />
EPI0320330 Interferon gamma 1b 2x0.6 mL<br />
EPI0320331 Interferon gamma-1b validation solution 0.2 mL<br />
EPI0328000 Iobenguane sulphate 25 mg<br />
New EPY0000839 Iobenguane sulphate - Reference Spectrum unit<br />
EPI0320800 Iohexol 150 mg<br />
EPI0320810<br />
EPI0320820<br />
Iohexol impurity A<br />
5-acetamido-N,N'-bis(2,3-dihydroxypropyl)-2,4,6-tri-iodobenzene-1,3- dicarboxamide<br />
Iohexol impurity J<br />
5-amino-N,N'-bis(2,3-dihydroxypropyl)-2,4,6-tri-iodobenzene-1,3-dicarboxamide<br />
30 mg<br />
20 mg<br />
10 mg<br />
10 mg<br />
5 mg<br />
50 mg<br />
125 mg<br />
EPY0000672 Iohexol for peak identification 10 mg<br />
EPI0329000 Iopamidol 50 mg<br />
EPI0329010<br />
EPY0000406<br />
Iopamidol impurity A<br />
N,N'-bis[2-hydroxy-1-(hydroxymethyl)ethy]-<br />
5-amino-2,4,6-tri-iodoisophthalamide<br />
Iopamidol impurity H<br />
4-chloro-N,N'-bis(2-hydroxy-1-(hydroxymethyl)ethyl)-<br />
5-(2-hydroxypropanoyl)amino)2,6-diiodobenzenz-1,3-dicarboxamide<br />
EPI0330000 Iopanoic acid 100 mg<br />
EPI0340000 Iotalamic acid 100 mg<br />
EPY0000555 Iotrolan 100 mg<br />
EPY0000658 Iotrolan for system suitability 5 mg<br />
EPY0000141 Ioxaglic acid 125 mg<br />
EPY0000142<br />
Ioxaglic acid impurity A<br />
3-amino-5[[(2-hydroxyethyl)amino]carbonyl]-2,4,6-trioiodobenzoic acid<br />
EPI0360000 Ipratropium bromide 120 mg<br />
EPY0000276<br />
Ipratropium bromide impurity A<br />
(1R,3r,5S,8r)-3-hydroxy-8-methyl-8-(1-methylethyl)-8-azoniabicyclo[3.2.1]octane<br />
10 mg<br />
10 mg<br />
20 mg<br />
5 mg<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 89
European Pharmacopoeia<br />
Code Product Unit<br />
EPI0361000<br />
Ipratropium bromide impurity B<br />
(1R,3r,5S,8s)-3-[[(2RS)-3-hydroxy-2-phenylpropanoyl]oxy]-8-methyl-8-(1-methylethyl)-<br />
8-azonia- bicyclo[3.2.1]octane<br />
EPI0375000 Isoconazole 200 mg<br />
EPI0380000 Isoconazole nitrate 200 mg<br />
EPI0400000 Isoemetine hydrobromide 25 mg<br />
EPY0000037 Isoflurane - Reference Spectrum unit<br />
EPI0460000 Isol<strong>eu</strong>cine 50 mg<br />
EPI0465000 Isomalt 3000 mg<br />
EPY0000070 Isomaltooligosaccharide 0.9 mg<br />
EPI0500000 Isoniazid 100 mg<br />
EPI0599990 Isoprenaline hydrochloride 50 mg<br />
EPI0600000 Isoprenaline sulphate 500 mg<br />
EPI0725000 Isopropyl hexadecanoate 100 mg<br />
EPI0750000 Isopropyl tetradecanoate 2 mL<br />
EPI0775000 Isosorbide dinitrate 250 mg<br />
EPI0775010 Isosorbide mononitrate 100 mg<br />
EPI0775020 Isosorbide-2-nitrate 50 mg<br />
EPI0800000 Isotretinoin 60 mg<br />
EPI0900000 Isoxsuprine hydrochloride 50 mg<br />
EPY0000366 Isradipine 125 mg<br />
EPY0000367<br />
Isradipine impurity D<br />
methyl 1-methylethyl 4-(2,1,3-benzoxadiazol-4-yl)-<br />
2,6-dimethylpyridine-3,5-dicarboxylate<br />
EPI7000000 Itraconazole 150 mg<br />
EPI8000010 Ivermectin 150 mg<br />
New EPY0000575 Ivy leaf st<strong>and</strong>ardised tincture 2 mL<br />
EPY0000041 Josamycin 150 mg<br />
EPY0000042 Josamycin propionate 150 mg<br />
EPK0100000 Kanamycin B sulphate 20 mg<br />
EPK0200000 Kanamycin monosulphate 150 mg<br />
EPY0000450 Ketamine hydrochloride Controlled Substance 10 mg<br />
EPK0551000<br />
Ketamine impurity A<br />
1-[(2-chlorophenyl)(methylimino)methyl]cyclopentanol<br />
EPY0000246 Ketobemidone hydrochloride - Reference Spectrum unit<br />
EPY0000244<br />
EPY0000245<br />
Ketobemidone impurity B<br />
1-(4-(3-hydroxyphenyl)-1-methyl-4-piperidyl)ethanone<br />
Ketobemidone impurity C<br />
1-(4-(3-hydroxyphenyl)-4-piperidyl)propan-1-one<br />
EPK0600000 Ketoconazole 150 mg<br />
EPK1000000 3-Ketofusidic acid 10 mg<br />
EPK2000000 Ketoprofen 50 mg<br />
EPK2000010<br />
EPK2000015<br />
Ketoprofen impurity A<br />
3-acetylbenzophenone<br />
Ketoprofen impurity C<br />
2-(3-carboxyphenyl)propionic acid<br />
EPY0000486 Ketorolac trometamol 10 mg<br />
EPY0000626 Ketorolac trometamol for peak identification 5 mg<br />
EPY0000164 Ketotifen hydrogen fumarate - Reference Spectrum unit<br />
EPY0000161<br />
Ketotifen impurity G<br />
4-(1-methylpiperidin-4-ylidene)-4H-benzo(4,5)cyclohepta<br />
(1,2-b)thiophen-9,10-dione<br />
EPL0050000 Labetalol hydrochloride 80 mg<br />
EPL0129000 Lactitol monohydrate 60 mg<br />
10 mg<br />
5 mg<br />
50 mg<br />
5 mg<br />
5 mg<br />
5 mg<br />
5 mg<br />
3 mg<br />
90 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
European Pharmacopoeia<br />
Code Product Unit<br />
EPY0000257 Lactobionic acid 100 mg<br />
EPA1206000 Lactose (anhydrous) 100 mg<br />
EPL0100000 Lactose 100 mg<br />
EPL0130000 Lactulose 3000 mg<br />
EPY0000188 Lactulose for system suitability 12 mg<br />
EPY0000425 Lamivudine 150 mg<br />
EPY0000518 Lamivudine for system suitability 1 10 mg<br />
EPY0000426 Lamivudine for system suitability 2 10.3 mg<br />
New EPY0000773 Lansoprazole 60 mg<br />
New EPY0000654 Leflunomide 100 mg<br />
EPY0000487<br />
Leflunomide impurity A<br />
4-(trifluoromethyl)aniline<br />
EPY0000674 Leflunomide for peak identification 1 mg<br />
EPY0000685 Letrozole 70 mg<br />
EPL0375000 L<strong>eu</strong>cine 50 mg<br />
EPL0376000 L<strong>eu</strong>prorelin 0.925 mg<br />
EPL0376001 L<strong>eu</strong>prorelin - Reference Spectrum unit<br />
EPY0000047 Levamisole for system suitability 80 mg<br />
EPL0380000 Levamisole hydrochloride 50 mg<br />
EPY0000048 Levamisole - Reference Spectrum unit<br />
EPL0390000 Levocabastine hydrochloride 125 mg<br />
EPL0390008<br />
Levocabastine impurity D<br />
1-[4-cyano-4-(4-fluorophenyl)cyclohexyl]-4-phenyl-4-piperidine<br />
carboxylic aicd<br />
EPL0399900 Levocarnitine 125 mg<br />
EPL0399905<br />
Levocarnitine impurity A<br />
4-(trimethylammonio)but-2-enoate<br />
EPL0400000 Levodopa 100 mg<br />
EPL0420000 Levodropropizine 60 mg<br />
EPL0420002<br />
Levodropropizine impurity A<br />
(2R)-3-(4-phenylpiperazin-1-yl)propane-1,2-diol(dextrodropropizine)<br />
EPL0500000 Levomepromazine hydrochloride 100 mg<br />
EPL0505000 Levomepromazine maleate 50 mg<br />
EPL0551000 Levonorgestrel 30 mg<br />
EPL0570000 Levothyroxine sodium 100 mg<br />
EPL0595000 Lidocaine 50 mg<br />
EPL0600000 Lidocaine hydrochloride 100 mg<br />
EPL0650000 Lincomycin hydrochloride 250 mg<br />
EPL0655000 Lindane 250 mg<br />
EPL0700000 Liothyronine sodium 50 mg<br />
EPL0702000 Lisinopril dihydrate 50 mg<br />
EPL0702100 Lisinopril dihydrate for performance test 2x2 mg<br />
EPL0720000 Lithium clavulanate 125 mg<br />
EPL0720800 Lithocholic acid 60 mg<br />
EPY0000112 Lobeline hydrochloride 50 mg<br />
EPL0745000 Lomustine 50 mg<br />
EPL0750000 Loperamide hydrochloride 150 mg<br />
EPY0000322 Loperamide hydrochloride for system suitability 15 mg<br />
EPY0000341 Loperamide oxide monohydrate 20 mg<br />
EPY0000688 Loratadine 60 mg<br />
EPY0000603 Loratadine for system suitability 20 mg<br />
25 mg<br />
20 mg<br />
50 mg<br />
20 mg<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 91
European Pharmacopoeia<br />
Code Product Unit<br />
EPY0000604<br />
EPY0000605<br />
Loratadine impurity F<br />
ethyl 4-[(11RS)-8-chloro-11-fluoro-6,11-dihydro-5H-benzo[5,6]cyclohepta<br />
[1,2-b]pyridin-11-yl]piperidine-1-carboxylate<br />
Loratadine impurity H<br />
ethyl 4-oxopiperidine-1-carboxylate<br />
EPL0750500 Lorazepam Controlled Substance 100 mg<br />
EPY0000576 Lorazepam for system suitability Controlled Substance 0.8 mg<br />
EPY0000718<br />
Lorazepam impurity D<br />
(5RS)-7-chloro-5-(2-chlorophenyl)-4,5-dihydro-1H-1,4-benzodiazepine-2,3-dione<br />
EPL0790000 Lovastatin 40 mg<br />
EPL0800000 Lynestrenol 50 mg<br />
EPY0000397 Lysine acetate 60 mg<br />
EPL0900000 Lysine hydrochloride 50 mg<br />
New EPY0000745 Macrogol 40 sorbitol heptaoleate 20 mg<br />
EPM0088000 Magnesium aspartate dihydrate 60 mg<br />
EPM0120000 Malathion 250 mg<br />
EPM0120005<br />
EPM0120010<br />
Malathion impurity A<br />
diethyl(2RS)-2-[(methoxy)(methylsulfanyl)-S-phosphinothioyl]<br />
butane dioate (isomalathion)<br />
Malathion impurity B<br />
diethyl(2RS)-2-(dimethoxy-S-phosphinothioyl)-butanedioate (maloxon)<br />
EPM0100000 Maleic acid 100 mg<br />
EPY0000143 Malic acid - Reference Spectrum unit<br />
EPM0160000 Maltitol 1200 mg<br />
EPM0200000 Mannitol 1200 mg<br />
EPM0206000 Maprotiline hydrochloride 100 mg<br />
EPM0206040<br />
Maprotiline impurity D<br />
3-(9,10-dihydro-9,10-ethanoanthracen-9-yl)-N-methylprop-2-en-1-amine;<br />
(dehydromaprotiline)<br />
New EPY0000819 Marbofloxacin 10 mg<br />
EPM0210000 Measles vaccine (live) BRP 5x80 mg<br />
EPM0215000 Mebendazole 20 mg<br />
EPY0000144 Mebendazole for system suitability 20 mg<br />
EPY0000168 Mebendazole - Reference Spectrum unit<br />
EPM0220000 Meclozine hydrochloride 150 mg<br />
EPM0240000 Medronic acid 20 mg<br />
EPM0250000 Medroxyprogesterone acetate 100 mg<br />
EPM0250010 Medroxyprogesterone acetate for performance test 50 mg<br />
EPY0000598 Medroxyprogesterone acetate for system suitability 10 mg<br />
EPM0252600 Mefenamic acid 50 mg<br />
EPM0253000 Mefloquine hydrochloride 100 mg<br />
EPM0260000 Megestrol acetate 50 mg<br />
EPM0260100 Megestrol acetate - Reference Spectrum unit<br />
EPY0000267 Meglumine - Reference Spectrum unit<br />
EPM0300000 Menadione 100 mg<br />
EPM0350000 Menthol 150 mg<br />
EPM0370000 Mepivacaine hydrochloride 100 mg<br />
EPM0370020<br />
Mepivacaine impurity B<br />
(RS)-N-(2,6-dimethylphenyl)piperidine-2-carboxamide<br />
EPM0400000 Meprobamate Controlled Substance 100 mg<br />
EPM0500000 Mepyramine maleate 1000 mg<br />
EPY0000679<br />
Mepyramine impurity A<br />
N-(4-methoxybenzyl)pyridin-2-amine<br />
10 mg<br />
50 mg<br />
10 mg<br />
10 mg<br />
10 mg<br />
25 mg<br />
60 mg<br />
10 mg<br />
92 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
European Pharmacopoeia<br />
Code Product Unit<br />
EPY0000680<br />
Mepyramine impurity C<br />
pyridin-2-amine<br />
EPY0000297 Mesalazine 125 mg<br />
EPY0000337 Mesna - Reference Spectrum unit<br />
EPY0000316<br />
EPY0000317<br />
Mesna impurity C<br />
2-(acetylsulphanyl)ethanesulphonic acid<br />
Mesna impurity D<br />
2,2'-disulphanediyl)bis(ethanesulphonic acid)<br />
EPY0000227 Meso-rich exametazime 0.5 mg<br />
EPY0000097 Mesterolone 60 mg<br />
EPY0000096<br />
Mesterolone impurity A<br />
17β-hydroxy-1-alpha-methyl<strong>and</strong>rost-4-en-3-one<br />
EPM0600000 Mestranol 100 mg<br />
EPY0000301 Metacresol - Reference Spectrum unit<br />
EPM0600500 Metacycline hydrochloride 50 mg<br />
EPM0600900 Metamizole sodium 100 mg<br />
EPM0600905<br />
Metamizole impurity A<br />
4-formylamino-1,5-dimethyl-2-phenyl-1,2-dihydro-3H-pyrazol-3-one<br />
EPM0605000 Metformin hydrochloride 50 mg<br />
EPY0000770 Methacrylic acid-ethylacrylate copolymer (1:1) type A 200 mg<br />
New EPY0000323 Methacrylic acid-ethyl acrylate copolymer (1:1) - type B 200 mg<br />
EPM0610000 Methacrylic acid-ethylacrylate copolymer (1:1) - Reference Spectrum unit<br />
EPM0610030 Methacrylic acid-ethyl acrylate copolymer (1:1), dispersion 30% - Reference Spectrum unit<br />
EPM0620000 Methacrylic acid-methylmethacrylate copolymer (1:1) - Reference Spectrum unit<br />
EPM0630000 Methacrylic acid-methylmethacrylate copolymer (1:2) - Reference Spectrum unit<br />
EPM0800000 Methadone hydrochloride - Reference Spectrum unit<br />
EPY0000428 Methanol - Reference Spectrum unit<br />
EPM0900000 Methaqualone - Reference Spectrum unit<br />
EPM0920001 Methenamine - Reference Spectrum unit<br />
New EPY0000754 Methenamine 10 mg<br />
EPM0950000 DL-Methionine 50 mg<br />
EPM0960000 Methionine 50 mg<br />
EPM1000000 Methotrexate 100 mg<br />
EPY0000602 Methotrexate for peak identification 20 mg<br />
New EPY0000663<br />
EPM1000008<br />
New EPY0000664<br />
Methotrexate impurity C<br />
(2S)-2-[[4-[[(2-amino-4-oxo-1,4-dihydropteridin-<br />
6-yl)methyl]methylamino]benzoyl]amino]pentanedioic acid (N-methylfolic acid,<br />
methopteridine)<br />
Methotrexate impurity D<br />
4-[[(2-amino-4hydroxypteridin-6-yl)methyl]methyl-amino]benzoic acid<br />
Methotrexate impurity E<br />
4-[[(2,4-diaminopteridin-6-yl)methyl]methylamino]benzoic acid (4-amino-N10-methylpteroic<br />
acid, APA)<br />
EPM1100000 3-Methoxymethyldopa 20 mg<br />
EPM1300000 Methylatropine bromide 100 mg<br />
EPM1400000 Methylatropine nitrate 100 mg<br />
EPM1450000 Methylcarbidopa 1 mg<br />
EPM1470000 Methyl 2-(4-chlorophenoxy)-2-methylpropionate 0.5 mL<br />
EPM1500000 Methyldopa 50 mg<br />
EPM1550000 Methylene chloride 2 mL<br />
EPM1551000 2-(1-Methylethyl)pentanoic acid 25 mg<br />
EPM1556000 Methyl 12-hydroxystearate 100 mg<br />
EPY0000398 Methyl nicotinate 25 mg<br />
New EPY0000776 Methylergometrine maleate 10 mg<br />
10 mg<br />
10 mg<br />
10 mg<br />
30 mg<br />
10 mg<br />
10 mg<br />
10 mg<br />
10 mg<br />
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Code Product Unit<br />
New EPY0000777 Methylergometrine maleate for system suitability 0.53 mg<br />
EPM1625000 Methylnitrosoindoline 100 mg<br />
EPM1650000 Methyl parahydroxybenzoate 50 mg<br />
EPM1700000 Methylphenobarbital Controlled Substance 500 mg<br />
EPM1750000 Methylprednisolone 150 mg<br />
EPM1755000 Methylprednisolone acetate 100 mg<br />
EPM1755200 Methylprednisolone hydrogen succinate 125 mg<br />
EPM1755220 Methylprednisolone hydrogen succinate for performance test 50 mg<br />
EPY0000190 N-Methylpyrrolidone - Reference Spectrum unit<br />
EPM1770180 Methyl ricinoleate 125 mg<br />
EPY0000418 Methylrosanilinium chloride 40 mg<br />
EPY0000407 Methylrosanilinium chloride for system suitability 10 mg<br />
EPM1770200 Methyl stearate 100 mg<br />
EPM1800000 Methyltestosterone 100 mg<br />
EPM1800900<br />
EPM1800902<br />
Methylthioninium chloride<br />
methylene blue<br />
Methylthioninium impurity A<br />
3-(dimethylamino)-7-(methylamino)phenothiazin-5-ylium<br />
EPM1808000 Metixene hydrochloride 75 mg<br />
EPM1824990 Metoclopramide 100 mg<br />
EPM1825000 Metoclopramide hydrochloride 50 mg<br />
EPM1824995<br />
EPM1825010<br />
Metoclopramide impurity A<br />
4-(acetylamino)-5-chloro-N-(2-diethylaminoethyl)-2-methoxybenzamide<br />
Metoclopramide impurity E<br />
N,N-diethylethane-1,2-diamine<br />
New EPY0000701 Metolazone 80 mg<br />
New EPY0000702 Metolazone for system suitability 10 mg<br />
EPY0000171 Metoprolol succinate - Reference Spectrum unit<br />
EPM1830000 Metoprolol tartrate 60 mg<br />
EPY0000145<br />
Metoprolol impurity A<br />
(2RS)-1-(ethylamino)-3-[4-(2-methoxyethyl)phenoxy]propan-2-ol<br />
EPM1845000 Metrifonate 100 mg<br />
EPM1850000 Metronidazole 50 mg<br />
EPM1851000 Metronidazole benzoate 50 mg<br />
EPY0000069 Metronidazole benzoate - Reference Spectrum unit<br />
EPY0000087<br />
Metronidazole impurity A<br />
2-methyl-4-nitroimidazole<br />
EPM1860000 Mexiletine hydrochloride 100 mg<br />
EPY0000202<br />
EPY0000203<br />
Mexiletine impurity C<br />
1,1'-[(3,3',5,5'-tetramethylbiphenyl-4,4'-diyl)bisoxy] dipropan-2-amine<br />
Mexiletine impurity D<br />
(2RS)-2-(2,6-dimethylphenoxy)propan-1-amine<br />
EPM1875000 Mianserin hydrochloride 50 mg<br />
EPM1880000 Miconazole 70 mg<br />
EPM1900000 Miconazole nitrate 100 mg<br />
EPY0000562<br />
Midazolam impurity C<br />
8-chloro-6-(2-fluorophenyl)-1-methyl-4H-imidazo[1,5-a][1,4]benzodiazepine-3-carboxylic acid<br />
50 mg<br />
20 mg<br />
25 mg<br />
20 mg<br />
10 mg<br />
10 mg<br />
2 mg<br />
2 mg<br />
0.08 mg<br />
EPM2200000 Midazolam Controlled Substance 50 mg<br />
EPY0000599 Midazolam for system suitability Controlled Substance 1 mg<br />
New EPY0000539 Milk thistle st<strong>and</strong>ardised dry extract 120 mg<br />
EPM2280000 Minocycline hydrochloride 125 mg<br />
EPM2300000 Minoxidil 50 mg<br />
New EPY0000705 Mirtazapine 10 mg<br />
New EPY0000721 Mirtazapine for system suitability 10 mg<br />
94 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
European Pharmacopoeia<br />
Code Product Unit<br />
EPY0000490 Misoprostol 30 mg<br />
EPY0000491<br />
Misoprostol impurity A<br />
mixture of methyl 7-[(1RS,2SR, 3SR)-3-hydroxy-2-[(1E,4RS)-4-hydroxy-4-methyloct1-enyl]<br />
-5-oxocyclopentyl]heptanoate <strong>and</strong> methyl- 7-[(1RS,2SR,3SR)-3-hydroxy-2-[(1E,4SR)<br />
-4-hydroxy4-methyloct-1-enyl]-5-oxocyclopentyl]heptanoate (8-epimisoprostol)<br />
EPY0000378 Mitomycin 120 mg<br />
EPM2305000 Mitoxantrone hydrochloride 60 mg<br />
EPM2305005<br />
Mitoxantrone impurity A<br />
1-amino-5,8-dihydroxy-4-[[2-[(2-hydroxyethyl)amino]ethyl]amino]<br />
anthracene-9,10-dione<br />
EPY0000635 Modafinil Controlled Substance 110 mg<br />
EPY0000636 Modafinil for system suitability Controlled Substance 0.1 mg<br />
EPY0000251 Molgramostim 0.3 mL<br />
New EPY0000821 Molsidomine 5 mg<br />
New EPY0000822<br />
New EPY0000823<br />
Molsidomine impurity B<br />
N-Nitrosomorpholine<br />
Molsidomine impurity D<br />
morpholine-4-carbaldehyde<br />
EPM2900000 Mometasone furoate 100 mg<br />
EPY0000028 Morantel hydrogen tartrate 50 mg<br />
EPY0000451 Morphine hydrochloride (trihydrate) Controlled Substance 25 mg<br />
EPY0000452 Morphine sulphate Controlled Substance 40 mg<br />
New EPY0000772 Moxidectin 70 mg<br />
New EPY0000747 Moxidectin for system suitability 10 mg<br />
New EPY0000703 Moxifloxacin hydrochloride 110 mg<br />
New EPY0000717 Moxifloxacin for peak identification 10 mg<br />
EPY0000226 Moxonidine 50 mg<br />
EPY0000222<br />
Moxonidine impurity A<br />
4,6-dichloro-N-(4,5-dihydro-1H-imidazol-2-yl)-2-methyl-5-pyrimidinamine<br />
EPM3600000 Mumps vaccine (live) BRP 5x33 mg<br />
EPM3805000 Mupirocin - Reference Spectrum unit<br />
EPM3805500 Mupirocin calcium - Reference Spectrum unit<br />
EPM3806000 Mupirocin lithium 100 mg<br />
EPY0000489 Mycophenolate mofetil 30 mg<br />
EPY0000519 Mycophenolate mofetil for peak identification 10 mg<br />
EPY0000692 Mycoplasma fermentans BRP 1 mL<br />
EPY0000690 Mycoplasma hyorhinis BRP 1 mL<br />
EPY0000691 Mycoplasma orale BRP 1 mL<br />
EPY0000689 Mycoplasma synoviae BRP 1 mL<br />
EPY0000485 Myo-inositol 1020 mg<br />
EPN0020020<br />
EPN0020030<br />
Nabumetone impurity D<br />
(E)-4-(6-methoxynaphthalen-2-yl)but-3-en-2-one<br />
Nabumetone impurity F<br />
6,6'-dimethoxy-2,2'-binaphthalenyl<br />
EPY0000146 Nadolol 100 mg<br />
EPN0025000 Nadroparin calcium 250 mg<br />
EPY0000077 Naftidrofuryl - Reference Spectrum unit<br />
EPY0000120<br />
EPY0000121<br />
EPY0000122<br />
EPY0000331<br />
Naftidrofuryl impurity A<br />
2-[(naphtalen-1-yl)methyl]-3-(tetrahydrofuran-2-yl)propanoic acid<br />
Naftidrofuryl impurity B<br />
ethyl 2-[(naphtalen-1-yl)methyl]-3-(tetrahydrofuran-2-yl)propanoate<br />
Naftidrofuryl impurity C<br />
2-(diethylamino)ethyl 3-[(naphtalen-1-yl)-2-[(naphtalen-1-yl)methyl]propanoate<br />
Naftidrofuryl impurity F<br />
2-[(diethylamino)ethyl 2-[(naphthalen-2-yl)methyl]-3-(tetrahydrofuran-2-yl) propanoate<br />
5 mg<br />
5 mg<br />
10 mg<br />
10 mg<br />
10 mg<br />
10 mg<br />
10 mg<br />
10 mg<br />
25 mg<br />
50 mg<br />
10 mg<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 95
European Pharmacopoeia<br />
Code Product Unit<br />
EPN0050000 Nalidixic acid 100 mg<br />
EPN0075000 Naloxone hydrochloride dihydrate 100 mg<br />
EPY0000695 Naloxone for peak identification 10 mg<br />
EPY0000400 Naltrexone hydrochloride 50 mg<br />
EPY0000410<br />
Naltrexone impurity C<br />
N-(3-butenyl)-noroxymorphone<br />
EPY0000542 N<strong>and</strong>rolone decanoate 5 mg<br />
EPY0000547 N<strong>and</strong>rolone decanoate for peak identification 10 mg<br />
EPY0000548 N<strong>and</strong>rolone decanoate for system suitability 10 mg<br />
EPN0080000 Naphazoline hydrochloride 50 mg<br />
EPY0000252 Naphazoline hydrochloride - Reference Spectrum unit<br />
EPN0100000 Naphazoline nitrate 10 mg<br />
EPN0200000<br />
Naphazoline impurity A<br />
N-(2-aminoethyl)-2-(naphthalen-1-yl)acetamide (Naphthylacetylethylenediamine)<br />
EPN0250000 Naproxen 100 mg<br />
EPY0000399 Naproxen (racemic) 10 mg<br />
EPY0000631<br />
Naproxen impurity L<br />
1-(6-Methoxynaphthalen-2-yl)ethanone (Acetylnerolin)<br />
EPN0300000 Neamine 0.5 mg<br />
EPN0399000 Neohesperidin dihydrochalcone 125 mg<br />
EPN0399004<br />
Neohesperidin dihydrochalcone impurity B<br />
7-[[2-O-(6-deoxy-α-L-mannopyranosyl)-ß-D-glucopyranosyl]oxy]-5-hydroxy-2-(3-hydroxy-<br />
4-methoxyphenyl)-4H-1-benzopyran-4-one (neodiosmin)<br />
EPN0400000 Neomycin sulphate 50 mg<br />
EPN0401000 Neomycin sulphate for microbiological assay 25 mg<br />
EPN0500000 Neostigmine bromide 50 mg<br />
EPN0550000 Neostigmine metilsulfate 50 mg<br />
EPN0559000 Netilmicin sulphate 2x25 mg<br />
New EPY0000520 Nevirapine (anhydrous) 30 mg<br />
EPY0000521 Nevirapine for peak identification 0.058 mg<br />
EPY0000388 Newcastle Disease Vaccine (inacativated) BRP 4 uc<br />
EPY0000287 Nicergoline - Reference Spectrum unit<br />
EPY0000283<br />
Nicergoline impurity A<br />
[(6aR,9R,10aS)-10a-methoxy-4,7-dimethyl-4,6,6a,7,8,9,10,10a-octahydroindol<br />
[4,3-fg]quinolin-9-yl]methyl 5-chloropyridine-3-carboxylate<br />
EPN0560000 Niclosamide (anhydrous) 50 mg<br />
EPN0600000 Nicotinamide 50 mg<br />
EPN0590000 Nicotine - Reference Spectrum unit<br />
EPN0590200 Nicotine ditartrate 120 mg<br />
EPN0700000 Nicotinic acid 100 mg<br />
EPN0750000 Nifedipine 50 mg<br />
EPN0750010<br />
EPN0750015<br />
Nifedipine impurity A<br />
Dimethyl 2,6-dimethyl-4-(2-nitrophenyl) pyridine-3,5-dicarboxylate<br />
Nifedipine impurity B<br />
Dimethyl 2,6-dimethyl-4-(2-nitrosophenyl) pyridine-3,5-dicarboxylate<br />
New EPY0000824 Niflumic acid 10 mg<br />
New EPY0000825<br />
New EPY0000826<br />
New EPY0000827<br />
Niflumic acid impurity A<br />
2-chloropyridine-3-carboxylic acid<br />
Niflumic acid impurity B<br />
2-hydroxy-N-(3-(trifluoromethyl)phenyl)pyridine-3-carboxamide<br />
Niflumic acid impurity E<br />
6-((3-(trifluoromethyl)phenyl)amino)pyridine-3-carboxylic acid<br />
New EPY0000836 Nifuroxazide 10 mg<br />
EPY0000178 Nifuroxazide - Reference Spectrum unit<br />
15 mg<br />
25 mg<br />
10 mg<br />
10 mg<br />
10 mg<br />
20 mg<br />
20 mg<br />
10 mg<br />
10 mg<br />
15 mg<br />
96 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
European Pharmacopoeia<br />
Code Product Unit<br />
EPN0800000 Nikethamide 1 mL<br />
EPN0845000 Nimesulide 100 mg<br />
EPN0845008<br />
Nimesulide Impurity D<br />
4-nitro-2-phenoxyaniline<br />
0.004 mg<br />
EPN0850000 Nimodipine 50 mg<br />
EPN0850010<br />
Nimodipine impurity A<br />
2-methoxyethyl 1-methylethyl 2,6-dimethyl-4-(3-nitrophenyl)<br />
pyridine-3,5-dicarboxylate<br />
EPN0900000 Nitrazepam Controlled Substance 100 mg<br />
EPN0900010<br />
Nitrazepam impurity A<br />
3-amino-6-nitro-4-phenylquinol-2-one<br />
EPN0905000 Nitrendipine 60 mg<br />
EPN0905005<br />
Nitrendipine impurity A<br />
ethyl methyl-2,6-dimethyl-4-(3-nitrophenyl) pyridine-3,5-dicarboxylate;<br />
(nitrophenylpyridine analogue)<br />
EPN0930000 Nitric oxide - Reference Spectrum unit<br />
EPN0950000 Nitrofural 100 mg<br />
EPN1000000 Nitrosotriaminopyrimidine 50 mg<br />
EPN1090000 Nizatidine 250 mg<br />
EPN1090060<br />
Nizatidine impurity F<br />
(EZ)N 1 ,N 1 ,-[thiazole-2,4-diylbis(methylenesulphanediylethylene)]<br />
bis(N’-methyl-2-nitroethene-1,1-diamine)<br />
EPN1080000 Nomegestrol acetate 100 mg<br />
EPN1080005<br />
Nomegestrol acetate impurity A<br />
17α-acetoxy-6α-methyl-19-norpregn-4-ene-3,20-dione<br />
EPY0000670 Nonivamide 10 mg<br />
New EPY0000755 Nonoxinol 9 10 mg<br />
EPN1084000 Nonoxinol 9 - Reference Spectrum unit<br />
EPN1100000 Noradrenaline tartrate 200 mg<br />
EPY0000681<br />
EPY0000682<br />
EPY0000686<br />
Noradrenaline impurity D<br />
4[(1R)-2-amino-1-methoxyethyl]benzene-1,2-diol (Noradrenaline methyl ether)<br />
Noradrenaline impurity E<br />
2-chloro-1-(3,4-dihydroxyphenyl)ethanone<br />
Noradrenaline impurity F<br />
N-benzyl-1-phenylmethanamine<br />
EPN1130000 Norcyclobenzaprine 25 mg<br />
EPN1140000<br />
Nordazepam Controlled Substance<br />
Dipotassium clorazepate impurity B<br />
EPN1200000 Norethisterone 100 mg<br />
EPN1225000 Norethisterone acetate 100 mg<br />
EPY0000522 Norethistherone for system suitability 10 mg<br />
EPN1230000 Norfloxacin 50 mg<br />
EPN1230010<br />
Norfloxacin impurity A<br />
7-chloro-1-ethyl-6-fluoro-4-oxo-1,4-dihydroquinoline-3-carboxylic acid<br />
New EPY0000724 Norgestimate 10 mg<br />
New EPY0000725 Norgestimate for system suitability 5 mg<br />
EPN1250000 Norgestrel 30 mg<br />
EPN1279000 Norps<strong>eu</strong>doephedrine hydrochloride Controlled Substance 50 mg<br />
EPN1280000 Nortriptyline hydrochloride 10 mg<br />
EPN1300000 Noscapine 100 mg<br />
EPN1400000 Nystatin 300 mg<br />
EPO0100900 Octoxinol 10 300 mg<br />
EPY0000368 Octyl gallate 30 mg<br />
EPO0101000 Octyldodecanol 400 mg<br />
EPO0120000 Ofloxacin 50 mg<br />
1 mL<br />
25 mg<br />
20 mg<br />
10 mg<br />
50 mg<br />
15 mg<br />
10 mg<br />
10 mg<br />
50 mg<br />
20 mg<br />
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Code Product Unit<br />
EPO0120010<br />
EPO0120050<br />
Ofloxacin impurity A<br />
(RS)-9,10-difluoro-3-methyl-7-oxo-2,3-dihydro-7H-pyrido<br />
[1,2,3-de][1,4]benzoxazine-6-carboxylic acid (FPA)<br />
Ofloxacin impurity E<br />
(RS)-9-fluoro-3-methyl-10-(piperazin-1-yl)-7-oxo-2,3-dihydro-7H-pyrido [1,2,3-de]<br />
[1,4]benzoxazine-6-carboxylic acid<br />
New EPY0000805 Ol<strong>eu</strong>ropein 20 mg<br />
EPO0146000 Olsalazine sodium 60 mg<br />
EPO0146010 Olsalazine sodium for performance test 60 mg<br />
EPO0150000 Omeprazole 50 mg<br />
EPO0151000<br />
Omeprazole impurity D<br />
Omeprazole sulphone<br />
EPY0000218 Ondansetron hydrochloride dihydrate 200 mg<br />
EPY0000197 Ondansetron for LC system suitability 10 mg<br />
EPY0000196 Ondansetron for TLC system suitability 30 mg<br />
EPY0000195<br />
Ondansetron impurity D<br />
9-methyl-3-methylene-1,2,3,9-tetrahydro-4H-carbazol-4-one<br />
EPO0180000 Orciprenaline sulphate 100 mg<br />
EPY0000101 Orphenadrine citrate 100 mg<br />
EPY0000100 Orphenadrine hydrochloride 100 mg<br />
EPY0000102<br />
Orphenadrine impurity E<br />
(RS)-N,N-dimethyl-2-[(3-methylphenyl)phenylmethoxy]ethanamine<br />
(meta-methylbenzyl isomer)<br />
EPO0200000 Ouabain 150 mg<br />
EPY0000638 Oxacillin sodium monohydrate 110 mg<br />
EPY0000560 Oxacillin for peak identification 10 mg<br />
EPY0000271 Oxaliplatin 250 mg<br />
EPY0000272<br />
EPY0000273<br />
EPY0000274<br />
Oxaliplatin impurity B<br />
(SP-4-2)-diaqua[(1R,2R)-cyclohexane-1,2-diamine-kN,kN']platinum<br />
(diaquodiaminocyclohexaneplatinum)<br />
Oxaliplatin impurity C<br />
(OC-6-33)-[(1R,2R)-cyclohexane-1,2-diamine-kN,kN'][ethanedioato(2-)-<br />
kO¹,kO²]dihydroxyplatinum<br />
Oxaliplatin impurity D<br />
(SP-4-2)-[(1S,2S)-cyclohexane-1,2-diamine-kN,kN'][ethanedioato(2-)-<br />
kO¹,kO² ]platinum (S,S-enantiomer of oxaliplatin)<br />
EPO0225000 Oxazepam Controlled Substance 50 mg<br />
EPY0000543 Oxazepam for peak identification 0.008 mg<br />
EPY0000350 Oxeladin hydrogen citrate 50 mg<br />
EPY0000404<br />
EPY0000390<br />
Oxeladin impurity C<br />
2-(diethylamino)ethyl 2-ethyl-2-phenylbutanoate<br />
Oxeladin impurity D<br />
2-(2-diethylaminoethoxy)ethyl 2-phenyl-butyrate dihydrogen citrate<br />
EPO0225800 Oxfendazole for veterinary use 50 mg<br />
EPY0000224<br />
Oxfendazole impurity B<br />
methyl[5-[phenylsulphonyl)-1H-benzimidazole-2-yl]carbamate<br />
EPY0000225 Oxfendazole with impurity D 10 mg<br />
EPY0000709 Oxitropium bromide 50 mg<br />
EPY0000715<br />
EPY0000713<br />
Oxitropium bromide impurity B<br />
(1R,2R,4S,5S,7s)-7-[[(2S)-3-hydroxy-2-phenylpropanoyl)oxy]-9,9-dimethyl-3-oxa-<br />
9-azoniatricyclo[3.3.1.0]nonane (methylhyoscine)<br />
Oxitropium bromide impurity D<br />
(1R,2R,4S,5S,7s,9r)-9-ethyl-9-methyl-7-[(2-phenylprop-2-enoyl)oxy]-3-oxa-<br />
9-azoniatricyclo[3.3.1.0]nonane (apo-N-ethylhyoscine)<br />
EPO0240000 Oxolinic acid 50 mg<br />
EPO0240005<br />
Oxolinic acid impurity A<br />
8-hydroxy-1,3-dioxolo[4,5-g]quinoline-7-carboxylic acid<br />
20 mg<br />
20 mg<br />
5 mg<br />
10 mg<br />
30 mg<br />
20 mg<br />
10 mg<br />
5 mg<br />
10 mg<br />
20 mg<br />
10 mg<br />
15 mg<br />
10 mg<br />
20 mg<br />
98 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
European Pharmacopoeia<br />
Code Product Unit<br />
EPO0240010<br />
Oxolinic acid impurity B<br />
ethyl 5-ethyl-8-oxo-5,8-dihydro-1,3-dioxolo[4,5-g]quinoline-7-carboxylate<br />
EPO0250000 Oxprenolol hydrochloride 50 mg<br />
EPO0260000 Oxybendazole 100 mg<br />
EPO0270000 Oxybuprocaine hydrochloride 150 mg<br />
EPO0288000 Oxybutynin hydrochloride 150 mg<br />
EPO0288005<br />
Oxybutynin impurity A<br />
4-(diethylamino)but-2-ynyl(RS)-2-(cyclohex-3-enyl)-2-cyclohexyl-2-hydroxyacetate<br />
EPY0000492 Oxycodone hydrochloride Controlled Substance 100 mg<br />
EPY0000453<br />
Oxycodone impurity D<br />
7,8-didehydro-4,5 alpha-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one<br />
(14-hydroxycodeinone)<br />
EPO0290000 Oxymetazoline hydrochloride 80 mg<br />
EPO0400000 Oxytetracycline 100 mg<br />
EPO0500000 Oxytetracycline hydrochloride 20 mg<br />
EPO0700000 Oxytocin 41 mg<br />
EPO0770000 Oxytocin/Desmopressin validation mixture 0.2 mg<br />
New EPY0000698 Paclitaxel 40 mg<br />
New EPY0000699<br />
Paclitaxel impurity C<br />
N-debenzoyl-N-hexanoylpaclitaxel<br />
New EPY0000700 Paclitaxel natural for peak identification 10 mg<br />
New EPY0000719 Paclitaxel semi-synthetic for peak identification 10 mg<br />
New EPY0000739 Paclitaxel semi-synthetic for system suitability 1 mg<br />
EPP0090000 Palmitic acid 100 mg<br />
EPY0000524 Pamidronate disodium pentahydrate 10 mg<br />
EPP0100000 Pancrease powder (amylse <strong>and</strong> lipase) BRP 2000 mg<br />
EPP0200000 Pancreas powder (protease) BRP 2000 mg<br />
EPP0250000<br />
Pancuronium bromide<br />
Vecuronium impurity B<br />
EPY0000577 Pancuronium bromide for system suitability 20 mg<br />
New EPY0000835 Pantoprazole sodium sesquihydrate 20 mg<br />
EPP0270000 Papaverine hydrochloride 25 mg<br />
EPP0300000 Paracetamol 50 mg<br />
EPP0302000 Paraffin (hard) - Reference Spectrum unit<br />
New EPY0000780 Paraffin (hard) 10 mg<br />
EPY0000058 Paraffin (liquid) - Reference Spectrum unit<br />
EPY0000293 Paraffin (white soft) - Reference Spectrum unit<br />
EPP0302500 Paraffin (yellow soft) - Reference Spectrum unit<br />
EPP0305000 Parnaparin sodium 250 mg<br />
EPY0000578 Paroxetine hydrochloride (anhydrous) 100 mg<br />
EPY0000281 Paroxetine hydrochloride hemihydrate 100 mg<br />
EPY0000233<br />
EPY0000579<br />
EPY0000256<br />
EPY0000580<br />
EPY0000581<br />
Paroxetine impurity A<br />
(3S,4R)-3-[[1,3-benzodioxol-5-yloxy]methyl]-4-phenylpiperidine (desfluoroparoxetine)<br />
Paroxetine hydrochloride (anhydrous) impurity C<br />
(3S,4R)-3-[(1,3-benzodioxol-5-yloxy)methyl]-1-benzyl-4-(4-fluorophenyl)piperidine<br />
(N-benzylparoxetine)<br />
Paroxetine impurity D<br />
(3R,4S)-3-[(1,3-benzodioxol-5-yloxy)methyl]-4-(4-fluorophenyl)piperidine ((+)-transparoxetine)<br />
Paroxetine impurity E<br />
(3RS,4RS)-3-[(1,3-benzodioxol-5-yloxy)methyl]-4-(4fluorophenyl)piperidine (cis-paroxetine)<br />
Paroxetine hydrochloride (anhydrous) impurity H<br />
[(3S,4R)-1-benzyl-4-(4-fluorophenyl)piperidin-3-yl]methanol<br />
EPY0000630 Paroxetine for system suitability 5 mg<br />
EPP0309000 Pefloxacin mesilate dihydrate 200 mg<br />
20 mg<br />
10 mg<br />
25 mg<br />
5 mg<br />
20 mg<br />
5 mg<br />
10 mg<br />
5 mg<br />
5 mg<br />
10 mg<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 99
European Pharmacopoeia<br />
Code Product Unit<br />
EPP0309020<br />
EPP0309030<br />
Pefloxacin impurity B<br />
1-ethyl-6-chloro-7-(4-methylpiperazin-1-yl)-4-oxo-1,4-dihydroquinoline-3-carboxylic acid<br />
(chlorinated homologue of pefloxacin)<br />
Pefloxacin impurity C<br />
1-ethyl-6-fluoro-5-(4-methylpiperazin-1yl)-4-oxo-1,4-dihydroquinoline-3-carboxylic acid<br />
(isopefloxacin)<br />
10 mg<br />
0.01 mg<br />
EPP0307000 Penbutolol sulphate 100 mg<br />
EPP0307005<br />
Penbutolol impurity A<br />
(2S)-1-[2-(cyclopent-1-enyl)phenoxy]-3-[(1,1-dimethylethyl)amino]propan-2-ol<br />
EPP0310000 Penicillamine 100 mg<br />
EPP0320000 Penicillamine disulphide 100 mg<br />
EPP0400100 Pentaerythrityl tetranitrate diluted 600 mg<br />
EPP0405000 Pentamidine diisetionate 30 mg<br />
EPP0405500 Pentazocine - Reference Spectrum unit<br />
EPP0405510 Pentazocine hydrochloride - Reference Spectrum unit<br />
EPY0000417 Pentazocine lactate - Reference Spectrum unit<br />
EPP0500000 Pentobarbital Controlled Substance 500 mg<br />
EPP0510000 Pentoxifylline 100 mg<br />
EPY0000076 Pentoxyverine hydrogen citrate - Reference Spectrum unit<br />
EPY0000098<br />
EPY0000099<br />
Pentoxyverine impurity A<br />
1-phenylcyclopentanecarboxylic acid<br />
Pentoxyverine impurity B<br />
2-(diethylamino)ethyl-1-phenylcyclopentanecarboxylate (caramiphen)<br />
EPP0525000 Pepsin powder BRP 2000 mg<br />
EPY0000010 Pergolide mesilate 150 mg<br />
EPY0000237<br />
Perindopril impurity A<br />
(2S,3aS,7aS)-octahydro-1Hindole-2-carboxylic acid<br />
EPY0000207 Perindopril for stereochemical purity 40 mg<br />
EPY0000206 Perindopril for system suitability 30 mg<br />
EPY0000238 Perindopril tert-butylamine 40 mg<br />
New EPY0000771 Perindopril for peak identification 5 mg<br />
EPP0550000 Perphenazine 100 mg<br />
EPY0000021 Pertussis toxin BRP 2x0.05 mg<br />
EPP0600000 Pethidine hydrochloride - Reference Spectrum unit<br />
EPP0600002 Pethidine impurity A<br />
20 mg<br />
1-methyl-4-phenylpiperidine (MPP)<br />
EPP0800000 Phenazone 20 mg<br />
EPP0850000 Pheniramine maleate 250 mg<br />
EPP0900000 Phenobarbital Controlled Substance 250 mg<br />
EPP0950000 Phenoxyethanol 2 mL<br />
EPP1000000 Phenoxymethylpenicillin 250 mg<br />
EPP1100000 Phenoxymethylpenicillin potassium 250 mg<br />
EPP1109000 Phentolamine mesilate - Reference Spectrum unit<br />
EPP1150000 Phenylalanine 60 mg<br />
EPP1200000 Phenylbutazone 100 mg<br />
EPY0000147<br />
Phenylbutazone impurity B<br />
(4-butyl-4-hydroxy-1,2-diphenyl-3,5)pyrazolidinedione<br />
EPP1240000 Phenylephrine 60 mg<br />
EPP1250000 Phenylephrine hydrochloride 50 mg<br />
EPY0000683 Phenylephrine hydrochloride for peak identification 2 mg<br />
EPY0000229 Phenylmercuric acetate - Reference Spectrum unit<br />
EPP1255100 Phenylmercuric borate - Reference Spectrum unit<br />
EPP1260000 Phenylpropanolamine hydrochloride Controlled Substance 50 mg<br />
EPP1290000 Phenytoin 100 mg<br />
20 mg<br />
10 mg<br />
10 mg<br />
10 mg<br />
20 mg<br />
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European Pharmacopoeia<br />
Code Product Unit<br />
EPP1300000 Phenytoin sodium 250 mg<br />
EPY0000493 Phloroglucinol (anhydrous) 210 mg<br />
New EPY0000761 Pholcodine Controlled Substance 10 mg<br />
EPP1400000 Pholcodine - Reference Spectrum unit<br />
New EPY0000798 Pholcodine for peak identification Controlled Substance 10 mg<br />
New EPY0000766 Phthalic acid 20 mg<br />
EPP1500000 Phthalylsulfathiazole 100 mg<br />
EPP1600000 Physostigmine salicylate 100 mg<br />
EPP1605000 Physostigmine sulphate 100 mg<br />
EPP1609000 Phytomenadione 150 mg<br />
EPP1609010 trans-Epoxyphytomenadione 10 mg<br />
EPP1645000 Picotamide monohydrate 125 mg<br />
EPP1645005<br />
EPY0000124<br />
Picotamide impurity A<br />
4-methoxybenzene-1,3-dicarboxylic acid<br />
Pidolate impurity B<br />
(2S)-2-[[[(2S)-5-oxopyrrolidin-2-yl]carbonyl]amino]pentanedioic acid<br />
EPY0000123 Pidolic acid 125 mg<br />
EPP1650000 Pilocarpine hydrochloride 50 mg<br />
EPP1700000 Pilocarpine nitrate 50 mg<br />
EPY0000106 Pilocarpine nitrate for system suitability 20 mg<br />
EPY0000525 Pimobendan 10 mg<br />
EPY0000401 Pimobendan for system suitability 0.1 mg<br />
EPP1750000 Pimozide 150 mg<br />
EPP1800000 Pindolol 100 mg<br />
EPY0000061 Pipemidic acid trihydrate - Reference Spectrum unit<br />
EPP1890000 Piperacillin 100 mg<br />
EPP1900000 Piperazine adipate 250 mg<br />
EPP2000000 Piperazine citrate 250 mg<br />
EPP2100000 Piperazine hydrate 250 mg<br />
EPY0000288 Piracetam 120 mg<br />
EPY0000038 Pirenzepine dihydrochloride monohydrate 250 mg<br />
EPP2120000 Piretanide 100 mg<br />
EPP2120002<br />
Piretanide impurity A<br />
4-phenoxy-3(1H-pyrrol-1-yl)-5-sulphamoylbenzoic acid<br />
EPP2130000 Piroxicam 100 mg<br />
EPP2130100 Piroxicam for system suitability 10 mg<br />
EPP2150000 Pivampicillin 50 mg<br />
EPP2152000 Pivmecillinam hydrochloride 100 mg<br />
EPP2152015<br />
Pivmecillinam impurity C<br />
methylene 2,2-dimethylpropanoate (2RS,4S)-2-[[[(hexahydo-1H-azepin-1-yl)<br />
methylene]amino]methyl]-5,5-dimethylthiazolidin-4-carboxylate<br />
EPP2155001 Plastic additive 01<br />
(2RS)-2-ethylhexyl)benzene-1,2-dicarboxylate Synonym: di(2-ethylhexyl)<br />
phthalate<br />
EPP2155003 Plastic additive 03<br />
N,N'-ethylenedialcanamide<br />
Synonym: N,N'-diacylethylenediamines<br />
EPE0800000 Plastic additive 04<br />
Epoxidised soya oil<br />
EPP2155005 Plastic additive 05<br />
Epoxidised linseed oil<br />
EPP2155008 Plastic additive 08<br />
Ethylene bis [3,3-di(3-1,1-dimethylethyl -4-hydroxyphenyl)-butyrate]R<br />
25 mg<br />
50 mg<br />
20 mg<br />
10 mg<br />
2 mL<br />
100 mg<br />
500 mg<br />
500 mg<br />
500 mg<br />
EPP2155009 Plastic additive 09 250 mg<br />
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Code Product Unit<br />
EPP2155010 Plastic additive 10<br />
4,4',4''-[(2,4,6-trimethylbenzene-1,3,5-triyl)tris(methylene)]-<br />
tris[2,6-bis(1,1-dimethylethyl)phenol] Synonym:2,2',2'',6,6',6''-hexatert-butyl-4,4',4''-<br />
[2,4,6-trtimethyl-1,3,5-benzenetriyl)trismethylene]triphenol<br />
EPP2155011 Plastic additive 11<br />
Octadecyl 3-(3,5-di-tert-butyl-4-hydroxyphenyl)-propionate<br />
EPP2155012 Plastic additive 12<br />
Tris(2,4-di-1,1-dimethylethylphenyl)phosphite R<br />
EPP2155013 Plastic additive 13<br />
1,3,5-tris(3,5-di-1,1-dimethylethyl-4-hydroxybenzyl)-1H,3H,5H-1,3,5-triazine-2,4,6-trione<br />
EPP2155014 Plastic additive 14<br />
2,2'-Di(octadecycloxy)5,5'-spirobi(1,3,2,-dioxaphosphorinane)R<br />
EPP2155015 Plastic additive 15<br />
Dioctadecyl disulphide<br />
EPP2155016 Plastic additive 16<br />
Didodecyl 3,3'-thiodipropionate R<br />
EPP2155017 Plastic additive 17<br />
Dioctadecyl 3,3'-thiodipropionate R<br />
250 mg<br />
500 mg<br />
200 mg<br />
250 mg<br />
200 mg<br />
500 mg<br />
500 mg<br />
500 mg<br />
EPP2155018 Plastic additive 18 100 mg<br />
EPO0140000 Plastic additive 20<br />
Oleamide R<br />
EPE1260000 Plastic additive 21<br />
Erucamide R<br />
EPP2155022 Plastic additive 22<br />
Copolymer of dimethyl butanedioate <strong>and</strong> 1-(2-hydroxyethyl)-2,2,6,6-tetramethylpiperidin-4-ol<br />
Synonyms: copolymer of dimethyl succinate <strong>and</strong> (4-hydroxy-2,2,6,6-tetramethylpiperidin-<br />
1-yl)ethanol<br />
EPP2155023 Plastic additive 23<br />
di(isooctyl)2,2'-[(dioctylstannylene)bis(thio)]diacetate containing about 27% of<br />
(tri(isooctyl)2,2',2''-[monooctylstannylidyne)tris(thio)]triacetate.<br />
Tin-content of 15.4%<br />
100 mg<br />
100 mg<br />
100 mg<br />
200 mg<br />
EPP2160000 Poliomyelitis vaccine (inactivated) BRP 5x0.6 mg<br />
EPP2161000 Poliomyelitis vaccine (oral) BRP 5x1 mL<br />
EPP2163920 Poloxamer 124 30 mg<br />
EPP2164009 Poloxamer 188 100 mg<br />
EPP2164020 Poloxamer 237 100 mg<br />
EPP2164021 Poloxamer 338 100 mg<br />
EPP2164030 Poloxamer 407 100 mg<br />
EPP2170000 Polyacrylate - Reference Spectrum unit<br />
EPP2400000 Polymyxin B sulphate 120 mg<br />
EPY0000355 Polymyxin B sulphate for microbiological assay 25 mg<br />
EPY0000289 Polysorbate 20 - Reference Spectrum unit<br />
EPY0000290 Polysorbate 40 - Reference Spectrum unit<br />
EPY0000291 Polysorbate 60 - Reference Spectrum unit<br />
EPY0000007 Polysorbate 80 - Reference Spectrum unit<br />
New EPY0000792 Poly(vinyl acetate) dispersion 30% 2x20 mg<br />
EPP2600000 Poly(vinyl chloride) 100 mg<br />
EPP2649610 Potassium clavulanate - Reference Spectrum unit<br />
EPY0000315 Potassium hydrogen aspartate hemihydrate 50 mg<br />
EPP2650000 Potassium sorbate 100 mg<br />
EPP2660000 Povidone 50 mg<br />
EPY0000466 Povidone (iodinated) 10 mg<br />
EPY0000215 Pravastatin sodium - Reference Spectrum unit<br />
EPY0000223<br />
Pravastatin impurity A<br />
(3R,5R)-3,5-dihydroxy-7-[(1S,2S,6R,8S,8aR)-6-hydroxy-2-methyl-8-[[(2S)-<br />
2-methylbutanoyl]oxy]-1,2,6,7,8,8a-hexahydronaphthalen-1-yl]heptanoic acid<br />
(6'-epipravastatin)<br />
10 mg<br />
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Code Product Unit<br />
EPY0000204 Pravastatin 1,1,3,3-tetramethylbutylamine 30 mg<br />
EPP2669000 Prazepam Controlled Substance 50 mg<br />
EPP2670000 Praziquantel 150 mg<br />
EPP2675000<br />
Praziquantel impurity A<br />
(RS)-2-benzoyl-1,2,3,6,7,11b-hexahydro-4H-pyrazino[2,1-a]isoquinolin-4-one<br />
EPP2680000 Prazosin hydrochloride 50 mg<br />
EPP2698000 Prednicarbate 100 mg<br />
EPP2698060<br />
Prednicarbate impurity F<br />
1,2-dihydroprednicarbate<br />
EPP2700000 Prednisolone 150 mg<br />
EPP2800000 Prednisolone acetate 120 mg<br />
EPY0000582 Prednisolone acetate for peak identification 10 mg<br />
EPP2804000 Prednisolone hexanoate 10 mg<br />
EPP2805000 Prednisolone pivalate 100 mg<br />
EPP2810000 Prednisolone sodium phosphate 150 mg<br />
EPP2900000 Prednisone 50 mg<br />
EPP2920000 Pregnenolone isobutyrate 150 mg<br />
EPY0000263 Prekallikrein activator in albumin BRP 3x1 mL<br />
EPP2939000 Prilocaine 150 mg<br />
EPP2939060 Prilocaine hydrochloride 100 mg<br />
EPP2939025<br />
Prilocaine impurity E<br />
(RS)-N-(methylphenyl)-2-(propylamino)propanamide<br />
EPP2940000 Primaquine diphosphate 500 mg<br />
EPP2950000 Primidone 150 mg<br />
EPY0000369 Primidone for peak identification 5 mg<br />
EPP3000000 Probenecid 100 mg<br />
EPP3050000 Procainamide hydrochloride 100 mg<br />
EPP3090000 Procaine benzylpenicillin 250 mg<br />
EPP3100000 Procaine hydrochloride 100 mg<br />
EPP3200000 Prochlorperazine maleate 100 mg<br />
EPP3300000 Progesterone 250 mg<br />
EPY0000148<br />
Progesterone impurity C<br />
(20R)-20-hydroxypregn-4-en-3-one<br />
EPY0000179 Proguanil hydrochloride - Reference Spectrum unit<br />
EPY0000181<br />
EPY0000182<br />
Proguanil impurity C<br />
1,5-bis(4-chlorophenyl)biguanide<br />
Proguanil impurity D<br />
1,5-bis(1-methylethyl)biguanide<br />
EPP3350000 Proline 60 mg<br />
EPP3390000 Promazine hydrochloride 100 mg<br />
EPP3400000 Promethazine hydrochloride 50 mg<br />
New EPY0000769<br />
Promethazine impurity D<br />
(2RS)-N,N-dimethyl-1-(10H-phenothiazin-10-yl)propan-2-amine S-oxide<br />
New EPY0000797 Promethazine for peak identification 10 mg<br />
EPP3490000 Propacetamol hydrochloride - Reference Spectrum unit<br />
EPY0000455 Propafenone hydrochloride 10 mg<br />
EPY0000456<br />
Propafenone impurity B<br />
1-[2-[(2RS)-2-hydroxy-3-(propylamino)propoxy]phenyl]-3-phenylpropenone<br />
EPY0000278 Propanol - Reference Spectrum unit<br />
EPY0000016 Propofol 290 mg<br />
EPY0000017 Propofol for peak identification 0.1 mL<br />
EPY0000018<br />
Propofol impurity J<br />
2,6-bis (1-methylethyl)-1,4-benzoquinone<br />
EPP3500000 Propranolol hydrochloride 30 mg<br />
10 mg<br />
10 mg<br />
25 mg<br />
10 mg<br />
10 mg<br />
10 mg<br />
10 mg<br />
10 mg<br />
20 mg<br />
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Code Product Unit<br />
EPP3600000 Propranolol hydrochloride for performance test 20 mg<br />
EPY0000318 Propylene glycol dilaurate 100 mg<br />
EPY0000319 Propylene glycol monolaurate 100 mg<br />
EPP3640000 Propyl gallate 50 mg<br />
EPP3650000 Propyl parahydroxybenzoate 100 mg<br />
EPP3700000 Propylthiouracil 100 mg<br />
EPP3750000 Propyphenazone 200 mg<br />
EPP3760000 Protirelin 2x5.03 mg<br />
EPP3760020 D-His Protirelin 0.1 mg<br />
EPP3800000 Proxyphylline 100 mg<br />
EPP3850000 Ps<strong>eu</strong>doephedrine hydrochloride Controlled Substance 100 mg<br />
EPY0000387 Ps<strong>eu</strong>doiso<strong>eu</strong>genyl 2-methylbutyrate for peak identification 100 mg<br />
EPP3900000 Purpureaglycoside A 25 mg<br />
EPP4000000 Purpureaglycoside B 25 mg<br />
EPY0000402 Pyrantel embonate 10 mg<br />
EPY0000403<br />
Pyrantel impurity A<br />
1-methyl-2-[(Z)-2-(thiophen-2-yl)ethenyl]-1,4,5,6-tetrahydropyrim idine<br />
EPP4050000 Pyrazinamide 30 mg<br />
EPP4099900 Pyridostigmine bromide 50 mg<br />
EPP4099910<br />
Pyridostigmine impurity A<br />
pyridin-3-yl-dimethylcarbamate<br />
EPP4100000 Pyridoxine hydrochloride 100 mg<br />
EPP4200000 Pyrimethamine 250 mg<br />
EPY0000659 Pyrrolidone 20 mg<br />
EPQ0100000 Quinidine sulphate 300 mg<br />
EPQ0200000 Quinine sulphate 300 mg<br />
EPR0100000 Rabies vaccine (inactivated) for veterinary use BRP 3x86 mg<br />
EPR0145000 Ramipril 20 mg<br />
EPR0145005<br />
EPR0145010<br />
EPR0145015<br />
EPR0145020<br />
Ramipril impurity A<br />
(2S,3aS,6aS)-1-[(S)-2-[[(S)-1-(methoxycarbonyl)-3-phenylpropyl]amino]<br />
propanoly]octahydrocyclopenta[b]pyrrole-2-carboxylic acid<br />
(ramipril methylester)<br />
Ramipril impurity B<br />
(2S,3aS,6aS)-1-[(S)-2-[[(S)-1-[(methylethoxy)carbonyl]-3-phenylpropyl]<br />
amino] propanoyl]octahydrocyclopenta[b]pyrrole-2-carboxylic acid<br />
(ramipril isopropyl ester)<br />
Ramipril Impurity C<br />
(2S,3aS,6aS)-1-[(S)-2-[[(S)-1-(ethoxycarbonyl)-3-cyclohexylpropyl]amino]<br />
propanoyl]octahydrocyclopenta[b]pyrrole-2-carboxylic acid (hexahydroramipril)<br />
Ramipril impurity D<br />
ethyl(2S)-2-[(3S,5aS,8aS,9aS)-3-methyl-1,4-dioxodecahydro<br />
-1H-cyclopenta[e]pyrrolo[1,2a]pyrazin-2-yl]-4-phenylbutanoate<br />
(ramipril diketopiperazine)<br />
EPR0150000 Ranitidine hydrochloride 100 mg<br />
EPY0000416<br />
Ranitidine impurity J<br />
1,1'-N-[methylenebis(sulphanediylethylene)]bis<br />
(N'-methyl-2-nitroethene-1,1-diamine)<br />
20 mg<br />
20 mg<br />
10 mg<br />
10 mg<br />
10 mg<br />
10 mg<br />
0.00025 mg<br />
EPY0000411 Ranitidine for system suitability 20 mg<br />
EPY0000457 Repaglinide 20 mg<br />
EPY0000458 Repaglinide for system suitability 6 mg<br />
EPY0000459<br />
Repaglinide impurity E<br />
2-ethoxy-4-[2-[[(1R)-3-methyl-1-[2-(piperidin-1-yl) phenyl]butyl]<br />
amino]-2-oxoethyl]benzoic acid<br />
EPR0200000 Reserpine 100 mg<br />
EPR0250000 Residual solvents solution class I 1500 mg<br />
New EPY0000767 Resorcinol 20 mg<br />
5 mg<br />
104 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
European Pharmacopoeia<br />
Code Product Unit<br />
EPR0300000 Retinol acetate 1000 mg<br />
EPR0290000 Retinol ester 100 mg<br />
EPR0500500 Reviparin sodium 250 mg<br />
EPY0000377 Ribavirin 100 mg<br />
EPY0000353 Ribavirin for system suitability 1 mg<br />
EPR0600000 Riboflavin (Vitamine B 2) 100 mg<br />
New EPY0000757 Riboflavin for peak identification 0.1 mg<br />
EPR0630000 Riboflavine sodium phosphate 250 mg<br />
EPY0000662 Ribonucleic acid 100 mg<br />
EPY0000149 Rifabutin 150 mg<br />
EPY0000184<br />
Rifabutin impurity A<br />
N-(2-methylpropyl)-4-piperidone<br />
EPR0700000 Rifampicin 500 mg<br />
EPR0800000 Rifampicin quinone 100 mg<br />
EPR0900000 Rifamycin B 50 mg<br />
EPR0950000 Rifamycin S 50 mg<br />
EPR1000000 Rifamycin sodium 300 mg<br />
EPY0000250 Rilmenidine dihydrogenophosphate - Reference Spectrum unit<br />
EPY0000187 Rilmenidine for system suitability 30 mg<br />
EPR1000600 Risperidone 50 mg<br />
EPY0000370 Risperidone for system suitability 20 mg<br />
EPR1300000<br />
RK 13 cells<br />
cell lines (kidney,rabbit) titration of live measles,<br />
mumps <strong>and</strong> rubella vaccines<br />
20 mg<br />
2x1 mL<br />
New EPY0000714 Ritonavir 80 mg<br />
New EPY0000706 Ritonavir for peak identification 10 mg<br />
EPY0000527 Rocuronium for peak identification 10 mg<br />
EPY0000594 Rocuronium bromide - Reference Spectrum unit<br />
New EPY0000742 Ropivacaine hydrochloride monohydrate 10 mg<br />
New EPY0000743<br />
Ropivacaine impurity G<br />
(+)-(2R)-N-(2,6-dimethylphenyl)-1-propylpiperidine-2-carboxamide ((R)-ropivacaine)<br />
EPR1500000 Roxithromycin 125 mg<br />
EPY0000220 Roxithromycin for system suitability 5 mg<br />
EPR2000000 Rubella vaccine (live) BRP 5x18 mg<br />
EPY0000494 Ruscogenins 10 mg<br />
EPY0000105 Rutoside trihydrate 100 mg<br />
New EPY0000669 Salicin 50 mg<br />
EPS0040000 Saccharin 30 mg<br />
EPS0050000 Saccharin Sodium 50 mg<br />
EPS0100000 Salbutamol 50 mg<br />
EPY0000030<br />
EPY0000071<br />
EPY0000031<br />
EPY0000034<br />
EPY0000032<br />
Salbutamol impurity B<br />
(1RS)-2-[(1,1-dimethylethyl)amino]-1-(4-hydroxyphenyl)ethanol<br />
Salbutamol impurity D<br />
(1RS)-2-[(1,1-dimethylethyl)amino]-1-hydroxyethyl]-2-<br />
hydroxybenzaldehyde<br />
Salbutamol impurity F<br />
1,1'[oxybis[methylene(4-hydroxy-1,3-phenylene)]]bis<br />
[2-[(1,1-dimethylethyl)amino]ethanol]<br />
Salbutamol impurity G<br />
2-[benzyl(1,1-dimethylethyl)amino]-1-[4-hydroxy-3-hydroxymethyl)<br />
phenyl]ethanone<br />
Salbutamol impurity I<br />
(1RS)-2-[(1,1-dimethylethyl)amino]-1-[3-(hydroxymethyl)-4-benzyloxyphenyl] ethanol<br />
5 mg<br />
5 mg<br />
5 mg<br />
5 mg<br />
5 mg<br />
0.006 mg<br />
EPS0150000 Salbutamol sulphate 50 mg<br />
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Code Product Unit<br />
EPS0200000 Salicylic acid 100 mg<br />
EPY0000405<br />
Salicylic acid impurity B<br />
4-hydroxyisophthalic acid<br />
EPY0000422 Salmeterol xinafoate 40 mg<br />
EPY0000423 Salmeterol for system suitability 25 mg<br />
EPS0360000 Selegiline hydrochloride 50 mg<br />
EPS0360090 (RS)-Selegiline hydrochloride 25 mg<br />
EPS0400000 Senna extract 50 mg<br />
EPS0450000 Serine 50 mg<br />
EPS0460000 Sertaconazole nitrate 125 mg<br />
EPY0000371 Sestamibi labelling kit unit<br />
EPS0500000 Silicone elastomer 2000 mg<br />
EPS0600000 Silicone oil 1 mL<br />
EPS0650000 Simvastatin 100 mg<br />
EPS0660000 Sisomicin sulphate 50 mg<br />
EPY0000014 Sodium alendronate 150 mg<br />
EPS0695000 Sodium amidotrizoate 125 mg<br />
EPY0000300 Sodium aminosalicylate dihydrate - Reference Spectrum unit<br />
EPY0000039 Sodium ascorbate 50 mg<br />
EPS0700000 Sodium calcium edetate 100 mg<br />
EPS0710000 Sodium cetostearylsulphate 100 mg<br />
EPS0750000 Sodium cromoglicate 10 mg<br />
EPS0760000 Sodium cyclamate 100 mg<br />
EPS0765000 Sodium diclofenac 100 mg<br />
EPS0781000 Sodium hyaluronate - Reference Spectrum unit<br />
EPS0780000 Sodium hyaluronate BRP 300 mg<br />
EPY0000620 Sodium laurilsulfate 40 mg<br />
New EPY0000808 Sodium phenylbutyrate 5 mg<br />
New EPY0000809<br />
Sodium phenylbutyrate impurity C<br />
4-cyclohexylbutanoic acid<br />
EPS0785000 Sodium picosulphate 100 mg<br />
EPY0000210 Sodium polystyrene sulphonate - Reference Spectrum unit<br />
EPY0000268 Sodium propionate - Reference Spectrum unit<br />
EPS0800000 Sodium salicylate 100 mg<br />
EPS0808000 Sodium stearyl fumarate 50 mg<br />
EPS0808060 Sodium stearyl maleate 10 mg<br />
EPS0900000 Sodium taurocholate BRP 10000 mg<br />
EPS0930000 Sodium valproate 150 mg<br />
EPS0945000 Somatostatin 2.55 mg<br />
EPS0947000 Somatropin 35 mg<br />
EPY0000711 Somatropin/desamidosomatropin resolution mixture 33 mg<br />
EPS0950000 Sorbic acid 100 mg<br />
EPY0000385 1,4-Sorbitan 50 mg<br />
EPS1000000 Sorbitol 1200 mg<br />
EPY0000114 Sotalol hydrochloride 25 mg<br />
EPY0000115<br />
Sotalol impurity B<br />
N-[4-[[(1-methylethyl)amino]acetyl]phenyl]methanesulphonamide<br />
EPY0000597 Spectinomycin hydrochloride 100 mg<br />
EPY0000549 Spectinomycin for system suitability 20 mg<br />
EPY0000655 Spectinomycin sulphate tetrahydrate 10 mg<br />
EPS1100000 Spiramycin 200 mg<br />
EPY0000381 Spirapril hydrochloride monohydrate 60 mg<br />
10 mg<br />
10 mg<br />
20 mg<br />
106 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
European Pharmacopoeia<br />
Code Product Unit<br />
EPY0000332 Spirapril for system suitability 15 mg<br />
EPS1200000 Spironolactone 100 mg<br />
EPY0000185 Squalane 0.25 mL<br />
EPS1250000 Stanozolol 125 mg<br />
EPS1250010<br />
Stanozolol impurity A<br />
(5α,17β)-17-hydroxy-17-methyl<strong>and</strong>rostan-3-one<br />
EPS1300000 Starch BRP 50000 mg<br />
EPY0000408 Stavudine 100 mg<br />
EPY0000421 Stavudine for system suitability 10 mg<br />
EPS1340000<br />
Stearic acid<br />
Plastic additive 19<br />
10 mg<br />
100 mg<br />
EPS1350000 Stearyl alcohol 250 mg<br />
EPS1400000 Streptomycin sulphate 100 mg<br />
EPS1500000 Succinylsulfathiazole 100 mg<br />
EPS1600000 Sucrose 100 mg<br />
EPS1608100 Sufentanil - Reference Spectrum unit<br />
EPS1609000 Sufentanil citrate - Reference Spectrum unit<br />
EPY0000529 Sulbactam sodium 10 mg<br />
EPY0000528 Sulbactam 150 mg<br />
EPY0000550 Sulbactam for peak identification 20 mg<br />
EPS1700000 Sulfacetamide sodium 50 mg<br />
EPS1800000 Sulfadiazine 100 mg<br />
EPS1900000 Sulfadimidine 100 mg<br />
EPS1950000 Sulfadoxine 50 mg<br />
EPS1975000 Sulfafurazole 100 mg<br />
EPS1975600 Sulfaguanidine 60 mg<br />
EPS2000000 Sulfamerazine 100 mg<br />
EPS2050000 Sulfamethizole 100 mg<br />
EPS2100000 Sulfamethoxazole 50 mg<br />
EPY0000412<br />
EPY0000413<br />
Sulfamethoxazole impurity A<br />
N-(4-(5-methyl)-isoxazol-3-ylsulphamoyl)phenylacetamide<br />
Sulfamethoxazole impurity F<br />
4-amino-N-(3-methylisoxazol-5-yl)benznesulphonamide<br />
EPS2150000 Sulfamethoxypyridazine 50 mg<br />
EPS2151000 Sulfanilamide 100 mg<br />
EPS2159100 Sulfapyridine 20 mg<br />
EPS2155000 Sulfasalazine 2x250 mg<br />
EPS2155010<br />
Sulfasalazine derivative for resolution<br />
2-hydroxy-5-[[4-[[(6-methylpyridin-2-yl)amino]-<br />
sulfonyl]phenyl]azo]benzoic acid<br />
EPS2158000 Sulfathiazole 100 mg<br />
EPS2159000 Sulfinpyrazone 30 mg<br />
EPS2159010<br />
EPS2159015<br />
Sulfinpyrazone impurity A<br />
1,2-diphenyl-4-(2-phenylsulphonylethyl)pyrazolidine-3,5-dione<br />
Sulfinpyrazone impurity B<br />
1,2-diphenyl-4-(2-phenylthioethyl)pyrazolidine-3,5-dione<br />
EPS2160000 Sulfisomidine 50 mg<br />
EPS2180000 Sulindac 50 mg<br />
EPS2190000 Sulpiride 100 mg<br />
EPS2191000<br />
EPS2192000<br />
Sulpiride impurity A<br />
2-aminomethyl-1-ethylpyrrolidine<br />
Sulpiride impurity B<br />
methyl 5-sulphamoyl-2-methoxybenzoate<br />
EPY0000530 Sultamicillin 10 mg<br />
5 mg<br />
5 mg<br />
20 mg<br />
20 mg<br />
20 mg<br />
20 mg<br />
30 mg<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 107
European Pharmacopoeia<br />
Code Product Unit<br />
EPY0000531 Sultamicillin tosilate 200 mg<br />
EPY0000532 Sultamicillin for peak identification 10 mg<br />
EPY0000022 Sumatriptan succinate 50 mg<br />
EPY0000026 Sumatriptan impurity mixture 3 mg<br />
EPY0000027 Sumatriptan for system suitability 2 mg<br />
EPS2200000 Suxamethonium chloride 1000 mg<br />
EPS2400000 Suxibuzone 50 mg<br />
EPS2400004<br />
EPS2400006<br />
Suxibuzone impurity B<br />
(4-butyl-3,5-dioxo-1,2-diphenylpyrazolidin-4-yl)methyl ethyl butanedioate<br />
Suxibuzone impurity C<br />
4-butyl-4-(hydroxymethyl)-1,2-diphenyl-1,2-dihydro-4H-pyrazole-3,5-dione<br />
EPS5000001 Swine erysipelas bacteria, serotyp 1 (for vaccines-vet.use) BRP 1 mg<br />
EPS5000002 Swine erysipelas bacteria, serotyp 2 (for vaccines-vet.use) BRP 1 mg<br />
EPT0010000 Talampicillin hydrochloride 50 mg<br />
EPT0014000 Tamoxifen citrate 80 mg<br />
EPT0015000 Tamoxifen citrate for performance test 50 mg<br />
EPY0000650 Tamsulosin hydrochloride 10 mg<br />
EPY0000653 Tamsulosin racemate 10 mg<br />
EPY0000651<br />
EPY0000652<br />
Tamsulosin impurity D<br />
2-methoxy-5[(2R)-2-[[2-(2-methyoxyphenoxy)ethyl]amino]propyl]benzenesulfonamide<br />
Tamsulosin impurity H<br />
(2R)-N-[2-(2-ethoxyphenoxy)ethyl]-1-(4-methoxyphenyl)propan-2-amine<br />
EPT0040000 Temazepam Controlled Substance 50 mg<br />
EPY0000344<br />
EPY0000345<br />
EPY0000346<br />
EPY0000347<br />
Temazepam impurity C<br />
(3RS)-7-chloro-1-methyl-2-oxo-5-phenyl-2,3-dihydro-1H-1,4-benzodiazepin-3-yl acetate<br />
Controlled Substance<br />
Temazepam impurity D<br />
(3RS)-7-chloro-3-methoxy-1-methyl-5-phenyl-1,3-dihydro-2H-1,4-benzodiazepin-2-one<br />
Controlled Substance<br />
Temazepam impurity F<br />
(5RS)-7-chloro-1-methyl-5-phenyl-4,5-dihydro-1H-<br />
1,4-benzodiazepine-2,3-dione<br />
Temazepam impurity G<br />
(5RS)-7-chloro-1,4-methyl-5-phenyl-4,5-dihydro-<br />
1H-1,4-benzodiazepine-2,3-dione<br />
EPT0040800 Tenoxicam 100 mg<br />
EPY0000621 Terazosin hydrochloride dihydrate 40 mg<br />
EPY0000666 Terazosin for system suitability 0.5 mg<br />
EPY0000622<br />
EPY0000665<br />
EPY0000623<br />
New EPY0000624<br />
Terazosin impurity A<br />
2-chloro-6,7-dimethoxyquinazolin-4-amine<br />
Terazosin impurity E<br />
2,2`-(piperazine-1,4-diyl)bis(6,7-dimethoxyquinazolin-4-amine)<br />
Terazosin impurity L<br />
1-(furan-2-ylcarbonyl)piperazine<br />
Terazosin impurity N<br />
1-[[(2RS)-tetrahydrofuran-2-yl]carbonyl]piperazine<br />
EPY0000535 Terbinafine hydrochloride 10 mg<br />
EPT0050000 Terbutaline sulphate 100 mg<br />
EPT0050015<br />
Terbutaline impurity C<br />
1-(3,5-dihydroxyphenyl)-2-[(1,1- dimethylethyl)amino]-ethanone<br />
EPT0060000 Terconazole 250 mg<br />
EPT0071000 Terfenadine 100 mg<br />
EPT0080000<br />
Terfenadine impurity A<br />
1-[4-(1,1-dimethylethyl)phenyl]-4-[4-(hydroxydiphenylmethyl)piperidin-1-yl] butan-1-one<br />
(ketone)<br />
EPT0100000 Testosterone 250 mg<br />
EPT0200000 Testosterone acetate 10 mg<br />
10 mg<br />
10 mg<br />
10 mg<br />
10 mg<br />
5 mg<br />
5 mg<br />
5 mg<br />
5 mg<br />
10 mg<br />
10 mg<br />
10 mg<br />
10 mg<br />
15 mg<br />
20 mg<br />
108 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
European Pharmacopoeia<br />
Code Product Unit<br />
EPT0210000 Testosterone caproate 50 mg<br />
EPT0240000 Testosterone decanoate 25 mg<br />
New EPY0000696 Testosterone decanoate for system suitability 0.4 mg<br />
EPT0250000 Testosterone enantate 100 mg<br />
EPY0000342 Testosterone for impurity D identification 15 mg<br />
EPY0000343 Testosterone for system suitability 15 mg<br />
EPT0260000 Testosterone isocaproate 25 mg<br />
New EPY0000716 Testosterone isocaproate for system suitability 5 mg<br />
EPT0300000 Testosterone propionate 50 mg<br />
EPY0000170 Testosterone propionate - Reference Spectrum unit<br />
EPT0400000 Tetanus vaccine (adsorbed) BRP 11 mg<br />
EPT0499000 1,3,4,6-Tetra-O-acetyl-2-O-trifluoromethane-sulphonyl-ßD-mannopyranose -<br />
Reference Spectrum<br />
EPT0500000 Tetracaine hydrochloride 100 mg<br />
EPT0550000 Tetracosactide 2x0.365 mg<br />
EPT0600000 Tetracycline hydrochloride 100 mg<br />
EPY0000015 Tetrazepam - Reference Spectrum unit<br />
EPY0000008<br />
Tetrazepam impurity C<br />
7-chloro-5-cyclohexyl-1-methyl-1,3-dihydro-2H-1,4-benzodiazepin-2-one<br />
EPY0000460 Tetryzoline hydrochloride 10 mg<br />
New EPY0000723 Thebaine Controlled Substance 10 mg<br />
EPT0700000 Theobromine 100 mg<br />
EPT0800000 Theophylline 100 mg<br />
EPY0000294 Theophylline - Reference Spectrum unit<br />
EPY0000336 Thiamazol 125 mg<br />
EPY0000372<br />
EPY0000373<br />
Thiamazol impurity A<br />
2,2-dimethoxy-N-methylethanamine<br />
Thiamazol impurity C<br />
1-methyl-2-(methylsulphanyl)-1H-imidazole<br />
EPY0000467 Thiamine hydrochloride 10 mg<br />
EPY0000059<br />
Thiamine impurity E<br />
3-[(4-amino-2-methylpyrimidin-5-yl)methyl]-5-(2-hydroxyethyl)<br />
4-methyl-4-thiazolidine-2-thione<br />
EPY0000060 Thiamine nitrate - Reference Spectrum unit<br />
EPT1100000 Thiamphenicol 125 mg<br />
EPY0000546 Thioctic acid 110 mg<br />
EPY0000592 Thioctic acid for system suitability 10 mg<br />
EPY0000545 Thioctic acid containing impurity B 30 mg<br />
EPY0000109 Thiomersal 30 mg<br />
EPT1200000 Thiopental 500 mg<br />
New EPY0000704 Thioridazine 10 mg<br />
EPY0000150 Thioridazine - Reference Spectrum unit<br />
EPT1300000 Thioridazine hydrochloride 50 mg<br />
EPY0000541 Thioridazine for system suitability 0.21 mg<br />
EPT1305100 Thioxanthene 20 mg<br />
EPT1305000 Thioxanthone 10 mg<br />
EPT1340000 Threonine 50 mg<br />
EPT1350000 Thymol 50 mg<br />
EPT1410000 Tiabendazole 50 mg<br />
EPY0000414 Tiamulin for peak identification 10 mg<br />
EPY0000333 Tiamulin hydrogen fumarate 450 mg<br />
EPY0000379 Tiamulin - Reference Spectrum unit<br />
EPY0000151 Tianeptine sodium - Reference Spectrum unit<br />
unit<br />
20 mg<br />
10 mg<br />
20 mg<br />
10 mg<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 109
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Code Product Unit<br />
EPY0000152 Tianeptine for system suitability 30 mg<br />
EPY0000153<br />
Tianeptine impurity A<br />
ethyl 7-bromoheptanoate<br />
EPT1405000 Tiapride hydrochloride 60 mg<br />
EPT1405050 Tiapride N-oxide 20 mg<br />
EPT1410900 Tiaprofenic acid 50 mg<br />
EPT1410910<br />
Tiaprofenic acid impurity C<br />
(RS)-2-(5-benzoyl-3-thienyl)propanoic acid<br />
New EPY0000748 Tibolone - Reference Spectrum unit<br />
EPY0000668 Tibolone for system suitability 10 mg<br />
EPY0000465 Ticarcillin monosodium 250 mg<br />
EPT1420010<br />
Ticarcillin impurity A<br />
(2S,5R,6R)-3,3-dimethyl-7-oxo-6-[[(thiophen-3-yl)acetyl]-amino]-4-thia-1-<br />
azabicyclo[3.2.0]heptane-2-carboxylic acid (decarboxyticarcillin)<br />
EPT1423000 Ticlopidine hydrochloride 50 mg<br />
EPT1423025<br />
Ticlopidine impurity F<br />
6-(2-chlorobenzyl)4,5,6,7-tetrahydrothieno [3,2-c]pyridine<br />
EPY0000325 Tilidine hydrochloride hemihydrate - Reference Spectrum unit<br />
EPT1450000 Timolol maleate 50 mg<br />
EPY0000644 (R)-timolol 20 mg<br />
EPT1470000 Tinidazole 100 mg<br />
EPT1471000<br />
Tinidazole impurity B<br />
1-(2-ethylsulphonylethyl)-2-methyl-4-nitroimidazole<br />
EPT1490000 Tinzaparin sodium 250 mg<br />
EPY0000292 Tioconazole - Reference Spectrum unit<br />
EPY0000282 Tioconazole for system suitability 50 mg<br />
EPT1500000 Tobramycin 250 mg<br />
EPY0000383 All-rac-alpha-tocopherol for peak identification 15 mg<br />
EPY0000384 All-rac-alpha-tocopheryl acetate for peak identification 15 mg<br />
EPT1550000 alpha-Tocopherol 250 mg<br />
EPT1600000 alpha-Tocopheryl acetate 250 mg<br />
EPT1610000 RRR-alpha-Tocopheryl hydrogen succinate 125 mg<br />
EPT1700000 Tolbutamide 100 mg<br />
EPY0000154 Tolfenamic acid 100 mg<br />
EPT1707000 Tolnaftate 60 mg<br />
EPY0000461 Torasemide anhydrous 10 mg<br />
EPY0000462 Torasemide for system suitability 0.4 mg<br />
EPY0000155 Tramadol hydrochloride 75 mg<br />
EPY0000156<br />
EPY0000157<br />
Tramadol impurity A<br />
(1RS,2SR)-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl)cyclohexanol<br />
Tramadol impurity E<br />
(2RS)-2-[(dimethylamino)methyl]cyclohexanone<br />
EPY0000072 Tramazoline hydrochloride monohydrate 20 mg<br />
EPY0000065<br />
EPY0000066<br />
Tramazoline impurity A<br />
N-(naphthalen-1-yl)-4,5-dihydro-1H-imidazol-2-amine<br />
Tramazoline impurity B<br />
mixture of: 1-acetyl-2-[(5,6,7,8-tetrahydronaphthalen-1-yl)amino]-4,5-dihydro-1H-imidazole<br />
<strong>and</strong> N-(4,5-dihydro-1H-imidazol-2-yl)-N-(5,6,7,8-tetrahydronaphthalen-1-yl)acetamide<br />
EPY0000501 Tr<strong>and</strong>olapril 10 mg<br />
EPY0000495<br />
EPY0000496<br />
Tr<strong>and</strong>olapril impurity C<br />
(2S,3aR,7aS)-1-[(2S)-2-[[(1S)-3-cyclohexyl-<br />
1-(ethoxycarbonyl)propyl]amino]propanoyl]octahydro-1H-indole-2-carboxylic acid<br />
(hexahydrotr<strong>and</strong>olapril)<br />
Tr<strong>and</strong>olapril impurity D<br />
ethyl (2S)-2-[(3S,5aS,9aR,10aS)-3-methyl-1,4-dioxodecahydropyrazino[1,2-a]indol-2(1H)-yl]-<br />
4-phenylbutanoate (tr<strong>and</strong>olapril diketopiperazine)<br />
20 mg<br />
20 mg<br />
50 mg<br />
10 mg<br />
20 mg<br />
15 mg<br />
10 mg<br />
10 mg<br />
10 mg<br />
10 mg<br />
10 mg<br />
110 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
European Pharmacopoeia<br />
Code Product Unit<br />
EPT1810000 Tranexamic acid 50 mg<br />
EPT1810030<br />
Tranexamic acid impurity C<br />
4-(aminomethyl)cyclohex-1-enecarboxylic acid<br />
EPT1820000 Trapidil 50 mg<br />
EPT1820002<br />
EPT1820004<br />
Trapidil impurity A<br />
5-methyl-[1,2,4]triazolo[1,5-a]pyrimidin-7-ol<br />
Trapidil impurity B<br />
1,2,4-triazol-3-amine<br />
EPT1850000 Tretinoin 50 mg<br />
EPT1899000 3,4,6-Tri-O-acetyl-D-glucal - Reference Spectrum unit<br />
EPG0400010 Triacetin - Reference Spectrum unit<br />
EPT1899990 Triamcinolone 150 mg<br />
EPT1900000 Triamcinolone acetonide 100 mg<br />
EPT1950000 Triamcinolone hexacetonide 100 mg<br />
EPY0000050<br />
Triamcinolone impurity C<br />
9-fluoro-11ß-16alpha,17,21-tetrahydroxypregn-4-ene-3,20-dione (pretriamcinolone)<br />
EPT1975000 Triazolam Controlled Substance 10 mg<br />
EPY0000165 Tribenoside 150 mg<br />
EPY0000166<br />
Tribenoside impurity A<br />
3,5,6-tri-O-benzyl-1,2-O-(1-methylethylidene)-α-D-glucofuranose<br />
EPY0000330 Tributyl acetylcitrate - Reference Spectrum unit<br />
EPY0000279 Tri-n-butyl phosphate 300 µL<br />
EPT1977990 Tricaprin 150 mg<br />
EPT1977995 Tricaproin 40 mg<br />
EPT1978000 Tricaprylin 225 mg<br />
EPY0000111 Trichloroacetic acid - Reference Spectrum unit<br />
EPT1985000 Trichlorotrifluoroethane 2x2.5 mL<br />
EPT1986000 Triethyl citrate - Reference Spectrum unit<br />
EPT2000000 Trifluoperazine hydrochloride 100 mg<br />
EPT2005000 Triflusal 50 mg<br />
EPT2005010<br />
Triflusal impurity B<br />
2-hydroxy-4-(trifluoromethyl)benzoic acid; (4-(trifluoromethyl)salicylic acid)<br />
New EPY0000720 Triglycerol diisostearate 200 mg<br />
EPY0000108 Trihexyphenidyl hydrochloride 100 mg<br />
EPY0000068<br />
Trihexyphenidyl impurity A<br />
1-phenyl-3-(piperidin-1-yl)propan-1-one<br />
EPT2009000 Trilaurin 1250 mg<br />
EPY0000092 Trimetazidine dihydrochloride - Reference Spectrum unit<br />
EPY0000093 Trimetazidine for system suitability 50 mg<br />
EPT2100000 Trimethadione 250 mg<br />
EPT2200000 Trimethoprim 50 mg<br />
EPY0000684 Trimethoprim for system suitability 0.00075 mg<br />
EPT2200010<br />
Trimethoprim impurity B<br />
(2,4-diaminopyrimidin-5-yl)(3,4,5- trimethoxyphenyl)methanone<br />
EPT2450000 Trimethyltetradecylammonium bromide 200 mg<br />
EPT2500000 Trimipramine maleate 100 mg<br />
EPT2500100 Trimyristin 500 mg<br />
EPT2501200 Tristearin 100 mg<br />
EPT2545000 Trolamine 2250 mg<br />
EPT2550000 Trometamol 100 mg<br />
EPT2580000 Tropicamide 50 mg<br />
EPY0000616 Tropisetron hydrochloride 40 mg<br />
EPY0000618<br />
Tropisetron impurity B<br />
1H-indole-3-carboxylic acid<br />
10 mg<br />
20 mg<br />
20 mg<br />
10 mg<br />
30 mg<br />
25 mg<br />
20 mg<br />
10 mg<br />
10 mg<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 111
European Pharmacopoeia<br />
Code Product Unit<br />
EPT2580300 Tropine 50 mg<br />
EPY0000429 Trospium chloride 10 mg<br />
EPY0000432<br />
EPY0000431<br />
EPY0000430<br />
Trospium impurity A<br />
Hydroxydiphenylacetic acid (benzilic acid)<br />
Trospium impurity B<br />
(1R,3r,5S)-8-azabicyclo[3.2.1]oct-3-yl hydroxydiphenylacetate<br />
Trospium impurity C<br />
(1R,3r,5S)-3-hydroxyspiro[8-azoniabicyclo[3.2.1]octane-8,1'-pyrrolidinium]<br />
EPY0000497 Troxerutin 30 mg<br />
EPT2600000 Trypsin BRP 100 mg<br />
EPT2610000 Tryptophan 100 mg<br />
EPT2800000 Tubocurarine chloride 100 mg<br />
EPT2880000 Tylosin 150 mg<br />
EPT2880100 Tylosin D 5 mg<br />
EPY0000498 Tylosin phosphate for peak identification 10 mg<br />
EPT2880200 Tylosin tartrate - Reference Spectrum unit<br />
EPT2900000 Tyrosine 50 mg<br />
EPT3000000 Tyrothricin 10 mg<br />
EPU0020000 Ubidecarenone 50 mg<br />
EPU0020001 Ubidecarenone for system suitability 10 mg<br />
EPU0020008<br />
Ubidecarenone impurity D<br />
5,6-dimethoxy-3-methyl-2-[(all-E)-3,7,11,15,19,23,27,31,35-<br />
nonamethylhexatriaconta-2,6,10,14,18,22,26,30,34-nonaenyl]<br />
benzene-1,4-dione (ubiquinone-9)<br />
EPU0100000 Uracil arabinoside 30 mg<br />
EPU0600000 Urea 100 mg<br />
EPU0800000 Ursodeoxycholic acid 60 mg<br />
EPY0000583 Valerian st<strong>and</strong>ardised dry extract 400 mg<br />
EPV0030000 Valine 50 mg<br />
EPY0000584 Valnemulin hydrochloride 10 mg<br />
EPY0000533 Valnemulin hydrogen tartrate 120 mg<br />
EPY0000585 Valnemulin for peak identification 10.25 mg<br />
EPY0000586<br />
Valnemulin impurity E<br />
(3aS,4R,5S,6S,8R,9R,9aR,10R)-6-ethenyl-5-hydroxy-4,6,9,10-tetramethyl-1-oxodecahydro-<br />
3a,9-propano-3aH-cyclopenta[8]annulen-8-yl 2-hydroxyacetate (pl<strong>eu</strong>romulin)<br />
EPV0033000 Valproic acid 100 mg<br />
EPV0045000 Vancomycin hydrochloride 100 mg<br />
EPV0050000 Vanillin 100 mg<br />
EPY0000561 Vecuronium bromide 10 mg<br />
EPY0000625 Vecuronium for peak identification 10 mg<br />
EPY0000587 Venlafaxine hydrochloride 50 mg<br />
EPY0000588 Venlafaxine for system suitability 1 mg<br />
EPV0100000 Verapamil hydrochloride 100 mg<br />
EPV0100018<br />
EPV0100026<br />
Verapamil impurity I<br />
(2RS)-2-(3,4-dimethoxyphenyl)-2-[2-[[2-(3,4)dimethoxyphenyl)-<br />
ethyl](methyl)amino]ethyl]3-methylbutanenitrile<br />
Verapamil impurity M<br />
5,5'-[[2-(3,4)dimethoxyphenyl)ethyl]imino]bis[2-(3,4-dimethoxyphenyl)-<br />
2-(1-methylethyl)pentanenitrile<br />
EPY0000661 Verbenalin 11 mg<br />
EPV0180000 VERO cells 2x1 mL<br />
EPV0200000 Viscosimeter calibration liquids 250 mL<br />
EPV0300000 Vinblastine sulphate 5 mg<br />
EPV0305000 Vinblastine sulphate - Reference Spectrum unit<br />
20 mg<br />
15 mg<br />
5 mg<br />
5 mg<br />
10 mg<br />
5 mg<br />
20 mg<br />
112 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
European Pharmacopoeia<br />
Code Product Unit<br />
EPV0400000 Vincristine sulphate 4.98 mg<br />
EPV0405000 Vincristine sulphate - Reference Spectrum unit<br />
EPV0500000 Vindesine sulphate 5.11 mg<br />
EPV0500010 Vindesine sulphate - Reference Spectrum unit<br />
EPY0000463 Vinorelbine tartrate 40 mg<br />
EPY0000464<br />
Vinorelbine impurity B<br />
4-O-deacetylvinorelbine<br />
New EPY0000589 Vinpocetine 10 mg<br />
New EPY0000590<br />
New EPY0000591<br />
New EPY0000790<br />
New EPY0000760<br />
Vinpocetine impurity A<br />
ethyl(12RS,13aSR,13bSR)-13a-ethyl-12-hydroxy-2,3,5,6,12,13,13a,13b-octahydro-1Hindolo[3,2,1-de]pyrido[3,2,1-ij][1,5]naphthyridine-12-carboxylate<br />
(ethyl vincaminate)<br />
Vinpocetine impurity B<br />
Methyl(13aS,13bS)-13a-ethyl-2,3,5,6,13a,13b-hexahydro-1Hindolo[3,2,1-de]pyrido[3,2,1-ij][1,5]naphthyridine-12-carboxylate<br />
(apovincamine)<br />
Vinpocetine impurity C<br />
ethyl(13aS,13bS)-13a-ethyl-9-methoxy-2,3,5,6,13a,13b-hexahydro-1Hindolo[3,2,1-de]pyrido[3,2,1-ij][1,5]naphthyridine-12-carboxylate<br />
(methoxyvinpocetine)<br />
Vinpocetine impurity D<br />
Ethyl(12RS,13aRS,13bRS)-13a-ethyl-2,3,5,6,12,13,13a,13b-octahydro-1H-<br />
indolo[3,2,1-de]pyrido[3,2,1-ij][1,5]naphthyridine-12-<br />
carboxylate (dihydrovinpocetine)<br />
New EPY0000793 Vinyl acetate 10 mg<br />
EPW0100000 Warfarin sodium 100 mg<br />
New EPY0000778 Warfarin sodium clathrate 10 mg<br />
EPX0075000 Xylazine hydrochloride 125 mg<br />
EPY0000158<br />
EPY0000159<br />
Xylazine impurity C<br />
2,6-dimethylphenyl isothiocyanate<br />
Xylazine impurity E<br />
N-(2,6-dimethylphenyl)-S-methyldithiourea<br />
EPX0080000 Xylitol 500 mg<br />
EPX0100000 Xylometazoline Hydrochloride 100 mg<br />
EPX0101000<br />
Xylometazoline impurity A<br />
N-(2-aminoethyl)-2-[4-(1,1-dimethylethyl)-2,6-dimethylphenyl]acetamide<br />
EPX0200000 Xylose 100 mg<br />
New EPY0000656 Yohimbine hydrochloride 20 mg<br />
EPZ1900000 Zidovudine 60 mg<br />
EPZ1902000<br />
EPZ1904000<br />
Zidovudine impurity A<br />
1-[(2R,5S)-5-hydroxymethyl-2,5-dihydro-2-furyl]-<br />
5-methylpyrimidine-2,4(1H,3H)-dione<br />
Zidovudine impurity B<br />
1-(3-chloro-2,3-dideoxy-ß-D-ribofuranosyl)-<br />
5-methylpyrimidine-2,4(1H,3H)-dione<br />
EPZ2000000 Zinc acexamate 50 mg<br />
EPZ2000010<br />
Zinc acexamate impurity A<br />
6-[[6-(acetylamino)hexanoyl]amino] hexanoic acid<br />
EPZ2500000 Zolpidem tartrate Controlled Substance 150 mg<br />
EPZ2500010<br />
Zolpidem impurity A<br />
N,N'-dimethyl-2-[7-methyl-2-(4-methylphenyl)imidazol<br />
[1,2-a]pyridin-3-yl] acetamide<br />
EPZ3000000 Zopiclone Controlled Substance 60 mg<br />
EPZ3001000 Zopiclone oxide 20 mg<br />
EPY0000062 Zuclopenthixol decanoate - Reference Spectrum unit<br />
EPY0000534 Zuclopenthixol for system suitability 0.1 mg<br />
EPY0000083<br />
Zuclopenthixol impurity B<br />
2-chloro-9H-thioxanthen-9-one<br />
7 mg<br />
10 mg<br />
10 mg<br />
10 mg<br />
10 mg<br />
50 mg<br />
50 mg<br />
10 mg<br />
10 mg<br />
10 mg<br />
50 mg<br />
10 mg<br />
10 mg<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 113
ATCC microbiology products<br />
ATCC microbiology products<br />
As a scientist you know the importance of using the best materials to support your quality control<br />
programme. As Europe’s only officially authorized distributor of ATCC ® cultures, LGC St<strong>and</strong>ards can<br />
supply all ATCC organisms specified in the pharmacopoeia.<br />
ATCC maintains the highest st<strong>and</strong>ards for its biological materials, employing stringent quality control<br />
procedures to produce cultures which are well characterized <strong>and</strong> have low passage numbers. Long-term<br />
subculturing of biological materials can have adverse effects on the culture population, including genetic<br />
drift, unwanted selection, contamination, <strong>and</strong> varied cell responses. ATCC quality control cultures sold by<br />
LGC Promochem are never subcultured or transferred in any way from ATCC’s strains <strong>and</strong> our European<br />
stock-holding means orders are usually filled within 3 - 5 working days.<br />
So whether it is quality control strains, genomic DNA, media or growth supplements, antibiotics for selection,<br />
or a huge selection of organisms, take the time <strong>and</strong> guesswork out of ordering your microbiology supplies<br />
with authentic, high-quality ATCC materials - exclusively from LGC St<strong>and</strong>ards.<br />
European Pharmacopoeia, 5th Edition 2005<br />
Code Product Unit<br />
EP 2.6.1 - Sterility<br />
ATCC-6633 Bacillus subtilis amp.<br />
ATCC-9027 Ps<strong>eu</strong>domonas aeruginosa amp.<br />
ATCC-19404 Clostridium sporogenes amp.<br />
ATCC-6538 Staphylococcus aur<strong>eu</strong>s ss. aur<strong>eu</strong>s amp.<br />
ATCC-16404 Aspergillus niger amp.<br />
ATCC-9027 Ps<strong>eu</strong>domonas aeruginosa amp.<br />
ATCC-2091 C<strong>and</strong>ida albicans amp.<br />
ATCC-10231 C<strong>and</strong>ida albicans amp.<br />
EP 2.6.2 - Mycobacterium tuberculosis<br />
ATCC-25177 Mycobacterium tuberculosis amp.<br />
EP 2.6.7 - Mycoplasma<br />
ATCC-23206 Acholeplasma laidlawii (Sabin) Edward <strong>and</strong> Fr<strong>eu</strong>ndt deposited as Mycoplasma laidlawii amp.<br />
ATCC-19610 Mycoplasma gallisepticum amp.<br />
ATCC-17981 Mycoplasma hyorhinis Switzer amp.<br />
ATCC-23714 Mycoplasma orale amp.<br />
ATCC-15531 Mycoplasma pn<strong>eu</strong>moniae amp.<br />
ATCC-25204 Mycoplasma synoviae amp.<br />
EP 2.6.12 - Microbiological examination of non-sterile products (total..........<br />
ATCC-6633 Bacillus subtilis amp.<br />
ATCC-2091 C<strong>and</strong>ida albicans amp.<br />
ATCC-10231 C<strong>and</strong>ida albicans amp.<br />
ATCC-8739 Escherichia coli amp.<br />
ATCC-6538 Staphylococcus aur<strong>eu</strong>s ss. aur<strong>eu</strong>s amp.<br />
ATCC-6538P Staphylococcus aur<strong>eu</strong>s subsp. aur<strong>eu</strong>s amp.<br />
EP 2.6.2 - EP 2.6.13 Microbial contamination of products not required........<br />
ATCC-13124 Clostridium perfringens amp.<br />
ATCC-19404 Clostridium sporogenes amp.<br />
ATCC-8739 Escherichia coli amp.<br />
ATCC-9027 Ps<strong>eu</strong>domonas aeruginosa amp.<br />
ATCC-6538 Staphylococcus aur<strong>eu</strong>s ss. aur<strong>eu</strong>s amp.<br />
ATCC-6538P Staphylococcus aur<strong>eu</strong>s subsp. aur<strong>eu</strong>s amp.<br />
114 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
European Pharmacopoeia, 5th Edition 2005<br />
Code Product Unit<br />
EP 2.7.2 - Microbiological assay of antibiotics<br />
ATCC-14884 Bacillus pumilus amp.<br />
ATCC-11774 Bacillus subtilis amp.<br />
ATCC-6633 Bacillus subtilis amp.<br />
ATCC-4617 Bordetella bronchiseptica amp.<br />
ATCC-10541 Enterococcus hirae (as Streptococcus faecalis) amp.<br />
ATCC-9637 Escherichia coli amp.<br />
ATCC-10536 Escherichia coli amp.<br />
ATCC-10031 Klebsiella pn<strong>eu</strong>moniae ss. pn<strong>eu</strong>moniae amp.<br />
ATCC-9341 Kocuria rhizophila amp.<br />
ATCC-10240 Micrococcus lut<strong>eu</strong>s amp.<br />
ATCC-607 Mycobacterium smegmatis amp.<br />
ATCC-9763 Saccharomyces cerevisiae amp.<br />
ATCC-9144 Staphylococcus aur<strong>eu</strong>s ss. aur<strong>eu</strong>s amp.<br />
ATCC-12228 Staphylococcus epidermidis amp.<br />
EP 5.1.2 - Biological indicators of sterilisation<br />
ATCC-27142** Bacillus pumilus amp.<br />
ATCC-7953** Bacillus stearothermophilus amp.<br />
ATCC-9372** Bacillus subtilis amp.<br />
EP 5.1.3 - Efficacy of antimicrobial preservation<br />
ATCC-16404 Aspergillus niger amp.<br />
ATCC-10231 C<strong>and</strong>ida albicans amp.<br />
ATCC-8739 Escherichia coli amp.<br />
ATCC-9027 Ps<strong>eu</strong>domonas aeruginosa amp.<br />
ATCC-6538 Staphylococcus aur<strong>eu</strong>s ss. aur<strong>eu</strong>s amp.<br />
** = Alternative strain<br />
All care has been taken in compiling catalogue numbers, however users should consult the Pharmacopoeia<br />
directly to confirm the testing requirements <strong>and</strong> recommended organisms before ordering or undertaking the<br />
testing procedures as described in the Pharmacopoeia.<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 115
Certified Liquids for Viscosity Measurements in the European Pharmacopoeia<br />
Certified Liquids for Viscosity Measurements in the European<br />
Pharmacopoeia<br />
Newtonian liquids with a certified viscosity are supplied by Van Swinden Laboratorium BV <strong>and</strong> are<br />
distributed by LGC St<strong>and</strong>ards.<br />
Liquids are available with kinematic viscosities up to 48000 mm 2·s-1 <strong>and</strong> certified at temperatures between<br />
15°C <strong>and</strong> 140°C.<br />
Viscosities are certified in mm 2·s-1 (kinematic viscosity, v) or in mPa . s (dynamic viscosity,η)<br />
1 mPa . s = 1 cps (centipoise) 1 mm 2. s -1 = 1 cst (centistoke)<br />
St<strong>and</strong>ard liquids are available from stock, in 250 ml packs <strong>and</strong> certified at 20°C to following viscosities:<br />
v = 0,6 ; 1,0 ; 2,2; 4,9 ; 1; 20 ; 31 ; 56 ; 67 ; 85 ; 100 ; 132 ; 167 ; 217 ; 262; 340 ; 423 ; 537 ; 644 ; 783 ;<br />
1000 ; 1260 ; 1800 ; 3650 ; 5075 ; 10175 ; 18400 ; 46500<br />
η= 0,4 ; 1,0 ; 1,8; 4,0 ; 8,9 ; 17,0 ; 26,0 ; 48,0 ; 58,0 ; 74,0 ; 87,0 ; 116,0 ; 146,0 ; 191,0 ; 230,0 ; 300,0 ;<br />
375,0 ; 474,0 ; 572,0 ; 700,0 ; 862,0 ; 1085 ; 1560 ; 3175 ; 4430 ; 8935 ; 16300 ; 41300<br />
All viscosities are calibrated relative to the viscosity of pure water. Stated values are nominal values,<br />
certified values will not deviate more than 10% from the nominal value.<br />
The uncertainty of the certified viscosities is at least 0.3% at the lowest viscosity, increasing up to 0.5%<br />
at 48000 mm 2. s -1 .<br />
Shelf life<br />
St<strong>and</strong>ards up to 500 mPa . s are mineral oil based, <strong>and</strong> have a shelf life of 12 months from date of<br />
certification. Above 500 mPa . s Polyisobutylene is used, these materials have a shorter shelf life, <strong>and</strong> should<br />
be ordered as needed.<br />
Liquids can be prepared <strong>and</strong> certified to any viscosity between 0.6 mm 2. s -1 <strong>and</strong> 80,000 mm 2. s -1 .<br />
The price depends on the viscosity required, the degree of precision between nominal viscosity required <strong>and</strong><br />
certified viscosity achieved, <strong>and</strong> temperature of certification.<br />
Additional charges are applied for extra certification temperatures <strong>and</strong> for certification of dynamic viscosity.<br />
Please ask for a quotation.<br />
Liquids supplied by customers may be certified for viscosity, charges vary: please ask for a quotation.<br />
116 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
International Commission on <strong>Pharmac<strong>eu</strong>tical</strong> Enzymes<br />
International Commission on <strong>Pharmac<strong>eu</strong>tical</strong> Enzymes<br />
The Commission on <strong>Pharmac<strong>eu</strong>tical</strong> Enzymes was formed in 1960, with a remit to establish quantitative<br />
methods <strong>and</strong> an exact definition of enzyme activity for pharmacologically significant enzymes.<br />
One consequence of the work of FIP “Federation International Pharmac<strong>eu</strong>tique” has been the production<br />
<strong>and</strong> certification of <strong>reference</strong> <strong>substances</strong> for both enzymes <strong>and</strong> substrates.<br />
More recently the work of the Commission has been reflected in those monographs of the European<br />
Pharmacopoeia which call for enzyme st<strong>and</strong>ards. The FIP products marked (EP) in this list are those<br />
which are required in certain EP monographs.<br />
Enzymes<br />
Code Product Unit<br />
FIP1 Fungal Amylase 2 g<br />
FIP2(EP) Amylase (pancreatic) 2 g<br />
FIP3 Fungal Protease 2 g<br />
FIP4 Bromelain 250 mg<br />
FIP5 Endocellulase 1 g<br />
FIP6(EP) Chymotrypsin 100 mg<br />
FIP7 Fungal Lipase 500 mg<br />
FIP8(EP) Lipase (pancreatic) 2 g<br />
FIP9 Lysozyme hydrochloride 250 mg<br />
FIP10 Papain 2 g<br />
FIP11(EP) Pepsin 2 g<br />
FIP12(EP) Protease (pancreatic) 2 g<br />
FIP13(EP) Trypsin 100 mg<br />
FIP14(EP) Hyaluronidase 50 mg<br />
Substrates<br />
FIP15(EP) Enterokinase 500 mg<br />
FIP16 Micrococcus Lut<strong>eu</strong>s sp. 1 g<br />
FIP17 Starch (EP) 50 g<br />
FIP18(EP) Casein 100 g<br />
FIP19 Hemoglobin 10 g<br />
FIP20 Hydroxyethylcellulose 100 g<br />
FIP21 Sodium Taurocholate 10 g<br />
FIP22(EP) Sodium hyaluronate 300 mg<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 117
European Pharmacopoeia Reagents from Reagecon<br />
European Pharmacopoeia Reagents from Reagecon<br />
Chapters 2 <strong>and</strong> 4 of the European Pharmacopoeia describe the preparation of several hundred reagents<br />
<strong>and</strong> st<strong>and</strong>ards used for the testing of pharmac<strong>eu</strong>tical raw materials.<br />
LGC St<strong>and</strong>ards is pleased to introduce a large number of these ready-to-use reagents <strong>and</strong> st<strong>and</strong>ard<br />
solutions within the spectrum of this new catalogue.<br />
The primary solutions for coloration are produced by LGC St<strong>and</strong>ards, the other reagents are manufactured<br />
by Reagecon. All are manufactured <strong>and</strong> tested in compliance with the prescriptions of EP. The products are<br />
supplied with certificates of analysis. Lot numbers <strong>and</strong> expiry dates are stated on all product labels as well.<br />
The reagents are always supplied as per the most recently issued EP supplement.<br />
Reagents from other pharmacopoeias are also available on request. Please contact your local<br />
LGC St<strong>and</strong>ards office for further details.<br />
Reagents as outlined in Chapter 2<br />
Code Product Unit<br />
REAEPPOSO1 Primary opalescence suspension 100 mL<br />
Coloration: primary solutions<br />
New WESEPYS01 Coloration-primary solution yellow 100 mL<br />
New WESEPRS01 Coloration-primary solution red 100 mL<br />
New WESEPBS01 Coloration-primary solution blue 100 mL<br />
Coloration: st<strong>and</strong>ard solutions<br />
REAEP703 St<strong>and</strong>ard solution B (brown) 125 mL<br />
REAEP704 St<strong>and</strong>ard solution BY (brownish yellow) 125 mL<br />
REAEP706 St<strong>and</strong>ard solution Y (yellow) 125 mL<br />
REAEP705 St<strong>and</strong>ard solution GY (greenish yellow) 125 mL<br />
REAEP707 St<strong>and</strong>ard solution R (red) 125 mL<br />
REAHADM1 HCL dilution matrix (10 g/l HCl) 1 L<br />
Reference buffer solutions - all @ 25°C<br />
REAEP168 ph Buffer solution 1.68 500 mL<br />
REAEP401 ph Buffer solution 4.01 500 mL<br />
REAEP687 ph Buffer solution 6.87 500 mL<br />
REAEP741 ph Buffer solution 7.41 500 mL<br />
REAEP918 ph Buffer solution 9.18 500 mL<br />
Conductivity & resistivity solutions - @ 20°C<br />
REAEP1330<br />
REAEP133<br />
REAEP266<br />
Conductivity st<strong>and</strong>ard<br />
Electrolytic conductivity.............1330 µS/cm at 20°C<br />
Resistivity...................................................752 Ω⋅cm<br />
Conductivity st<strong>and</strong>ard<br />
Electrolytic conductivity...............133 µS/cm at 20°C<br />
Resistivity.................................................7519 Ω⋅cm<br />
Conductivity st<strong>and</strong>ard<br />
Electrolytic conductivity..............26.6 µS/cm at 20°C<br />
Resistivity...............................................37594 Ω⋅cm<br />
500 mL<br />
500 mL<br />
500 mL<br />
Reagents as outlined in Chapter 4 (4.1.1) of Ph.Eur.<br />
REA1000401 Acetic acid (30%) 1 L<br />
REA1000402 Acetic acid, dilute (12%) 1 L<br />
REA1000501 Acetic anhydride solution R1 1 L<br />
REA1002501 Alcohol, aldehyde free 1 L<br />
REA1004702 Ammonia, dilute R1 1 L<br />
REA1004703 Ammonia, dilute R2 1 L<br />
REA105201 Ammonium carbonate, solution (short shelf life) 1 L<br />
REA1007301 Anisaldehyde, solution 100 mL<br />
REA1007302 Anisaldehyde, solution R1 100 mL<br />
REA1009301 Barium chloride, solution R1 1 L<br />
118 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
European Pharmacopoeia Reagents from Reagecon<br />
Code Product Unit<br />
REA1009401 Barium hydroxide, solution 1 L<br />
REA1011601 Biuret reagent 1 L<br />
REA1012601 Bromocresol green solution 100 mL<br />
REA1012602 Bromocresol green-methyl red solution 100 mL<br />
REA1012701 Bromocresol purple solution 100 mL<br />
REA1012801 Bromophenol blue solution 100 mL<br />
REA1012803 Bromophenol blue solution R2 100 mL<br />
REA1012901 Bromothymol blue solution R1 100 mL<br />
REA1015201 Calcium sulphate solution 1 L<br />
REA1022901 Crystal violet solution 100 mL<br />
REA1023100 Cupri-citric solution 1 L<br />
REA1023300 Cupri-tartaric (Solution I 500 mL & Solution II 500 mL) 1 L<br />
REA1031101 Dimidium bromide - sulphan blue mixed solution 1 L<br />
REA1032101 Diphenylamine solution 1 L<br />
REA1032102 Diphenylamine solution R1 1 L<br />
REA1037702 Ferric ammonium sulphate solution R2 100 mL<br />
REA1038100 Ferroin 100 mL<br />
REA1039101 Formaldehyde solution 100 mL<br />
REA1039401 Fuchsin solution, decolorised 100 mL<br />
REA1039402 Fuchsin solution, decolorised R1 100 mL<br />
REA1043101 Holmium perchlorate solution 1 L<br />
REA1043501 Hydrochloric acid R1 1 L<br />
REA1043503 Hydrochloric acid, dilute 1 L<br />
REA1043504 Hydrochloric acid, dilute R1 1 L<br />
REA1045901 Iodine bromide solution 1 L<br />
REA1046300 Iodoplatinate reagent 200 mL<br />
REA1048001 Lanthanum nitrate solution 1 L<br />
REA1048101 Lead acetate cotton 10 g<br />
REA1048102 Lead acetate paper Pack of 50<br />
REA1052101 Mercuric bromide paper Pack of 50<br />
REA1053601 Methoxyphenylacetic reagent 100 mL<br />
REA1054801 Methyl orange mixed solution 100 mL<br />
REA1054802 Methyl orange solution 100 mL<br />
REA1055101 Methyl red mixed solution 100 mL<br />
REA1055102 Methyl red solution 100 mL<br />
REA1056700 Molybdovanadic reagent 100 mL<br />
REA1056801 Mordant black 11 triturate 100 mL<br />
REA1057601 Naphtobenzein solution 100 mL<br />
REA1058201 Nile blue A solution 100 mL<br />
REA1058303 Ninhydrin, solution 100 mL<br />
REA1058304 Ninhydrin solution R1 100 mL<br />
REA1058305 Ninhydrin solution R2 100 mL<br />
REA1058402 Acide nitrique dilué 100 mL<br />
REA1062901 Perchloric acid solution 100 mL<br />
REA1063601 Phenol red solution 100 mL<br />
REA1063603 Phenol red solution R2 500 mL<br />
REA1063702 Phenolphthalein solution 100 mL<br />
REA1063703 Phenolphthalein solution R1 100 mL<br />
REA1065000 Phosphomolybdotungstic reagent 100 mL<br />
REA1065200 Phosphomolybdotungstic solution 100 mL<br />
REA1065801 Picric acid solution 100 mL<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analyis - email pharma@lgcst<strong>and</strong>ards.com 119
European Pharmacopoeia Reagents from Reagecon<br />
Code Product Unit<br />
REA1065802 Picric acid solution R1 100 mL<br />
REA1069101 Potassium chloride, 0.1 M 1 L<br />
REA1069201 Potassium chromate, solution 1 L<br />
REA1069501 Potassium dichromate, solution 1 L<br />
REA1069801 Potassium ferrocyanide, solution 100 mL<br />
REA1070001 Potassium hydrogen phthalate, 0.2 M 1 L<br />
REA1070302 Potassium hydroxide in alcohol (10% v/v) 1 L<br />
REA1070303 Potassium hydroxide solution alcoholic 100 mL<br />
REA1070501 Potassium iodide <strong>and</strong> starch solution 125 mL<br />
REA1070502 Potassium iodide solution 1 L<br />
REA1070600 Potassium iodobismuthate, solution 100 mL<br />
REA1070602 Potassium iodobismuthate, solution R2 (short shelf life) 100 mL<br />
REA1070902 Potassium permanganate, solution 1 L<br />
REA1071301 Potassium pyroantimonate, solution 125 mL<br />
REA1071600 Potassium tetraiodomercurate, solution alkaline (100 ml of both solutions) 200 mL<br />
REA1075201 Ruthenium red solution 100 mL<br />
REA1078301 Silver nitrate solution R1 1 L<br />
REA1078302 Silver nitrate solution R2 1 L<br />
REA1079301 Sodium carbonate solution 1 L<br />
REA1081401 Sodium hydroxide solution 1 L<br />
REA1081402 Sodium hydroxide solution dilute 1 L<br />
REA1081404 Sodium hydroxide solution strong 1 L<br />
REA10816005 Sodium hypochlorite solution strong 500 mL<br />
REA1083901 Sodium sulfure solution 100 mL<br />
REA1085103 Starch, solution 100 mL<br />
REA1086804 Sulphuric acid, dilute 1 L<br />
REA1089602 Thiocetamide solution 1 L<br />
REA1090701 Thymolphthalein solution 100 mL<br />
REA1102301 Zinc acetate solution 1 L<br />
REA1096601 Zinc chloride formic acid solution 1 L<br />
REA1096602 Zinc chloride solution, iodinated 1 L<br />
St<strong>and</strong>ard solutions for limit tests as outlined in Chapter 4 (4.1.2) of Ph.Eur.<br />
REA5000200 Aluminium st<strong>and</strong>ard solution (200 ppm Al) 100 mL<br />
REA5000300C Ammonium st<strong>and</strong>ard solution (100 ppm NH 4) 100 mL<br />
REA5000500C Arsenic st<strong>and</strong>ard solution (10 ppm As) 100 mL<br />
REA5000700C Cadmium st<strong>and</strong>ard solution (0.1% Cd) 100 mL<br />
REA5000800C Calcium st<strong>and</strong>ard solution (400 ppm Ca) 100 mL<br />
REA5000802C Calcium st<strong>and</strong>ard solution alcoholic (400 ppm Ca) 1 L<br />
REA5000900C Chloride st<strong>and</strong>ard solution (8 ppm CI) 100 mL<br />
REA5001000 Chromium st<strong>and</strong>ard solution (100 ppm Cr) 1 L<br />
REA5001100 Copper st<strong>and</strong>ard solution (0.1% Cu) 100 mL<br />
REA5001200C Ferrocyanide st<strong>and</strong>ard solution (100 ppm Fe) 100 mL<br />
REA5001400C Fluoride st<strong>and</strong>ard solution (10 ppm F) 100 mL<br />
REA5001600C Iron st<strong>and</strong>ard solution (20 ppm Fe) 100 mL<br />
REA5001602C Iron st<strong>and</strong>ard solution (8 ppm Fe) 100 mL<br />
REA5001701C Lead st<strong>and</strong>ard solution (100 ppm Pb) 100 mL<br />
REA5001800C Lagnesium st<strong>and</strong>ard solution (100 ppm Mg) 100 mL<br />
REA5002000C Nickel st<strong>and</strong>ard solution (10 ppm Ni) 100 mL<br />
REA5002100C Nitrate st<strong>and</strong>ard solution (100 ppm NO 3) 100 mL<br />
120 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
European Pharmacopoeia Reagents from Reagecon<br />
Code Product Unit<br />
REA5002200C Phosphate st<strong>and</strong>ard solution (5 ppm PO 4) 100 mL<br />
REA5002400C Potassium st<strong>and</strong>ard solution (100 ppm K) 100 mL<br />
REA5002500 Selenium st<strong>and</strong>ard solution (100 ppm Se) 1 L<br />
REA5002700C Sodium st<strong>and</strong>ard solution (200 ppm Na) 100 mL<br />
REA5002800C Sulphate st<strong>and</strong>ard solution (10 ppm SO 4) 100 mL<br />
REA5003100C Tin st<strong>and</strong>ard solution (5 ppm Sn) 1 L<br />
REA5003401C Zinc st<strong>and</strong>ard solution (100 ppm Zn) 100 mL<br />
Buffer solutions as outlined in Chapter 4 (4.1.3) of Ph.Eur.<br />
REA4000100 Buffered acetone solution 1 L<br />
REA4000600 Buffer solution pH 3.5 1 L<br />
REA4001400 Acetate buffer solution pH 4.6 1 L<br />
REA4004800 Phosphate buffer solution pH 7.4 1 L<br />
REA4008300 Buffer (phosphate) solution pH 9.0 1 L<br />
REA4007200 Ammonium chloride buffer solution pH 9.5 1 L<br />
REA4007300 Ammonium chloride buffer solution pH 10.0 1 L<br />
Volumetric solutions as outlined in Chapter 4 (4.2.2) of Ph.Eur.<br />
REA3000100 0.1M Ammonium <strong>and</strong> cerium nitrate 1 L<br />
REA3000200 0.01M Ammonium <strong>and</strong> cerium nitrate 1 L<br />
REA3000300 0.1M Ammonium <strong>and</strong> cerium sulphate 1 L<br />
REA3000500 0.1M Ammonium thiocyanate 1 L<br />
REA3000600 0.1M Barium chloride 1 L<br />
REA3000900 0.004M Benzethonium chloride 1 L<br />
REA3001100 0.1M Cerium sulphate 1 L<br />
REA3008700 1M Cupriethylenediamine hydroxide solution 1 L<br />
REA3001300 0.1M Ferric ammonium sulphate 1 L<br />
REA3001500 6M Hydrochloric acid 1 L<br />
REA3001700 2M Hydrochloric acid 1 L<br />
REA3001800 1M Hydrochloric acid 1 L<br />
REA3002100 0.1M Hydrochloric acid 1 L<br />
REA3008800 0.1M Hydrochloric acid, alcoholic 1 L<br />
REA3002700 0.05M Iodine 1 L<br />
REA3003100 0.1M Lead nitrate 1 L<br />
REA3003300 0.1M Lithium methoxide 1 L<br />
REA3003500 0.02M Mercuric nitrate 1 L<br />
REA3003900 0.1M Perchloric acid 1 L<br />
REA3004200 0.033M Potassium bromate 1 L<br />
REA3002900 0.01M Iodine 1 L<br />
REA3009100 11M Potassium hydroxide 1 L<br />
REA3004800 0.1M Potassium hydroxide 1 L<br />
REA3004900 0.5M Potassium hydroxide 1 L<br />
REA3005000 0.5M Potassium hydroxide, alcoholic 1 L<br />
REA3005100 0.1M Potassium hydroxide, alcoholic 1 L<br />
REA3005300 0.02M Potassium permanganate 1 L<br />
REA3005600 0.1M Silver nitrate 1 L<br />
REA3005800 0.1M Sodium arsenite 1 L<br />
REA3005900 0.1M Sodium edetate 1 L<br />
REA3006300 1M Sodium hydroxide 1 L<br />
REA3006600 0.1M Sodium hydroxide 1 L<br />
REA3007100 0.1M Sodium methoxide 1 L<br />
REA3007200 0.1M Sodium nitrate 1 L<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analyis - email pharma@lgcst<strong>and</strong>ards.com 121
European Pharmacopoeia Reagents from Reagecon<br />
Code Product Unit<br />
REA3007300 0.1M Sodium thiosulphate 1 L<br />
REA3007800 0.5M Sulphuric acid 1 L<br />
REA3008000 0.05M Sulphuric acid 1 L<br />
REA3008300 0.1M Tetrabutylammonium hydroxide 1 L<br />
REA3008400 0.1M Tetrabutylammonium hydroxide in 2-propanol 1 L<br />
REA3008600 0.1M Zinc sulphate 1 L<br />
122 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
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British Pharmacopoeia<br />
Background<br />
British Pharmacopoeia<br />
British Pharmacopoeia chemical <strong>reference</strong> <strong>substances</strong> (BPCRS) available from BP are issued under the<br />
authority of the British Pharmacopoeia Commission <strong>and</strong> are solely for use in tests <strong>and</strong> assays of the British<br />
Pharmacopoeia or the British Pharmacopoeia (Veterinary).<br />
The list in this catalogue is current as of June 2007, <strong>and</strong> includes all available BPCRS needed to follow<br />
the current official monographs. Most BP monographs for active <strong>substances</strong> conform with the monographs<br />
issued by the European Pharmacopoeia, <strong>and</strong> so require the use of European Pharmacopoeia chemical<br />
<strong>reference</strong> <strong>substances</strong>. Details of these are to be found under the ‘European Pharmacopoeia’ section of<br />
this catalogue.<br />
Production <strong>and</strong> certification<br />
British Pharmacopoeia <strong>reference</strong> <strong>substances</strong> <strong>and</strong> preparations are selected <strong>and</strong> verified by the BP<br />
Laboratories as being suitable for the use as prescribed in the relevant monographs of the British<br />
Pharmacopoeia.<br />
Documentation<br />
BPCRS are of two types – normal CRS for identification purposes <strong>and</strong> Assay St<strong>and</strong>ards. Assay St<strong>and</strong>ards<br />
are provided with a documented assay value, determined by the BP Laboratories. The values are given in<br />
a booklet provided with the <strong>reference</strong> substance.<br />
The BP laboratories do not make available any other BPCRS certificates of analysis or other information,<br />
in connection with the prescribed use of the BPCRS.<br />
Controlled <strong>substances</strong><br />
Controlled drugs are subject to import <strong>and</strong> export control restrictions. Please contact LGC St<strong>and</strong>ards for<br />
details.<br />
Shelf life <strong>and</strong> expiry dates<br />
British Pharmacopoeia chemical <strong>reference</strong> <strong>substances</strong> are subjected to regular inspection <strong>and</strong> repeat<br />
analysis by BP scientific staff. Each BPCRS is, on receipt by the customer, fit for the intended use. All<br />
BPCRS are supplied with at least three months shelf life.<br />
BP supplies only current lots. For this reason users are advised to order only as required.<br />
Code Product Unit<br />
BP 001 Acepromazine maleate 50 mg<br />
BP 681 4-Acetyl 2-fluorobiphenyl 25 mg<br />
BP 438 Aciclovir Assay St<strong>and</strong>ard 100 mg<br />
BP 003 Adrenaline (epinephrine) acid tartrate Assay St<strong>and</strong>ard 100 mg<br />
New BP 763 Albendazole Assay St<strong>and</strong>ard 100 mg<br />
BP 436 Alex<strong>and</strong>rian senna fruit powder Assay St<strong>and</strong>ard 1 g<br />
BP 006 Alfadolone acetate Assay St<strong>and</strong>ard 100 mg<br />
BP 007 Alfaxalone Assay St<strong>and</strong>ard 100 mg<br />
BP 415 Alimemazine tarate Assay St<strong>and</strong>ard 100 mg<br />
BP 560 9-Allyl-2-chlorothioxanthen-9-ol 25 mg<br />
BP 725 Alverine citrate Assay St<strong>and</strong>ard 100 mg<br />
BP 724 Alverine citrate impurity st<strong>and</strong>ard solution 1.0 mL<br />
BP 530 Amantadine hydrochloride Assay St<strong>and</strong>ard 200 mg<br />
BP 008 Amiloride hydrochloride Assay St<strong>and</strong>ard 100 mg<br />
BP 010 4-Amino-6-chlorobenzene-1-3-disulphonamide 50 mg<br />
BP 374 3-Amino-6-chloro-1-methyl-4-phenylquinolin-2-ol 50 mg<br />
BP 012 2-Amino-4,6-Dichlorophenol hydrochloride 50 mg<br />
BP 602 (E)-4-Amino-2-ethylidenebutyric acid hydrochloride 25 mg<br />
BP 684 Aminoglutethimide Assay St<strong>and</strong>ard 100 mg<br />
BP 417 2-Amino-1-(4-nitrophenyl)propane-1,3-diol 50 mg<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 125
British Pharmacopoeia<br />
Code Product Unit<br />
BP 601 3-Aminopent-4-ene-1,1-dicarboxylic acid 25 mg<br />
BP 536 3-Amino-4-phenoxy-5-sulphamoylbenzoic acid 25 mg<br />
BP 014 3-Amino-4-propoxybenzoic acid 50 mg<br />
BP 532 Amiodarone hydrochloride Assay St<strong>and</strong>ard 100 mg<br />
BP 015 Amitraz Assay St<strong>and</strong>ard 200 mg<br />
BP 016 Amitriptyline hydrochloride Assay St<strong>and</strong>ard 150 mg<br />
BP 748 Amoxicillin impurity st<strong>and</strong>ard 25 mg<br />
BP 546 Apramycin 250 mg<br />
BP 694 Arginine hydrochloride Assay St<strong>and</strong>ard 100 mg<br />
BP 617 Aspirin Assay St<strong>and</strong>ard 100 mg<br />
BP 492 Atenolol Assay St<strong>and</strong>ard 100 mg<br />
BP 370 Atenolol impurity st<strong>and</strong>ard 50 mg<br />
BP 023 Atropine sulphate Assay St<strong>and</strong>ard 200 mg<br />
BP 366 1-(3-Azabicyclo[3.3.0]oct-3-yl)-3-o-tolylsulphonylurea 30 mg<br />
BP 024 2-Azahypoxanthine 50 mg<br />
BP 025 Azaperone Assay St<strong>and</strong>ard 100 mg<br />
BP 534 Azapropazone Assay St<strong>and</strong>ard 100 mg<br />
BP 515 Azapropazone impurity A 10 mg<br />
BP 516 Azapropazone impurity B 10 mg<br />
BP 517 Azapropazone impurity C 10 mg<br />
BP 527 Azapropazone impurity st<strong>and</strong>ard 50 mg<br />
BP 028 Baclofen Assay St<strong>and</strong>ard 150 mg<br />
BP 535 Baclofen lactam 25 mg<br />
BP 030 Beclometasone dipropionate Assay St<strong>and</strong>ard 100 mg<br />
New BP 760 Beclometasone 17-propionate 25 mg<br />
New BP 761 Beclometasone 21-propionate 25 mg<br />
BP 685 Benserazide hydrochloride Assay St<strong>and</strong>ard 100 mg<br />
BP 036 Benzatropine mesilate Assay St<strong>and</strong>ard 100 mg<br />
BP 610 Benzydamine hydrochloride Assay St<strong>and</strong>ard 100 mg<br />
BP 426 Benzyl benzoate Assay St<strong>and</strong>ard 0.1 mL<br />
BP 611 1-Benzyl-3-(3-diethylamino-propoxy)-1H-indazole 50 mg<br />
BP 037<br />
(1S,2R)-1-benzyl-3-dimethylamino-2<br />
-methyl-1-phenylpropyl acetate<br />
BP 609 1-Benzyl-1-H-indazol-3-ol 50 mg<br />
BP 575 Betamethasone Assay St<strong>and</strong>ard 100 mg<br />
BP 041 Betamethasone sodium phosphate 100 mg<br />
BP 042 Betamethasone valerate Assay St<strong>and</strong>ard 100 mg<br />
BP 043 Betamethasone 21-valerate 50 mg<br />
BP 686 Betaxolol hydrochloride Assay St<strong>and</strong>ard 100 mg<br />
New BP 755 Bezafibrate Assay St<strong>and</strong>ard 100 mg<br />
BP 046 2-(Biphenyl-4-yl)propionic acid 25 mg<br />
BP 612 Bretylium tosilate Assay St<strong>and</strong>ard 200 mg<br />
BP 613 2-Bromobenzyldimethylamine hydrochloride 25 mg<br />
BP 050 Bromocriptine Mesilate Assay St<strong>and</strong>ard 100 mg<br />
BP 440 Buclizine hydrochloride impurity st<strong>and</strong>ard 100 mg<br />
BP 537 Bumetanide Assay St<strong>and</strong>ard 100 mg<br />
BP 479 Bupivacaine hydrochloride Assay St<strong>and</strong>ard 100 mg<br />
BP 403 Busulfan Assay St<strong>and</strong>ard 25 mg<br />
BP 192 2-tert-Butylamino-1-(4-hydroxy-3-methylphenyl)ethanol sulphate 25 mg<br />
BP 531 2-Butyl-3-(4-hydroxy-3,5-di-iodobenzoyl)benzofuran 25 mg<br />
New BP 766 Caffeine Assay St<strong>and</strong>ard 100 mg<br />
25 mg<br />
126 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
British Pharmacopoeia<br />
Code Product Unit<br />
BP 355 Calcitonin (salmon) Assay St<strong>and</strong>ard ca. 10 µg<br />
BP 059 Capreomycin sulphate 50 mg<br />
BP 538 Captopril Assay St<strong>and</strong>ard 100 mg<br />
BP 500 Captopril disulphide 25 mg<br />
BP 477 2-Carbamoyl-1-methyl-3-[2-(5-methylimidazol-4-yl-methylthio)ethyl]guanidine dihydrochloride 25 mg<br />
BP 523 Carbaryl Assay St<strong>and</strong>ard 100 mg<br />
BP 060 Carbidopa Assay St<strong>and</strong>ard 100 mg<br />
BP 749 Carbimazole Assay St<strong>and</strong>ard 100 mg<br />
BP 711 Carboplatin Assay St<strong>and</strong>ard 100 mg<br />
New BP 767 Carmellose sodium Assay St<strong>and</strong>ard 100 mg<br />
BP 567 Carteolol hydrochloride Assay St<strong>and</strong>ard 100 mg<br />
BP 562 Cefalonium Assay St<strong>and</strong>ard 100 mg<br />
BP 502 Cefuroxime axetil Assay St<strong>and</strong>ard 100 mg<br />
New BP 757 Celiprolol hydrochloride Assay St<strong>and</strong>ard 100 mg<br />
BP 064 Chlorambucil Assay St<strong>and</strong>ard 100 mg<br />
BP 067 Chlorcyclizine hydrochloride 100 mg<br />
BP 068 Chlorhexidine acetate Assay St<strong>and</strong>ard 100 mg<br />
BP 441 1,4-bis(4-Chlorobenzhydryl)piperazine 25 mg<br />
New BP 756 N-p-chlorobenzoyltyramine 25 mg<br />
BP 604 4-Chlorobenzylphthalazinone 25 mg<br />
BP 376 6-Chloro-4-(2-chlorophenyl)quinazoline-2-carboxaldehyde 50 mg<br />
BP 442 6-Chloro-1,4-dihydro-1-methyl-4-phenylquinazolin-4-ol 25 mg<br />
BP 470 7-Chloro-1-5-dihydro-5-phenyl-1,5-benzodiazepine-2,4(3H)-dione 25 mg<br />
BP 049<br />
17β,17'β-bis{3-[bis-(2-chloroethyl)carbamoyloxy]<br />
estra-1,3,5,(10)-trienyl}pyrophosphate<br />
BP 446 5-(2-Chloroethyl)-4-methyl-3-[2-(4-methylthiazol-5-yl)ethyl]thiazolium chloride 25 mg<br />
BP 071 4-[2-(5-Chloro-2-methoxybenzamido)ethyl]benzenesulphonamide 25 mg<br />
BP 378 5-Chloro-2-methylaminobenzophenone 50 mg<br />
BP 443<br />
6-(2-Chlorophenyl)-2,4-dihydro-2-[(dimethylamino)methylene]<br />
8-nitroimidazo[1,2-a][1,4]benzodiazepin-1-one<br />
BP 074 4-Chloro-5-sulphamoylanthranilic acid 25 mg<br />
BP 559 2-Chlorothioxanthone 25 mg<br />
BP 077 2-(6-Chlorothymoxy)ethyldimethylamine hydrochloride 25 mg<br />
BP 079 2-Chlorotritanol 25 mg<br />
BP 080 Chloroxylenol Assay St<strong>and</strong>ard 500 mg<br />
BP 081 Chlorphenamine maleate Assay St<strong>and</strong>ard 100 mg<br />
BP 467 Chlorpromazine sulphoxide 50 mg<br />
BP 491 Chlortalidone Assay St<strong>and</strong>ard 100 mg<br />
BP 618 Cholic acid Assay St<strong>and</strong>ard 100 mg<br />
BP 475 Cimetidine Assay St<strong>and</strong>ard 100 mg<br />
BP 747 Clavulanate polymer 25 mg<br />
BP 525 Clemastine fumarate Assay St<strong>and</strong>ard 200 mg<br />
BP 084 Clioquinol Assay St<strong>and</strong>ard 200 mg<br />
BP 507 Clobazam Assay St<strong>and</strong>ard Controlled Substance 100 mg<br />
BP 522 Clobetasol impurity A 25 mg<br />
BP 521 Clobetasol propionate Assay St<strong>and</strong>ard 100 mg<br />
BP 482 Clobetasone butyrate Assay St<strong>and</strong>ard 100 mg<br />
BP 406 Clocortolone hexanoate 100 mg<br />
BP 663 Clofazimine Assay St<strong>and</strong>ard 100 mg<br />
BP 543 Clomethiazole edisilate Assay St<strong>and</strong>ard 100 mg<br />
BP 085 Clonidine hydrochloride Assay St<strong>and</strong>ard 100 mg<br />
25 mg<br />
25 mg<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 127
British Pharmacopoeia<br />
Code Product Unit<br />
BP 565 trans-Clopenthixol acetate dihydrochloride 50 mg<br />
BP 566 trans-Clopenthixol decanoate dihydrochloride 25 mg<br />
BP 561 trans-Clopenthixol hydrochloride 25 mg<br />
BP 628 Cloprostenol sodium Assay St<strong>and</strong>ard 20 mg<br />
BP 379 Clotrimazole Assay St<strong>and</strong>ard 50 mg<br />
BP 088 Cloxacillin benzathine Assay St<strong>and</strong>ard 250 mg<br />
BP 091 Co-dergocrine mesilate Assay St<strong>and</strong>ard 50 mg<br />
BP 715 Cocaine hydrochloride Assay St<strong>and</strong>ard Controlled Substance 100 mg<br />
BP 514 Codeine hydrochloride Assay St<strong>and</strong>ard Controlled Substance 100 mg<br />
BP 090 Codeine Phosphate Assay St<strong>and</strong>ard Controlled Substance 200 mg<br />
BP 614 Colestipol hydrochloride 50 mg<br />
BP 551 Colestyramine Assay St<strong>and</strong>ard 500 mg<br />
BP 585 Cortisone acetate Assay St<strong>and</strong>ard 100 mg<br />
BP 094 Crotamiton Assay St<strong>and</strong>ard 100 mg<br />
BP 466 Cyanocobalamin Assay St<strong>and</strong>ard 100 mg<br />
BP 478 2-Cyano-1-methyl-3-[2-(5-methylimidazol-4-yl-methylsulphinyl)ethyl]guanidine 25 mg<br />
BP 096 Cyclizine hydrochloride Assay St<strong>and</strong>ard 100 mg<br />
BP 098 Cyclopenthiazide 100 mg<br />
BP 380 Cyclopentolate hydrochloride Assay St<strong>and</strong>ard 100 mg<br />
BP 688 Cyproterone acetate Assay St<strong>and</strong>ard 100 mg<br />
BP 383 Cytarabine Assay St<strong>and</strong>ard 100 mg<br />
BP 100 Dacarbazine 25 mg<br />
New BP 771 Dantrolene Assay St<strong>and</strong>ard 100 mg<br />
BP 428 Dantron 50 mg<br />
BP 429 Dantron impurity st<strong>and</strong>ard 100 mg<br />
BP 102 Dapsone Assay St<strong>and</strong>ard 100 mg<br />
BP 103 Debrisoquine sulphate 100 mg<br />
BP 104 Decoquinate 50 mg<br />
BP 572 Deltamedrane 25 mg<br />
BP 631 Deltamethrin Assay St<strong>and</strong>ard 100 mg<br />
BP 632 Deltamethrin impurity st<strong>and</strong>ard 40 mg<br />
BP 504 Desacetylmetipranolol 25 mg<br />
BP 730 N-Desalkylflurazepam 25 mg<br />
BP 689 Desmethyl benzatropine hydrochloride 50 mg<br />
BP 594 Desogestrel ∆ 3- isomer 25 mg<br />
BP 578 Dexamethasone Assay St<strong>and</strong>ard 100 mg<br />
BP 108 Dexamethasone sodium phosphate 50 mg<br />
BP 646 Dexamethasone phosphate Assay St<strong>and</strong>ard 100 mg<br />
BP 465 Dextropropoxyphene hydrochloride Assay St<strong>and</strong>ard Controlled Substance 100 mg<br />
BP 549 Diacetylfluorescein Assay St<strong>and</strong>ard 200 mg<br />
BP 111 Diazepam Controlled Substance 100 mg<br />
BP 114 Dibenzo[b,e]thiepin-11(6H)-one 25 mg<br />
BP 124<br />
3-(Dibenzo[b,e]thiepin-11(6H)-ylidene)-N,N-dimethylaminopropan-1-amine-S-oxide<br />
hydrochloride<br />
BP 608 3-(1,5-Dibenzyl-1H-indazole-3-yl)oxypropyl dimethylamine hydrochloride 25 mg<br />
BP 116 Dichlorophen Assay St<strong>and</strong>ard 100 mg<br />
BP 420 Dichlorophen impurity st<strong>and</strong>ard Assay St<strong>and</strong>ard 100 mg<br />
BP 721 1-(2,5-Dichlorophenyl)-5-isopropylbiguanide hydrochloride 25 mg<br />
BP 598 Diclofenac diethylamine 100 mg<br />
BP 619 Diclofenac sodium Assay St<strong>and</strong>ard 100 mg<br />
BP 118 Diethanolamine fusidate Assay St<strong>and</strong>ard 100 mg<br />
25 mg<br />
128 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
British Pharmacopoeia<br />
Code Product Unit<br />
BP 361 2-Diethylaminoethyl-3-(1-naphthyl)-2-(1-naphthylmethyl)propionate oxalate 25 mg<br />
BP 737 Diethylcarbamazine citrate 100 mg<br />
BP 119 Diethyl-4-decyloxy-3-ethoxyanilinomethylenemalonate 50 mg<br />
BP 677 Diethylstilbestrol monophosphate 25 mg<br />
BP 401 Diflucortolone valerate Assay St<strong>and</strong>ard 100 mg<br />
BP 397 Diflucortolone valerate impurity st<strong>and</strong>ard 25 mg<br />
BP 431 Dihydrocodeine tartrate Assay St<strong>and</strong>ard Controlled Substance 100 mg<br />
BP 120 Dihydroergocristine mesilate 25 mg<br />
BP 122 2,3-Dihydro-6-phenylimidazo [2,1-b] thiazole 50 mg<br />
BP 582 6,6-Dimethoxy-2,2'-binaphthyl 25 mg<br />
BP 195 4-Dimethylamino-3-methyl-1,2-diphenylbutan-2-ol hydrochloride 25 mg<br />
BP 607 3-Dimethylaminopropyl 2-benzylaminobenzoate hydrochloride 25 mg<br />
BP 456 1,5-Dimethylhexyl(methyl)amine 50 mg<br />
BP 511 Dimethyl{5-[2-(1-methylamino-2-nitrovinylamino) ethylsulphinylmethyl]furfuryl}amine 25 mg<br />
BP 303<br />
Gemfibrozil impurity A<br />
2,2-dimethyl-5-(4-propen-1-yl)-2,5-xylyloxy)valeric acid<br />
BP 364 2,2-Dimethyl-5(2,4-xylyloxy)valeric acid 25 mg<br />
BP 690 Dimpylate Assay St<strong>and</strong>ard 0.1 mL<br />
BP 691 Dimpylate for chromatography 0.1 mL<br />
BP 128 Dipipanone hydrochloride Assay St<strong>and</strong>ard Controlled Substance 100 mg<br />
BP 673 Dipivefrine hydrochloride Assay St<strong>and</strong>ard 100 mg<br />
BP 659 Dipivefrine impurity st<strong>and</strong>ard 100 mg<br />
BP 589 Diprenorphine Assay St<strong>and</strong>ard 100 mg<br />
BP 131 Dipyridamole Assay St<strong>and</strong>ard 100 mg<br />
BP 384 N1,N2-Diquinoxalin-2-ylsulphanilamide 25 mg<br />
BP 615 Disodium pamidronate Assay St<strong>and</strong>ard 100 mg<br />
BP 132 Disulfiram Assay St<strong>and</strong>ard 50 mg<br />
BP 385 Dithranol Assay St<strong>and</strong>ard 100 mg<br />
BP 674 Dobutamine hydrochloride Assay St<strong>and</strong>ard 100 mg<br />
BP 133 Docusate sodium Assay St<strong>and</strong>ard 200 mg<br />
BP 669 Domperidone maleate Assay St<strong>and</strong>ard 100 mg<br />
BP 468 Dopamine hydrochloride Assay St<strong>and</strong>ard 100 mg<br />
BP 134 Dosulepin hydrochloride Assay St<strong>and</strong>ard 100 mg<br />
BP 135 Doxapram hydrochloride Assay St<strong>and</strong>ard 100 mg<br />
BP 136 Doxepin hydrochloride Assay St<strong>and</strong>ard 100 mg<br />
BP 675 Droperidol Assay St<strong>and</strong>ard 100 mg<br />
BP 139 Econazole nitrate Assay St<strong>and</strong>ard 100 mg<br />
BP 741 Enalapril maleate 100 mg<br />
BP 742 Enalaprilat 20 mg<br />
BP 743 Enalapril diketopiperazine 20 mg<br />
BP 387 Ephedrine hydrochloride Assay St<strong>and</strong>ard Controlled Substance 100 mg<br />
BP 405 Ergometrine maleate Assay St<strong>and</strong>ard Controlled Substance 100 mg<br />
BP 141 Ergotamine tartrate Assay St<strong>and</strong>ard Controlled Substance 50 mg<br />
BP 488 Erythromycin stearate Assay St<strong>and</strong>ard 100 mg<br />
BP 396 Estradiol benzoate Assay St<strong>and</strong>ard 50 mg<br />
BP 729 Estradiol hemihydrate Assay St<strong>and</strong>ard 100 mg<br />
BP 142 Estramustine 25 mg<br />
New BP 752 Estriol Assay St<strong>and</strong>ard 100 mg<br />
New BP 753 Estriol impurity st<strong>and</strong>ard 25 mg<br />
BP 616 Estropipate Assay St<strong>and</strong>ard 100 mg<br />
BP 143 Etacrynic acid Assay St<strong>and</strong>ard 100 mg<br />
25 mg<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 129
British Pharmacopoeia<br />
Code Product Unit<br />
BP 421 Ethinylestradiol Assay St<strong>and</strong>ard 100 mg<br />
BP 145 Ethopabate Assay St<strong>and</strong>ard 100 mg<br />
BP 146 Ethosuximide Assay St<strong>and</strong>ard 200 mg<br />
BP 437 N-Ethylglucamine hydrochloride 500 mg<br />
BP 149 Ethyl meclofenamate 25 mg<br />
BP 529 Etodolac Assay St<strong>and</strong>ard 150 mg<br />
BP 533 Etodolac acid dimer 25 mg<br />
BP 541 Etodolac 1-methyl analogue 25 mg<br />
BP 542 Etodolac 8-methyl analogue 25 mg<br />
BP 653 Famotidine Assay St<strong>and</strong>ard 100 mg<br />
BP 655 Famotidine degradation impurity 1 25 mg<br />
BP 656 Famotidine degradation impurity 2 25 mg<br />
BP 654 Famotidine impurity C 25 mg<br />
BP 620 Felbinac Assay St<strong>and</strong>ard 100 mg<br />
BP 692 Fenbendazole 100 mg<br />
BP 693<br />
Fenbendazole impurity C<br />
5-(phenylthio)-2-aminobenzimidazole<br />
BP 354 Fenbufen Assay St<strong>and</strong>ard 100 mg<br />
BP 661 Fenoterol degradation impurity A 25 mg<br />
BP 660 Fenoterol hydrobromide Assay St<strong>and</strong>ard 100 mg<br />
BP 665 Fentanyl citrate Assay St<strong>and</strong>ard Controlled Substance 100 mg<br />
BP 666 Fentanyl impurity A 25 mg<br />
BP 156 Fenthion Assay St<strong>and</strong>ard 0.25 mL<br />
BP 740 Finasteride Assay St<strong>and</strong>ard 100 mg<br />
BP 571 Flavoxate hydrochloride Assay St<strong>and</strong>ard 100 mg<br />
BP 676 Flecainide acetate Assy St<strong>and</strong>ard 100 mg<br />
BP 159 Fludrocortisone acetate Assay St<strong>and</strong>ard 50 mg<br />
BP 160 Fluocinolone acetonide Assay St<strong>and</strong>ard 50 mg<br />
BP 489 Fluocinonide Assay St<strong>and</strong>ard 100 mg<br />
BP 161 Fluocortolone hexanoate Assay St<strong>and</strong>ard 50 mg<br />
BP 162 Fluocortolone pivalate Assay St<strong>and</strong>ard 50 mg<br />
BP 163 4'-Fluoro-4-chlorobutyrophenone 0.5 mL<br />
BP 573 Fluorometholone Assay St<strong>and</strong>ard 100 mg<br />
BP 164 Fluoxymesterone 50 mg<br />
BP 738 cis-Flupentixol 25 mg<br />
BP 554 Flupentixol decanoate dihydrochloride Assay St<strong>and</strong>ard 100 mg<br />
BP 556 trans-Flupentixol decanoate dihydrochloride 25 mg<br />
BP 597 cis-Flupenthixol propionate dihydrochloride 100 mg<br />
BP 167 Fluphenazine hydrochloride Assay St<strong>and</strong>ard 100 mg<br />
BP 574 Flurbiprofen sodium Assay St<strong>and</strong>ard 100 mg<br />
BP 587 Fluticasone propionate Assay St<strong>and</strong>ard 100 mg<br />
BP 588 Fluticasone S-methyl impurity 25 mg<br />
BP 600 Fluvoxamine maleate Assay St<strong>and</strong>ard 100 mg<br />
BP 671 Fluvoxamine maleate impurity st<strong>and</strong>ard 100 mg<br />
BP 627 3-Formylrifamycin SV 25 mg<br />
BP 639 Form-2',4'-xylidide 25 mg<br />
BP 623 Foscarnet sodium Assay St<strong>and</strong>ard 100 mg<br />
BP 678 Fosfestrol sodium 50 mg<br />
BP 172 Furazolidone 50 mg<br />
BP 547 Furosemide Assay St<strong>and</strong>ard 100 mg<br />
BP 643 Gallamine impurity st<strong>and</strong>ard 100 mg<br />
25 mg<br />
130 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
British Pharmacopoeia<br />
Code Product Unit<br />
BP 363 Gemfibrozil Assay St<strong>and</strong>ard 100 mg<br />
BP 365 Gemfibrozil methyl ester 0.1 mL<br />
BP 175 Glibenclamide Assay St<strong>and</strong>ard 100 mg<br />
BP 368 Gliclazide Assay St<strong>and</strong>ard 200 mg<br />
BP 580 Gliquidone Assay St<strong>and</strong>ard 150 mg<br />
BP 581 Gliquidone sulphonamide 25 mg<br />
BP 180 Griseofulvin Assay St<strong>and</strong>ard 100 mg<br />
BP 181 Guanethidine monosulphate Assay St<strong>and</strong>ard 100 mg<br />
BP 407 Haloperidol Assay St<strong>and</strong>ard 150 mg<br />
BP 182 Haloxon Assay St<strong>and</strong>ard 300 mg<br />
BP 185 Homatropine hydrobromide Assay St<strong>and</strong>ard 100 mg<br />
BP 186 Hydrochlorothiazide Assay St<strong>and</strong>ard 200 mg<br />
BP 576 Hydrocortisone Assay St<strong>and</strong>ard 100 mg<br />
BP 584 Hydrocortisone acetate Assay St<strong>and</strong>ard 100 mg<br />
BP 188 Hydrocortisone sodium phosphate 100 mg<br />
BP 190 Hydroflumethiazide 100 mg<br />
New BP 770 4'Hydroxyacetophenone 25 mg<br />
BP 197 Hydroxycarbamide Assay St<strong>and</strong>ard 200 mg<br />
BP 526 2-(2-Hydroxyethyl)-1-methylpyrrolidine 0.1 mL<br />
BP 196 5-[1-Hydroxy-2-(1-methyl-3-phenylpropylamino)ethyl]salicylic acid hydrochloride 50 mg<br />
BP 193 Hydroxyprogesterone caproate (hexanoate) Assay St<strong>and</strong>ard 50 mg<br />
BP 194 2-(6-Hydroxythymoxy)ethyldimethylamine hydrochloride 25 mg<br />
BP 198 Hyoscine butylbromide Assay St<strong>and</strong>ard 100 mg<br />
BP 199 Hyoscine Hydrobromide Assay St<strong>and</strong>ard 200 mg<br />
New BP 774 Hypromellose Assay St<strong>and</strong>ard 100 mg<br />
BP 539 Ibuprofen Assay St<strong>and</strong>ard 200 mg<br />
BP 202 Idoxuridine Assay St<strong>and</strong>ard 100 mg<br />
BP 664 Iminophenazine 25 mg<br />
BP 625 Ipratropium bromide Assay St<strong>and</strong>ard 100 mg<br />
BP 557 4'-Isobutylacetophenone 0.1 mL<br />
BP 550 Isoconazole nitrate Assay St<strong>and</strong>ard 100 mg<br />
BP 205 Isoprenaline hydrochloride Assay St<strong>and</strong>ard 100 mg<br />
BP 499 4'-(2-Isopropylaminoethyl)methanesulphonanilide hydrochloride 25 mg<br />
BP 626 8s-Isopropyl-3β-hydroxytropanium bromide 25 mg<br />
BP 621 Isradipine Assay St<strong>and</strong>ard 100 mg<br />
BP 622 Isradipine impurity B 25 mg<br />
BP 624 Isradipine impurity D 25 mg<br />
BP 736 Ketamine Hydrochloride Controlled Substance 100 mg<br />
BP 668 Ketoprofen Assay St<strong>and</strong>ard 100 mg<br />
BP 667 Ketoprofen ethyl ester 0.1 mL<br />
BP 707 Lacidipine Assay St<strong>and</strong>ard 100 mg<br />
BP 647 Lacidipine impurity St<strong>and</strong>ard 25 mg<br />
BP 212 Levamisole hydrochloride 100 mg<br />
BP 356 Levobunolol hydrochloride Assay St<strong>and</strong>ard 100 mg<br />
BP 213 Levodopa Assay St<strong>and</strong>ard 100 mg<br />
New BP 772 Levomenthol Assay St<strong>and</strong>ard 100 mg<br />
BP 723 Levomepromazine maleate Assay St<strong>and</strong>ard 100 mg<br />
BP 634 Levomepromazine sulphoxide 25 mg<br />
BP 501 Levonorgestrel Assay St<strong>and</strong>ard 100 mg<br />
BP 727 Lidocaine Assay St<strong>and</strong>ard 100 mg<br />
BP 733 Linseed oil 0.5 mL<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 131
British Pharmacopoeia<br />
Code Product Unit<br />
BP 695 Lisinopril dihydrate Assay St<strong>and</strong>ard 100 mg<br />
BP 696 Lisinopril diketopiperazine 25 mg<br />
BP 433 Lithium lactate Assay St<strong>and</strong>ard 100 mg<br />
BP 697 Lofepramine hydrochloride Assay St<strong>and</strong>ard 100 mg<br />
BP 635 Loperamide hydrochloride Assay St<strong>and</strong>ard 100 mg<br />
BP 636 Loperamide N-oxide 25 mg<br />
BP 447 Loprazolam mesilate Controlled Substance 50 mg<br />
BP 434 Lorazepam Assay St<strong>and</strong>ard Controlled Substance 50 mg<br />
BP 528 Lormetazepam Assay St<strong>and</strong>ard Controlled Substance 100 mg<br />
BP 218 Lymecycline 100 mg<br />
BP 221 Medroxyprogesterone acetate Assay St<strong>and</strong>ard 100 mg<br />
BP 222 Megestrol 25 mg<br />
BP 223 Megestrol acetate Assay St<strong>and</strong>ard 100 mg<br />
BP 629 Meloxicam Assay Stadard 100 mg<br />
BP 630 Meloxicam impurity st<strong>and</strong>ard 50 mg<br />
BP 391 Melphalan Assay St<strong>and</strong>ard 100 mg<br />
BP 699 Mepivacaine hydrochloride Assay St<strong>and</strong>ard 100 mg<br />
BP 583 Meptazinol hydrochloride Assay St<strong>and</strong>ard 100 mg<br />
New BP 773 Mercaptopurine Assay St<strong>and</strong>ard 100 mg<br />
BP 496 Mesoridazine besilate 50 mg<br />
BP 226 Metaraminol tartrate 100 mg<br />
BP 552 Methadone hydrochloride Assay St<strong>and</strong>ard Controlled Substance 100 mg<br />
BP 359 5-(6-methoxy-2-naphthyl)-3-methylcyclohexan-1-one 25 mg<br />
BP 232 1-(2-Methoxyphenyl)piperazine 25 mg<br />
BP 644 Methyl 4-acetamido-2-hydroxybenzoate 25 mg<br />
BP 606 1-Methylazepan-4-one hydrochloride 25 mg<br />
BP 605 1-Methyl-4-(2-benzoylhydrazino)azepan hydrochloride 25 mg<br />
BP 239 3-Methyl-2,2-diphenyl-4-piperidinobutyronitrile 50 mg<br />
BP 240 Methyldopa Assay St<strong>and</strong>ard 100 mg<br />
BP 241 Methyldopate hydrochloride Assay St<strong>and</strong>ard 100 mg<br />
BP 569 3-Methylflavone-8-carboxylic acid 25 mg<br />
BP 570 3-Methylflavone-8-carboxylic acid ethyl ester 25 mg<br />
BP 444 4-methyl-5-(2-hydroxyethyl)thiazole 25 mg<br />
BP 457 2-Methyl-6-methylaminoheptan-2-ol 50 mg<br />
BP 233 Methyl[2-(2-methylbenzhydryloxy)ethyl]amine hydrochloride 25 mg<br />
BP 476 1-methyl-3-[2-(5-methylimidazol-4-yl-methylthio)ethyl]guanidine dihydrochloride 25 mg<br />
BP 237<br />
Methyl N-4[2-(5-chloro-<br />
2-methoxybenzamido)ethyl]benzenesulphonyl carbamate<br />
BP 244 2-Methyl-5-Nitroimidazole 50 mg<br />
BP 245 (1-Methyl-5-nitroimidazol-2-yl)methanol 25 mg<br />
BP 641 N-Methyl-N'-(2,4-xylyl)formamidine hydrochloride 25 mg<br />
BP 662 Methylphenobarbital Assay St<strong>and</strong>ard Controlled Substance 100 mg<br />
BP 248 Methylprednisolone Assay St<strong>and</strong>ard 100 mg<br />
BP 249 Methylprednisolone acetate Assay St<strong>and</strong>ard 200 mg<br />
BP 445 4-Methyl-5-vinylthiazole edisilate 25 mg<br />
BP 409 Methysergide maleate Assay St<strong>and</strong>ard 50 mg<br />
BP 642 Metipranolol Assay St<strong>and</strong>ard 100 mg<br />
BP 357 Metoclopramide hydrochloride Assay St<strong>and</strong>ard 100 mg<br />
BP 540 Metoprolol tartrate Assay St<strong>and</strong>ard 100 mg<br />
BP 603 Metronidazole Assay St<strong>and</strong>ard 150 mg<br />
BP 735 Metronidazole benzoate 100 mg<br />
25 mg<br />
132 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
British Pharmacopoeia<br />
Code Product Unit<br />
BP 251 Mexenone 100 mg<br />
BP 252 Mianserin hydrochloride Assay St<strong>and</strong>ard 100 mg<br />
BP 253 Miconazole nitrate Assay St<strong>and</strong>ard 100 mg<br />
BP 722 Midazolam Assay St<strong>and</strong>ard Controlled Substance 100 mg<br />
BP 637 Minoxidil Assay St<strong>and</strong>ard 100 mg<br />
New BP 768 Mometasone furoate Assay St<strong>and</strong>ard 100 mg<br />
BP 254 Monosulfiram 100 mg<br />
BP 648 Morphine sulphate Assay St<strong>and</strong>ard Controlled Substance 100 mg<br />
BP 358 Nabumetone Assay St<strong>and</strong>ard 200 mg<br />
BP 362 Naftidrofuryl oxalate Assay St<strong>and</strong>ard 100 mg<br />
BP 548 Naloxone hydrochloride Assay St<strong>and</strong>ard 100 mg<br />
BP 257 N<strong>and</strong>rolone Assay St<strong>and</strong>ard Controlled Substance 100 mg<br />
BP 425 N<strong>and</strong>rolone decanoate Controlled Substance 50 mg<br />
BP 259 N<strong>and</strong>rolone laurate Controlled Substance 50 mg<br />
BP 260 N<strong>and</strong>rolone Phenylpropionate Assay St<strong>and</strong>ard Controlled Substance 100 mg<br />
BP 360 3-(1-Naphthyl)-2-tetrahydrofurfurylpropionic acid 25 mg<br />
BP 435 Naproxen Assay St<strong>and</strong>ard 100 mg<br />
BP 460 Nicotinamide Assay St<strong>and</strong>ard 100 mg<br />
BP 395 Nicotinyl alcohol tartrate 50 mg<br />
BP 462 Nifedipine Assay St<strong>and</strong>ard 100 mg<br />
BP 651 Nimodipine Assay St<strong>and</strong>ard 100 mg<br />
BP 262 Nitrazepam Assay St<strong>and</strong>ard Controlled Substance 100 mg<br />
BP 263 Nitrofurfural diacetate 50 mg<br />
BP 367 3-Nitroso-3-azabicyclo[3.3.O]octane 0.1 mL<br />
BP 512 Noradrenaline (norepinephrine) acid tartrate 100 mg<br />
BP 266 Norethisterone Assay St<strong>and</strong>ard 50 mg<br />
New BP 267 Norethisterone acetate Assay St<strong>and</strong>ard 100 mg<br />
BP 670 Norfloxacin Assay St<strong>and</strong>ard 100 mg<br />
BP 714 Norgestrel 100 mg<br />
BP 269 Nortriptyline hydrochloride Assay St<strong>and</strong>ard 200 mg<br />
New BP 765 Omeprazole Assay St<strong>and</strong>ard 100 mg<br />
BP 272 Orciprenaline sulphate 100 mg<br />
New BP 764 Oxibendazole 25 mg<br />
BP 700 Oxybuprocaine hydrochloride Assay St<strong>and</strong>ard 100 mg<br />
BP 701 Oxybutynin hydrochloride Assay St<strong>and</strong>ard 100 mg<br />
BP 273 Oxyclozanide 200 mg<br />
BP 276 Pancuronium bromide Assay St<strong>and</strong>ard 25 mg<br />
New BP 769 Paeoniflorin Assay St<strong>and</strong>ard 20 mg<br />
BP 277 Papaverine hydrochloride Assay St<strong>and</strong>ard 100 mg<br />
BP 371 Paracetamol Assay St<strong>and</strong>ard 100 mg<br />
BP 746 Paroxetine impurity st<strong>and</strong>ard 25 mg<br />
BP 278 Pentagastrin 0.1 mg<br />
BP 422 Perphenazine Assay St<strong>and</strong>ard 100 mg<br />
BP 683 Pethidine hydrochloride Assay St<strong>and</strong>ard Controlled Substance 100 mg<br />
BP 282 Phenoxymethylpenicillin potassium Assay St<strong>and</strong>ard 500 mg<br />
BP 520 Phentolamine mesilate 50 mg<br />
BP 703 Phenylcyclohexylglycolic acid 25 mg<br />
BP 284 Phenylephrine Hydrochloride Assay St<strong>and</strong>ard 100 mg<br />
BP 035 1-Phenyl-3-pyrrolidinopropan-1-one hydrochloride 50 mg<br />
BP 503 Pilocarpine nitrate Assay St<strong>and</strong>ard 200 mg<br />
BP 682 Pimozide Assay St<strong>and</strong>ard 100 mg<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 133
British Pharmacopoeia<br />
Code Product Unit<br />
BP 450 3-Piperidylpropiophenone hydrochloride 50 mg<br />
BP 463 Piroxicam Assay St<strong>and</strong>ard 100 mg<br />
BP 411 Pizotifen malate Assay St<strong>and</strong>ard 50 mg<br />
BP 288 Poldine metisulfate Assay St<strong>and</strong>ard 100 mg<br />
BP 289 Polythiazide Assay St<strong>and</strong>ard 100 mg<br />
BP 510 Potassium trichloroammineplatinate 25 mg<br />
BP 399 Prazosin hydrochloride Assay St<strong>and</strong>ard 100 mg<br />
BP 464 Prednisolone Assay St<strong>and</strong>ard 100 mg<br />
BP 292 Prednisolone sodium phosphate Assay St<strong>and</strong>ard 100 mg<br />
BP 553 Prednisone Assay St<strong>and</strong>ard 250 mg<br />
BP 497 Prilocaine hydrochloride Assay St<strong>and</strong>ard 100 mg<br />
BP 293 Primidone Assay St<strong>and</strong>ard 100 mg<br />
BP 295 Procaine benzylpenicillin Assay St<strong>and</strong>ard 100 mg<br />
BP 638 Prochlorperazine maleate Assay St<strong>and</strong>ard 100 mg<br />
BP 493 Prochlorperazine mesilate Assay St<strong>and</strong>ard 100 mg<br />
BP 494 Prochlorperazine sulphoxide 25 mg<br />
BP 296 Procyclidine hydrochloride Assay St<strong>and</strong>ard 100 mg<br />
BP 449 Progesterone Assay St<strong>and</strong>ard 50 mg<br />
BP 297 Proguanil hydrochloride Assay St<strong>and</strong>ard 100 mg<br />
BP 412 Promethazine hydrochloride Assay St<strong>and</strong>ard 100 mg<br />
BP 505 Promethazine sulphoxide 25 mg<br />
BP 698 Propofol dimer 25 mg<br />
BP 413 Ps<strong>eu</strong>doephedrine hydrochloride Assay St<strong>and</strong>ard Controlled Substance 100 mg<br />
BP 717 Ps<strong>eu</strong>domorphine trihydrate 25 mg<br />
BP 458 Pyridoxine hydrochloride Assay St<strong>and</strong>ard 100 mg<br />
New BP 751 Ramipril Assay St<strong>and</strong>ard 100 mg<br />
New BP 754<br />
Ramipril impurity K<br />
Ramipril diketopiperazine acid Assay St<strong>and</strong>ard<br />
BP 471 Ranitidine hydrochloride Assay St<strong>and</strong>ard 100 mg<br />
BP 593 Ribavirin Assay St<strong>and</strong>ard 100 mg<br />
BP 592 Ribavirin impurity st<strong>and</strong>ard 50 mg<br />
BP 459 Riboflavin sodium phosphate 50 mg<br />
BP 400 Rifampicin N-oxide 25 mg<br />
BP 586 Ritodrine hydrochloride Assay St<strong>and</strong>ard 200 mg<br />
BP 451 Salbutamol Assay St<strong>and</strong>ard 100 mg<br />
BP 712 Salbutamol aldehyde impurity 25 mg<br />
BP 704 Salbutamol ketone impurity 25 mg<br />
BP 302 Salbutamol sulphate Assay St<strong>and</strong>ard 100 mg<br />
BP 705 Selegiline hydrochloride Assay St<strong>and</strong>ard 100 mg<br />
BP 739 Simvastatin Assay St<strong>and</strong>ard 100 mg<br />
BP 750 Sodium alginate 200 mg<br />
BP 453 Sodium nitroprusside Assay St<strong>and</strong>ard 200 mg<br />
BP 490 Sodium picosulfate Assay St<strong>and</strong>ard 100 mg<br />
BP 452 Sodium valproate Assay St<strong>and</strong>ard 500 mg<br />
BP 498 Sotalol hydrochloride 100 mg<br />
BP 312 Sulfadiazine Assay St<strong>and</strong>ard 100 mg<br />
BP 310 Sulfadoxine Assay St<strong>and</strong>ard 100 mg<br />
BP 314 Sulfamethoxazole Assay St<strong>and</strong>ard 100 mg<br />
BP 679 Sulpiride Assay St<strong>and</strong>ard 100 mg<br />
BP 745 Sumatriptan impurity st<strong>and</strong>ard 25 mg<br />
BP 455 Temazepam Assay St<strong>and</strong>ard Controlled Substance 100 mg<br />
25 mg<br />
134 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
British Pharmacopoeia<br />
Code Product Unit<br />
BP 708 Tenoxicam Assay St<strong>and</strong>ard 100 mg<br />
BP 709 Tenoxicam degradation impurity st<strong>and</strong>ard 100 mg<br />
BP 318 Terbutaline sulphate Assay St<strong>and</strong>ard 100 mg<br />
BP 650 Terfenadine Assay St<strong>and</strong>ard 100 mg<br />
BP 319 Testosterone decanoate Controlled Substance 100 mg<br />
BP 321 Testosterone isocaproate Controlled Substance 100 mg<br />
BP 322 Testosterone phenylpropionate Assay St<strong>and</strong>ard Controlled Substance 100 mg<br />
BP 702 Testosterone propionate Assay St<strong>and</strong>ard Controlled Substance 100 mg<br />
BP 327 Theophylline Assay St<strong>and</strong>ard 100 mg<br />
BP 414 Thiamine mononitrate Assay St<strong>and</strong>ard 100 mg<br />
BP 495 Thioridazine Assay St<strong>and</strong>ard 100 mg<br />
BP 331 Thiotepa Assay St<strong>and</strong>ard 100 mg<br />
BP 332 2-Thymoxyethyldimethylamine hydrochloride 25 mg<br />
BP 645 Tioconazole Assay St<strong>and</strong>ard 100 mg<br />
BP 687 Tioconazole impurity st<strong>and</strong>ard 100 mg<br />
BP 744 Tramadol hydrochloride 100 mg<br />
BP 734 Tranexamic acid impurity st<strong>and</strong>ard 25 mg<br />
BP 544 Transplatin 25 mg<br />
BP 591 Trazodone hydrochloride impurity st<strong>and</strong>ard 50 mg<br />
BP 338 Triamcinolone Assay St<strong>and</strong>ard 100 mg<br />
BP 339 Triamcinolone acetonide Assay St<strong>and</strong>ard 50 mg<br />
BP 680 Triamcinolone hexacetonide Assay St<strong>and</strong>ard 100 mg<br />
BP 340 Triamterene Assay St<strong>and</strong>ard 100 mg<br />
BP 341 3,5,6-Trichloro-2-hydroxybenzoic acid 50 mg<br />
BP 555 2-Trifluoromethylthioxanthone 25 mg<br />
BP 034 Trihexyphenidyl hydrochloride Assay St<strong>and</strong>ard 100 mg<br />
BP 344 Trimethoprim Assay St<strong>and</strong>ard 100 mg<br />
BP 346 z-Triprolidine hydrochloride 50 mg<br />
BP 347 Triprolidine hydrochloride 100 mg<br />
BP 349 Tylosin 50 mg<br />
BP 350 Urea Assay St<strong>and</strong>ard 1 g<br />
BP 706 Ursodeoxycholic acid Assay St<strong>and</strong>ard 150 mg<br />
BP 563 Vigabatrin Assay St<strong>and</strong>ard 150 mg<br />
BP 564 5-Vinyl-2-pyrrolidone 25 mg<br />
BP 672 Warfarin Assay St<strong>and</strong>ard 100 mg<br />
BP 353 Xylometazoline hydrochloride Assay St<strong>and</strong>ard 100 mg<br />
BP 640 N,N'-bis(2,4-Xylyl)formamidine 25 mg<br />
BP 599 Zuclopenthixol acetate dihydrochloride Assay St<strong>and</strong>ard 100 mg<br />
BP 596 Zuclopenthixol decanoate dihydrochloride 25 mg<br />
BP 558 Zuclopenthixol hydrochloride Assay St<strong>and</strong>ard 100 mg<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 135
ATCC microbiology products<br />
ATCC microbiology products<br />
As a scientist you know the importance of using the best materials to support your quality control<br />
programme. As Europe’s only officially authorized distributor of ATCC ® cultures, LGC St<strong>and</strong>ards can<br />
supply all ATCC organisms specified in the pharmacopoeia.<br />
ATCC maintains the highest st<strong>and</strong>ards for its biological materials, employing stringent quality control<br />
procedures to produce cultures which are well characterized <strong>and</strong> have low passage numbers. Long-term<br />
subculturing of biological materials can have adverse effects on the culture population, including genetic<br />
drift, unwanted selection, contamination, <strong>and</strong> varied cell responses. ATCC quality control cultures sold<br />
by LGC St<strong>and</strong>ards are never subcultured or transferred in any way from ATCC’s strains <strong>and</strong> our European<br />
stock-holding means orders are usually filled within 3 - 5 working days.<br />
So whether it is quality control strains, genomic DNA, media or growth supplements, antibiotics for selection,<br />
or a huge selection of organisms, take the time <strong>and</strong> guesswork out of ordering your microbiology supplies<br />
with authentic, high-quality ATCC materials - exclusively from LGC St<strong>and</strong>ards.<br />
British Pharmacopoeia 2003, volume IV <strong>and</strong> Addenda<br />
Code Product Unit<br />
BP 2003 Appendix XIV A - Biological assay of antibiotics<br />
ATCC-11778 Bacillus cer<strong>eu</strong>s amp.<br />
ATCC-14884 Bacillus pumilus amp.<br />
ATCC-11774 Bacillus subtilis amp.<br />
ATCC-6633 Bacillus subtilis amp.<br />
ATCC-4617 Bordetella bronchiseptica amp.<br />
ATCC-9637 Escherichia coli amp.<br />
ATCC-10536 Escherichia coli amp.<br />
ATCC-10031 Klebsiella pn<strong>eu</strong>moniae ss. pn<strong>eu</strong>moniae amp.<br />
ATCC-10240 Micrococcus lut<strong>eu</strong>s amp.<br />
ATCC-9763 Saccharomyces cerevisiae amp.<br />
ATCC-6538P Staphylococcus aur<strong>eu</strong>s subsp. aur<strong>eu</strong>s amp.<br />
ATCC-9144 Staphylococcus aur<strong>eu</strong>s ss. aur<strong>eu</strong>s amp.<br />
ATCC-9341 Kocuria rhizophila amp.<br />
ATCC-12228 Staphylococcus epidermidis amp.<br />
ATCC-607 Mycobacterium smegmatis amp.<br />
BP 2003 Appendix XVI - Test for absence of Mycoplasma<br />
ATCC-23206 Acholeplasma laidlawii (Sabin) Edward <strong>and</strong> Fr<strong>eu</strong>ndt deposited as Mycoplasma laidlawii amp.<br />
ATCC-19610 Mycoplasma gallisepticum amp.<br />
ATCC-23714 Mycoplasma orale amp.<br />
ATCC-15531 Mycoplasma pn<strong>eu</strong>moniae amp.<br />
ATCC-25204 Mycoplasma synoviae amp.<br />
ATCC-CCL-81 Vero cells amp.<br />
BP 2003 Appendix XVI A - Test for sterility<br />
ATCC-6633 Bacillus subtilis amp.<br />
ATCC-2091 C<strong>and</strong>ida albicans amp.<br />
ATCC-10231 C<strong>and</strong>ida albicans amp.<br />
ATCC-19404 Clostridium sporogenes amp.<br />
ATCC-9027 Ps<strong>eu</strong>domonas aeruginosa amp.<br />
ATCC-6538 Staphylococcus aur<strong>eu</strong>s ss. aur<strong>eu</strong>s amp.<br />
136 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
ATCC microbiology products<br />
Code Product Unit<br />
BP 2003 Appendix XVI B - Tests for microbial contamination<br />
ATCC-6633 Bacillus subtilis amp.<br />
ATCC-2091 C<strong>and</strong>ida albicans amp.<br />
ATCC-10231 C<strong>and</strong>ida albicans amp.<br />
ATCC-13124 Clostridium perfringens amp.<br />
ATCC-19404 Clostridium sporogenes amp.<br />
ATCC-8739 Escherichia coli amp.<br />
ATCC-9027 Ps<strong>eu</strong>domonas aeruginosa amp.<br />
ATCC-6538 Staphylococcus aur<strong>eu</strong>s ss. aur<strong>eu</strong>s amp.<br />
ATCC-6538P Staphylococcus aur<strong>eu</strong>s subsp. aur<strong>eu</strong>s amp.<br />
BP Appendix XVI C - Efficacy of antimicrobial preservation<br />
ATCC-16404 Aspergillus niger amp.<br />
ATCC-10231 C<strong>and</strong>ida albicans amp.<br />
ATCC-8739 Escherichia coli amp.<br />
ATCC-9027 Ps<strong>eu</strong>domonas aeruginosa amp.<br />
ATCC-6538 Staphylococcus aur<strong>eu</strong>s ss. aur<strong>eu</strong>s amp.<br />
BP Appendix XVIII - Methods of sterilization<br />
ATCC-27142** Bacillus pumilus amp.<br />
ATCC-7953** Bacillus stearothermophilus amp.<br />
ATCC-9372** Bacillus subtilis amp.<br />
ATCC-7955 Clostridium sporogenes (Metchnikoff) Bergey et al. amp.<br />
ATCC-19146 Brevendimonas diminuta (as Ps<strong>eu</strong>domonas diminuta) amp.<br />
BP Appendix XVI (Vet) 3 - Test for absence of mycoplasmas<br />
ATCC-23206 Acholeplasma laidlawii (Sabin) Edward <strong>and</strong> Fr<strong>eu</strong>ndt deposited as Mycoplasma laidlawii amp.<br />
ATCC-19610 Mycoplasma gallisepticum amp.<br />
ATCC-17981 Mycoplasma hyorhinis Switzer amp.<br />
ATCC-23714 Mycoplasma orale amp.<br />
ATCC-25204 Mycoplasma synoviae amp.<br />
ATCC-CCL-81 Vero cells amp.<br />
** = Alternative strain<br />
All care has been taken in compiling catalogue numbers, however users should consult the Pharmacopoeia<br />
directly to confirm the testing requirements <strong>and</strong> recommended organisms before ordering or undertaking the<br />
testing procedures as described in the Pharmacopoeia.<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 137
Pharmacopée Française<br />
Pharmacopée Française<br />
The list of <strong>reference</strong> <strong>substances</strong> <strong>and</strong> <strong>reference</strong> spectra available from the Pharmacopée Française (PF)<br />
are issued under the authority of the PF <strong>and</strong> are solely for use in tests <strong>and</strong> assays of the Pharmacopoeia<br />
Française <strong>and</strong> Pharmacopoeia Française (Vétérinaire).<br />
The list in this catalogue is based on the PF list of January 2007.<br />
All PF CRS are available in restricted quantity <strong>and</strong> orders for multiple units will be reduced to a single unit.<br />
Proper use<br />
Reference <strong>substances</strong> from the PF are designed for specific applications, which can be identified<br />
by consulting the monographs in which the corresponding <strong>reference</strong> <strong>substances</strong> are used.<br />
Uses other than those are possible, but the user is responsible for checking the suitability of the<br />
PF CRS for any non-monograph use.<br />
The list below is for information purposes only.<br />
It was included in former lot lists of FP but is not included as of January 2007.<br />
1 Identification by infrared spectrophotometry<br />
2 Identification by thin layer chromatography<br />
3 Test for related <strong>substances</strong> by thin layer chromatography<br />
4 Test for related <strong>substances</strong> by liquid chromatography<br />
5 Test for related <strong>substances</strong> by gas chromatography<br />
6 Assay by UV spectrophotometry by gas chromatography<br />
7 Assay by fluorimetry<br />
8 Assay by liquid chromatography<br />
9 Assay by gas chromatography<br />
10 Microbiological assay<br />
11 Assay by volumetric titration<br />
Shelf life <strong>and</strong> expiry dates<br />
French Pharmacopoeia chemical <strong>reference</strong> <strong>substances</strong> are subject to regular inspection <strong>and</strong> repeated<br />
analysis by PF scientific staff. Each PF CRS is, on receipt by the customer, fit for the intended use. The<br />
shelf life <strong>and</strong> the expiry date are not given, <strong>and</strong> PF advises that unopened vials should not be stored for<br />
a long period of time.<br />
Code Product Unit<br />
FPC2700 Adrénaline Reference Spectrum unit<br />
FPC0050 Alimémazine tartrate 25 mg<br />
FPC0071 Amodiaquine chlorhydrate 25 mg<br />
FPC0072 Amprolium chlorhydrate (usage vétérinaire) 25 mg<br />
FPC0073 Arécoline bromhydrate (usage vétérinaire) 100 mg<br />
FPC0141 Benzododecinium bromure 1000 mg<br />
FPC0172 Bithionol 500 mg<br />
FPC0173 Bithionol dioxyde 500 mg<br />
FPC0174 Bithionoloxide (usage vétérinaire) 2000 mg<br />
FPC0190 Bl<strong>eu</strong> patente V 1000 mg<br />
FPC0200 Boldine 100 mg<br />
FPC0210 Butoformé 150 mg<br />
FPC0271 Chlormadinone acetate 100 mg<br />
FPC0320 Chloro-2 nicotinique acide 100 mg<br />
FPC0422 Diavéridine (usage vétérinaire) 250 mg<br />
FPC0423 Dichlorvos (usage vétérinaire) 1000 mg<br />
FPC0600 Eosine disodique 200 mg<br />
FPC0610 Epivincamine 50 mg<br />
FPC0510 Erythromycine propionate 200 mg<br />
FPC0722 Furaltadone (usage vétérinaire) 250 mg<br />
FPC0730 Furazolidone Reference Spectrum unit<br />
FPC0892 Histamine 50 mg<br />
FPC0898 Hydroquinidine chlorhydrate 100 mg<br />
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Pharmacopée Française<br />
Code Product Unit<br />
FPC0930 Hydroxy-2 N-(trifluorométhyl-3'phényl) nicotinamide 60 mg<br />
FPC1222 Linalyle acétate 2 mL<br />
FPC2900 Lysine acétylsalicylate Reference Spectrum unit<br />
FPC1350 Methylanthranilate de methyle 2 mL<br />
FPC1540 Niflumique acide 120 mg<br />
FPC1560 Nifurtimox 250 mg<br />
FPC1572 Nitro-5 furaldazine (usage vétérinaire) 50 mg<br />
FPC1576 Nitroxinil (usage vétérinaire) 500 mg<br />
FPC1600 Oxyquinol Reference Spectrum unit<br />
FPC3300 Polytétrafluoroéthylène Reference Spectrum unit<br />
FPC1780 Potassium gluconate 50 mg<br />
FPC1785 Prasterone 300 mg<br />
FPC2032 Strychnine sulfate (usage vétérinaire) 225 mg<br />
FPC2034 Suc de papayer 500 mg<br />
FPC2036 Sulconazole nitrate 200 mg<br />
FPC2044 Sulfadiméthoxine 100 mg<br />
FPC2090 Sulfaquinoxaline 100 mg<br />
FPC2100 Sulfaquinoxaline sodique 100 mg<br />
FPC2120 Sulfogaiacol 100 mg<br />
FPC2122 Sulfogaiacol (exempt de gaiacol) 1000 mg<br />
FPC2210 Terpine 1000 mg<br />
FPC2212 Tétramisole chlorhydrate 50 mg<br />
FPC2230 Thiocolchicoside 300 mg<br />
FPC2520 Vincamine 250 mg<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 139
Pharmacopoeia Helvetica<br />
Pharmacopoeia Helvetica<br />
Background<br />
The range of <strong>reference</strong> <strong>substances</strong> available from the Pharmacopoeia Helvetica is issued under the authority<br />
of the Pharmacopoeia Helvetica, <strong>and</strong> is solely for use in tests <strong>and</strong> assays of the Pharmacopoeia Helvetica.<br />
The Pharmacopoeia Helvetica contains, in addition to harmonised European Pharmacopoeia monographs,<br />
a number of national monographs. Some of the national monographs require CRS described in the list<br />
below.<br />
The list in this catalogue is based on the current Pharmacopoeia Helvetica.<br />
Code Product Unit<br />
SPC 015 α-(2-Piperidyl)phenylessigsäure 50 mg<br />
SPC 170 Diamorphinhydrochlorid wasserfrei Reference Spectrum unit<br />
SPC 190 Drofeninhydrochlorid 1 g<br />
SPC 204 Ethanol 70% Reference Spectrum unit<br />
SPC 210 Ethanol with 2 % Ketone Reference Spectrum unit<br />
SPC 285 Hydrocodon Reference Spectrum unit<br />
SPC 300 Methacholinchlorid Reference Spectrum unit<br />
SPC 335 Methylphenidathydrochlorid Reference Spectrum unit<br />
SPC 320 Moclobemid Reference Spectrum unit<br />
SPC 340 2-Naphthol Reference Spectrum unit<br />
SPC 380 Oxychinolinsulfat Reference Spectrum unit<br />
SPC 455 Saponin 500 mg<br />
SPC 505 Terpinhydrat Reference Spectrum unit<br />
SPC 515 Thiethylperazinhydrogenmaleat 200 mg<br />
140 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
International Pharmacopeia<br />
Background<br />
International Pharmacopeia<br />
The World Health Organization (WHO) as a specialised agency of the United Nations with a primary<br />
responsibility for international health matters <strong>and</strong> public health, is the issuing body of the <strong>substances</strong><br />
described in the International Pharmacopoeia. Progress towards better health requires international<br />
cooperation in the establishment of international st<strong>and</strong>ards for biological <strong>substances</strong> <strong>and</strong> pharmac<strong>eu</strong>ticals.<br />
The WHO has therefore authorised the establishment <strong>and</strong> maintenance of a number of <strong>reference</strong> collections.<br />
Two are of particular interest to analysts involved in pharmac<strong>eu</strong>tical <strong>and</strong> clinical measurement sciences: the<br />
collections of international biological <strong>reference</strong> <strong>substances</strong> <strong>and</strong> international chemical <strong>reference</strong> <strong>substances</strong>.<br />
International biological <strong>reference</strong> <strong>substances</strong><br />
The range of biological <strong>reference</strong> <strong>substances</strong> was established to provide a means of ensuring International<br />
uniformity in the designation of the potency, activity or specificity of preparations that are used in the<br />
prevention, treatment or diagnosis of human or animal diseases, <strong>and</strong> for which chemical <strong>and</strong> physical<br />
assay terms are inappropriate.<br />
WHO biological <strong>reference</strong> <strong>substances</strong> are needed for certain antibiotic <strong>and</strong> hormone assays described in<br />
a number of pharmacopoeia. The majority of the preparations of interest to the analyst working in the fields<br />
of pharmac<strong>eu</strong>tical analysis are held by the NIBSC in Engl<strong>and</strong>.<br />
International chemical <strong>reference</strong> <strong>substances</strong><br />
International chemical <strong>reference</strong> <strong>substances</strong> are established upon the advice of the WHO expert committee<br />
on specifications for pharmac<strong>eu</strong>tical preparations. They are intended for use in physical <strong>and</strong> chemical tests<br />
<strong>and</strong> assays described in the specifications for quality control published in the International Pharmacopoeia<br />
(IP CRS), or as proposed in draft monographs.<br />
The list in this catalogue is based on the current WHO information.<br />
Proper use<br />
Whilst the primary application of IP CRS is in physical <strong>and</strong> chemical tests <strong>and</strong> assays as described in the<br />
International Pharmacopoeia, IP CRS do have applications in other aspects of pharmac<strong>eu</strong>tical analysis<br />
where a certificate of purity is required.<br />
Documentation<br />
Directions for use <strong>and</strong> analytical data are provided in certificates distributed with the IP CRS. The certificates<br />
show how the identity <strong>and</strong> purity of the material was confirmed, <strong>and</strong> in many cases demonstrate traceability<br />
to another PRM. This information fulfills most of the requirements of a Certification Report as defined by the<br />
ISO Guides on the preparation <strong>and</strong> use of Certified Reference Materials.<br />
Shelf life <strong>and</strong> expiry dates<br />
International Pharmacopoeia chemical <strong>reference</strong> <strong>substances</strong> are subject to regular inspection <strong>and</strong> repeated<br />
analysis by the WHO Collaborating Centre. Each IP CRS is, on receipt by the customer, suitable for the<br />
intended use. Shelf life <strong>and</strong> expiry dates are not given, <strong>and</strong> IP advises that once opened, vials should not<br />
be stored for long periods of time.<br />
Only current lots are supplied by IP. For this reason users are advised to order only as required. Once<br />
opened IP can no longer guarantee the stability of the material <strong>and</strong> any of the CRS not used should be<br />
disposed of.<br />
Controlled <strong>substances</strong><br />
For information on ordering please contact LGC St<strong>and</strong>ards.<br />
Code Product Unit<br />
WHO9931422 Abacavir sulfate 100 mg<br />
WHO9930375 p-Acetamidobenzalazine 25 mg<br />
WHO9930201 Acetanilide (116°C) Melting Point St<strong>and</strong>ard 1 g<br />
WHO9930202 Acetazolamide 100 mg<br />
WHO9930204 Allopurinol 100 mg<br />
WHO9930206 Amidotrizoic acid 100 mg<br />
WHO9930191 2-Amino-5-nitrothiazole 25 mg<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 141
International Pharmacopeia<br />
Code Product Unit<br />
WHO9930194 3-Aminopyrazole-4-carboxamide hemisulfate 100 mg<br />
WHO9930193 3-Amino-2,4,6-triiodobenzoic acid 100 mg<br />
WHO9930208 Amitriptyline hydrochloride 100 mg<br />
WHO9930209 Amodiaquine hydrochloride 200 mg<br />
WHO9930210 Amphotericin B 400 mg<br />
WHO9930211 Ampicillin (anhydrous) 200 mg<br />
WHO9930212 Ampicillin sodium 200 mg<br />
WHO9930213 Ampicillin trihydrate 200 mg<br />
WHO9930214 Anhydrotetracycline hydrochloride 25 mg<br />
WHO9931408 Artemether 100 mg<br />
WHO9931406 Artemisinin 100 mg<br />
WHO9931407 Artemotil 100 mg<br />
WHO9931410 Artenimol 100 mg<br />
WHO9931409 Artesunate 100 mg<br />
WHO9930215 Atropine sulfate 100 mg<br />
WHO9930216 Azathioprine 100 mg<br />
WHO9930217 Azobenzene (69°C) Melting Point St<strong>and</strong>ard 1 g<br />
WHO9930218 Bacitracin zinc 200 mg<br />
WHO9930219 Beclometasone dipropionate 200 mg<br />
WHO9930221 Benzanilide (165°C) Melting Point St<strong>and</strong>ard 1 g<br />
WHO9930222 Benzil (96°C) Melting Point St<strong>and</strong>ard 1 g<br />
WHO9930225 Benzylpenicillin potassium 200 mg<br />
WHO9930226 Benzylpenicillin sodium 200 mg<br />
WHO9930227 Bephenium hydroxynaphthoate 100 mg<br />
WHO9930228 Betamethasone 100 mg<br />
WHO9930229 Betamethasone sodium phosphate 100 mg<br />
WHO9930230 Betamethasone valerate 100 mg<br />
WHO9930233 Bupivacaine hydrochloride 100 mg<br />
WHO9930234 Caffeine 100 mg<br />
WHO9930235 Caffeine (237°C) Melting Point St<strong>and</strong>ard 1 g<br />
WHO9930236 Calcium folinate (L<strong>eu</strong>covorin calcium) 100 mg<br />
WHO9930237 Captopril 100 mg<br />
WHO9930238 Captopril disulfide 25 mg<br />
WHO9930239 Carbamazepine 100 mg<br />
WHO9930240 Carbenicillin monosodium 200 mg<br />
WHO9930241 Chloramphenicol 200 mg<br />
WHO9930242 Chloramphenicol palmitate 1 g<br />
WHO9930243 Chloramphenicol palmitate (Polymorph A) 200 mg<br />
WHO9930199 5-Chloro-2-methylaminobenzophenone 100 mg<br />
WHO9930245 Chloroquine sulfate 200 mg<br />
WHO9930190 2-(4-Chloro-3-sulfamoylbenzoyl)benzoic acid 50 mg<br />
WHO9930246 Chlorphenamine hydrogen maleate 100 mg<br />
WHO9930247 Chlorpromazine hydrochloride 100 mg<br />
WHO9930248 Chlortalidone 100 mg<br />
WHO9930249 Chlortetracycline hydrochloride 200 mg<br />
WHO9930250 Cimetidine 100 mg<br />
WHO9930256 Ciprofloxacin hydrochloride 400 mg<br />
WHO9930252 Ciprofloxacin by compound A 20 mg<br />
WHO9930253 Ciprofloxacin desfluoro-compound 20 mg<br />
WHO9930254 Ciprofloxacin ethylenediamine-compound 20 mg<br />
WHO9930255 Ciprofloxacin fluoroquinolonic acid 20 mg<br />
142 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
International Pharmacopeia<br />
Code Product Unit<br />
WHO9930258 Cisplatin 100 mg<br />
WHO9930259 Clomifene citrate 100 mg<br />
WHO9930261 Cloxacillin sodium 200 mg<br />
WHO9930262 Colecalciferol (Vitamin D 3) 500 mg<br />
WHO9930263 Cortisone acetate 100 mg<br />
WHO9930265 Dapsone 100 mg<br />
WHO9930266 Desoxycortone acetate 100 mg<br />
WHO9930267 Dexamethasone 100 mg<br />
WHO9930268 Dexamethasone acetate 100 mg<br />
WHO9930269 Dexamethasone phosporic acid 100 mg<br />
WHO9930270 Dexamethasone sodium phosphate 100 mg<br />
WHO9930282 Diazoxide 100 mg<br />
WHO9930283 Dicloxacillin sodium 200 mg<br />
WHO9930285 Dicoumarol 100 mg<br />
WHO9930286 Dicyanodiamide (210°C) Melting Point St<strong>and</strong>ard 1 g<br />
WHO9930287 Diethylcarbamazine dihydrogen citrate 100 mg<br />
WHO9930288 Digitoxin 100 mg<br />
WHO9930289 Digoxin 100 mg<br />
WHO9930290 Dopamine hydrochloride 100 mg<br />
WHO9930292 Doxorubicin hydrochloride 100 mg<br />
WHO9930294 Emetine hydrochloride 100 mg<br />
WHO9930197 4-Epianhydrotetracycline hydrochloride 25 mg<br />
WHO9930295 Ergocalciferol (Vitamin D 2) 500 mg<br />
WHO9930296 Ergometrine hydrogen maleate Controlled Substance 50 mg<br />
WHO9930297 Ergotamine tartrate Controlled Substance 50 mg<br />
WHO9930298 Erythromycin 250 mg<br />
WHO9930300 Erythromycin C 25 mg<br />
WHO9930301 Estradiol benzoate 100 mg<br />
WHO9930302 Estrone 100 mg<br />
WHO9930304 Ethambutol hydrochloride 100 mg<br />
WHO9930305 Ethinylestradiol 100 mg<br />
WHO9930306 Ethisterone 100 mg<br />
WHO9930307 Ethosuximide 100 mg<br />
WHO9930309 Flucloxacillin sodium 200 mg<br />
WHO9930310 Flucytosine 100 mg<br />
WHO9930311 Fludrocortisone acetate 200 mg<br />
WHO9930312 Fluorouracil 100 mg<br />
WHO9930313 Fluphenazine decanoate dihydrochloride 100 mg<br />
WHO9930314 Fluphenazine enantate dihydrochloride 100 mg<br />
WHO9930315 Fluphenazine hydrochloride 100 mg<br />
WHO9930316 Folic acid 100 mg<br />
WHO9930195 3-Formylrifamycin 200 mg<br />
WHO9930355 Framycetin sulfate (Neomycin B sulfate) 200 mg<br />
WHO9930318 Furosemide 100 mg<br />
WHO9930322 Griseofulvin 200 mg<br />
WHO9930323 Haloperidol 100 mg<br />
WHO9930324 Hydrochlorothiazide 100 mg<br />
WHO9930325 Hydrocortisone 100 mg<br />
WHO9930326 Hydrocortisone acetate 100 mg<br />
WHO9930327 Hydrocortisone sodium succinate 200 mg<br />
WHO9930188 (-)-3-(4-Hydroxy-3-methoxyphenyl)-2-hydrazino-2-methylalanine (3-O-Methylcarbidopa) 25 mg<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 143
International Pharmacopeia<br />
Code Product Unit<br />
WHO9930189 (-)-3-(4-Hydroxy-3-methoxyphenyl)-2-methylalanine (3-O-Methylmethyldopa) 25 mg<br />
WHO9930328 Ibuprofen 100 mg<br />
WHO9930329 Imipramine hydrochloride 100 mg<br />
WHO9931415 Indinavir 100 mg<br />
WHO9930330 Indometacin 100 mg<br />
WHO9930331 Isoniazid 100 mg<br />
WHO9930332 Kanamycin monosulfate 12 mg<br />
WHO9930333 Lanatoside C 100 mg<br />
WHO9930334 Levodopa 100 mg<br />
WHO9930335 Levonorgestrel 200 mg<br />
WHO9930336 Levothyroxine sodium 100 mg<br />
WHO9930337 Lidocaine 100 mg<br />
WHO9930338 Lidocaine hydrochloride 100 mg<br />
WHO9930339 Liothyronine sodium 50 mg<br />
WHO9930340 Loperamide hydrochloride 100 mg<br />
WHO9930341 Mebendazole 200 mg<br />
WHO9930345 Methotrexate 100 mg<br />
WHO9930346 Methyldopa 100 mg<br />
WHO9930347 Methyltestosterone 100 mg<br />
WHO9930348 Meticillin sodium 200 mg<br />
WHO9930350 Metronidazole 100 mg<br />
WHO9930351 Nafcillin sodium 200 mg<br />
WHO9930354 Neamine hydrochloride (Neomycin A hydrochloride) 0.5 mg<br />
WHO9931417 Nelfinavir mesilate 100 mg<br />
WHO9930356 Neostigmine metilsulfate 100 mg<br />
WHO9931412 Nevirapine anhydrous 100 mg<br />
WHO9930357 Nicotinamide 100 mg<br />
WHO9930358 Nicotinic acid 100 mg<br />
WHO9930359 Nifurtimox 100 mg<br />
WHO9930360 Niridazole 200 mg<br />
WHO9930361 Niridazole-chlorethylcarboxamide 25 mg<br />
WHO9930366 Norethisterone 100 mg<br />
WHO9930367 Norethisterone acetate 100 mg<br />
WHO9930369 Nystatin 200 mg<br />
WHO9930371 Oubain 100 mg<br />
WHO9930372 Oxacillin sodium 200 mg<br />
WHO9930373 Oxytetracycline dihydrate 200 mg<br />
WHO9930374 Oxytetracycline hydrochloride 200 mg<br />
WHO9930376 Papaverine hydrochloride 100 mg<br />
WHO9930377 Paracetamol 100 mg<br />
WHO9930378 Paromomycin sulfate 75 mg<br />
WHO9930380 Phenacetin (136°C) Melting Point St<strong>and</strong>ard 1 g<br />
WHO9930382 Phenolphthalein (263°C) Melting Point St<strong>and</strong>ard 1 g<br />
WHO9930383 Phenoxymethylpenicillin 200 mg<br />
WHO9930384 Phenoxymethylpenicillin calcium 200 mg<br />
WHO9930385 Phenoxymethylpenicillin potassium 200 mg<br />
WHO9930387 Phenytoin 100 mg<br />
WHO9930388 Piperazine adipate 100 mg<br />
WHO9930389 Piperazine citrate 100 mg<br />
WHO9930390 Praziquantel 100 mg<br />
WHO9930391 Prednisolone 100 mg<br />
144 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
International Pharmacopeia<br />
Code Product Unit<br />
WHO9930392 Prednisolone acetate 100 mg<br />
WHO9930393 Prednisolone hemisuccinate 200 mg<br />
WHO9930394 Prednisolone sodium phosphate 200 mg<br />
WHO9930395 Prednisone 100 mg<br />
WHO9930396 Prednisone acetate 100 mg<br />
WHO9930397 Probenecid 100 mg<br />
WHO9930398 Procaine hydrochloride 100 mg<br />
WHO9930399 Procarbazine hydrochloride 100 mg<br />
WHO9930400 Progesterone 100 mg<br />
WHO9930402 Propanolol hydrochlorid 100 mg<br />
WHO9930403 Propylthiouracil 100 mg<br />
WHO9930404 Pyrantel embonate (Pyrantel pamoate) 500 mg<br />
WHO9930405 Pyridostigmine bromide 100 mg<br />
WHO9930406 Reserpine 100 mg<br />
WHO9930408 Riboflavin 250 mg<br />
WHO9930409 Rifampicin 300 mg<br />
WHO9930410 Rifampicin quinone 200 mg<br />
WHO9931421 Ritonavir 100 mg<br />
WHO9930411 Saccharin (229°C) Melting Point St<strong>and</strong>ard 1 g<br />
WHO9931418 Saquinavir mesilate 100 mg<br />
WHO9930412 Sodium amidotrizoate 100 mg<br />
WHO9930413 Sodium cromoglicate 100 mg<br />
WHO9930415 Spectinomycin hydrochloride 200 mg<br />
WHO9931419 Stavudine 100 mg<br />
WHO9930416 Streptomycin sulfate 100 mg<br />
WHO9930417 Sulfacetamide 100 mg<br />
WHO9930419 Sulfamethoxazole 100 mg<br />
WHO9930420 Sulfamethoxypyridazine 100 mg<br />
WHO9930421 Sulfanilamide 100 mg<br />
WHO9930422 Sulfanilamide (166°C) Melting Point St<strong>and</strong>ard 1 g<br />
WHO9930423 Sulfapyridine (193°C) Melting Point St<strong>and</strong>ard 4 g<br />
WHO9930424 Sulfasalazine 100 mg<br />
WHO9930425 Tamoxifen citrate 100 mg<br />
WHO9930426 Tamoxifen citrate E-isomer 10 mg<br />
WHO9930427 Testosterone enantate 200 mg<br />
WHO9930428 Testosterone propionate 100 mg<br />
WHO9930429 Tetracycline hydrochloride 200 mg<br />
WHO9930430 Thioacetazone 100 mg<br />
WHO9930196 4,4'-Thiodianiline 50 mg<br />
WHO9930431 Tolbutamide 100 mg<br />
WHO9930432 Tolnaftate 100 mg<br />
WHO9930433 Toluene-2-sulfonamide 100 mg<br />
WHO9930434 Trimethadione 200 mg<br />
WHO9930435 Trimethoprim 100 mg<br />
WHO9930438 Vanillin (83°C) Melting Point St<strong>and</strong>ard 1 g<br />
WHO9930440 Vincristine sulfate 9.7 mg/vial<br />
WHO9930439 Warfarin 100 mg<br />
WHO9930260 Zuclomifene 50 mg<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 145
International Pharmacopeia<br />
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• Forensic drugs - e.g.<br />
Amphetamines, Cocaine, Heroin etc.<br />
• Anabolic steroids <strong>and</strong> metabolites e.g. Trenbolone,<br />
N<strong>and</strong>rolone, Dehydroepi<strong>and</strong>rosterone (DHEA) etc.<br />
• Growth promotants, stimulants <strong>and</strong> metabolites e.g.<br />
Zearalenone, Cropropamide, 6-Hydroxybromantan<br />
etc.<br />
Certified <strong>reference</strong><br />
materials for:<br />
Sports drugs analysis<br />
Forensic analysis<br />
Agricultural <strong>and</strong><br />
Veterinary Residue<br />
Analysis<br />
Features:<br />
• Certified property values with associated uncertainty<br />
statements<br />
• Traceability of assigned values to the international<br />
system of units<br />
• Comprehensive analysis report<br />
• Third-party accreditation as a <strong>reference</strong> materials<br />
producer operating to ISO Guide 34<br />
For further information on these products or to receive<br />
any one of our catalogues, please contact your local<br />
office or visit our web site.<br />
www.lgcst<strong>and</strong>ards.com<br />
St<strong>and</strong>ards<br />
Excellence through measurement
Institute of Dyes <strong>and</strong> Organic Products<br />
Institute of Dyes <strong>and</strong> Organic Products<br />
The use of colouring agents in pharmac<strong>eu</strong>tical preparations <strong>and</strong> dose forms is widespread. In most<br />
cases food colouring materials are used.<br />
The following st<strong>and</strong>ards of dyes, used in the pharmac<strong>eu</strong>tical <strong>and</strong> food industry, are listed with common<br />
description, E code <strong>and</strong> colour index number (C.I.) for an easy assignment.<br />
The IBPO is accredited by the Polish Centre for Testing <strong>and</strong> Certification according to the st<strong>and</strong>ard<br />
PN-EN 45001 <strong>and</strong> ISO/IEC Guide 25:1990.<br />
Each colour <strong>reference</strong> st<strong>and</strong>ard is supplied with a detailed certificate of analysis, which includes dye<br />
content value determined by spectrophotometry <strong>and</strong> values of <strong>impurities</strong>.<br />
Black<br />
Code Product Unit<br />
IBPO010 Brilliant Black PN (E 151) 1 g<br />
Blue<br />
IBPO015 Brilliant Blue FCF (E 133) 1 g<br />
IBPO002 Indigotine (E 132) 1 g<br />
IBPO012 Patent Blue V (E 131) 1 g<br />
Brown<br />
IBPO017 Brown HT(E 155) 1 g<br />
Green<br />
IBPO016 Brilliant Green BS (E 142) 1 g<br />
Red<br />
IBPO014 Allura Red AC (E 129) 1 g<br />
IBPO005 Amaranth (E 123) 1 g<br />
IBPO003 Azorubin (E 122) 1 g<br />
IBPO011 Erythrosine (E 127) 1 g<br />
IBPO004 Ponceau 4R (E 124) 1 g<br />
IBPO013 Red 2 G (E 128) 1 g<br />
Yellow<br />
IBPO007 Quinoline Yellow (E 104) 1 g<br />
IBPO009 Sunset Yellow FCF (E 110) 1 g<br />
IBPO008 Tartrazine (E 102) 1 g<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 149
Refractive index CRMs<br />
Refractive index CRMs<br />
The revised EP general method 2.2.6 replaces CRS <strong>reference</strong> liquids with certified <strong>reference</strong> materials<br />
available from suppliers of chemical reagents or materials certified for metrology.<br />
11 liquid CRMs, certified by the Physical Chemistry Division of the Central Office of Measures (GUM),<br />
Warsaw in Pol<strong>and</strong>, cover the wide range of refractive index from 1,333 (water) to 1,657<br />
(1-bromonaphthalene).<br />
These CRMs are intended for calibration <strong>and</strong> checking refractive index scales of laboratory refractometers<br />
of an uncertainty expected not less than ±0,00005.<br />
The n values were determined on a Pulfrich refractometer, previously calibrated with solid class 1 CRMs,<br />
for which values were established using goniometric procedures.<br />
All CRMs are supplied with a certificate. Certified values to 5 significant figures for the refractive index<br />
λ at = 589.3 nm t = 20°C <strong>and</strong> associated uncertainties are given.<br />
Reference liquids are packed in glass ampoules or plastic drop-bottles.<br />
Code Product Unit<br />
PRG 7.21<br />
PRG 7.1<br />
PRG 7.11<br />
PRG 7.2<br />
Water<br />
Refractive index ................................. 1.333 at 20 °C<br />
2,2,4-Trimethylpentane<br />
Refractive index ................................. 1.391 at 20 °C<br />
Methylsilicone oil<br />
Refractive index ................................. 1.405 at 20 °C<br />
Methylcyclohexane<br />
Refractive index ................................. 1.423 at 20 °C<br />
10 mL<br />
10 mL<br />
10 mL<br />
10 mL<br />
PRG 7.12 Silicone oil DC 556<br />
Refractive index ................................. 1.462 at 20 °C<br />
10 mL<br />
PRG 7.20<br />
PRG 7.5<br />
PRG 7.6<br />
Paraffin oil<br />
Refractive index ................................. 1.475 at 20 °C<br />
Toluene<br />
Refractive index ................................. 1.496 at 20 °C<br />
Chlorobenzene<br />
Refractive index ................................. 1.524 at 20 °C<br />
10 mL<br />
10 mL<br />
10 mL<br />
PRG 7.13 Silicone oil AN 140<br />
Refractive index .................................. 1.560 at 20°C<br />
10 mL<br />
PRG 7.8<br />
PRG 7.9<br />
1-Bromonaphthalene<br />
Refractive index ................................. 1.657 at 20 °C<br />
1-Iodonaphthalene<br />
Refractive index ................................. 1.702 at 20 °C<br />
10 mL<br />
10 mL<br />
150 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
<strong>Pharmac<strong>eu</strong>tical</strong><br />
<strong>impurities</strong><br />
St<strong>and</strong>ards<br />
Excellence through measurement
CERTAN ®<br />
The ampoule in a bottle<br />
Unopened glass ampoules are ideal for storing<br />
volatile st<strong>and</strong>ards, but once opened they are no<br />
longer suitable for storage. The alternative use of<br />
screw cap bottles can result in evaporation through<br />
the thread. There is also a risk of contamination<br />
from the cap.<br />
The CERTAN ® bottle is a sample container with a<br />
capillary-opening. It has been specifically developed<br />
for use with organic <strong>reference</strong> solutions. Using the<br />
CERTAN ® bottle makes the problems of storing<br />
volatile solutions a thing of the past.<br />
Advantages of CERTAN ®<br />
• Minimal change in concentration, even when open<br />
• Totally secure, free of losses<br />
• Less risk of contamination<br />
• Aliquots easily removed using a st<strong>and</strong>ard GC<br />
syringe<br />
• Proven usability from -30 o C to +50 o C<br />
• Almost impossible to spill<br />
For further information on these products or to<br />
receive any one of our catalogues, please contact<br />
your local office or visit our web site.<br />
Applications for CERTAN ®<br />
Supply of<br />
st<strong>and</strong>ard solutions<br />
Long term storage for<br />
solutions from ampoules<br />
Storage of stock solution<br />
Archiving of production<br />
samples<br />
Holding difficult samples,<br />
such as volatile organic<br />
compounds (VOCs)<br />
Transport <strong>and</strong> storage of<br />
ring-test samples<br />
www.lgcst<strong>and</strong>ards.com
<strong>Pharmac<strong>eu</strong>tical</strong> <strong>impurities</strong><br />
<strong>Pharmac<strong>eu</strong>tical</strong> <strong>impurities</strong><br />
Background<br />
The pharmacopeial monographs regulate the legal definition but also the analysis <strong>and</strong> the limits of <strong>impurities</strong><br />
in a given substance. Impurities in a pharmac<strong>eu</strong>tical substance can change the effects <strong>and</strong> side effects of<br />
a drug significantly. It is therefore important to have an accurate detection of <strong>impurities</strong>.<br />
The increasing importance of impurity <strong>reference</strong> materials is also becoming apparent in the registration of<br />
drugs, where an exact identification <strong>and</strong> quantification of susceptible <strong>impurities</strong> is required for an assured<br />
documentation.<br />
A wide range of known <strong>impurities</strong> is listed in individual pharmacopeial monographs. However, <strong>impurities</strong> that<br />
are still protected by a patent, as well as those that are only known to the manufacturer, are not listed.<br />
Guidelines <strong>and</strong> limits for <strong>impurities</strong> have been laid out in compendial monographs, in specifications from<br />
the manufacturer internally or in the International Conference on Harmonisation (ICH) Guidelines which<br />
have been agreed by Europe, Japan <strong>and</strong> the United States. The ICH conducted three guidelines on impurity<br />
issues:<br />
ICH Q3A (R1): Impurities in New Drug Substances<br />
ICH Q3B (R2): Impurities in New Drug Products<br />
ICH Q3C (R3): Impurity Guidelines for Residual Solvents.<br />
The full wording of the ICH guidelines is available at the official website of the ICH: www.ich.org.<br />
About LGC<br />
Certification<br />
The pharmac<strong>eu</strong>tical <strong>impurities</strong> listed in this section are produced by LGC, whose Research & Technology<br />
Division acts as the designated UK National Measurement Institute for Chemical <strong>and</strong> Biochemical<br />
Measurements.<br />
LGC is an independent, science-based service company providing chemical, biochemical <strong>and</strong> DNA based<br />
analytical <strong>and</strong> diagnostic services, <strong>and</strong> <strong>reference</strong> st<strong>and</strong>ards. Europe's largest, independent analytical<br />
laboratory, LGC's services include analytical testing, research, consultancy, validation, training <strong>and</strong><br />
knowledge transfer.<br />
LGC St<strong>and</strong>ards, a division of LGC, provides the most comprehensive source of certified <strong>reference</strong> materials<br />
<strong>and</strong> st<strong>and</strong>ards, pharmac<strong>eu</strong>tical <strong>reference</strong> <strong>substances</strong> <strong>and</strong> <strong>impurities</strong>, biomaterials, cell lines <strong>and</strong> high purity<br />
solvents to the scientific community worldwide.<br />
LGC St<strong>and</strong>ards has successfully established a global reputation for the production of <strong>impurities</strong> <strong>and</strong> working<br />
st<strong>and</strong>ards, <strong>and</strong> as a single source for the supply of pharmacopeia <strong>reference</strong> materials. Our menu of custom<br />
services, including custom synthesis of <strong>impurities</strong> <strong>and</strong> metabolites, characterisation, certification, packaging<br />
<strong>and</strong> distribution, adds value to the scientific support we provide to our pharmac<strong>eu</strong>tical customers.<br />
For more information about these services, please contact your local LGC St<strong>and</strong>ards office.<br />
Each product is accompanied by a detailed certificate of analysis, which gives information on the identity<br />
<strong>and</strong> purity, together with the various analytical methods <strong>and</strong> their conditions. A sample of such a certificate<br />
is printed on the following pages.<br />
In the past, we received some inquiries from a few customers wondering why there is no declaration on the<br />
certificates of analysis (CofA) for LGC products stating that the <strong>substances</strong> are fulfilling the specifications<br />
for reagents, as described for example in chapter 4 of the European Pharmacopeia.<br />
The LGC impurity st<strong>and</strong>ards are thoroughly tested chemical <strong>reference</strong> <strong>substances</strong> <strong>and</strong> are used for reliable<br />
identification <strong>and</strong> quantification of <strong>impurities</strong> of pharmac<strong>eu</strong>tical ingredients <strong>and</strong> products.<br />
The abbreviations EP, Pharm<strong>eu</strong>ropa, BP <strong>and</strong> USP in the article description are indicating that the particular<br />
substance is mentioned as an impurity in that particular compendial publication. They do not indicate that<br />
certain specification of reagents or drug <strong>substances</strong> mentioned in the publications are fulfilled. The<br />
st<strong>and</strong>ards - where they are actually listed as reagents or drug <strong>substances</strong> - may fulfill this specification,<br />
but this is not the intention <strong>and</strong> is not certified on the CofA.<br />
Production of our 2000+ LGC <strong>impurities</strong> <strong>reference</strong> st<strong>and</strong>ards now follow the principles of ISO Guide 34<br />
"General requirements for the competence of <strong>reference</strong> materials producers". This applies to new products<br />
<strong>and</strong> new batches of already existing products. In combination with ISO 17025, the ISO Guide 34 principles<br />
provide the best approach to the production of <strong>reference</strong> materials. Due to this new approach, you will notice<br />
two differences in associated products:<br />
-The <strong>reference</strong> st<strong>and</strong>ards will now be valid for twelve months from the date of despatch, in contrast to the<br />
fixed date given on the certificates before. There will still be the potential for recertification after twelve<br />
months, provided that the stability data supports this.<br />
- Furthermore, newly released batches of <strong>reference</strong> st<strong>and</strong>ards will be filled in tamper evident bottles, giving<br />
confidence to the user on the integrity of the product on arrival. However, this lies in the responsibility of the<br />
user once the product has been received <strong>and</strong> opened.<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 153
<strong>Pharmac<strong>eu</strong>tical</strong> <strong>impurities</strong><br />
Narcotics<br />
Some of the <strong>substances</strong> described in this section are subject to narcotics legislation. These are marked<br />
as [Controlled Substance]. Please contact your local LGC St<strong>and</strong>ards office for information on the legal<br />
requirements in order to purchase these products.<br />
Delivery time<br />
The majority of products mentioned in this section are available from stock; others may have a delivery time<br />
of approximately four weeks. For <strong>substances</strong> marked with "on request", longer delivery times may apply. For<br />
custom synthesis, the time is estimated from previous experience. Customers will be notified if unforeseen<br />
complications arise during the synthesis. In the unlikely event that a synthesis does not reach the expected<br />
result, LGC St<strong>and</strong>ards reserves the right to cancel the order.<br />
154 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
<strong>Pharmac<strong>eu</strong>tical</strong> <strong>impurities</strong><br />
Code Product Category Unit<br />
Acebutolol Hydrochloride<br />
MM 0435.00 Acebutolol Hydrochloride<br />
O<br />
O<br />
OH H<br />
O N<br />
(A) 500 mg<br />
N<br />
H<br />
x HCl<br />
MM 0435.02<br />
Imp. B (EP) as Hydrochloride:N-[3-Acetyl-4-[(2RS)-<br />
2-hydroxy-3-[(1-methylethyl)amino]-<br />
propoxy]phenyl]acetamide Hydrochloride<br />
(Diacetolol Hydrochloride)<br />
O<br />
N<br />
H<br />
O<br />
O<br />
OH<br />
H<br />
N<br />
x HCl<br />
(A)<br />
100 mg<br />
Aceclofenac<br />
MM 0181.00<br />
Aceclofenac<br />
Cl<br />
O<br />
O<br />
NH<br />
Cl<br />
O<br />
(A) 250 mg<br />
OH<br />
MM 0181.07<br />
Imp. A (EP): [2-[(2,6-Dichlorophenyl)amino]phenyl]acetic Acid<br />
(Diclofenac)<br />
Cl<br />
OH<br />
O<br />
NH<br />
Cl<br />
(A)<br />
100 mg<br />
MM 0181.08<br />
Imp. B (EP): Methyl [2-[(2,6-Dichlorophenyl)amino]phenyl]acetate<br />
(Methyl Ester of Diclofenac)<br />
Cl<br />
O<br />
O<br />
NH<br />
Cl<br />
(A)<br />
100 mg<br />
MM 0181.09<br />
Imp. C (EP): Ethyl 2-{2-[(2,6-dichlorophenyl)amino]phenyl}acetate<br />
(Ethyl Ester of Diclofenac)<br />
Cl<br />
O<br />
O<br />
NH<br />
Cl<br />
(A)<br />
100 mg<br />
MM 0181.01<br />
Imp. D (EP): Methyl [[[2-[(2,6-Dichloro-<br />
phenyl)amino]phenyl]acetyl]oxy]-<br />
acetate (Methyl Ester of Aceclofenac)<br />
Cl<br />
O<br />
O<br />
NH<br />
Cl<br />
O<br />
(A) 100 mg<br />
O<br />
MM 0181.02 Imp. E (EP): Ethyl [[[2-[(2,6-<br />
Dichlorophenyl)amino]phenyl]acetyl]oxy]acetate<br />
(Ethyl Ester of Aceclofenac)<br />
Cl<br />
O<br />
O<br />
NH<br />
Cl<br />
O<br />
(A) 100 mg<br />
O<br />
MM 0181.03 Imp. F (EP): ): Benzyl [[[2-[(2,6-<br />
Dichlorophenyl)amino]phenyl]acetyl]oxy]acetate (Benzyl Ester<br />
of Aceclofenac)<br />
Cl<br />
O<br />
O<br />
NH<br />
Cl<br />
O<br />
(A) 100 mg<br />
O<br />
MM 0181.04<br />
Imp. G (EP): [[[[[2-[(2,6-Dichlorophenyl)amino]phenyl]-<br />
acetyl]oxy]acetyl]oxy]acetic Acid (Acetic Aceclofenac)<br />
Cl<br />
O<br />
O<br />
NH<br />
Cl<br />
O<br />
O<br />
OH<br />
O<br />
(A)<br />
100 mg<br />
MM 0181.10<br />
Imp. I (EP):1-(2,6-Dichlorophenyl)-1,3-dihydro-2H-indol-2-one<br />
Cl<br />
N<br />
O<br />
Cl<br />
(A)<br />
100 mg<br />
MM 0181.06<br />
Isopropyl [2-[(2,6-Dichlorophenyl)amino]phenyl]acetate<br />
(Isopropyl Ester of Diclofenac)<br />
Cl<br />
O<br />
O<br />
NH<br />
Cl<br />
(A)<br />
100 mg<br />
Acetazolamide<br />
MM 0648.00<br />
Acetazolamide<br />
H<br />
N<br />
S<br />
O O<br />
(A) 500 mg<br />
S NH2<br />
O<br />
N<br />
N<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 159
<strong>Pharmac<strong>eu</strong>tical</strong> <strong>impurities</strong><br />
Code Product Category Unit<br />
Acetylcysteine<br />
MM 0024.00 N-Acetyl-L-cysteine<br />
O<br />
HS OH<br />
HN<br />
(A) 500 mg<br />
MM 0024.03<br />
MM 0024.02<br />
MM 0024.04<br />
MM 0024.01<br />
Imp. A (EP): L-Cystine<br />
Imp. B (EP): L-Cysteine<br />
Imp. C (EP): N,N’-Diacetyl-L-cystine<br />
Imp. D (EP): N,S-Diacetyl-L-cysteine<br />
HO<br />
O<br />
NH<br />
HO<br />
O<br />
O<br />
O<br />
S<br />
S OH<br />
NH 2<br />
NH 2 (B) 100 mg<br />
O<br />
NH 2<br />
(B) 100 mg<br />
HS OH<br />
O<br />
(A) 100 mg<br />
O<br />
S<br />
S OH<br />
HN<br />
O<br />
O O<br />
(A) 100 mg<br />
S OH<br />
HN<br />
MM 0024.05<br />
Acetylsalicylic Acid<br />
Sodium 2-Methyl-4,5-dihydro-1,3-thiazol-4-carboxylate<br />
MM 0133.00 Acetylsalicylic Acid<br />
O<br />
HO<br />
N<br />
S<br />
O<br />
O<br />
(A) 100 mg<br />
O<br />
ONa<br />
O<br />
(A) 500 mg<br />
MM 0133.05<br />
Imp. A (EP): 4-Hydroxybenzoic Acid<br />
HO<br />
O<br />
(B) 100 mg<br />
OH<br />
MM 0133.06<br />
Imp. B (EP): 4-Hydroxybenzene-1,3-dicarboxylic Acid<br />
(4-Hydroxyisophthalic Acid)<br />
HO<br />
O<br />
O<br />
(A) 100 mg<br />
OH<br />
OH<br />
MM 0133.07<br />
Imp. C (EP): Salicylic Acid<br />
O<br />
(A)<br />
500 mg<br />
OH<br />
OH<br />
MM 0133.01<br />
Imp. D (EP): 2-[[2-(Acetyloxy)benzoyl]oxy]benzoic Acid<br />
(Acetylsalicylsalicylic Acid)<br />
O<br />
OH<br />
O<br />
(A)<br />
100 mg<br />
O<br />
O<br />
O<br />
MM 0133.03<br />
Imp. E (EP):2-[(2-Hydroxybenzoyl)oxy]benzoic Acid<br />
(Salicylsalicylic Acid)<br />
O<br />
OH<br />
(A)<br />
100 mg<br />
O<br />
OH<br />
O<br />
MM 0133.02<br />
Imp. F (EP): 2-(Acetyloxy)benzoic Anhydride<br />
(Acetylsalicylic Anhydride)<br />
O O O<br />
O<br />
O<br />
O<br />
(A) 100 mg<br />
O<br />
MM 0133.04<br />
2-(2,4-Dihydroxybenzoyl)benzoic Acid<br />
O<br />
(A)<br />
100 mg<br />
OH<br />
O<br />
OH<br />
OH<br />
Aciclovir<br />
MM 0061.00<br />
Aciclovir<br />
O<br />
HN<br />
H 2N N<br />
N<br />
N<br />
O<br />
OH<br />
(A)<br />
500 mg<br />
160 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
<strong>Pharmac<strong>eu</strong>tical</strong> <strong>impurities</strong><br />
Code Product Category Unit<br />
MM 0061.01 Imp. A (EP): 2-[(2-Amino-6-oxo-1,6-dihydro-9H-purin-9-<br />
O<br />
(A) 100 mg<br />
yl)methoxy]ethyl Acetate<br />
N<br />
HN<br />
O<br />
H 2 N N N<br />
O<br />
O<br />
MM 0061.02<br />
Imp. B (EP): 2-Amino-1,7-dihydro-6H-purin-6-one (Guanine)<br />
HN<br />
O<br />
H<br />
N<br />
(B)<br />
100 mg<br />
H 2 N<br />
N<br />
N<br />
MM 0061.04<br />
MM 0061.06<br />
MM 0061.07<br />
Imp. D (EP): 2-[(2-Amino-6-oxo-1,6-dihydro-9H-purin-9-<br />
yl)methoxy]ethyl Benzoate<br />
Imp. F (EP): N-[9-[(2-Hydroxyethoxy)methyl]-6-oxo-6,9-<br />
dihydro-1H-purin-2-yl]acetamide<br />
Imp. G (EP): 2-[[(2-(Acetylamino)-6-oxo-1,6-dihydro-9Hpurin-9-yl]methoxy]ethyl<br />
Acetate<br />
H 2 N<br />
HN<br />
O<br />
O<br />
N<br />
N<br />
H<br />
O<br />
HN<br />
N<br />
H<br />
N<br />
N<br />
HN<br />
O<br />
N<br />
O<br />
N<br />
O<br />
N<br />
N<br />
N<br />
N<br />
O<br />
O<br />
O<br />
O<br />
O<br />
OH<br />
O<br />
(A)<br />
(A)<br />
(A)<br />
100 mg<br />
100 mg<br />
100 mg<br />
MM 0061.08<br />
Imp. H (EP): 2-[[2-(Acetylamino)-6-oxo-1,6-dihydro-<br />
9H-purin-9-yl]methoxy]ethyl Benzoate<br />
O<br />
N<br />
H<br />
HN<br />
O<br />
N<br />
N<br />
N<br />
O<br />
O<br />
O<br />
(A)<br />
100 mg<br />
MM 0061.13<br />
Imp. L (Pharm<strong>eu</strong>ropa): 9,N 9 -Diacetylguanine<br />
O<br />
HN<br />
O<br />
N<br />
(A)<br />
100 mg<br />
N<br />
H<br />
N<br />
N<br />
O<br />
MM 0061.10<br />
2,6-Dichloropurine<br />
N<br />
Cl<br />
N<br />
(B)<br />
100 mg<br />
Cl<br />
N<br />
N<br />
H<br />
Adenosine<br />
MM 0784.00<br />
Adenosine<br />
N<br />
NH 2<br />
N<br />
(A)<br />
500 mg<br />
HO<br />
N<br />
O<br />
N<br />
OH OH<br />
Adiphenine Hydrochloride<br />
New MM 1172.00<br />
Adiphenine Hydrochloride<br />
O<br />
O<br />
N<br />
x HCl<br />
(A)<br />
250 mg<br />
Adrenaline Tartrate<br />
MM 0614.00<br />
Adrenaline Tartrate<br />
HO<br />
OH<br />
OH<br />
H<br />
N<br />
x<br />
OH O<br />
HO<br />
OH<br />
O OH<br />
(A)<br />
500 mg<br />
MM 0614.02<br />
L-Adrenaline<br />
OH<br />
H<br />
N<br />
(A)<br />
500 mg<br />
HO<br />
OH<br />
MM 0614.01<br />
(1R)-1-(3,4-Dihydroxyphenyl)-2-methylaminoethanesulphonic Acid<br />
(Adrenaline β-Sulphonate)<br />
SO 3 H<br />
H (A) 100 mg<br />
N<br />
HO<br />
OH<br />
MM 0614.05<br />
Imp. C (EP) as Hydrochloride Monohydrate:<br />
1-(3,4-Dihydroxyphenyl)-2-(methylamino)-<br />
ethanone Hydrochloride Monohydrate<br />
(Adrenalone Hydrochloride Monohydrate)<br />
HO<br />
HO<br />
O<br />
H<br />
N<br />
x HCl<br />
x H 2 O<br />
(A)<br />
100 mg<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 161
<strong>Pharmac<strong>eu</strong>tical</strong> <strong>impurities</strong><br />
Code Product Category Unit<br />
Alanine<br />
MM 0566.00 Alanine<br />
NH 2<br />
(A) 500 mg<br />
OH<br />
Albendazole<br />
MM 0382.00<br />
New MM 0382.01<br />
MM 0382.02<br />
MM 0382.03<br />
MM 0382.04<br />
MM 0382.05<br />
Albendazole<br />
Alfuzosin Hydrochloride<br />
MM 1004.02<br />
Allobarbital<br />
MM 0899.00<br />
Imp. A (EP): 5-(Propylsulphanyl)-1H-benzimidazol-2-amine<br />
Imp. B (EP): Methyl [5-Propylsulphinyl)-1H-benzimidazol-2-<br />
yl]carbamate<br />
Imp. C (EP): Methyl [5-Propylsulphonyl)-1H-benzimidazol-<br />
2-yl]carbamate<br />
Imp. D (EP): 5-(Propylsulphonyl)-1H-benzimidazol-2-amine<br />
Imp. E (EP): Methyl (1H-Benzimidazol-2-yl)carbamate<br />
Imp. B (EP): 2-Chloro-6,7-dimethoxyquinazolin-4-amine<br />
Allobarbital [Controlled Substance]<br />
S<br />
S<br />
S<br />
O O<br />
S<br />
O<br />
S<br />
O O<br />
O<br />
O<br />
H<br />
N<br />
N<br />
H<br />
N<br />
N<br />
O<br />
H<br />
N<br />
N<br />
H<br />
N<br />
N<br />
H<br />
N<br />
N<br />
O<br />
O<br />
(A) 500 mg<br />
O<br />
NH<br />
O<br />
O<br />
NH<br />
O<br />
NH<br />
H<br />
N<br />
N<br />
NH<br />
NH 2<br />
(A) 100 mg<br />
O<br />
NH 2<br />
(A)<br />
(A)<br />
(A)<br />
100 mg<br />
100 mg<br />
100 mg<br />
O<br />
(A) 100 mg<br />
O<br />
(A)<br />
N Cl<br />
100 mg<br />
NH 2<br />
N<br />
H<br />
N<br />
O<br />
(A)<br />
100 mg<br />
NH<br />
Allopurinol<br />
MM 0034.00<br />
MM 0034.01<br />
MM 0034.05<br />
MM 0034.06<br />
MM 0034.07<br />
Alprazolam<br />
MM 0136.03<br />
Allopurinol<br />
O<br />
Imp. A (EP) as Hemisulphate: 5-Amino-1H-pyrazole-4-<br />
carboxamide Hemisulphate NH 2<br />
Imp. D (EP): Ethyl 5-Amino1H-pyrazole-4-carboxylate<br />
Imp. E (EP): Ethyl 5-(Formylamino)-1H-pyrazole-4-carboxylate<br />
Oxypurinol<br />
Imp. E (EP): (2-Amino-5-chlorophenyl)phenylmethanone<br />
N<br />
N<br />
H<br />
NH 2<br />
Cl<br />
N<br />
N<br />
H<br />
N<br />
N<br />
H<br />
N<br />
N<br />
H<br />
N<br />
N<br />
H<br />
O<br />
O<br />
(A) 500 mg<br />
NH<br />
N<br />
x 1 / 2 H 2 SO 4<br />
(A) 100 mg<br />
O<br />
(A) 100 mg<br />
O<br />
NH 2<br />
O<br />
O<br />
N O<br />
H<br />
O<br />
N<br />
H<br />
NH<br />
O<br />
O<br />
(A)<br />
(A)<br />
100 mg<br />
100 mg<br />
NH 2<br />
(B) 100 mg<br />
162 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
<strong>Pharmac<strong>eu</strong>tical</strong> <strong>impurities</strong><br />
Code Product Category Unit<br />
Alverine Citrate<br />
MM 0454.00<br />
MM 0454.02<br />
MM 0454.03<br />
MM 0454.04<br />
MM 0454.05<br />
Alverine Citrate<br />
Amantadine Hydrochloride<br />
Imp. A (EP): 1-Chloro-3-phenyl-propane<br />
Imp. B (EP): 3-Phenylpropan-1-ol<br />
Imp. C (EP) as Hydrochloride: N-Ethyl-<br />
3-phenylpropan-1-amine Hydrochloride<br />
Imp. D (EP) as Hydrochloride: N-(3-<br />
Cyclohexylpropyl)-N-ethyl-3-phenylpropan-1-amine<br />
Hydrochloride<br />
MM 0564.00 Amantadine Hydrochloride<br />
NH 2<br />
x HCl<br />
N<br />
N<br />
x<br />
NH<br />
O<br />
O<br />
OH<br />
OH<br />
O<br />
OH<br />
OH<br />
Cl<br />
OH<br />
(A)<br />
(A)<br />
(A)<br />
250 mg<br />
100 mg<br />
100 mg<br />
x HCl<br />
(A) 100 mg<br />
x HCl<br />
(A) 100 mg<br />
(A)<br />
500 mg<br />
Ambroxol Hydrochloride<br />
MM 0005.00<br />
Ambroxol Hydrochloride<br />
Br<br />
N<br />
H<br />
OH<br />
(A) 500 mg<br />
x HCl<br />
Br<br />
NH 2<br />
MM 0005.01<br />
Imp. A (EP): (2-Amino-3,5-dibromophenyl)methanol<br />
Br<br />
OH (A) 100 mg<br />
Br<br />
NH 2<br />
MM 0005.04<br />
Imp. B (EP) as Hydrochloride: trans-4-(6,8-Dibromo-1,4-<br />
dihydroquinazolin-3(2H)-yl)cyclohexanol Hydrochloride<br />
Br<br />
N<br />
OH<br />
(A) 100 mg<br />
x HCl<br />
Br<br />
N<br />
H<br />
MM 0005.03<br />
Imp. C (EP): trans-4-[[(E)-2-Amino-3,5-<br />
dibromobenzyliden]amino]cyclohexanol<br />
Br<br />
N<br />
OH<br />
(A) 100 mg<br />
Br<br />
NH 2<br />
MM 0005.05<br />
Imp. D (EP) as Hydrochloride: cis-4-[(2-Amino-3,5-<br />
dibromobenzyl)amino]cyclohexanol Hydrochloride<br />
Br<br />
N<br />
H<br />
OH<br />
(A) 100 mg<br />
x HCl<br />
Br<br />
NH 2<br />
MM 0005.02<br />
Imp. E (EP): 2-Amino-3,5-dibromobenzaldehyde<br />
Br<br />
O (A) 100 mg<br />
Br<br />
NH 2<br />
MM 0005.06<br />
trans-4-Aminocyclohexanol Hydrochloride<br />
H 2N<br />
OH<br />
(A) 100 mg<br />
x HCl<br />
MM 0005.07<br />
cis-4-Aminocyclohexanol Hydrochloride<br />
H 2N<br />
OH<br />
(A) 100 mg<br />
x HCl<br />
Amiloride Hydrochloride<br />
MM 0560.00 Amiloride Hydrochloride Dihydrate<br />
Aminocaproic Acid<br />
MM 0896.00 Aminocaproic Acid<br />
Amiodarone Hydrochloride<br />
MM 0697.00 Amiodarone Hydrochloride<br />
O<br />
O<br />
Cl<br />
H 2N<br />
O NH<br />
N<br />
N NH 2<br />
H<br />
N NH 2<br />
H 2 N<br />
I<br />
N<br />
O<br />
I<br />
x HCl<br />
x 2 H 2 O<br />
OH<br />
(A)<br />
500 mg<br />
O<br />
(A) 500 mg<br />
x HCl<br />
(A)<br />
250 mg<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 163
<strong>Pharmac<strong>eu</strong>tical</strong> <strong>impurities</strong><br />
Code Product Category Unit<br />
MM 0697.02 Imp. A (EP) as Hydrochloride: (2-<br />
O<br />
(A) 100 mg<br />
Butylbenzofuran-3-yl)[4-[2-<br />
O<br />
x HCl<br />
(diethylamino)ethoxy]phenyl]methanone<br />
N<br />
O<br />
Hydrochloride<br />
New MM 0697.03<br />
Imp. B (EP) as Hydrochloride: (2-Butylbenzofuran-3-yl)[4-[2-(ethylamino)ethoxy]-3,5-diiodophenyl]methanone<br />
Hydrochloride<br />
O<br />
O<br />
I<br />
I<br />
O<br />
H<br />
N<br />
x HCl<br />
(D)<br />
100 mg<br />
MM 0697.04 Imp. C (EP) as Hydrochloride: (2-<br />
Butylbenzofuran-3-yl)<br />
[4-[2-(diethylamino)ethoxy]-<br />
3-iodophenyl]methanone Hydrochloride<br />
O<br />
O<br />
I<br />
O<br />
N<br />
x HCl<br />
(A)<br />
100 mg<br />
MM 0697.05<br />
Imp. D (EP): (2-Butylbenzofuran-3-yl)(4-hydroxy-3,5-<br />
diiodophenyl)methanone<br />
O<br />
O<br />
I<br />
(A)<br />
100 mg<br />
OH<br />
I<br />
MM 0697.06<br />
Imp. E (EP): (2-Butylbenzofuran-3-yl)(4-<br />
hydroxyphenyl)methanone<br />
O<br />
O<br />
(A)<br />
100 mg<br />
OH<br />
MM 0697.07<br />
Imp. F (EP): (2-Butylbenzofuran-3-yl)(4-hydroxy-3-<br />
iodophenyl)methanone<br />
O<br />
O<br />
I<br />
(A)<br />
100 mg<br />
OH<br />
MM 0697.09<br />
Imp. H (EP) as Hydrochloride: 2-Chloro-N,N-diethylethanamine<br />
Hydrochloride (2-Chlorotriethylamine Hydrochloride;<br />
(2-Chloroethyl)diethylamine Hydrochloride)<br />
Cl<br />
N<br />
x HCl<br />
(C)<br />
100 mg<br />
MM 0697.10 Amiodarone N-Oxide Hydrochloride<br />
O<br />
O<br />
I<br />
I<br />
O<br />
O<br />
N<br />
x HCl<br />
(A)<br />
100 mg<br />
Amisulpride<br />
MM 0793.01 Imp. A (EP): [(2RS)-1-Ethylpyrrolidin-2-yl]methanamine H 2 N<br />
N<br />
(A)<br />
100 mg<br />
Amitriptyline Hydrochloride<br />
MM 0062.00<br />
Amitriptyline Hydrochloride<br />
(A)<br />
500 mg<br />
N<br />
x HCl<br />
MM 0062.01<br />
Imp. A (EP): 10,11-Dihydro-5H-dibenzo-[a,d][7]annulen-5-one<br />
(Dibenzosuberone)<br />
O<br />
(B)<br />
100 mg<br />
MM 0062.02<br />
Imp. B (EP) as Hydrochloride: 3-(5H-<br />
Dibenzo[a,d][7]annulen-5-ylidene)-N,N-dimethylpropan-1-<br />
amine Hydrochloride (Cyclobenzaprine Hydrochloride)<br />
N<br />
x HCl<br />
(A)<br />
100 mg<br />
MM 0062.11<br />
Imp. C (EP) as Hydrochloride: 3-(10,11-Dihydro-5Hdibenzo[a,d][7]annulen-5-ylidene)-N-methylpropan-1-amine<br />
Hydrochloride (Nortriptyline Hydrochloride)<br />
N<br />
H<br />
x HCl<br />
(A)<br />
500 mg<br />
MM 0062.03<br />
Imp. D (EP): 5-[3-(Dimethylamino)propyl]-10,11-dihydro-5Hdibenzo[a,d][7]annulen-5-ol<br />
OH<br />
N<br />
(A)<br />
100 mg<br />
164 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
<strong>Pharmac<strong>eu</strong>tical</strong> <strong>impurities</strong><br />
Code Product Category Unit<br />
MM 0062.05 Imp. F (EP): (5EZ,10RS)-5-[3-(Dimethyl-<br />
(A) 100 mg<br />
amino)propylidene]-10,11-dihydro-5H-<br />
N<br />
dibenzo[a,d][7]annulen-10-ol<br />
HO<br />
MM 0062.12<br />
Amitriptyline N-Oxide Hydrochloride<br />
(A)<br />
100 mg<br />
N<br />
O<br />
x HCl<br />
MM 0062.13 10,11-Dihydro-5H-dibenzo[a,d]cycloheptene (Dibenzosuberane) (A) 100 mg<br />
Amlodipine Besilate<br />
MM 0383.00 Amlodipine Besilate<br />
H<br />
N<br />
O<br />
O<br />
O<br />
NH 2<br />
O<br />
O<br />
S<br />
OH<br />
(D)<br />
100 mg<br />
O<br />
O<br />
Cl<br />
x<br />
MM 0383.01<br />
Imp. A (EP): 3-Ethyl-5-Methyl (4RS)-4-(2-Chlorophenyl)-2-<br />
[[2-(1,3-dioxo-1,3-dihydro-2H-isoindol-2-yl)ethoxy]methyl]-6-<br />
methyl-1,4-dihydropyridine-3,5-dicarboxylate<br />
O<br />
H<br />
N<br />
O<br />
O<br />
O<br />
N<br />
O<br />
(D)<br />
100 mg<br />
O<br />
O<br />
Cl<br />
MM 0383.02<br />
Imp. B (EP): 3-Ethyl 5-Methyl (4RS)-4-(2-<br />
Chlorophenyl)-6-methyl-2-[[2-[[2-<br />
(methylcarbamoyl)benzoyl]amino]-ethoxy]methyl]-<br />
1,4-dihydropyridine-3,5-dicarboxylate<br />
O<br />
O<br />
H<br />
N<br />
O<br />
O<br />
O<br />
Cl<br />
H<br />
N<br />
O<br />
O<br />
N<br />
H<br />
(D)<br />
100 mg<br />
MM 0383.03<br />
Imp. C (EP) as Dihydrochloride: Ethyl Methyl (4RS)-<br />
2,6-Bis[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-<br />
1,4-dihydropyridine-3,5-dicarboxylate Dihydrochloride<br />
H 2 N<br />
O<br />
O<br />
O<br />
H<br />
N<br />
O<br />
O<br />
O<br />
Cl<br />
x 2 HCl<br />
NH 2<br />
(D)<br />
100 mg<br />
MM 0383.04<br />
Imp. D (EP): 3-Ethyl-5-Methyl 2-[(2-Aminoethoxy)methyl]-4-(2-<br />
chlorophenyl)-6-methylpyridine-3,5-dicarboxylate<br />
O<br />
O<br />
N<br />
O<br />
O<br />
O<br />
Cl<br />
NH 2<br />
(D)<br />
100 mg<br />
MM 0383.05<br />
Benzenesulfonic Acid<br />
O<br />
O<br />
S<br />
OH<br />
(B)<br />
100 mg<br />
MM 0383.06 Amlodipine<br />
H N<br />
O<br />
O<br />
O<br />
NH 2<br />
(A)<br />
100 mg<br />
O<br />
O<br />
Cl<br />
Amlodipine Maleate<br />
MM 0631.00 Amlodipine Maleate<br />
H<br />
N<br />
O<br />
O<br />
O<br />
O<br />
O<br />
Cl<br />
NH 2<br />
x<br />
O<br />
OH<br />
OH<br />
O<br />
(D)<br />
100 mg<br />
Amlodipine Mesilate<br />
MM 0592.00 Amlodipine Mesilate<br />
H<br />
N<br />
O<br />
O<br />
O<br />
O<br />
O<br />
Cl<br />
NH 2<br />
O O<br />
x<br />
S<br />
HO<br />
on request<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 165
<strong>Pharmac<strong>eu</strong>tical</strong> <strong>impurities</strong><br />
Code Product Category Unit<br />
Amodiaquine Dihydrochloride Dihydrate<br />
Cl N<br />
MM 0617.00 Amodiaquine Dihydrochloride Dihydrate<br />
(A)<br />
500 mg<br />
HN<br />
N<br />
x 2 HCl<br />
x 2 H 2 O<br />
OH<br />
MM 0617.01<br />
4-Acetamido-2-diethylaminomethylphenol<br />
H<br />
N<br />
N<br />
(A)<br />
100 mg<br />
O<br />
OH<br />
Cl N<br />
MM 0617.02 7-Chloro-4-(4-hydroxyphenylamino)quinoline<br />
(A)<br />
100 mg<br />
HN<br />
Cl N<br />
MM0617.03 4,7-Dichloroquinoline<br />
OH<br />
(C)<br />
100 mg<br />
Cl<br />
MM 0617.04<br />
Monodesethylamodiaquine Dihydrochloride<br />
Cl<br />
N<br />
(A)<br />
100 mg<br />
HN<br />
HN<br />
x 2 HCl<br />
Amoxicillin Trihydrate<br />
MM 0232.00<br />
MM 0232.13<br />
MM 0232.03<br />
Amoxicillin Trihydrate<br />
Imp. A (EP): (2S,5R,6R)-6-Amino-3,3-dimethyl-7-oxo-4-thia-1-<br />
azabicyclo[3.2.0]-heptane-2-carboxylic Acid<br />
(6-Aminopenicillanic Acid)<br />
HO<br />
O<br />
NH 2<br />
H<br />
N<br />
O<br />
O<br />
Imp. C (EP): (4S)-2-[5-(4-Hydroxyphenyl)-3,6-<br />
dioxopiperazin-2-yl]-5,5-dimethyl-thiazolidine-4-carboxylic<br />
HN<br />
Acid (Amoxicillin Diketopiperazines) H<br />
O N<br />
S<br />
N<br />
H<br />
O<br />
S<br />
O<br />
H 2 N<br />
OH<br />
OH<br />
N<br />
H<br />
O<br />
x 3 H 2 O<br />
S<br />
OH<br />
OH<br />
(A)<br />
(B)<br />
(A)<br />
500 mg<br />
100 mg<br />
100 mg<br />
N<br />
H<br />
O<br />
HO<br />
MM 0232.04<br />
Imp. D (EP) as Sodium Salt:(4S)-2-[[[(2R)-2-Amino-2-(4-<br />
hydroxyphenyl)acetyl]amino]-carboxymethyl]-5,5-<br />
dimethylthiazolidine-4-carboxylic Acid Sodium Salt<br />
(Penicilloic Acids of Amoxicillin Sodium Salt)<br />
H<br />
N<br />
HN<br />
O<br />
S<br />
ONa<br />
(A)<br />
100 mg<br />
MM 0232.05<br />
Imp. E (EP): (2RS,4S)-2-[[[(2R)-2-Amino-2-(4-<br />
hydroxyphenyl)acetyl]amino]methyl]-5,5-<br />
dimethylthiazolidine-4-carboxylic Acid<br />
(Penilloic Acids of Amoxicillin)<br />
HO<br />
NH 2<br />
O<br />
HO<br />
NH 2<br />
H<br />
N<br />
O<br />
O<br />
O<br />
HN<br />
S<br />
OH (A) 50 mg<br />
HO<br />
MM 0232.06<br />
Imp. F (EP): 3-(4-Hydroxyphenyl)pyrazin-2-ol<br />
HO N<br />
(A) 100 mg<br />
N<br />
HO<br />
MM 0232.08<br />
Imp. H (EP): (2R)-2-[(2,2-Dimethylpropanoyl)amino]-2-<br />
(4-hydroxyphenyl)acetic Acid<br />
O<br />
NH<br />
OH<br />
(A)<br />
100 mg<br />
MM 0232.09<br />
Imp. I (EP): (2R)-2-Amino-2-(4-hydroxyphenyl)acetic Acid<br />
HO<br />
O<br />
NH 2<br />
OH<br />
(B)<br />
100 mg<br />
HO<br />
O<br />
MM 0232.12<br />
(2R)-2-Amino-2-(4-hydroxyphenyl)acetamide<br />
NH 2<br />
NH 2<br />
(A)<br />
100 mg<br />
HO<br />
O<br />
166 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
<strong>Pharmac<strong>eu</strong>tical</strong> <strong>impurities</strong><br />
Code Product Category Unit<br />
Ampicillin Sodium<br />
MM 0253.00<br />
Ampicillin Sodium<br />
O<br />
NH 2<br />
H<br />
N<br />
O<br />
N<br />
H<br />
O<br />
S<br />
ONa<br />
(A)<br />
500 mg<br />
MM 0253.17<br />
Imp. A (EP): (2S,5R,6R)-6-Amino-3,3-dimethyl-7-oxo-4-thia-1-<br />
azabicyclo[3.2.0]-heptane-2-carboxylic Acid (6-Aminopenicillanic Acid)<br />
O<br />
N<br />
O<br />
OH<br />
(B)<br />
100 mg<br />
MM 0253.03<br />
Imp. C (EP): (4S)-2-(3,6-Dioxo-5-phenylpiperazin-2-yl)-5,5-<br />
dimethylthiazolidine-4-carboxylic Acid (Diketopiperazines of<br />
H 2 N<br />
H<br />
HN<br />
O<br />
S<br />
OH<br />
(A)<br />
100 mg<br />
Ampicillin) H<br />
O N<br />
S<br />
N<br />
H<br />
O<br />
MM 0253.06<br />
Imp. F (EP): (2RS,4S)-2-[[[(2R)-2-Amino-2-<br />
phenylacetyl]amino]methyl]-5,5-dimethyl-thiazolidine-4-<br />
carboxylic Acid (Penilloic Acids of Ampicillin)<br />
H<br />
N<br />
HN<br />
O<br />
S<br />
OH (A) 100 mg<br />
NH 2<br />
O<br />
MM 0253.08<br />
Imp. H (EP): 3-Phenylpyrazin-2-ol<br />
HO N<br />
(A) 100 mg<br />
N<br />
MM 0253.11<br />
MM 0253.12<br />
Imp. K (EP): (2R)-2-[(2,2-Dimethylpropanoyl)amino]-2-phenylacetic<br />
Acid<br />
Imp. L (EP): (2R)-2-Amino-2-phenylacetic Acid (D-Phenylglycine)<br />
O<br />
(A) 100 mg<br />
NH<br />
O<br />
O<br />
OH<br />
NH 2<br />
(B) 100 mg<br />
OH<br />
MM0253.15<br />
Ampicillin Trihydrate<br />
O<br />
NH 2<br />
H<br />
N<br />
O<br />
O<br />
N<br />
S<br />
H<br />
OH<br />
x 3 H 2 O<br />
(A)<br />
500 mg<br />
MM 0253.16<br />
Ampicillin, anhydrous<br />
O<br />
NH 2<br />
H<br />
N<br />
O<br />
O<br />
N<br />
S<br />
H<br />
OH<br />
(A)<br />
500 mg<br />
Androstanolone<br />
MM 0565.00<br />
Androstanolone<br />
OH<br />
(A) 250 mg<br />
O<br />
Anise Oil<br />
MM 0164.01<br />
trans-Anethole<br />
(C)<br />
100 mg<br />
O<br />
MM 0164.02<br />
Estragole<br />
(C)<br />
100 mg<br />
O<br />
MM 0164.03<br />
Anise Aldehyde<br />
O (C) 100 mg<br />
O<br />
MM 0164.05<br />
Linalol<br />
(C)<br />
100 mg<br />
HO<br />
MM 0164.06<br />
cis-Anethole<br />
(D)<br />
100 mg<br />
O<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 167
<strong>Pharmac<strong>eu</strong>tical</strong> <strong>impurities</strong><br />
Code Product Category Unit<br />
Antazoline Hydrochloride<br />
MM 0171.00<br />
MM 0171.01<br />
Antazoline Hydrochloride<br />
Imp. A (EP) as Dihydrochloride: N-(2-Aminoethyl)-2-<br />
(benzylphenylamino)acetamide Dihydrochloride<br />
N<br />
O<br />
N<br />
H<br />
N<br />
N<br />
NH 2<br />
N<br />
H<br />
x HCl<br />
x 2 HCl<br />
(A)<br />
(A)<br />
500 mg<br />
100 mg<br />
MM 0171.03 N-Benzylaniline NH (B) 100 mg<br />
MM 0171.04 2-Chloromethyl-4,5-dihydro-1H-imidazole Hydrochloride<br />
Antazoline Phosphate<br />
MM 0561.00 Antazoline Phosphate<br />
H<br />
N<br />
N<br />
N<br />
Cl<br />
H<br />
N<br />
N<br />
x HCl<br />
(A) 100 mg<br />
x H 3 PO 4<br />
(A) 500 mg<br />
Apomorphine Hydrochloride<br />
MM 0562.00<br />
Apomorphine Hydrochloride Hemihydrate<br />
HO<br />
OH<br />
N<br />
H<br />
x HCl<br />
x ½ H 2O<br />
(A)<br />
250 mg<br />
MM 0562.02<br />
Imp. B (EP) as Hydrochloride Trihydrate: Morphine<br />
Hydrochloride Trihydrate<br />
[Controlled Substance]<br />
N<br />
x HCl<br />
x 3 H 2 O<br />
(A)<br />
250 mg<br />
HO<br />
O<br />
OH<br />
Aprindine Hydrochloride<br />
MM 0467.00<br />
Aprindine Hydrochloride<br />
N<br />
on request<br />
N<br />
HCl<br />
Arginine<br />
MM 0568.00<br />
Arginine<br />
H 2 N<br />
H<br />
N<br />
NH 2<br />
(A) 500 mg<br />
OH<br />
NH<br />
O<br />
Arginine Hydrochloride<br />
MM 0569.00<br />
Arginine Hydrochloride<br />
H 2 N<br />
H<br />
N<br />
NH 2<br />
OH<br />
x HCl<br />
(A)<br />
500 mg<br />
NH<br />
O<br />
Articaine Hydrochloride<br />
MM 0369.00<br />
Articaine Hydrochloride<br />
O<br />
S<br />
O<br />
H<br />
N<br />
O<br />
N<br />
H<br />
x HCl<br />
(A)<br />
100 mg<br />
MM 0369.01 Imp. A (EP) as Hydrochloride: Methyl 3-[[2-<br />
(Propylamino)acetyl]amino]-4-methylthiophene-2-<br />
carboxylate Hydrochloride (Acetamidoarticaine<br />
Hydrochloride)<br />
O<br />
O<br />
S<br />
H<br />
N<br />
O<br />
N<br />
H<br />
x HCl<br />
(A)<br />
100 mg<br />
MM 0369.02<br />
Imp. B (EP) as Hydrochloride: 4-Methyl-3-[[(2RS)-2-<br />
(propylamino)propanoyl]amino]thiophene-2-carboxylic Acid<br />
Hydrochloride (Articaine Acid Hydrochloride)<br />
O<br />
HO<br />
S<br />
H<br />
N<br />
O<br />
N<br />
H<br />
x HCl<br />
(A)<br />
50 mg<br />
MM 0369.03<br />
Imp. C (EP) as Hydrochloride: 1-Methylethyl 4-Methyl-3-<br />
[[(2RS)-2-(propylamino)propanoyl]amino]thiophene-2-<br />
carboxylate Hydrochloride (Articaine Isopropyl Ester<br />
Hydrochloride)<br />
O<br />
O<br />
S<br />
H<br />
N<br />
O<br />
N<br />
H<br />
x HCl<br />
(A)<br />
100 mg<br />
MM 0369.04<br />
Imp. D (EP) as Hydrochloride: Methyl 3-[[(2RS)-2-<br />
(Ethylamino)propanoyl]amino]-4-methylthiophene-2-<br />
carboxylate Hydrochloride (Ethylarticaine Hydrochloride)<br />
O<br />
O<br />
S<br />
H<br />
N<br />
O<br />
N<br />
H<br />
x HCl<br />
(A)<br />
100 mg<br />
168 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
<strong>Pharmac<strong>eu</strong>tical</strong> <strong>impurities</strong><br />
Code Product Category Unit<br />
MM 0369.05<br />
MM 0369.06<br />
MM 0369.07<br />
MM 0369.08<br />
Imp. E (EP) as Hydrochloride: Methyl 4-Methyl-3-[[(2RS)-2-<br />
[(1-methylethyl)amino]propanoyl]amino]thiophene-2-<br />
carboxylate Hydrochloride (Isopropylarticaine<br />
Hydrochloride)<br />
Imp. F (EP) as Hydrochloride: 4-Methyl-N-propyl-3-<br />
[[(2RS)-2-(propylamino)propanoyl]amino]thiophene-2-<br />
carboxamide Hydrochloride (Articaine Acid<br />
Propionamide Hydrochloride)<br />
Imp. G (EP) as Hydrochloride: Methyl 3-[[(2RS)-2-<br />
(Butylamino)propanoyl]amino]-4-methylthiophene-2-<br />
carboxylate Hydrochloride (Butylarticaine Hydrochloride)<br />
Imp. H (EP) as Hydrochloride: Methyl 3-[[(2RS)-2-<br />
(Dipropylamino)propanoyl]amino]-4-methylthiophene-2-<br />
carboxylate Hydrochloride (Dipropylarticaine Hydrochloride)<br />
MM 0369.09 Imp. I (EP): Methyl 3-Amino-4-methylthiophene-2-carboxylate (3-<br />
Aminoarticaine)<br />
O<br />
H<br />
N<br />
O<br />
O<br />
S<br />
S<br />
S<br />
S<br />
O<br />
O<br />
O<br />
O<br />
H<br />
N<br />
H<br />
N<br />
H<br />
N<br />
H<br />
N<br />
O<br />
O<br />
O<br />
O<br />
N<br />
H<br />
N<br />
H<br />
N<br />
H<br />
N<br />
O<br />
S<br />
x HCl<br />
x HCl<br />
x HCl<br />
x HCl<br />
NH 2<br />
(A)<br />
(A)<br />
(A)<br />
(A)<br />
100 mg<br />
50 mg<br />
100 mg<br />
100 mg<br />
O<br />
(C) 100 mg<br />
MM 0369.10<br />
Imp. J (EP): Methyl 3-[[(2RS)-2-Bromopropanoyl]amino]-4-<br />
methylthiophene-2-carboxylate (Bromo Compound)<br />
O<br />
S<br />
O<br />
H<br />
N<br />
O<br />
Br<br />
(A)<br />
100 mg<br />
Ascorbic Acid<br />
MM 0166.00 L-Ascorbic Acid<br />
Asparagine Monohydrate<br />
MM 0765.01 Phenylacetylasparagine<br />
OH<br />
HO<br />
O<br />
O<br />
HO OH<br />
(A) 500 mg<br />
O (A) 100 mg<br />
Aspartame<br />
O HN<br />
OH<br />
H 2 N<br />
O<br />
O NH<br />
MM 0314.00 Aspartame 2 H<br />
O<br />
(A) 500 mg<br />
N<br />
HO<br />
O<br />
O<br />
MM 0314.01<br />
Imp. A (EP): 2-(5-Benzyl-3,6-dioxopiperazin-2-yl)acetic Acid<br />
(Diketopiperazine)<br />
O<br />
HO<br />
O<br />
(A) 100 mg<br />
HN<br />
NH<br />
O<br />
O NH<br />
MM 0314.02 Imp. B (EP): L-Aspartyl-L-phenylalanine 2 H<br />
O<br />
(A) 100 mg<br />
HO<br />
O<br />
N<br />
OH<br />
MM 0314.03<br />
Imp. C (EP): Phenylalanine<br />
H 2 N<br />
O<br />
(B) 100 mg<br />
OH<br />
Aspartic Acid<br />
MM 0567.00<br />
Astemizole<br />
MM 0184.00<br />
Aspartic Acid<br />
Astemizole<br />
HN<br />
N<br />
N<br />
O<br />
(A) 500 mg<br />
NH 2<br />
OH<br />
HO<br />
O<br />
F<br />
(A) 250 mg<br />
N<br />
O<br />
MM 0184.13<br />
Desmethyl Astemizole Hydrochloride<br />
F<br />
N<br />
HN<br />
N<br />
N<br />
OH<br />
(A)<br />
100 mg<br />
x HCl<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 169
<strong>Pharmac<strong>eu</strong>tical</strong> <strong>impurities</strong><br />
Code Product Category Unit<br />
Atenolol<br />
MM 0013.00 Atenolol<br />
O<br />
O<br />
H 2N<br />
OH HN (A) 500 mg<br />
MM 0013.03<br />
Imp. A (EP): 2-(4-Hydroxyphenyl)acetamide<br />
O<br />
OH<br />
(B) 100 mg<br />
H 2N<br />
MM 0013.05<br />
Imp. B (EP): 2-[4-[(2RS)-2,3-<br />
Dihydroxypropoxy)phenyl]acetamide<br />
H 2N<br />
O<br />
O<br />
OH<br />
OH<br />
(A)<br />
100 mg<br />
MM 0013.01<br />
Imp. C (EP): 2-[4-[[(2RS)-Oxiran-2-yl]methoxy]phenyl]acetamide<br />
O<br />
O<br />
O<br />
(A) 100 mg<br />
H 2N<br />
MM 0013.06<br />
Imp. D (EP): 2-[4-[(2RS)-3-Chloro-2-<br />
hydroxypropoxy]phenyl]acetamide<br />
O<br />
H 2N<br />
O<br />
OH<br />
Cl<br />
(A)<br />
50 mg<br />
MM 0013.07<br />
Imp.E (EP): 2,2'-[2-Hydroxypropan-1,3-diylbis-<br />
(oxy-4,1-phenylene)]diacetamide<br />
H 2N<br />
O<br />
O<br />
OH<br />
(A) 50 mg<br />
O<br />
O<br />
NH 2<br />
MM 0013.02<br />
Imp. F (EP): 2,2'-[(1-Methylethyl)-iminobis(2-<br />
hydroxypropan-3,1-diyloxy-4,1-<br />
phenylene)]diacetamide<br />
H 2N<br />
O<br />
O<br />
OH<br />
N<br />
OH (A) 50 mg<br />
O<br />
O<br />
NH 2<br />
MM 0013.04<br />
Imp. G (EP): 2-[4-[(2RS)-2-Hydroxy-3-[(1-<br />
methylethyl)amino]propoxy]phenyl]acetic Acid<br />
O<br />
HO<br />
O<br />
OH HN (A) 50 mg<br />
MM 0013.08<br />
Imp. H (EP): 2-[4-[(2RS)-2-Hydroxy-3-[(1-<br />
methylethyl)amino]propoxy]phenyl]acetonitrile<br />
N<br />
O<br />
OH<br />
HN<br />
(A)<br />
100 mg<br />
MM 0013.13<br />
4-Hydroxyphenylacetic Acid<br />
O<br />
OH<br />
(B) 100 mg<br />
HO<br />
Atorvastatin Calcium<br />
MM 0400.00<br />
Atorvastatin Calcium<br />
O<br />
O<br />
on request<br />
OH<br />
OH<br />
H<br />
N<br />
O<br />
N<br />
F<br />
2<br />
Ca 2+<br />
MM 0400.04<br />
1,1-Dimethylethyl (4R-cis)-6-[2-[2-(4-Fluorophenyl)-5-(1-<br />
methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1-Hpyrrol-1-yl]ethyl]-2,2-dimethyl-1,3-dioxane-4-acetate<br />
O O<br />
(A) 100 mg<br />
O<br />
O<br />
N<br />
F<br />
H<br />
N<br />
O<br />
MM 0400.05<br />
1,1-Dimethylethyl (4R-cis)-6-Aminoethyl-2,2-dimethyl-1,3-<br />
dioxane-4-acetate<br />
O<br />
O<br />
O<br />
O<br />
NH 2<br />
(A) 100 mg<br />
Atracurium Besilate<br />
MM 0858.13<br />
Imp. J (EP): Methyl Benzenesulphonate<br />
O O<br />
(A) 100 mg<br />
S<br />
O<br />
Atropine<br />
MM 0289.18<br />
Atropine<br />
O<br />
H<br />
O<br />
H<br />
N<br />
(A)<br />
250 mg<br />
OH H<br />
<strong>and</strong> enantiomer<br />
170 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
<strong>Pharmac<strong>eu</strong>tical</strong> <strong>impurities</strong><br />
Code Product Category Unit<br />
MM 0289.00<br />
MM 0289.01<br />
MM 0289.15<br />
Atropine Sulphate<br />
Imp. A (EP) as Hydrochloride: (1R,3r,5S)-8-Methyl-8-<br />
azabicyclo[3.2.1]oct-3-yl 2-Phenylpropenoate<br />
Hydrochloride<br />
(Apoatropine Hydrochloride)<br />
O<br />
H<br />
Imp. C (EP): (2RS)-3-Hydroxy-2-phenylpropanoic Acid (Tropic Acid)<br />
OH<br />
O<br />
H<br />
(A) 500 mg<br />
H<br />
N<br />
O<br />
H<br />
O<br />
x H 2 SO 4<br />
x H 2 O<br />
<strong>and</strong> enantiomer<br />
2<br />
H<br />
(D) 100 mg<br />
H<br />
N<br />
x HCl<br />
O (A) 100 mg<br />
OH<br />
OH<br />
MM 0289.16<br />
Imp. F (EP) as Hydrobromide Trihydrate: Hyoscine<br />
Hydrobromide Trihydrate<br />
O<br />
H<br />
O<br />
H<br />
N<br />
H<br />
O<br />
x HBr<br />
x 3 H 2 O<br />
(A)<br />
500 mg<br />
OH<br />
H<br />
H<br />
MM 0289.03<br />
Atropic Acid<br />
O (A) 100 mg<br />
OH<br />
Avobenzone<br />
MM 0902.00 Avobenzone<br />
O O<br />
(A)<br />
500 mg<br />
O<br />
Azelaic Acid<br />
MM 0687.00 Azelaic Acid<br />
Azelastine Hydrochloride<br />
MM 0362.00 Azelastine Hydrochloride<br />
HO<br />
O O<br />
(A) 500 mg<br />
O<br />
N<br />
N<br />
N<br />
OH<br />
x HCl<br />
on request<br />
Cl<br />
MM 0362.04<br />
Imp. A (EP): Benzoyldiazane (Benzohydrazide)<br />
O<br />
NH<br />
NH 2<br />
(C) 100 mg<br />
MM 0362.02<br />
MM 0362.05<br />
Imp. B (EP) as Hydrochloride: 1-Benzoyl-2-[(4RS)-1-<br />
methylhexahydro-1H-azepin-4-yl]diazane Hydrochloride<br />
Imp. C (EP): 2-[(4-Chlorophenyl)acetyl]benzoic Acid<br />
H<br />
N<br />
N<br />
H<br />
O<br />
N<br />
x HCl<br />
O<br />
(A)<br />
(A)<br />
100 mg<br />
100 mg<br />
OH<br />
O<br />
Cl<br />
MM 0362.01<br />
Imp. D (EP): 4-(4-Chlorobenzyl)phthalazin-1(2H)-one<br />
O<br />
NH<br />
(A)<br />
100 mg<br />
N<br />
Cl<br />
MM 0362.06<br />
Imp. E (EP) Z-Isomer: (Z)-3-(4-Chlorobenzylidene)-<br />
isobenzofuran-1(3H)-one<br />
O<br />
O<br />
(A)<br />
100 mg<br />
Cl<br />
MM 0362.03<br />
1-Methylazepan-4-one Hydrochloride<br />
O<br />
N<br />
x HCl<br />
(A)<br />
100 mg<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 171
<strong>Pharmac<strong>eu</strong>tical</strong> <strong>impurities</strong><br />
Code Product Category Unit<br />
Bambuterol Hydrochloride<br />
MM 0773.04<br />
Imp. D (EP): 5-[(1RS)-1-Hydroxyethyl]-1,3-phenylene<br />
Bis(dimethylcarbamate)<br />
N<br />
O<br />
O<br />
OH<br />
(A)<br />
100 mg<br />
N<br />
O<br />
O<br />
MM 0773.05<br />
Imp. E (EP): 5-Acetyl-1,3-phenylene Bis-(dimethylcarbamate)<br />
N<br />
O<br />
O<br />
(A)<br />
100 mg<br />
O<br />
N<br />
O<br />
Basic Butylated Methacrylate Copolymer<br />
MM 0753.01 Imp. A (EP): Butyl Methacrylate<br />
O<br />
O<br />
O<br />
(A)<br />
100 mg<br />
MM 0753.02 Imp. B (EP): Methyl Methacrylate<br />
O<br />
O<br />
(A)<br />
100 mg<br />
MM 0753.03 Imp. C (EP): 2-(Dimethylamino)ethyl Methacrylate<br />
O<br />
O<br />
N<br />
(A)<br />
100 mg<br />
Beclometasone Dipropionate<br />
MM 0199.00<br />
Beclometasone Dipropionate<br />
O<br />
O<br />
O<br />
O<br />
(A) 250 mg<br />
HO<br />
O<br />
O<br />
Cl<br />
New MM 0199.06<br />
Imp. B (EP): 21-(Acetyloxy)-9-chloro-11βhydroxy-16β-methyl-3,20-dioxopregna-1,4-<br />
dien-17-yl Propanoate (Beclometasone 21-<br />
Acetate 17-Propionate)<br />
HO<br />
O<br />
O<br />
O<br />
O<br />
O<br />
(A)<br />
100 mg<br />
Cl<br />
O<br />
New MM 0199.01<br />
Imp. H (EP): 9-Chloro-11,21-dihydroxy-16methyl-3,20-dioxopregna-1,4-dien-17-yl<br />
Propanoate (Beclometasone 17-Propionate)<br />
HO<br />
O<br />
O<br />
OH<br />
O<br />
(A) 100 mg<br />
Cl<br />
O<br />
MM 0199.03<br />
Imp. G (EP): 9-Chloro-11β,17,21-trihydroxy-16βmethylpregna-1,4-diene-3,20-dione<br />
(Beclometasone)<br />
HO<br />
O<br />
OH<br />
OH<br />
(A) 100 mg<br />
Bendroflumethiazide<br />
MM 0674.01<br />
Imp. A (EP): 4-Amino-6-(trifluoromethyl)benzene-1,3-<br />
disulphonamide<br />
O<br />
Cl<br />
O O O<br />
H S S<br />
2 N<br />
NH 2<br />
F<br />
NH 2<br />
F F<br />
O (A) 100 mg<br />
Benperidol<br />
MM 0113.00<br />
Benperidol<br />
O<br />
N<br />
O<br />
(A) 100 mg<br />
N<br />
NH<br />
F<br />
MM 0113.03<br />
Imp. A (EP): 1-(Piperidin-4-yl)-1,3-dihydro-2Hbenzimidazol-2-one<br />
O<br />
(A) 100 mg<br />
N<br />
NH<br />
HN<br />
MM 0113.07<br />
4-Chloro-4'-fluorobutyrophenone<br />
O<br />
Cl<br />
(B)<br />
100 mg<br />
F<br />
172 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
<strong>Pharmac<strong>eu</strong>tical</strong> <strong>impurities</strong><br />
Code Product Category Unit<br />
Benzalkonium Chloride<br />
MM 0224.00 Benzalkonium Chloride<br />
Cl<br />
N<br />
n<br />
(A) 500 mg<br />
New MM 0224.04 Imp. A (Pharm<strong>eu</strong>ropa): Benzyl Alcohol OH (A) 500 mg<br />
New MM 0224.05 Imp. B (Pharm<strong>eu</strong>ropa): Benzaldehyde O (B) 100 mg<br />
MM 0224.01<br />
Benzyldimethyldodecylammonium Chloride<br />
N<br />
Cl<br />
5<br />
(A)<br />
500 mg<br />
MM 0224.02<br />
Benzyldimethyltetradecylammonium Chloride<br />
N<br />
Cl<br />
6<br />
(A)<br />
500 mg<br />
MM 0224.03<br />
Benzyldimethylhexadecylammonium Chloride<br />
N<br />
Cl<br />
7<br />
(A)<br />
500 mg<br />
Benzbromarone<br />
MM 0456.00 Benzbromarone<br />
O<br />
O<br />
Br<br />
Br<br />
OH<br />
(A)<br />
500 mg<br />
Benzocaine<br />
MM 0094.00<br />
Benzocaine<br />
O<br />
(A) 500 mg<br />
O<br />
H 2 N<br />
MM 0094.01<br />
Benzocaine Acetylsalicylamide<br />
O<br />
(A)<br />
100 mg<br />
O<br />
O<br />
N<br />
H<br />
O<br />
O<br />
MM 0094.02<br />
N-Acetylbenzocaine<br />
O<br />
(A)<br />
100 mg<br />
O<br />
O<br />
N<br />
H<br />
MM 0094.03<br />
4-Aminobenzoic Acid<br />
O<br />
(B) 100 mg<br />
OH<br />
H 2 N<br />
MM 0094.04<br />
Ethyl 4-Nitrobenzoate<br />
O<br />
(B) 100 mg<br />
O<br />
O 2 N<br />
Benzydamine Hydrochloride<br />
MM 0142.00<br />
Benzydamine Hydrochloride<br />
N<br />
N<br />
x HCl<br />
(A)<br />
500 mg<br />
O<br />
N<br />
New MM 0142.04<br />
Imp. C (BP): 1-Benzyl-1H-indazol-3-ol<br />
(A)<br />
100 mg<br />
N<br />
N<br />
OH<br />
MM 0142.08<br />
Benzydamine N-Oxide Hydrochloride<br />
(A)<br />
100 mg<br />
N<br />
N<br />
x HCl<br />
O<br />
N<br />
O<br />
MM 0142.05 1-Chloropropyl(dimethyl)amine Hydrochloride Cl N x HCl (B) 100 mg<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 173
<strong>Pharmac<strong>eu</strong>tical</strong> <strong>impurities</strong><br />
Code Product Category Unit<br />
Benzyl Alcohol<br />
MM 0795.00 Benzyl Alcohol OH (A) 500 mg<br />
MM 0795.01 Imp. A (EP): Benzaldehyde O (B) 100 mg<br />
MM 0795.02 Imp. B (EP): Cyclohexylmethanol OH (A) 100 mg<br />
Benzyl Benzoate<br />
MM 0570.00<br />
Benzyl Benzoate<br />
O<br />
(A) 500 mg<br />
O<br />
Benzyl Nicotinate<br />
MM 0104.00<br />
Benzyl Nicotinate<br />
N<br />
O<br />
(A) 500 mg<br />
O<br />
MM 0104.01<br />
Nicotinic Acid<br />
N<br />
O<br />
(A) 500 mg<br />
OH<br />
Benzylpenicillin Benzathine<br />
MM 0513.00<br />
Benzylpenicillin Benzathine<br />
MM 0513.02 Imp. A (EP): Monobenzylethylendiamine HN<br />
H<br />
N<br />
N<br />
H<br />
x<br />
O<br />
H<br />
N<br />
O<br />
N<br />
H<br />
O<br />
S<br />
OH<br />
2<br />
(A) 500 mg<br />
NH 2<br />
(C) 100 mg<br />
MM 0513.03 Imp. B (EP): Phenylacetic Acid [Controlled Substance]<br />
OH<br />
O<br />
(B)<br />
100 mg<br />
MM 0513.04<br />
MM 0513.05<br />
Imp. D (EP): (3S,7R,7aR)-5-Benzyl-2,2-dimethyl-2,3,7,7atetrahydroimidazo[5,1-b]-thiazole-3,7-dicarboxylic<br />
Acid (Penillic Acid<br />
of Benzylpenicillin)<br />
Imp. E (EP): (4S)-2-[Carboxy[(phenylacetyl)amino]methyl]-5,5-<br />
dimethylthiazolidine-4-carboxylic Acid (Penicilloic Acids of<br />
Benzylpenicillin)<br />
O<br />
N<br />
N<br />
S<br />
H<br />
HO<br />
O<br />
OH<br />
(A)<br />
100 mg<br />
O<br />
OH (A) 100 mg<br />
HN<br />
H<br />
N<br />
S<br />
O O OH<br />
MM 0513.06<br />
Imp. F (EP): (2RS,4S)-2-[[(Phenylacetyl)amino]methyl]-5,5-<br />
dimethylthiazolidine-4-carboxylic Acid (Penilloic Acids of<br />
Benzylpenicillin)<br />
H<br />
N<br />
O<br />
HN<br />
S<br />
OH<br />
(A)<br />
100 mg<br />
O<br />
MM 0513.01<br />
N,N’-Dibenzylethylenediamine Diacetate<br />
H<br />
N<br />
N<br />
H<br />
x<br />
HO<br />
O<br />
2<br />
(C)<br />
100 mg<br />
Benzylpenicillin Potassium<br />
MM 0160.00<br />
MM 0160.11<br />
Benzylpenicillin Potassium<br />
Imp. A (EP): (2S,5R,6R)-6-Amino-3,3-dimethyl-7-oxo-4-thia-1-<br />
azabicyclo[3.2.0]-heptane-2-carboxylic Acid (6-Aminopenicillanic Acid)<br />
MM 0160.03 Imp. B (EP): Phenylacetic Acid [Controlled Substance] O<br />
O<br />
O<br />
N<br />
H<br />
O<br />
H 2N<br />
O<br />
N<br />
S<br />
H<br />
O<br />
N<br />
S<br />
H<br />
OK (A) 250 mg<br />
OH (B) 100 mg<br />
OH<br />
(B)<br />
100 mg<br />
174 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
<strong>Pharmac<strong>eu</strong>tical</strong> <strong>impurities</strong><br />
Code Product Category Unit<br />
MM 0160.07<br />
MM 0160.01<br />
Imp. D (EP): (3S,7R,7aR)-5-Benzyl-2,2-dimethyl-2,3,7,7atetrahydroimidazo[5,1-b]-thiazole-3,7-dicarboxylic<br />
Acid (Penillic<br />
Acid of Benzylpenicillin)<br />
Imp. E (EP): (4S)-2-[Carboxy[(phenylacetyl)amino]methyl]-5,5-<br />
dimethyl-thiazolidine-4-carboxylic Acid (Penicilloic Acids of<br />
Benzylpenicillin)<br />
O<br />
N<br />
N<br />
S<br />
H<br />
HO<br />
O<br />
OH<br />
(A)<br />
100 mg<br />
O<br />
OH (A) 100 mg<br />
HN<br />
H<br />
N<br />
S<br />
O O OH<br />
MM 0160.05<br />
Imp. F (EP): (2RS,4S)-2-[[(Phenylacetyl)amino]methyl]-5,5-<br />
dimethylthiazolidine-4-carboxylic Acid (Penilloic Acids of<br />
Benzylpenicillin)<br />
H<br />
N<br />
O<br />
HN<br />
S<br />
OH<br />
(A)<br />
100 mg<br />
O<br />
Benzylpenicillin Procaine<br />
New MM 0302.01<br />
Imp. A (EP): 4-Aminobenzoic Acid<br />
O<br />
(B) 100 mg<br />
OH<br />
New MM 0302.02<br />
Imp. B (EP): (4S)-2-[Carboxy[(phenylacetyl)amino]methyl]-5,5-dimethylthiazolidine-4-carboxylic<br />
Acid<br />
(Penicilloic Acids of Benzylpenicillin)<br />
H 2 N<br />
O<br />
OH (A) 100 mg<br />
HN<br />
H<br />
N<br />
S<br />
O<br />
O OH<br />
New MM 0302.03<br />
Imp. C (EP): (2RS,4S)-2-[[(Phenylacetyl)-<br />
amino]methyl]-5,5-dimethylthiazolidine-4-<br />
carboxylic Acid (Penilloic Acids of<br />
Benzylpenicillin)<br />
O<br />
H<br />
N<br />
HN<br />
O<br />
S<br />
OH<br />
(A)<br />
100 mg<br />
New MM 0302.04<br />
Imp. D (EP): (3S,7R,7aR)-5-Benzyl-2,2-<br />
dimethyl-2,3,7,7a-tetrahydroimidazo[5,1-<br />
b]thiazole-3,7-dicarboxylic Acid (Penillic<br />
Acid of Benzylpenicillin)<br />
New MM 0302.05 Imp. E (EP): Phenylacetic Acid<br />
OH<br />
HO<br />
N<br />
O<br />
N<br />
H<br />
O<br />
S<br />
O<br />
OH<br />
(A)<br />
(B)<br />
100 mg<br />
100 mg<br />
Betahistine Dihydrochloride<br />
MM 0587.00 Betahistine Dihydrochloride<br />
N<br />
H<br />
N<br />
x 2 HCl<br />
(A)<br />
500 mg<br />
MM 0587.01 Imp. A (EP): 2-Ethenylpyridine (2-Vinylpyridine)<br />
N<br />
(C) 100 mg<br />
MM 0587.02 Imp. B (EP): 2-(Pyridin-2-yl)ethanol (2-(2-Hydroxyethyl)pyridine)<br />
N OH<br />
(B) 100 mg<br />
MM 0587.03<br />
Imp. C (EP) as Trihydrochloride: N-Methyl-2-(pyridin-2-<br />
yl)-N-[2-(pyridin-2-yl)ethyl]ethanamine Trihydrochloride<br />
N N N<br />
x 3 HCl<br />
(A)<br />
100 mg<br />
MM 0587.04<br />
Imp. C (EP) as Trimesilate: N-Methyl-2-(pyridin-2-yl)-<br />
N-[2-(pyridin-2-yl)ethyl]ethanamine Trimesilate<br />
N N N<br />
x 3<br />
O O<br />
(A) 100 mg<br />
S OH<br />
Betaine Hydrochloride<br />
MM 0611.00<br />
Betaine Hydrochloride<br />
N<br />
O<br />
OH<br />
Cl<br />
(A)<br />
500 mg<br />
Betamethasone<br />
MM 0200.00<br />
Betamethasone<br />
HO<br />
O<br />
OH<br />
OH<br />
(A)<br />
250 mg<br />
F<br />
O<br />
MM 0200.11<br />
Imp. A (EP): Dexamethasone<br />
HO<br />
O<br />
OH<br />
OH<br />
(A)<br />
250 mg<br />
F<br />
O<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 175
<strong>Pharmac<strong>eu</strong>tical</strong> <strong>impurities</strong><br />
Code Product Category Unit<br />
MM 0200.01<br />
Imp. B (EP): 21-Chloro-9-fluoro-11β,17-dihydroxy-16βmethylpregna-1,4-diene-3,20-dione<br />
(Clobetasol)<br />
HO<br />
O<br />
Cl<br />
OH<br />
(A)<br />
100 mg<br />
F<br />
O<br />
Betamethasone Acetate<br />
MM 0201.00<br />
Betamethasone Acetate<br />
HO<br />
O<br />
O<br />
OH<br />
O<br />
(A) 250 mg<br />
O<br />
F<br />
MM 0201.05<br />
Imp. A (EP): Betamethasone<br />
HO<br />
O<br />
OH<br />
OH (A) 250 mg<br />
O<br />
F<br />
MM 0201.02<br />
Imp. B (EP): Dexamethasone Acetate<br />
HO<br />
O<br />
O<br />
OH<br />
O<br />
(A) 250 mg<br />
MM 0201.03<br />
Imp. C (EP): Betamethasone 11,21-Diacetate<br />
F<br />
O<br />
O O<br />
O<br />
(A) 100 mg<br />
O<br />
O<br />
OH<br />
F<br />
O<br />
Betamethasone Dipropionate<br />
MM 0202.00<br />
Betamethasone Dipropionate<br />
O<br />
O<br />
O<br />
O<br />
(A)<br />
250 mg<br />
HO<br />
O<br />
O<br />
F<br />
MM 0202.04<br />
Betamethasone 21-Propionate<br />
O<br />
O<br />
O<br />
(A) 100 mg<br />
HO<br />
OH<br />
F<br />
O<br />
Betamethasone Sodium Phosphate<br />
MM 0303.00<br />
Betamethasone Sodium Phosphate<br />
O<br />
O<br />
O<br />
P ONa<br />
ONa<br />
on request<br />
HO<br />
OH<br />
O<br />
F<br />
Betamethasone 17-Valerate<br />
MM 0203.00<br />
Betamethasone 17-Valerate<br />
O<br />
OH<br />
O<br />
(A) 250 mg<br />
HO<br />
O<br />
O<br />
F<br />
New MM 0203.02<br />
Imp. A (Pharm<strong>eu</strong>ropa): (11β,16β)-9-Fluoro-<br />
11,17,21-trihydroxy-16-methylpregna-1,4-<br />
diene-3,20-dione (Betamethasone)<br />
HO<br />
O<br />
OH<br />
OH<br />
(A) 250 mg<br />
F<br />
O<br />
Betaxolol Hydrochloride<br />
MM 0436.00<br />
Betaxolol Hydrochloride<br />
O<br />
OH<br />
HN<br />
on request<br />
O<br />
x HCl<br />
176 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
<strong>Pharmac<strong>eu</strong>tical</strong> <strong>impurities</strong><br />
Code Product Category Unit<br />
MM 0436.02 Imp. B (EP): (2RS)-1-[4-(2-Hydroxyethyl)phenoxy]-<br />
OH<br />
HN (A) 100 mg<br />
3-[(1-methylethyl)amino]propan-2-ol<br />
O<br />
HO<br />
Bezafibrate<br />
MM 0063.00<br />
Bezafibrate<br />
O<br />
O<br />
O<br />
(A) 500 mg<br />
OH<br />
Cl<br />
N<br />
H<br />
MM 0063.01<br />
Imp. A (EP): 4-Chloro-N-[2-(4-<br />
hydroxyphenyl)ethyl]benzamide (4-Chlorobenzoyltyramine)<br />
Cl<br />
O<br />
N<br />
H<br />
OH<br />
(A) 100 mg<br />
MM 0063.03<br />
Imp. B (EP): 4-Chlorobenzoic Acid<br />
O<br />
OH<br />
(B)<br />
100 mg<br />
Cl<br />
MM 0063.04 Imp. C (EP): Methyl 2-[4-[2-[(4-<br />
Chlorobenzoyl)amino]ethyl]phenoxy]-2-<br />
methylpropanoate<br />
Cl<br />
O<br />
N<br />
H<br />
O<br />
O<br />
(A) 100 mg<br />
O<br />
MM 0063.02<br />
Imp. D (EP): Ethyl 2-[4-[2-[(4-Chlorobenzoyl)amino]-<br />
ethyl]phenoxy]-2-methylpropanoate<br />
Cl<br />
O<br />
N<br />
H<br />
O<br />
O<br />
(A) 100 mg<br />
O<br />
MM 0063.05<br />
Imp. E (EP): Butyl 2-[4-[2-[(4-Chlorobenzoyl)amino]-<br />
ethyl]phenoxy]-2-methylpropanoate<br />
Cl<br />
O<br />
N<br />
H<br />
O<br />
O<br />
(A) 100 mg<br />
O<br />
MM 0063.06<br />
Tyramine<br />
OH<br />
(B) 100 mg<br />
H 2N<br />
MM 0063.07<br />
N,O-Bis-(4-chlorobenzoyl)tyramine<br />
Cl<br />
O<br />
N<br />
H<br />
O<br />
O<br />
Cl<br />
(A) 100 mg<br />
Bicalutamide<br />
MM 0894.00 Bicalutamide F<br />
S<br />
O O<br />
O<br />
OH<br />
N<br />
H<br />
F<br />
N<br />
F<br />
F<br />
(A)<br />
100 mg<br />
Bifonazole<br />
MM 0318.00<br />
Bifonazole<br />
(A)<br />
500 mg<br />
N<br />
N<br />
MM 0318.01<br />
Imp. A (EP): (RS)-(Biphenyl-4-yl)phenylmethanol<br />
(A)<br />
100 mg<br />
OH<br />
MM 0318.04<br />
Imp. C (EP): 1H-Imidazole<br />
H<br />
N (B) 100 mg<br />
N<br />
MM 0318.03<br />
Imp. D (EP) as Chloride: 1,3-Bis[(biphenyl-4-yl)phenylmethyl]-<br />
1H-imidazolium Chloride<br />
N + N<br />
Cl - (D) 100 mg<br />
Bisacodyl<br />
MM 0031.00<br />
Bisacodyl<br />
O<br />
O<br />
O<br />
O<br />
(A)<br />
500 mg<br />
N<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 177
<strong>Pharmac<strong>eu</strong>tical</strong> <strong>impurities</strong><br />
Code Product Category Unit<br />
MM 0031.01 Imp. A (EP): 4,4'-(Pyridin-2-ylmethylene)diphenol<br />
HO OH<br />
(A) 100 mg<br />
N<br />
MM 0031.04<br />
Imp. B (EP): 2-[(RS)-(4-Hydroxyphenyl)(pyridin-2-yl)<br />
methyl]phenol<br />
OH OH<br />
(A) 50 mg<br />
N<br />
MM 0031.02<br />
Imp. C (EP): 4-[(RS)-(4-Hydroxyphenyl)(pyridin-2-<br />
yl)methyl]phenyl Acetate<br />
HO<br />
O<br />
O<br />
(A)<br />
100 mg<br />
N<br />
MM 0031.03<br />
Imp. E (EP): 2-[(RS)-[4-(Acetyloxy)phenyl](pyridin-2-<br />
yl)methyl]phenyl Acetate<br />
O<br />
O<br />
O<br />
(A)<br />
50 mg<br />
O<br />
N<br />
MM 0031.05<br />
Sodium 4-[(4-Hydroxyphenyl)-(2-pyridinyl)methyl]phenyl<br />
Hydrogensulphate<br />
HO<br />
O<br />
S<br />
ONa<br />
O<br />
O<br />
(A)<br />
100 mg<br />
N<br />
MM 0031.06<br />
Disodium 2,4'-(2-Pyridinylmethylene)bisphenyl<br />
Bis(hydrogensulphate)<br />
NaO O<br />
S<br />
O O<br />
(D)<br />
50 mg<br />
N<br />
O ONa<br />
S<br />
O O<br />
Bisoprolol Hemifumarate<br />
MM 0460.00<br />
Bisoprolol<br />
O<br />
OH<br />
H<br />
N<br />
(A)<br />
100 mg<br />
O<br />
O<br />
MM 0460.08<br />
Bisoprolol Hemifumarate<br />
O<br />
OH<br />
HN<br />
O<br />
OH<br />
(A)<br />
100 mg<br />
x 1/2<br />
O<br />
O<br />
HO<br />
O<br />
MM 0460.01<br />
Imp. A (Pharm<strong>eu</strong>ropa): (RS)-1-(4-Hydroxymethylphenoxy)-<br />
3-isopropylaminopropan-2-ol<br />
O<br />
OH<br />
HN<br />
(A)<br />
100 mg<br />
OH<br />
MM 0460.07<br />
Imp. B (Pharm<strong>eu</strong>ropa): (RS)-1-Isopropylamino-3-[4-(2-<br />
propoxyethoxymethyl)phenoxy]propan-2-ol<br />
O<br />
OH<br />
HN<br />
(A)<br />
100 mg<br />
MM 0460.15<br />
New MM 0460.21<br />
Imp. C (Pharm<strong>eu</strong>ropa): (RS)-1-[4-[4-(2-<br />
Hydroxy-3-isopropopylaminopropoxy)-<br />
benzyl]phenoxy]-3-<br />
isopropylaminopropan-2-ol<br />
Imp. G (Pharm<strong>eu</strong>ropa): (2RS)-1-[4-(((2-Isopropoxyethoxy)methoxy)methyl)phenoxy]-3-(isopropylamino)-2-propanol<br />
H<br />
N<br />
O<br />
O<br />
OH OH<br />
O<br />
O<br />
HN (A) 100 mg<br />
O<br />
OH<br />
HN<br />
(D)<br />
100 mg<br />
O<br />
O<br />
O<br />
MM 0460.24<br />
Imp. J (Pharm<strong>eu</strong>ropa): (2RS)-3-[4-((2-<br />
Isopropoxyethoxy)methyl)phenoxy]-1,2-propanediol<br />
O<br />
O<br />
O<br />
OH<br />
OH<br />
(A)<br />
100 mg<br />
New MM 0460.18 Imp. K (Pharm<strong>eu</strong>ropa): 2-Isopropoxyethyl 4-<br />
[((2RS)-2-Hydroxy-3-(isopropylamino)propyl)-<br />
oxy]benzoate (Bisoprolol Ester)<br />
O<br />
O<br />
O<br />
OH<br />
HN<br />
(A)<br />
100 mg<br />
O<br />
178 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
<strong>Pharmac<strong>eu</strong>tical</strong> <strong>impurities</strong><br />
Code Product Category Unit<br />
MM 0460.09<br />
Imp. L (Pharm<strong>eu</strong>ropa) as Hydrochloride: 4-[((2RS)-2-<br />
Hydroxy-3-(isopropylamino)-propyl)oxy]benzaldehyde<br />
Hydrochloride<br />
O<br />
OH<br />
HN<br />
x HCl<br />
(A)<br />
100 mg<br />
O<br />
MM 0460.02<br />
Imp. M (Pharm<strong>eu</strong>ropa): 4-[(2-Isopropoxyethoxy)<br />
methyl]phenol<br />
O<br />
O<br />
OH<br />
(A)<br />
100 mg<br />
MM 0460.25<br />
Imp. N (Pharm<strong>eu</strong>ropa): (2RS)-1-[4-((2-<br />
Ethoxyethoxy)methyl)phenoxy]-3-(isopropylamino)-<br />
2-propanol<br />
O<br />
O<br />
O<br />
OH<br />
HN<br />
(A)<br />
100 mg<br />
MM 0460.05<br />
Imp. Q (Pharm<strong>eu</strong>ropa): (2RS)-1-Isopropylamino-3-[4-<br />
(2-methoxyethoxy)methyl]-<br />
phenoxy-2-propanol<br />
O<br />
O<br />
O<br />
OH<br />
HN<br />
(A)<br />
100 mg<br />
MM 0460.03 2-[4-(2-Isopropoxyethoxymethyl)phenoxymethyl]oxirane O<br />
O<br />
(A) 100 mg<br />
O<br />
O<br />
MM 0460.06 4-Hydroxybenzyl Alcohol<br />
OH<br />
HO<br />
(B)<br />
100 mg<br />
MM 0460.10<br />
Fumaric Acid<br />
HO<br />
O<br />
O<br />
(B) 100 mg<br />
OH<br />
MM 0460.14 4-Hydroxybenzaldehyde<br />
OH<br />
Boldenone<br />
O<br />
(C)<br />
100 mg<br />
MM 0864.00<br />
Boldenone<br />
OH<br />
(A) 100 mg<br />
O<br />
Bromazepam<br />
MM 0064.00<br />
Bromazepam [Controlled Substance]<br />
H<br />
N<br />
O<br />
(A)<br />
100 mg<br />
Br<br />
N<br />
N<br />
MM 0064.01<br />
Imp. A (EP): (2-Amino-5-bromophenyl)(pyridin-2-yl)methanone<br />
(A)<br />
100 mg<br />
NH 2<br />
O<br />
Br<br />
N<br />
Bromhexine Hydrochloride<br />
MM 0065.00 Bromhexine Hydrochloride<br />
Br<br />
(A)<br />
500 mg<br />
Br<br />
N<br />
x HCl<br />
NH 2<br />
MM 0065.06<br />
Imp. A (EP): (2-Amino-3,5-dibromophenyl)methanol<br />
Br<br />
OH (A) 100 mg<br />
Br<br />
NH 2<br />
MM 0065.07<br />
Imp. B (EP): 2-Amino-3,5-dibromobenzaldehyde<br />
Br<br />
O (A) 100 mg<br />
Br<br />
NH 2<br />
MM 0065.02<br />
Imp. C (EP): N-(2-Aminobenzyl)-N-methylcyclohexanamine<br />
(A)<br />
100 mg<br />
N<br />
NH 2<br />
MM 0065.03<br />
Imp. D (EP) as Dihydrochloride: N-(2-Amino-5-bromobenzyl)-Nmethylcyclohexanamine<br />
Dihydrochloride<br />
Br<br />
N<br />
x 2 HCl<br />
(A)<br />
100 mg<br />
NH 2<br />
MM 0065.01<br />
N-(2-Nitrobenzyl)-N-cyclohexyl-N-methylamine<br />
N<br />
(A)<br />
100 mg<br />
NO 2<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 179
<strong>Pharmac<strong>eu</strong>tical</strong> <strong>impurities</strong><br />
Code Product Category Unit<br />
MM 0065.05 6,8-Dibromo-3-cyclohexyl-3,4-dihydro-2(1H)-quinazolinone<br />
Br<br />
(A)<br />
100 mg<br />
Br<br />
HN<br />
N<br />
O<br />
MM 0065.09 Bromhexine N-Oxide<br />
Br<br />
(A)<br />
100 mg<br />
Br<br />
NH 2<br />
N<br />
O<br />
Bromisoval<br />
MM 1128.01<br />
Ethyl 2-Bromoisovalerate<br />
O<br />
(A) 100 mg<br />
O<br />
Br<br />
Brompheniramine<br />
MM 0271.00 Brompheniramine<br />
Br<br />
(A)<br />
100 mg<br />
N<br />
N<br />
Brompheniramine Maleate<br />
MM 0060.00 Brompheniramine Maleate O<br />
MM 0060.13 Imp. A (EP) as Maleate: Chlorphenamine Maleate O<br />
MM 0060.15 Imp. B (EP) as Maleate: Dexchlorpheniramine Maleate O<br />
MM 0060.11<br />
Imp. C (EP): (3RS)-N,N-Dimethyl-3-phenyl-3-(pyridin-2-yl)-<br />
propan-1-amine (Pheniramine)<br />
Br<br />
Cl<br />
Cl<br />
N<br />
N<br />
N<br />
N<br />
N<br />
N<br />
x<br />
x<br />
x<br />
N<br />
O<br />
O<br />
O<br />
OH<br />
OH<br />
OH<br />
OH<br />
OH<br />
OH<br />
(A)<br />
(A)<br />
(A)<br />
(A)<br />
500 mg<br />
500 mg<br />
100 mg<br />
100 mg<br />
N<br />
MM 0060.14<br />
Imp. C (EP) as Maleate: (3RS)-N,N-Dimethyl-<br />
3-phenyl-3-(pyridin-2-yl)propan-1-amine<br />
Maleate (Pheniramine Maleate)<br />
N<br />
N<br />
x<br />
O<br />
OH<br />
OH<br />
(A)<br />
100 mg<br />
O<br />
MM 0060.12<br />
Brompheniramine N-Oxide<br />
on request<br />
N<br />
N<br />
O<br />
MM 0060.16 Desmethylbrompheniramine Maleate O<br />
Buclizine Hydrochloride<br />
Br<br />
Br<br />
N<br />
N<br />
H<br />
x<br />
O<br />
OH<br />
OH<br />
(A)<br />
100 mg<br />
MM 0475.01<br />
Imp. A (BP): 1,4-Bis(4-chlorobenzhydryl)piperazine<br />
(A)<br />
100 mg<br />
Cl<br />
N<br />
N<br />
Cl<br />
180 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
<strong>Pharmac<strong>eu</strong>tical</strong> <strong>impurities</strong><br />
Code Product Category Unit<br />
MM 0475.02 4-Chlorobenzhydrol<br />
Cl<br />
(B) 100 mg<br />
OH<br />
MM 0475.03<br />
4-Chlorobenzophenone<br />
Cl<br />
(B) 100 mg<br />
O<br />
Cl<br />
MM 0475.04 1-(4-Chlorobenzhydryl)piperazine NH (A) 100 mg<br />
N<br />
Budesonide<br />
New MM 0204.01<br />
Imp. A (EP): 11β,16α,17,21-Tetrahydroxypregna-1,4-diene-3,20-dione<br />
(16α-Hydroxyprednisolone)<br />
HO<br />
O<br />
OH OH<br />
OH<br />
(A)<br />
100 mg<br />
O<br />
Bufexamac<br />
MM 0179.00<br />
Bufexamac<br />
H<br />
N OH<br />
(A)<br />
500 mg<br />
O<br />
O<br />
MM 0179.01<br />
Imp. A (EP): 2-(4-Butoxyphenyl)acetic Acid<br />
O<br />
OH<br />
O<br />
(A)<br />
100 mg<br />
MM 0179.02<br />
Imp. B (EP): Methyl 2-(4-Butoxyphenyl)acetate<br />
O<br />
O<br />
O<br />
(A)<br />
100 mg<br />
MM 0179.03<br />
Imp. C (EP): Butyl 2-(4-Butoxyphenyl)acetate<br />
O<br />
O<br />
O<br />
(A)<br />
100 mg<br />
MM 0179.04<br />
Imp. D (EP): 2-(4-Butoxyphenyl)acetamide<br />
O<br />
NH 2<br />
O<br />
(A)<br />
100 mg<br />
MM 0179.05<br />
4'-Butoxyacetophenone<br />
O<br />
(A) 100 mg<br />
MM 0179.06<br />
Buflomedil Hydrochloride<br />
MM 0066.00<br />
MM 0066.01<br />
MM 0066.02<br />
MM 0066.03<br />
Ethyl 2-(4-Butoxyphenyl)acetate<br />
Buflomedil Hydrochloride<br />
Imp. A (EP) as Hydrochloride: 4-(Pyrrolidin-<br />
1-yl)-1-(2-hydroxy-4,6-dimethoxyphenyl)-<br />
butan-1-one Hydrochloride<br />
(o-Desmethyl-Buflomedil Hydrochloride)<br />
Imp. B (EP) as Hydrochloride: 4-(Pyrrolidin-1-yl)-1-(4-<br />
hydroxy-2,6-dimethoxyphenyl)butan-1-one Hydrochloride<br />
(p-Desmethyl-Buflomedil Hydrochloride)<br />
4-(1-Pyrrolidino)butyronitrile<br />
O<br />
O<br />
HO<br />
O<br />
OH<br />
O<br />
O<br />
O<br />
O<br />
O<br />
O<br />
O<br />
O<br />
O<br />
N<br />
N<br />
N<br />
O<br />
O<br />
x HCl<br />
x HCl<br />
x HCl<br />
(A)<br />
(A)<br />
(A)<br />
on request<br />
500 mg<br />
100 mg<br />
100 mg<br />
N (C) 100 mg<br />
N<br />
MM 0066.05 1,3,5-Trimethoxybenzene O<br />
(C)<br />
100 mg<br />
O<br />
O<br />
Bunolol Hydrochloride<br />
MM 0642.00<br />
Bunolol Hydrochloride<br />
O<br />
O<br />
OH HN<br />
x HCl<br />
(A)<br />
100 mg<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 181
<strong>Pharmac<strong>eu</strong>tical</strong> <strong>impurities</strong><br />
Code Product Category Unit<br />
Buphenine Hydrochloride<br />
MM 0710.00 Buphenine Hydrochloride<br />
OH<br />
(A) 500 mg<br />
HO<br />
HN<br />
x HCl<br />
Bupivacaine Hydrochloride<br />
MM 0613.00<br />
Bupivacaine Hydrochloride Monohydrate<br />
H<br />
N<br />
O<br />
N<br />
x HCl<br />
x H 2 O<br />
(A)<br />
500 mg<br />
MM 0613.06<br />
Imp. F (EP): 2,6-Dimethylaniline<br />
NH 2<br />
(B) 100 mg<br />
MM 0613.07<br />
Bupivacaine N-Oxide<br />
H<br />
N<br />
O<br />
N<br />
O<br />
(A) 100 mg<br />
Bupropion Hydrochloride<br />
MM 0745.00<br />
Bupropion Hydrochloride<br />
Cl<br />
O<br />
H<br />
N<br />
x HCl<br />
(A)<br />
100 mg<br />
MM 0745.02 2-(tert-Butylamino)-4'-chloropropiophenone Hydrochloride O<br />
H<br />
N<br />
x HCl<br />
(A)<br />
100 mg<br />
Cl<br />
MM 0745.03 2-(tert-Butylamino)-3'-bromopropiophenone Hydrochloride O<br />
Br<br />
H<br />
N<br />
x HCl<br />
(A)<br />
100 mg<br />
MM 0745.05 2-(tert-Butylamino)propiophenone Hydrochloride<br />
O<br />
H<br />
N<br />
x HCl<br />
(A)<br />
100 mg<br />
MM 0745.08<br />
3-Chloropropiophenone<br />
Cl<br />
O<br />
(B) 100 mg<br />
Buspirone Hydrochloride<br />
MM 0464.00 Buspirone Hydrochloride O<br />
N<br />
(A)<br />
500 mg<br />
N<br />
O<br />
N<br />
N<br />
N<br />
x HCl<br />
New MM 0464.02<br />
Imp. A (EP) as Dihydrochloride: 2-(Piperazin-<br />
1-yl)pyrimidine Dihydrochloride<br />
HN<br />
N<br />
N<br />
x 2 HCl<br />
(A)<br />
100 mg<br />
N<br />
MM 0464.08<br />
Imp. K (EP): 8-Azaspiro[4,5]-decane-7,9-dione<br />
O<br />
(B)<br />
100 mg<br />
NH<br />
Butenafine Hydrochloride<br />
MM 1041.00<br />
Butenafine Hydrochloride<br />
O<br />
on request<br />
N<br />
x HCl<br />
Butetamate Citrate<br />
MM 0606.00<br />
Butetamate Citrate<br />
O<br />
O<br />
N<br />
x<br />
O<br />
O<br />
OH<br />
OH<br />
O<br />
OH<br />
OH<br />
(A)<br />
500 mg<br />
Butyl Parahydroxybenzoate<br />
MM 0496.00<br />
Butyl Parahydroxybenzoate<br />
O<br />
(A) 500 mg<br />
O<br />
HO<br />
182 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
<strong>Pharmac<strong>eu</strong>tical</strong> <strong>impurities</strong><br />
Code Product Category Unit<br />
MM 0496.01 Imp. A (EP): 4-Hydroxybenzoic Acid<br />
O<br />
(B) 100 mg<br />
OH<br />
HO<br />
MM0496.02<br />
Imp. B (EP): Methyl 4-Hydroxybenzoate<br />
O<br />
(A) 500 mg<br />
O<br />
HO<br />
MM 0496.03<br />
Imp. C (EP): Ethyl 4-Hydroxybenzoate<br />
O<br />
(A) 500 mg<br />
O<br />
HO<br />
MM 0496.04<br />
Imp. D (EP): Propyl 4-Hydroxybenzoate<br />
O<br />
(A) 500 mg<br />
O<br />
HO<br />
MM 0496.05<br />
Isobutyl Parahydroxybenzoate<br />
O<br />
(A) 100 mg<br />
O<br />
HO<br />
Butylhydroxytoluene<br />
MM 0679.00<br />
Butylhydroxytoluene<br />
(A)<br />
500 mg<br />
OH<br />
Caffeine<br />
MM 0494.00<br />
Caffeine<br />
O<br />
N<br />
N<br />
(A)<br />
500 mg<br />
O<br />
N<br />
N<br />
MM 0494.01<br />
Imp. A (EP): Theophylline<br />
N<br />
O N<br />
O<br />
(A) 500 mg<br />
H<br />
N<br />
N<br />
MM 0494.02<br />
Imp. B (EP): N-[6-Amino-1,3-dimethyl-2,4(1H,3H)-dioxopyrimidin-5-<br />
yl]formamide<br />
O<br />
N<br />
H<br />
N<br />
O<br />
on request<br />
O<br />
N<br />
NH 2<br />
MM 0494.03<br />
Imp. C (EP): 1,3,9-Trimethyl-3,9-dihydro-1H-purine-2,6-dione (Isocaffeine)<br />
O<br />
N<br />
N<br />
(A)<br />
50 mg<br />
O<br />
N<br />
N<br />
MM 0494.08<br />
Imp. D (Pharm<strong>eu</strong>ropa): 3,7-Dimethyl-3,7-dihydro-1H-purine-2,6-dione<br />
(Theobromine)<br />
O<br />
HN<br />
N<br />
(A)<br />
500 mg<br />
O<br />
N<br />
N<br />
MM 0494.06<br />
O<br />
Imp. E (Pharm<strong>eu</strong>ropa) as Nitrate: N,1-Dimethyl-4-(methylamino)-<br />
1H-imidazole-5-carboxamide Nitrate (Caffeidine Nitrate)<br />
N<br />
N<br />
H<br />
HN N<br />
x HNO 3<br />
(A) 100 mg<br />
MM 0494.04<br />
Captopril<br />
MM 0067.00<br />
Imp. F (Pharm<strong>eu</strong>ropa): 1,7-Dimethyl-3,7-dihydro-1H-purine-2,6-<br />
dione(Paraxanthine; 1,7-Dimethylxanthine)<br />
Captopril<br />
HS<br />
O<br />
N<br />
O<br />
N<br />
H<br />
N<br />
N<br />
N<br />
(D)<br />
50 mg<br />
O O OH (A) 500 mg<br />
MM 0067.01<br />
Imp. A (EP): (2S,2'S)-1,1'-[Disulphanediyl-bis[(2S)-2-<br />
methyl-1-oxopropane-3,1-diyl]-bis[pyrrolidine-2-carboxylic]<br />
Acid (Captopril-Disulphide)<br />
HO<br />
N<br />
O<br />
O<br />
S<br />
S<br />
O O<br />
N<br />
OH<br />
(A)<br />
100 mg<br />
MM 0067.02<br />
Imp. C (Pharm<strong>eu</strong>ropa): (2RS)-2-Methyl-3-sulphanylpropanoic Acid<br />
HS<br />
O<br />
(A) 100 mg<br />
OH<br />
MM 0067.06 Imp. D (Pharm<strong>eu</strong>ropa): (2RS)-3-Bromo-2-methylpropanoic Acid<br />
O<br />
Br<br />
OH<br />
(A)<br />
100 mg<br />
MM 0067.08<br />
Imp. E (Pharm<strong>eu</strong>ropa): (2S)-1-[2-Methylpropanoyl]-<br />
pyrrolidine-2-carboxylic Acid<br />
O O OH (A) 100 mg<br />
N<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 183
<strong>Pharmac<strong>eu</strong>tical</strong> <strong>impurities</strong><br />
Code Product Category Unit<br />
MM 0067.03 Captopril Ethyl Ester<br />
O O O on request<br />
HS<br />
N<br />
MM 0067.04<br />
(S)-(-)-3-Acetylthio-2-methylpropanoic Acid<br />
O O<br />
(C) 100 mg<br />
S<br />
OH<br />
MM 0067.05<br />
(2S)-1-[(2S)-3-Acetylthio-2-methylpropanoyl]pyrrolidine-2-<br />
carboxylic Acid Hydrate (S-Acetylcaptopril Hydrate)<br />
O<br />
S<br />
O O<br />
N<br />
OH<br />
x H 2 O<br />
(A)<br />
100 mg<br />
Carbamazepine<br />
MM 0076.00 Carbamazepine O<br />
(A)<br />
250 mg<br />
N<br />
NH 2<br />
MM 0076.04<br />
Imp. A (EP): 10,11-Dihydro-5H-dibenzo[b,f]-azepine-5-carboxamide<br />
(10,11-Dihydrocarbamazepine)<br />
N<br />
O<br />
NH 2<br />
(A)<br />
100 mg<br />
MM 0076.09<br />
Imp. B (EP): 9-Methylacridine<br />
(A)<br />
100 mg<br />
N<br />
MM 0076.12<br />
Imp. C (EP): (5H-Dibenzo[b,f]azepin-5-yl-carbonyl)urea(N-<br />
Carbamoylcarbamazepine)<br />
O<br />
N N NH 2<br />
H<br />
O (A) 100 mg<br />
MM 0076.08<br />
Imp. D (EP): 5H-Dibenzo[b,f]azepine (Iminostilbene)<br />
(B)<br />
100 mg<br />
NH<br />
MM 0076.06<br />
Imp. E (EP): 10,11-Dihydro-5H-dibenzo[b,f]-azepine (Iminodibenzyl)<br />
(B)<br />
100 mg<br />
NH<br />
MM 0076.01 Carbamazepine 10,11-Epoxide O<br />
(A)<br />
100 mg<br />
N<br />
NH 2<br />
O<br />
MM 0076.05 10-Bromocarbamazepine O<br />
(A)<br />
100 mg<br />
N<br />
NH 2<br />
MM 0076.10 10-Hydroxy-10,11-dihydrocarbamazepine O<br />
Br<br />
(A)<br />
100 mg<br />
N<br />
NH 2<br />
MM 0076.17 Oxcarbazepine O<br />
HO<br />
(A)<br />
100 mg<br />
N<br />
NH 2<br />
O<br />
Carbasalate Calcium<br />
MM 0353.01<br />
Imp. A (EP): 2-(Acetyloxy)benzoic Anhydride (Acetylsalicylic<br />
Anhydride)<br />
O O O<br />
O<br />
(A)<br />
100 mg<br />
O<br />
O<br />
O<br />
184 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
<strong>Pharmac<strong>eu</strong>tical</strong> <strong>impurities</strong><br />
Code Product Category Unit<br />
MM 0353.02 Imp. B (EP): 2-[[2-(Acetyloxy)benzoyl]oxy]benzoic Acid<br />
O<br />
(A) 100 mg<br />
(Acetylsalicylsalicylic Acid)<br />
OH O<br />
O<br />
O<br />
O<br />
MM 0353.03<br />
Imp. C (EP): 2-Hydroxybenzoic Acid (Salicylic Acid)<br />
O<br />
(A)<br />
500 mg<br />
OH<br />
Carbendazim<br />
MM 2500.00<br />
MM 2500.01<br />
MM 2500.02<br />
Carbendazim<br />
2,3-Diaminophenazine<br />
2-Amino-3-hydroxyphenazine<br />
H<br />
N<br />
N<br />
N<br />
NH<br />
OH<br />
O<br />
(A) 100 mg<br />
O<br />
N NH 2<br />
N NH 2<br />
NH 2<br />
(A) 100 mg<br />
(A)<br />
100 mg<br />
N<br />
OH<br />
Carbenicillin Sodium<br />
MM 0805.00<br />
Carbenicillin Sodium<br />
O<br />
O<br />
N<br />
O<br />
ONa<br />
(A)<br />
250 mg<br />
Carbocisteine<br />
MM 0236.00<br />
MM 0236.01<br />
MM 0236.02<br />
Carbocisteine<br />
O<br />
N<br />
H<br />
ONa<br />
HO<br />
O<br />
S<br />
H<br />
S<br />
O<br />
OH<br />
NH 2<br />
(S)-Carboxymethyl-L-cysteine<br />
(R/S)-Sulphoxide<br />
HO<br />
S OH<br />
Lactam of (S)-Carboxymethyl-L-cysteine<br />
O<br />
O<br />
S<br />
NH 2<br />
O<br />
NH<br />
OH<br />
(A)<br />
(A)<br />
500 mg<br />
100 mg<br />
O<br />
(A) 100 mg<br />
O<br />
MM 0236.03<br />
L-Cysteinesulfinic Acid<br />
HO<br />
S<br />
O<br />
O<br />
OH<br />
NH 2<br />
(C)<br />
100 mg<br />
Carisoprodol<br />
MM 0782.03 Imp. C (EP): 2-Methyl-2-propylpropane-1,3-diol HO OH (A) 100 mg<br />
Carteolol Hydrochloride<br />
MM 0437.00<br />
Carteolol Hydrochloride<br />
O<br />
HN<br />
O<br />
OH<br />
HN<br />
x HCl<br />
on request<br />
Carvedilol<br />
MM 0291.00<br />
Carvedilol<br />
O<br />
OH<br />
H<br />
N<br />
O<br />
O<br />
(A)<br />
100 mg<br />
HN<br />
MM 0291.02<br />
Imp. B (EP): 1,1'-[[2-(2-<br />
Methoxyphenoxy)ethyl]nitrilo]bis[3-(9H-carbazol-4-<br />
yloxy)propan-2-ol]<br />
O<br />
OH<br />
N<br />
OH<br />
O<br />
O<br />
O<br />
NH<br />
(A)<br />
100 mg<br />
HN<br />
MM 0291.04 Imp. D (Pharm<strong>eu</strong>ropa): Toluene (C) 100 mg<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 185
<strong>Pharmac<strong>eu</strong>tical</strong> <strong>impurities</strong><br />
Code Product Category Unit<br />
New MM 0291.11 2-(2-Methoxyphenoxy)ethylamine Hydrochloride<br />
H 2 N<br />
O<br />
O x HCl<br />
(A) 100 mg<br />
MM 0291.10<br />
4-(2,3-Epoxypropoxy)carbazole<br />
O<br />
O<br />
(A) 100 mg<br />
HN<br />
Cefaclor<br />
MM 0326.00<br />
Cefaclor Monohydrate<br />
NH 2<br />
O<br />
H<br />
N<br />
O<br />
O OH<br />
Cl<br />
N<br />
S<br />
H<br />
x H 2 O<br />
(A)<br />
100 mg<br />
MM 0326.07<br />
MM 0326.08<br />
Imp. A (EP): (2R)-2-Amino-2-phenylacetic Acid (D-Phenylglycine)<br />
Imp. F (EP): 3-Phenylpyrazin-2-ol<br />
N<br />
NH 2<br />
(B) 100 mg<br />
OH<br />
O<br />
N OH<br />
(A) 100 mg<br />
Cefadroxil Monohydrate<br />
MM 0972.01<br />
Imp. A (EP): (2R)-2-Amino-2-(4-hydroxyphenyl)acetic Acid<br />
NH 2<br />
OH<br />
(B)<br />
100 mg<br />
MM 0972.02<br />
Imp. B (EP): (6R,7R)-7-Amino-3-methyl-8-oxo-5-thia-1-<br />
azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid (7-ADCA)<br />
HO<br />
O<br />
O<br />
N<br />
O<br />
OH<br />
(A)<br />
100 mg<br />
Cefalexin Monohydrate<br />
MM 0605.00<br />
Cefalexin Monohydrate<br />
O<br />
NH 2 H<br />
N<br />
O<br />
H S<br />
2 N<br />
H<br />
O OH<br />
(A) 500 mg<br />
N<br />
x H 2O<br />
S<br />
H<br />
MM 0605.01<br />
Imp. A (EP): (2R)-2-Amino-2-phenylacetic Acid<br />
(D-Phenylglycine)<br />
NH 2<br />
(B) 100 mg<br />
OH<br />
O<br />
MM 0605.02<br />
Imp. B (EP): (6R,7R)-7-Amino-3-methyl-8-oxo-5-thia-1-<br />
azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid (7-<br />
Aminodesacetoxycephalosporanic Acid; 7-ADCA)<br />
O<br />
H 2 N<br />
O OH<br />
N<br />
S<br />
H<br />
(A)<br />
100 mg<br />
Cefazolin Sodium<br />
MM 0238.00<br />
Cefazolin Sodium<br />
N<br />
N<br />
N<br />
N<br />
O<br />
O<br />
H<br />
N<br />
O ONa<br />
N<br />
S<br />
S<br />
H<br />
S N<br />
N<br />
(A)<br />
100 mg<br />
MM 0238.05<br />
Imp. E (EP): 5-Methyl-1,3,4-thiadiazol-2-thiol (MMTD)<br />
SH<br />
(A) 100 mg<br />
S<br />
N<br />
N<br />
MM 0238.08<br />
Imp. H (EP): (6R,7R)-3-[(Acetyloxy)methyl]-7-amino-8-oxo-5-<br />
thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid (7-ACA)<br />
O<br />
O<br />
N<br />
OH<br />
O<br />
O (A) 100 mg<br />
H 2 N<br />
H<br />
S<br />
Cefetamet<br />
MM 0811.01<br />
7-Aminodesacetoxycephalosporanic Aicd<br />
O<br />
O<br />
N<br />
OH<br />
(A)<br />
100 mg<br />
H 2 N<br />
H<br />
S<br />
186 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
<strong>Pharmac<strong>eu</strong>tical</strong> <strong>impurities</strong><br />
Code Product Category Unit<br />
Cefoperazone Sodium<br />
MM 0853.03<br />
MM 0853.05<br />
Cefradine<br />
New MM 0833.01<br />
Celecoxib<br />
MM 0344.02<br />
MM 0344.03<br />
Imp. C (EP): 1-Methyl-1H-tetrazole-5-thiol<br />
Imp. E (EP): (6R,7R)-3-[(Acetyloxy)methyl]-7-amino-<br />
8-oxo-5-thia-1-azabicyclo-<br />
[4.2.0]oct-2-ene-2-carboxylic Acid (7-ACA)<br />
Imp. A (EP): (6R,7R)-7-Amino-3-methyl-8-oxo-<br />
5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic<br />
Acid (7-Aminodeacetoxycephalosporanic Acid,<br />
7-ADCA)<br />
4-[5-[4-(Hydroxymethyl)phenyl]-3-(trifluoromethyl)-1H-pyrazol-<br />
1-yl]-benzenesulfonamide<br />
4-[1-[4-(Aminosulfonyl)phenyl]-3-(trifluoromethyl)-1H-pyrazol-<br />
5-yl]benzoic Acid<br />
O<br />
H 2 N<br />
O O<br />
S<br />
H 2 N<br />
HO<br />
O O<br />
S<br />
H 2 N<br />
O<br />
N<br />
S<br />
H<br />
O<br />
H 2 N<br />
N<br />
N<br />
N N<br />
OH<br />
N<br />
O<br />
N<br />
SH<br />
(A) 100 mg<br />
O<br />
S<br />
H<br />
N<br />
F<br />
F<br />
O (A) 100 mg<br />
OH<br />
F<br />
N N F<br />
F<br />
F<br />
(A)<br />
(D)<br />
100 mg<br />
100 mg<br />
on request<br />
HO<br />
O<br />
Celiprolol Hydrochloride<br />
MM 0128.00 Celiprolol Hydrochloride<br />
O<br />
(A)<br />
100 mg<br />
OH<br />
HN<br />
x HCl<br />
O<br />
O<br />
N<br />
N<br />
H<br />
MM 0128.01<br />
Imp. A (EP): 1-[5-Amino-2-[(2RS)-3-[(1,1-<br />
dimethylethyl)amino]-2-hydroxypropoxy]phenyl]ethanone<br />
O<br />
O<br />
OH<br />
HN<br />
(A) 100 mg<br />
H 2 N<br />
MM 0128.03<br />
MM 0128.10<br />
Imp. C (EP): 1-[3-Acetyl-4-[(2RS)-3-[(1,1-<br />
dimethylethyl)amino]-2-hydroxypropoxy]phenyl]-3-<br />
(1,1-dimethylethyl)urea<br />
Imp. D (EP):3-[3-Acetyl-4-[(RS)-3-(diethylamino)-2-<br />
hydroxypropoxy]phenyl]-1,1-diethylurea<br />
N<br />
H<br />
O<br />
O<br />
O<br />
N<br />
H<br />
O<br />
O<br />
O<br />
OH<br />
HN<br />
(A) 100 mg<br />
OH<br />
N<br />
(D) 100 mg<br />
N<br />
N<br />
H<br />
MM 0128.05<br />
Imp. E (EP): 1,1'-[[(1,1-Dimethylethyl)-<br />
imino]bis[(2-hydroxypropane-1,3-diyl)-oxy(3-<br />
acetyl-1,4-phenylene)]]bis(3,3-diethylurea)<br />
O<br />
O<br />
OH<br />
N<br />
OH<br />
O<br />
O<br />
(D)<br />
50 mg<br />
HN<br />
NH<br />
O<br />
N<br />
N<br />
O<br />
MM 0128.07 Imp. F (EP): 3-(3-Acetyl-4-hydroxyphenyl)-1,1-diethylurea<br />
O<br />
(A)<br />
100 mg<br />
O<br />
OH<br />
N<br />
N<br />
H<br />
MM 0128.06<br />
Imp. G (EP): 3-[3-Acetyl-4-[[(RS)-oxiranyl]methoxy]phenyl]-<br />
1,1-diethylurea<br />
O<br />
O<br />
O<br />
O<br />
(A)<br />
100 mg<br />
N<br />
N<br />
H<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 187
<strong>Pharmac<strong>eu</strong>tical</strong> <strong>impurities</strong><br />
Code Product Category Unit<br />
MM 0128.04<br />
Imp. H (EP): 3-[3-Acetyl-4-[(2RS)-3-bromo-2-<br />
hydroxypropoxy]phenyl]-1,1-diethylurea (Bromhydrin<br />
Compound)<br />
N<br />
O<br />
N<br />
H<br />
O<br />
O<br />
OH<br />
Br<br />
(A)<br />
100 mg<br />
MM 0128.11 3-Acetyl-4-hydroxyaniline Hydrochloride<br />
O<br />
OH x HCl<br />
(A) 100 mg<br />
H 2 N<br />
MM 0128.58 5-Acetamido-2-hydroxyacetophenone<br />
O<br />
(A)<br />
100 mg<br />
O<br />
OH<br />
N<br />
H<br />
Cethexonium Bromide<br />
MM 0501.01<br />
rac-trans-2-Dimethylaminocyclohexanol Hydrochloride<br />
N<br />
OH<br />
x HCl<br />
(A)<br />
100 mg<br />
<strong>and</strong> enantiomer<br />
Cetirizine Dihydrochloride<br />
MM 0380.00<br />
Cetirizine Dihydrochloride<br />
Cl<br />
N<br />
N<br />
O<br />
O<br />
(A) 100 mg<br />
OH<br />
x 2 HCl<br />
MM 0380.01<br />
Imp. A (EP): (RS)-1-[(4-Chlorophenyl)phenylmethyl]piperazine<br />
Cl<br />
(A) 100 mg<br />
N<br />
NH<br />
MM 0380.02<br />
Imp. B (EP) as Dihydrochloride: (RS)-2-[4-[(4-<br />
Chlorophenyl)phenylmethyl]-<br />
piperazin-1-yl]acetic Acid Dihydrochloride<br />
Cl<br />
N<br />
N<br />
OH<br />
O<br />
x 2 HCl<br />
(A)<br />
100 mg<br />
MM 0380.03<br />
Imp. C (EP) as Dihydrochloride: (RS)-2-[2-[4-[(2-Chlorophenyl)phenylmethyl]piperazin-1-yl]ethoxy]acetic<br />
Acid<br />
Dihydrochloride<br />
Cl<br />
N<br />
N<br />
O<br />
O<br />
OH<br />
x 2 HCl<br />
(A)<br />
50 mg<br />
MM 0380.04<br />
Imp. D (EP): 1,4-Bis[(4-<br />
chlorophenyl)phenylmethyl]piperazine<br />
Cl<br />
N<br />
N<br />
Cl<br />
(A)<br />
100 mg<br />
MM 0380.12<br />
Imp. E (EP): (RS)-2-[2-[2-[4-[(4-<br />
Chlorophenyl)phenylmethyl]piperazin-1-yl]<br />
ethoxy]ethoxy]acetic Acid (Ethoxycetirizine)<br />
Cl<br />
N<br />
N<br />
O<br />
O<br />
OH<br />
O<br />
(D)<br />
100 mg<br />
MM 0380.06 Imp. F (EP) as Dihydrochloride: [2-[4-<br />
[Diphenylmethyl]piperazin-1-yl]ethoxy]acetic Acid<br />
Dihydrochloride<br />
N<br />
N<br />
O<br />
O<br />
OH<br />
(A)<br />
100 mg<br />
x 2 HCl<br />
MM 0380.11<br />
Imp. G (EP) as Dihydrochloride: 2-[4-[(RS)-(4-<br />
Chlorophenyl)phenylmethyl]-piperazin-1-yl]ethanol<br />
Dihydrochloride<br />
Cl<br />
N<br />
N<br />
OH<br />
x 2 HCl<br />
(A)<br />
100 mg<br />
MM 0380.07<br />
Ethyl Ester of Cetirizine<br />
Cl<br />
N<br />
N<br />
O<br />
O<br />
(A) 100 mg<br />
O<br />
188 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
<strong>Pharmac<strong>eu</strong>tical</strong> <strong>impurities</strong><br />
Code Product Category Unit<br />
MM 0380.08 Isopropyl Ester of Cetirizine<br />
Cl<br />
O<br />
N<br />
O<br />
N<br />
O<br />
(A) 100 mg<br />
MM 0380.09 4-Chlorobenzhydrol<br />
OH<br />
(B)<br />
100 mg<br />
MM 0380.10 4-Chlorobenzophenone<br />
O<br />
Cl<br />
(B)<br />
100 mg<br />
Cl<br />
MM 0380.13<br />
Cetirizine N-Oxide<br />
Cl<br />
N<br />
O<br />
O (A) 100 mg<br />
O<br />
N<br />
OH<br />
Chlorambucil<br />
MM 0821.00 Chlorambucil<br />
OH<br />
Cl<br />
O<br />
N<br />
(A)<br />
500 mg<br />
Chloramphenicol<br />
OH NO<br />
MM 0516.00 Chloramphenicol 2<br />
OH NO<br />
MM 0516.01 (D)-(-)-threo-2-Amino-1-(4-nitrophenyl)-1,3-propanediol 2<br />
Cl<br />
Cl<br />
Cl<br />
O<br />
N<br />
H<br />
OH<br />
(A)<br />
(A)<br />
500 mg<br />
100 mg<br />
H 2 N<br />
OH<br />
Chlordiazepoxide Hydrochloride<br />
MM 0028.02<br />
Imp. A (EP): 7-Chloro-5-phenyl-1,3-dihydro-2H-1,4-<br />
benzodiazepin-2-one 4-Oxide (Demoxepam)<br />
H<br />
N<br />
O<br />
(A)<br />
100 mg<br />
Cl<br />
N<br />
O<br />
MM 0028.04 Imp. B (EP): 6-Chloro-2-(chloromethyl)-4-phenylquinazoline 3-<br />
Oxide<br />
Cl<br />
N<br />
N<br />
O<br />
Cl (A) 100 mg<br />
MM 0028.03<br />
Imp. C (EP): (2-Amino-5-chlorophenyl)phenyl-methanone<br />
(Aminochlorobenzophenone)<br />
Cl<br />
NH 2<br />
O<br />
(B)<br />
100 mg<br />
Chlorhexidine Diacetate<br />
MM 0162.00<br />
Chlorhexidine Diacetate<br />
MM 0162.05 4-Chloroaniline<br />
NH 2<br />
MM 0162.07 (4-Chlorophenyl)urea<br />
H<br />
N NH2<br />
MM 0162.08 (4-Chlorophenyl)guanidine Hydrochloride<br />
H<br />
N NH2<br />
Cl<br />
H<br />
N<br />
NH<br />
H<br />
N<br />
NH<br />
H<br />
N<br />
x 2<br />
O<br />
OH<br />
Cl<br />
N<br />
H<br />
NH<br />
Cl<br />
N<br />
H<br />
NH<br />
Cl<br />
N<br />
H<br />
NH<br />
O<br />
Cl<br />
x HCl<br />
(A)<br />
(B)<br />
(A)<br />
(A)<br />
500 mg<br />
100 mg<br />
100 mg<br />
100 mg<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 189
<strong>Pharmac<strong>eu</strong>tical</strong> <strong>impurities</strong><br />
Code Product Category Unit<br />
Chlorhexidine Dihydrochloride<br />
MM 0946.00<br />
Chlorhexidine Dihydrochloride<br />
H<br />
N<br />
H<br />
N<br />
H<br />
N<br />
(A)<br />
500 mg<br />
Cl<br />
Cl<br />
NH<br />
NH<br />
NH<br />
NH<br />
x 2 HCl<br />
N<br />
H<br />
N<br />
H<br />
N<br />
H<br />
Chlormezanone<br />
MM 0017.00<br />
Chlormezanone<br />
O O<br />
S<br />
Cl<br />
(A) 250 mg<br />
N<br />
O<br />
MM 0017.02<br />
2-(4-Chlorophenyl)-3-methylperhydro-1,3-thiazin-4-one<br />
S<br />
Cl<br />
on request<br />
MM 0017.03<br />
4-Chlorobenzaldehyde<br />
Chlorobutanol Hemihydrate<br />
OH<br />
MM 0535.00 Chlorobutanol Hemihydrate Cl<br />
Chlorocresol<br />
MM 0459.00 Chlorocresol<br />
OH<br />
Cl<br />
O<br />
H<br />
N<br />
O<br />
(B) 100 mg<br />
Cl<br />
Cl<br />
Cl<br />
x ½ H 2 O<br />
(A)<br />
(A)<br />
500 mg<br />
500 mg<br />
Chlorphenamine Maleate<br />
MM 0090.00<br />
Chlorphenamine Maleate<br />
Cl<br />
(A) 500 mg<br />
O<br />
N<br />
N<br />
x<br />
OH<br />
OH<br />
O<br />
MM 0090.03<br />
Imp. A (EP) as Dihydrochloride: 2-(4-Chlorophenyl)-4-<br />
(dimethylamino)-2-<br />
[2-(dimethylamino)ethyl]butanenitrile Dihydrochloride<br />
Cl<br />
N<br />
x 2 HCl<br />
(A)<br />
100 mg<br />
N<br />
N<br />
H<br />
MM 0090.04 Imp. B (EP): N-(Pyridin-2-yl)pyridin-2-amine(2,2'-Dipyridylamine) N N<br />
(A)<br />
100 mg<br />
N<br />
New MM 0090.13<br />
Imp. C (EP) as Maleate: (3RS)-3-(4-Chlorophenyl)-N-methyl-3-(pyridin-2-yl)propan-1-<br />
amine Maleate<br />
N<br />
Cl<br />
(A) 100 mg<br />
O<br />
OH<br />
x<br />
OH<br />
NH<br />
O<br />
MM 0090.05<br />
Imp. D (EP) as Maleate: (2RS)-2-(4-Chlorophenyl)-4-<br />
(dimethylamino)-2-<br />
(pyridin-2-yl)butanenitrile Maleate<br />
Cl<br />
N<br />
N<br />
N<br />
x<br />
O<br />
OH<br />
OH<br />
O<br />
(A)<br />
100 mg<br />
MM 0090.11<br />
Chlorphenamine N-Oxide Dihydrochloride<br />
Cl<br />
(A)<br />
100 mg<br />
x 2 HCl<br />
N<br />
N<br />
O<br />
190 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
<strong>Pharmac<strong>eu</strong>tical</strong> <strong>impurities</strong><br />
Code Product Category Unit<br />
Chlorpromazine Hydrochloride<br />
MM 0420.00 Chlorpromazine Hydrochloride<br />
(A) 500 mg<br />
S<br />
N<br />
N<br />
x HCl<br />
Cl<br />
MM 0420.01<br />
Imp. A (EP): 3-(2-Chloro-10H-phenothiazin-10-yl)-N,Ndimethylpropan-1-amine<br />
S-Oxide (Chlorpromazine Sulphoxide)<br />
S<br />
O<br />
N<br />
N<br />
(A)<br />
100 mg<br />
Cl<br />
MM 0420.06<br />
Imp. B (EP) as Dihydrochloride: N-[3-(2-Chloro-10H-<br />
phenothiazin-10-yl)propyl]-N,N',N'-trimethylpropane-1,2-<br />
diamine Dihydrochloride<br />
S<br />
N<br />
N<br />
x 2 HCl<br />
N<br />
(A)<br />
100 mg<br />
Cl<br />
MM 0420.03<br />
Imp. C (EP) as Hydrochloride: Promazine Hydrochloride<br />
(A)<br />
500 mg<br />
S<br />
N<br />
N<br />
x HCl<br />
MM 0420.07<br />
Imp. D (EP) as Hydrochloride: 3-(2-Chloro-10H-phenothiazin-<br />
10-yl)-N-methylpropan-1-amine Hydrochloride<br />
(Desmethylchlorpromazine Hydrochloride)<br />
S<br />
N<br />
NH x HCl<br />
(A) 100 mg<br />
Cl<br />
MM 0420.04<br />
Imp. E (EP): 2-Chloro-10H-phenothiazine<br />
(A)<br />
100 mg<br />
S<br />
NH<br />
Cl<br />
MM 0420.02<br />
Chlorpromazine Sulphoxide N-Oxide Maleate<br />
O<br />
(A)<br />
100 mg<br />
S<br />
O<br />
N<br />
N<br />
O<br />
x<br />
OH<br />
OH<br />
Cl<br />
O<br />
Chlorquinaldol<br />
MM 0390.00 Chlorquinaldol<br />
OH<br />
Cl<br />
N<br />
(A)<br />
500 mg<br />
Cl<br />
Chlortalidone<br />
MM 0297.00 Chlortalidone HN<br />
O O<br />
S<br />
H 2 N<br />
HO<br />
O<br />
(A)<br />
250 mg<br />
Cl<br />
Chlortetracycline Hydrochloride<br />
MM 0607.00 Chlortetracycline Hydrochloride<br />
OH O OH O<br />
OH<br />
O<br />
(A)<br />
500 mg<br />
Cl<br />
H<br />
OH<br />
H<br />
N<br />
OH<br />
NH 2<br />
x HCl<br />
MM 0607.02<br />
Imp. B (EP) as Hydrochloride: Demeclocycline<br />
Hydrochloride<br />
OH O OH O<br />
OH<br />
H<br />
Cl OH<br />
H<br />
N<br />
O<br />
NH 2<br />
OH<br />
x HCl<br />
(A)<br />
250 mg<br />
MM 0607.03 Tetracycline Hydrochloride<br />
OH O OH O<br />
OH<br />
O<br />
(A)<br />
500 mg<br />
HO<br />
H<br />
H<br />
N<br />
OH<br />
NH 2<br />
x HCl<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 191
<strong>Pharmac<strong>eu</strong>tical</strong> <strong>impurities</strong><br />
Code Product Category Unit<br />
Cholecalciferol<br />
MM 0249.02<br />
Imp. B (EP): Cholesta-5,7-dien-3β-ol<br />
(7,8-Didehydrocholesterol; Provitamin D3)<br />
(A)<br />
100 mg<br />
HO<br />
Ciclopirox Olamine<br />
MM 0418.00<br />
Ciclopirox Olamine<br />
OH<br />
N<br />
O<br />
x<br />
H 2 N<br />
OH<br />
(A)<br />
250 mg<br />
Cimetidine Hydrochloride<br />
MM 0020.00<br />
Cimetidine<br />
N<br />
(A) 500 mg<br />
MM 0020.08<br />
MM 0020.12<br />
MM 0020.03<br />
MM 0020.06<br />
MM 0020.04<br />
MM 0020.15<br />
Imp. A (EP): 3-Cyano-2-methyl-1-[2-<br />
[[(5-methyl-1H-imidazol-4-yl)methyl]-<br />
sulphanyl]ethyl]isothiourea<br />
Imp. B (EP): 3-Cyano-2-methyl-1-[2-[[(5-methyl-1Himidazol-4-yl)methyl]-sulphanyl]ethyl]isourea<br />
Imp. C (EP) as Dihydrochloride: 1-[(Methylamino)[[2-<br />
[[(5-methyl-1H-imidazol-4-yl)-<br />
methyl]sulphanyl]ethyl]amino]-<br />
methylene]urea Dihydrochloride<br />
(Cimetidine Amide Dihydrochloride)<br />
Imp. D (EP) as Dihydrochloride:1-Methyl-3-[2-[[(5-<br />
methyl-1H-imidazol-4-<br />
yl)methyl]sulphanyl]ethyl]guanidine Dihydrochloride<br />
Imp. E (EP): 2-Cyano-1-methyl-3-[2-[[(5-methyl-1Himidazol-4-yl)methyl]sulphinyl]ethyl]guanidine<br />
(Cimetidine Sulphoxide)<br />
Imp. G (Pharm<strong>eu</strong>ropa): 2-Cyano-1,3-dimethylguanidine<br />
HN<br />
N<br />
HN<br />
HN<br />
HN<br />
S<br />
N<br />
N<br />
N<br />
N<br />
H<br />
S<br />
S<br />
S<br />
N<br />
N<br />
H<br />
N<br />
H<br />
N<br />
H<br />
N<br />
H<br />
N<br />
N<br />
N<br />
H<br />
N<br />
(A) 100 mg<br />
N<br />
S<br />
N<br />
(A) 100 mg<br />
O<br />
O NH 2<br />
(A) 100 mg<br />
x 2 HCl<br />
N<br />
NH<br />
(A) 100 mg<br />
HN<br />
S<br />
x 2 HCl<br />
N N<br />
H H<br />
HN<br />
N<br />
O<br />
S<br />
N<br />
H<br />
N<br />
N<br />
N<br />
H<br />
(A)<br />
100 mg<br />
N<br />
(A) 100 mg<br />
MM 0020.07<br />
Imp. H (Pharm<strong>eu</strong>ropa): 2-Cyano-3-[2-[[2-[[(1Z)-<br />
(cyanoamino)(methylamino)methylene]amino]-<br />
ethyl]disulphanyl]ethyl]-1-methylguanidine<br />
N<br />
H<br />
N<br />
N<br />
H<br />
S<br />
S<br />
N<br />
H<br />
H<br />
N<br />
N<br />
N<br />
N<br />
H<br />
N<br />
(A) 100 mg<br />
H<br />
N<br />
MM 0020.50<br />
MM 0020.10<br />
Imp. J (Pharm<strong>eu</strong>ropa) as Dihydrobromide: 2-[[(5-Methyl-<br />
1H-imidazol-4-yl)methyl]-sulphanyl]ethanamine<br />
Dihydrobromide<br />
1,1-Dimethyl-3-cyanoguanidine<br />
MM 0020.13 Cyanoguanidine H 2N<br />
Cinchocaine Hydrochloride<br />
MM 0604.00<br />
Cinchocaine Hydrochloride<br />
N<br />
N<br />
(A) 100 mg<br />
HN<br />
S<br />
x 2 HBr<br />
NH 2<br />
O<br />
N<br />
O<br />
N<br />
H<br />
H<br />
N N<br />
NH<br />
H<br />
N<br />
NH<br />
N<br />
N<br />
N<br />
x HCl<br />
(A)<br />
(B)<br />
(A)<br />
100 mg<br />
100 mg<br />
500 mg<br />
192 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
<strong>Pharmac<strong>eu</strong>tical</strong> <strong>impurities</strong><br />
Code Product Category Unit<br />
MM 0604.02<br />
Imp. B (EP): 2-Hydroxyquinoline-4-carboxylic Acid<br />
HO<br />
O<br />
OH<br />
(A)<br />
100 mg<br />
N<br />
MM 0604.05<br />
Cinchocaine N-Oxide<br />
O<br />
on request<br />
O<br />
N<br />
N<br />
H<br />
N<br />
O<br />
Ciprofloxacin Hydrochloride<br />
MM 0018.06<br />
Ciprofloxacin Hydrochloride Monohydrate<br />
HN<br />
(A)<br />
500 mg<br />
N<br />
F<br />
N<br />
OH<br />
x HCl<br />
x H 2 O<br />
O<br />
O<br />
MM 0018.01<br />
Imp. A (EP): 7-Chloro-1-cyclopropyl-6-fluoro-4-oxo-1,4-<br />
dihydroquinoline-3-carboxylic Acid (Fluoroquinolonic Acid)<br />
Cl<br />
N<br />
(A)<br />
100 mg<br />
F<br />
OH<br />
O<br />
O<br />
MM 0018.05<br />
Imp. B (EP): 1-Cyclopropyl-4-oxo-7-(piperazin-1-yl)-1,4-<br />
dihydroquinoline-3-carboxylic Acid (Desfluoro Compound)<br />
HN<br />
(A) 100 mg<br />
N N<br />
OH<br />
O<br />
O<br />
MM 0018.04<br />
Imp. C (EP): 7-(2-Aminoethylamino)-1-cyclopropyl-6-fluoro-4-<br />
oxo-1,4-dihydroquinoline-3-carboxylic Acid (Ethylenediamine<br />
Compound)<br />
H 2N<br />
H<br />
N<br />
F<br />
N<br />
OH<br />
(D)<br />
50 mg<br />
O<br />
O<br />
MM 0018.02<br />
Imp. D (EP): 7-Chloro-1-cyclopropyl-4-oxo-6-(piperazin-1-yl)-<br />
1,4-dihydroquinoline-3-carboxylic Acid<br />
Cl<br />
N<br />
(D)<br />
50 mg<br />
N<br />
OH<br />
HN<br />
O<br />
O<br />
MM 0018.03<br />
Imp. E (EP): 1-Cyclopropyl-6-fluoro-7-(piperazin-1-yl)-<br />
quinolin-4(1H)-one (Decarboxylated Compound)<br />
HN<br />
N<br />
N<br />
(A)<br />
100 mg<br />
F<br />
O<br />
MM 0018.10<br />
6-(2-Aminoethylamino)-7-chloro-1-cyclopropyl-4-oxo-<br />
1,4-dihydroquinoline-3-carboxylic Acid Hydrochloride<br />
Cl<br />
N<br />
x HCl<br />
(D)<br />
100 mg<br />
H 2 N<br />
N<br />
H<br />
O<br />
O<br />
OH<br />
Citalopram Hydrobromide<br />
MM 0242.00<br />
Citalopram Hydrobromide<br />
F<br />
(A)<br />
250 mg<br />
x HBr<br />
O<br />
N<br />
N<br />
MM 0242.14<br />
Imp. A (Pharm<strong>eu</strong>ropa): (1RS)-1-[3-(Dimethylamino)propyl]-1-(4-fluorophenyl)-1,3-dihydroisobenzofuran-5-carboxamide<br />
(Citalopram-<br />
Amide)<br />
H 2 N<br />
F<br />
O<br />
N<br />
(A)<br />
100 mg<br />
O<br />
MM 0242.16<br />
Imp. B (Pharm<strong>eu</strong>ropa): 1-[3-(Dimethylamino)-<br />
propyl]-1-(4-fluoropheny)-3-hydroxy-1,3-<br />
dihydroisobenzofuran-5-carbonitrile<br />
F<br />
(A)<br />
100 mg<br />
O<br />
N<br />
N<br />
OH<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 193
<strong>Pharmac<strong>eu</strong>tical</strong> <strong>impurities</strong><br />
Code Product Category Unit<br />
MM 0242.17<br />
Imp. C (Pharm<strong>eu</strong>ropa): (3RS)-6-Cyano-3-[3-<br />
(dimethylamino)propyl]-3-(4-fluorophenyl)isobenzofuran-1(3H)-one<br />
F<br />
(A)<br />
100 mg<br />
O<br />
N<br />
MM 0242.09<br />
Imp. D (Pharm<strong>eu</strong>ropa) as Hydrochloride: (1RS)-<br />
1-(4-Fluorophenyl)-1-[3-(methylamino)propyl]-1,3-<br />
dihydroisobenzofuran-5-carbonitrile Hydrochloride<br />
(Desmethyl-Citalopram Hydrochloride)<br />
N<br />
O<br />
F<br />
O<br />
x HCl<br />
N<br />
H<br />
(A)<br />
100 mg<br />
Citric Acid Monohydrate<br />
MM 0575.00<br />
Citric Acid Monohydrate<br />
N<br />
O OH (A) 500 mg<br />
O HO O<br />
x H 2 O<br />
HO<br />
OH<br />
Clarithromycin<br />
MM 0057.00<br />
Clarithromycin<br />
O<br />
on request<br />
OH<br />
OH<br />
O<br />
O<br />
HO<br />
O<br />
O<br />
N<br />
O<br />
O<br />
O<br />
O<br />
OH<br />
Clioquinol<br />
MM 0312.00<br />
Clioquinol<br />
I<br />
OH<br />
N<br />
(A)<br />
500 mg<br />
MM 0312.01<br />
Imp. A (EP): 5-Chloroquinolin-8-ol<br />
Cl<br />
OH<br />
(B) 100 mg<br />
N<br />
Cl<br />
MM 0312.02<br />
Imp. B (EP): 5,7-Dichloroquinolin-8-ol<br />
Cl<br />
OH<br />
N<br />
(B)<br />
100 mg<br />
Cl<br />
MM 0312.03<br />
Imp. C (EP): 5,7-Diiodoquinolin-8-ol<br />
I<br />
OH<br />
N<br />
(B)<br />
100 mg<br />
I<br />
Clobenzorex Hydrochloride<br />
MM 0649.00 Clobenzorex Hydrochloride<br />
H<br />
N<br />
x HCl<br />
(A)<br />
500 mg<br />
Cl<br />
Clobetasol Propionate<br />
MM 0769.00<br />
Clobetasol Propionate<br />
O<br />
Cl<br />
O<br />
(A)<br />
100 mg<br />
HO<br />
O<br />
F<br />
O<br />
MM 0769.01<br />
Imp. G (EP): 21-Chloro-9-fluoro-11β,17-dihydroxy-16βmethylpregna-1,4-diene-3,20-dione<br />
(Clobetasol)<br />
HO<br />
O<br />
Cl<br />
OH<br />
(A)<br />
100 mg<br />
O<br />
F<br />
194 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
<strong>Pharmac<strong>eu</strong>tical</strong> <strong>impurities</strong><br />
Code Product Category Unit<br />
New MM 0769.08 Imp. K (EP):9-Fluoro-11β,17-dihydroxy-<br />
16β-methyl-3,20-dioxopregna-1,4-dien-<br />
O<br />
O<br />
21-yl Propanoate (Betamethasone 21-<br />
O<br />
(A) 100 mg<br />
Propionate)<br />
HO<br />
OH<br />
F<br />
O<br />
Clobetasone Butyrate<br />
MM 0207.00<br />
Clobetasone Butyrate<br />
O<br />
Cl<br />
O<br />
on request<br />
O<br />
O<br />
O<br />
F<br />
Clobutinol Hydrochloride<br />
MM 0038.00<br />
Clobutinol Hydrochloride<br />
Cl<br />
OH<br />
N<br />
x HCl<br />
(A)<br />
100 mg<br />
MM 0038.01<br />
1-Dimethylamino-2-methylbutan-3-one<br />
N<br />
(A)<br />
100 mg<br />
O<br />
Clomifene Citrate<br />
MM 0650.00<br />
Clomifene Citrate<br />
Cl<br />
O<br />
N<br />
<strong>and</strong> Z-Isomer<br />
x<br />
O<br />
O<br />
OH<br />
OH<br />
O<br />
OH<br />
OH<br />
(A)<br />
250 mg<br />
MM 0650.01<br />
Clomifene N-Oxide Hydrochloride<br />
Cl<br />
O<br />
N<br />
O<br />
(A)<br />
100 mg<br />
<strong>and</strong> Z-Isomer<br />
x HCl<br />
MM 0650.03<br />
Desethylclomifene Hydrochloride<br />
Cl<br />
O<br />
N<br />
H<br />
(A)<br />
100 mg<br />
<strong>and</strong> Z-Isomer<br />
x HCl<br />
Clomipramine Hydrochloride<br />
MM 0545.00<br />
Clomipramine Hydrochloride<br />
Cl<br />
(A) 500 mg<br />
N<br />
N<br />
x HCl<br />
MM 0545.01<br />
Imp. A (EP) as Dihydrochloride: N-[3-(3-<br />
Chloro-10,11-dihydro-5H-dibenzo[b,f]azepin-<br />
5-yl)propyl]-N,N',N'-trimethylpropane-1,3-<br />
diamine Dihydrochloride<br />
Cl<br />
N<br />
N<br />
N<br />
(A)<br />
100 mg<br />
x 2 HCl<br />
MM 0545.02<br />
Imp. B (EP) as Hydrochloride: Imipramine Hydrochloride<br />
(A)<br />
500 mg<br />
N<br />
N<br />
x HCl<br />
MM 0545.03<br />
Imp. C (EP) as Hydrochloride: 3-(3-Chloro-5Hdibenzo[b,f]azepin-5-yl)-N,N-dimethylpropan-1-amine<br />
Hydrochloride<br />
Cl<br />
(A) 50 mg<br />
N<br />
N<br />
x HCl<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 195
<strong>Pharmac<strong>eu</strong>tical</strong> <strong>impurities</strong><br />
Code Product Category Unit<br />
MM 0545.04 Imp. D (EP) as Hydrochloride: 3-(3,7-Dichloro-<br />
Cl<br />
on request<br />
10,11-dihydro-5H-dibenzo[b,f]azepin-5-yl)-N,Ndimethylpropan-1-amine<br />
Hydrochloride<br />
N<br />
N<br />
x HCl<br />
Cl<br />
MM 0545.05<br />
Imp. E (EP): 10,11-Dihydro-5H-dibenzo[b,f]-azepine (Iminodibenzyl)<br />
(B)<br />
100 mg<br />
NH<br />
MM 0545.06<br />
Imp. F (EP): 3-Chloro-10,11-dihydro-5H-dibenzo[b,f]azepine<br />
Cl<br />
(A) 100 mg<br />
NH<br />
MM 0545.07<br />
Imp. G (EP): 3-Chloro-5-(prop-2-enyl)-10,11-dihydro-5Hdibenzo[b,f]azepine<br />
Cl<br />
(A) 100 mg<br />
N<br />
MM 0545.08<br />
Desmethylclomipramine Hydrochloride<br />
Cl<br />
(A) 100 mg<br />
N<br />
N<br />
H<br />
x HCl<br />
MM 0545.09<br />
Clomipramine N-Oxide<br />
Cl<br />
(A)<br />
100 mg<br />
N<br />
N<br />
O<br />
MM 0545.13<br />
3-Chloro-10-[3(dimethylamino)propyl]-9-acridanone<br />
Cl<br />
(A) 100 mg<br />
N<br />
N<br />
O<br />
Clonidine Hydrochloride<br />
MM 0983.00 Clonidine Hydrochloride<br />
MM 0983.01 Imp. C (EP): 2,6-Dichloroaniline<br />
Cl<br />
Cl<br />
HN<br />
N<br />
N<br />
H<br />
x HCl<br />
(A)<br />
100 mg<br />
Cl<br />
(B) 100 mg<br />
NH 2<br />
MM 0983.02<br />
1-(2,6-Dichlorophenyl)thiourea<br />
Cl<br />
Cl<br />
S (A) 100 mg<br />
Cl<br />
N<br />
H<br />
NH 2<br />
Clopidogrel Hydrogen Sulphate<br />
MM 0455.10<br />
Clopidogrel Hydrogen Sulphate<br />
O<br />
N<br />
O<br />
x H 2 SO 4<br />
(A) 100 mg<br />
MM 0455.09<br />
Clopidogrel Alcohol<br />
S<br />
Cl<br />
OH<br />
(D)<br />
100 mg<br />
N<br />
MM 0455.12<br />
(R)-Clopidogrel Hydrogen Sulphate<br />
O<br />
N<br />
S<br />
O<br />
Cl<br />
x H 2 SO 4<br />
(A) 100 mg<br />
S<br />
Cl<br />
196 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
<strong>Pharmac<strong>eu</strong>tical</strong> <strong>impurities</strong><br />
Code Product Category Unit<br />
O O<br />
MM 0455.13 Methyl (+/-)-(o-Chlorophenyl)-4,5-dihydrothieno-[2,3-<br />
(A) 100 mg<br />
c]pyridine-6(7H)-acetate Hydrogen Sulphate<br />
S x H<br />
N<br />
2 SO 4<br />
Cl<br />
Clotrimazole<br />
MM 0015.00<br />
Clotrimazole<br />
Cl<br />
(A) 500 mg<br />
N<br />
N<br />
MM 0015.01<br />
Imp. A (Pharm<strong>eu</strong>ropa): (2-Chlorophenyl)diphenylmethanol<br />
(A)<br />
100 mg<br />
MM 0015.10<br />
Imp. B (Pharm<strong>eu</strong>ropa): 1-[(4-Chlorophenyl)diphenylmethyl]-1Himidazole<br />
Cl<br />
OH<br />
Cl (A) 100 mg<br />
N<br />
N<br />
MM 0015.03<br />
Imp. C (Pharm<strong>eu</strong>ropa): 1-Chloro-2-(chlorodiphenylmethyl)benzene<br />
(A)<br />
100 mg<br />
Cl<br />
Cl<br />
MM 0015.02<br />
Imp. D (Pharm<strong>eu</strong>ropa): Imidazole<br />
H<br />
N (B) 100 mg<br />
N<br />
MM 0015.06<br />
Imp. E (Pharm<strong>eu</strong>ropa): (2-Chlorophenyl)phenylmethanone<br />
(A)<br />
100 mg<br />
MM 0015.11<br />
Imp. F (Pharm<strong>eu</strong>ropa): 1-Triphenylmethyl-1H-imidazole<br />
(Deschloroclotrimazole)<br />
Cl<br />
O<br />
(A)<br />
100 mg<br />
N<br />
N<br />
MM 0015.04<br />
(2-Chlorophenyl)diphenylmethane<br />
(A)<br />
100 mg<br />
Cl<br />
MM 0015.05<br />
(2-Chlorophenyl)diphenylmethyl Ethyl Ether<br />
(A)<br />
100 mg<br />
Cl<br />
O<br />
MM 0015.07<br />
(2-Chlorophenyl)phenyldichloromethane<br />
(A)<br />
100 mg<br />
Cl Cl<br />
Cl<br />
MM 0015.08<br />
(2-Chlorophenyl)trichlormethane<br />
Cl<br />
(A)<br />
100 mg<br />
Cl Cl<br />
Cl<br />
MM 0015.09<br />
1-[(2-Chlorophenyl)diphenylmethyl]-1H-pyrazole<br />
(A)<br />
100 mg<br />
Cl<br />
N<br />
N<br />
Cloxacillin Sodium<br />
MM 0682.00<br />
MM 0682.03<br />
Cloxacillin Sodium Monohydrate<br />
Imp. C (EP): (2S,5R,6R)-6-Amino-3,3-dimethyl-7-oxo-4-thia-1-<br />
azabicyclo[3.2.0]heptane-2-carboxylic Acid<br />
(6-Aminopenicillanic Acid)<br />
Cl O<br />
(A) 500 mg<br />
ONa<br />
O<br />
N<br />
N<br />
H<br />
x H 2 O<br />
O N<br />
S<br />
H<br />
O<br />
O<br />
H 2 N<br />
N<br />
H<br />
O<br />
S<br />
OH<br />
(B)<br />
100 mg<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 197
<strong>Pharmac<strong>eu</strong>tical</strong> <strong>impurities</strong><br />
Code Product Category Unit<br />
MM 0682.04<br />
Imp. D (EP): 3-(2-Chlorophenyl)-5-methylisoxazole-4-carboxylic Acid<br />
N<br />
O<br />
Cl<br />
OH<br />
(A)<br />
100 mg<br />
Cloxiquine<br />
MM 0391.00 Cloxiquine<br />
OH<br />
O<br />
N<br />
(A)<br />
500 mg<br />
Clozapine<br />
MM 0480.00<br />
Clozapine<br />
Cl<br />
Cl N (A) 100 mg<br />
N N<br />
HN<br />
MM 0480.01<br />
MM 0480.03<br />
Imp. A (EP): 8-Chloro-5,10-dihydro-11H-dibenzo[b,e][1,4]diazepin-<br />
11-one<br />
Imp. C (EP): 8-Chloro-11-(piperazin-1-yl)-5Hdibenzo[b,e][1,4]diazepine<br />
Cl<br />
(A) 100 mg<br />
HN<br />
H<br />
N<br />
O<br />
Cl NH (A) 100 mg<br />
N N<br />
HN<br />
Codeine<br />
MM 0442.00<br />
Codeine Phosphate Hemihydrate [Controlled Substance]<br />
N<br />
(A) 100 mg<br />
x ½ H 2 O<br />
O<br />
O<br />
OH<br />
MM 0004.00<br />
Codeine Monohydrate [Controlled Substance]<br />
N<br />
(A)<br />
100 mg<br />
x H 2O<br />
O<br />
O<br />
OH<br />
MM 0004.03<br />
Imp. A (EP): 7,8-Didehydro-4,5α-epoxy-3,6α-dimethoxy-<br />
17-methylmorphinan<br />
(O-Methylcodeine) [Controlled Substance]<br />
N<br />
(A) 100 mg<br />
O<br />
O<br />
O<br />
MM 0004.16<br />
Imp. B (EP) as Hydrochloride Trihydrate: Morphine<br />
Hydrochloride Trihydrate [Controlled Substance]<br />
N<br />
x HCl<br />
x 3 H 2 O<br />
(A)<br />
250 mg<br />
MM 0004.17<br />
Imp. B (EP) as Hemisulphate Pentahemihydrate:<br />
Morphine Hemisulphate Pentahemihydrate<br />
[Controlled Substance]<br />
HO<br />
O<br />
N<br />
OH<br />
x H 2 SO 4<br />
x 5 H 2 O<br />
(A)<br />
250 mg<br />
HO<br />
O<br />
OH<br />
2<br />
MM 0004.15<br />
Imp. C (EP): 7,7',8,8'-Tetradehydro-4,5α:4',5'α-diepoxy-<br />
3,3'-dimethoxy-17,17'-dimethyl-2,2'-bimorphinanyl-6α,6'αdiol<br />
(Codeine Dimer; Dimethyl Ps<strong>eu</strong>domorphine)<br />
HO<br />
O<br />
O<br />
N<br />
(A)<br />
100 mg<br />
N<br />
O<br />
O<br />
OH<br />
MM 0004.01<br />
Codeine N-Oxide [Controlled Substance]<br />
O<br />
(A) 250 mg<br />
N<br />
O<br />
O<br />
OH<br />
MM 0004.02<br />
Codeinone<br />
N<br />
(A) 100 mg<br />
O<br />
O<br />
O<br />
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<strong>Pharmac<strong>eu</strong>tical</strong> <strong>impurities</strong><br />
Code Product Category Unit<br />
MM 0004.04 Codeimethine<br />
(A) 100 mg<br />
N<br />
O<br />
O<br />
OH<br />
MM 0004.05<br />
Norcodeine [Controlled Substance]<br />
HN<br />
(A) 100 mg<br />
O<br />
O<br />
OH<br />
MM 0004.06<br />
Acetylcodeine [Controlled Substance]<br />
N<br />
(A)<br />
100 mg<br />
O<br />
O<br />
O<br />
O<br />
MM 0004.08<br />
Isocodeine [Controlled Substance]<br />
N<br />
(A) 100 mg<br />
O<br />
O<br />
OH<br />
MM 0004.14<br />
Ps<strong>eu</strong>domorphine<br />
HO<br />
O<br />
OH<br />
N<br />
(A)<br />
100 mg<br />
N<br />
HO<br />
O<br />
OH<br />
Colchicine<br />
MM 1083.00 Colchicine<br />
O<br />
O<br />
O<br />
NH<br />
O<br />
O<br />
(A)<br />
100 mg<br />
O<br />
MM 1083.04<br />
Imp. D (EP): N-[(7S,12aS)-3-(β-D-Glucopyranosyloxy)-<br />
1,2,10-trimethoxy-9-oxo-5,6,7,9-<br />
tetrahydrobenzo[a]heptalen-7-yl]acetamide<br />
(Colchicoside)<br />
HO<br />
O<br />
OH<br />
HO<br />
OH<br />
O<br />
O<br />
O<br />
NH<br />
O<br />
O<br />
(A)<br />
100 mg<br />
O<br />
Cortisone<br />
MM 0214.00<br />
Cortisone<br />
O<br />
O<br />
OH<br />
OH<br />
(A)<br />
500 mg<br />
O<br />
Cortisone Acetate<br />
MM 0186.00<br />
Cortisone Acetate<br />
O<br />
O<br />
O<br />
OH<br />
O<br />
(A) 500 mg<br />
O<br />
MM 0186.01<br />
Imp. A (EP): Hydrocortisone Acetate<br />
HO<br />
O<br />
O<br />
OH<br />
O<br />
(A) 500 mg<br />
O<br />
Cyclopentolate Hydrochloride<br />
MM 0580.00 Cyclopentolate Hydrochloride O<br />
O<br />
HO<br />
N<br />
x HCl<br />
(A)<br />
500 mg<br />
MM 0580.02<br />
MM 0580.03<br />
Imp. B (Pharm<strong>eu</strong>ropa): Phenylacetic Acid<br />
[Controlled Substance]<br />
Imp. C (Pharm<strong>eu</strong>ropa) as Hydrochloride:<br />
2-(Dimethylamino)ethyl Phenylacetate<br />
Hydrochloride<br />
O<br />
O<br />
N<br />
O<br />
OH<br />
x HCl<br />
(B)<br />
(A)<br />
100 mg<br />
100 mg<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 199
<strong>Pharmac<strong>eu</strong>tical</strong> <strong>impurities</strong><br />
Code Product Category Unit<br />
Cynarine<br />
MM 0048.01 3,4-Dihydroxycinnamic Acid (Caffeic Acid)<br />
O<br />
HO<br />
OH<br />
HO<br />
(B) 100 mg<br />
Cyproheptadine Hydrochloride<br />
MM 0609.00 Cyproheptadine Hydrochloride Sesquihydrate N<br />
(A)<br />
500 mg<br />
x HCl x 1 1 / 2 H 2O<br />
MM 0609.02<br />
Imp. B (EP): 5H-Dibenzo[a,d]cyclohepten-5-one<br />
(Dibenzosuberenone)<br />
O<br />
(C)<br />
100 mg<br />
MM 0609.04 Demethylcyproheptadine Hydrochloride NH<br />
(A)<br />
100 mg<br />
x HCl<br />
MM 0609.05<br />
Cyproheptadine α-N-Oxide<br />
O<br />
(A) 100 mg<br />
N<br />
MM 0609.06<br />
Cyproheptadine β-N-Oxide<br />
O<br />
(A) 100 mg<br />
N<br />
Cyproterone Acetate<br />
MM 0215.00<br />
Cyproterone Acetate<br />
O<br />
O<br />
(A)<br />
250 mg<br />
O<br />
O<br />
Cl<br />
DDT<br />
New MM 2513.01<br />
2,2-Bis(4-chlorophenyl)-1-chloroethane<br />
Cl<br />
(A)<br />
100 mg<br />
Cl<br />
Cl<br />
New MM 2513.02<br />
1-Chloro-3-[1-(4-chlorophenyl)ethyl]benzene<br />
Cl<br />
(A)<br />
100 mg<br />
Dembrexine Hydrochloride Monohydrate<br />
New MM 1200.04<br />
Imp. D (EP): 2-Hydroxybenzaldehyde<br />
(Salicylaldehyde)<br />
Cl<br />
O<br />
(A) 100 mg<br />
OH<br />
Demeclocycline Hydrochloride<br />
MM 0636.00 Demeclocycline Hydrochloride<br />
OH O OH O<br />
OH<br />
O<br />
(A)<br />
250 mg<br />
Cl<br />
H<br />
OH<br />
H<br />
N<br />
OH<br />
NH 2<br />
x HCl<br />
Desipramine Hydrochloride<br />
MM 0589.00<br />
Desipramine Hydrochloride<br />
(A)<br />
250 mg<br />
N<br />
N<br />
H<br />
x HCl<br />
200 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
<strong>Pharmac<strong>eu</strong>tical</strong> <strong>impurities</strong><br />
Code Product Category Unit<br />
MM 0589.02 Imipramine Hydrochloride<br />
(A) 500 mg<br />
N<br />
N<br />
x HCl<br />
MM 0589.03<br />
Iminodibenzyl<br />
(B)<br />
100 mg<br />
NH<br />
Dexamethasone<br />
MM 0213.00<br />
Dexamethasone<br />
HO<br />
O<br />
OH<br />
OH<br />
(A)<br />
250 mg<br />
F<br />
O<br />
MM 0213.02<br />
Betamethasone<br />
HO<br />
O<br />
OH<br />
OH<br />
(A)<br />
250 mg<br />
F<br />
O<br />
MM 0213.01<br />
9-α-Fluoro-11β,17α,21-trihydroxy-16α-methylpregn-<br />
4-ene-3,20-dione<br />
HO<br />
O<br />
OH<br />
OH<br />
(D)<br />
50 mg<br />
F<br />
O<br />
Dexamethasone Acetate<br />
MM 0445.00<br />
Dexamethasone Acetate<br />
O<br />
O<br />
(A) 250 mg<br />
HO<br />
O<br />
OH<br />
F<br />
O<br />
Dexamethasone Sodium Phosphate<br />
MM 0210.00<br />
Dexamethasone Sodium Phosphate<br />
HO<br />
O<br />
O ONa<br />
(A) 250 mg<br />
O P OH ONa<br />
F<br />
O<br />
MM 0210.01<br />
Imp. A (EP): Dexamethasone<br />
HO<br />
O<br />
OH<br />
OH<br />
(A)<br />
250 mg<br />
F<br />
O<br />
MM 0210.02<br />
Imp. B (EP): Betamethasone Sodium Phosphate<br />
HO<br />
O<br />
O ONa<br />
on request<br />
O P OH ONa<br />
F<br />
O<br />
Dexchlorpheniramine Maleate<br />
MM 1114.00<br />
Dexchlorpheniramine Maleate<br />
Cl<br />
O<br />
(A)<br />
100 mg<br />
N<br />
N<br />
x<br />
O<br />
OH<br />
OH<br />
MM 1114.01<br />
Imp. A (EP) as Maleate: (3RS)-N,N-Dimethyl-3-phenyl-3-<br />
(pyridin-2-yl)propan-1-amine Maleate<br />
N<br />
N<br />
x<br />
O<br />
OH<br />
OH<br />
O<br />
(A)<br />
100 mg<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 201
<strong>Pharmac<strong>eu</strong>tical</strong> <strong>impurities</strong><br />
Code Product Category Unit<br />
Dextromethorphan Hydrobromide<br />
MM 0033.00<br />
Dextromethorphan Hydrobromide Monohydrate<br />
N<br />
x HBr<br />
x H 2O<br />
(A)<br />
500 mg<br />
O<br />
MM 0033.10<br />
Imp. A (EP) as Hydrochloride: ent-3-Methoxymorphinan<br />
Hydrochloride<br />
HN<br />
x HCl<br />
(A)<br />
100 mg<br />
O<br />
MM 0033.09<br />
Imp. B (EP) as (L)-Tartrate: ent-17-Methylmorphinan-3-<br />
ol (L)-Tartrate<br />
N<br />
x<br />
HO<br />
O<br />
OH<br />
OH<br />
O<br />
OH<br />
(A)<br />
100 mg<br />
HO<br />
MM 0033.02<br />
Imp. C (EP): ent-3-Methoxy-17-methylmorphinan-10-one<br />
(D) 100 mg<br />
O N<br />
O<br />
MM 0033.11<br />
Dextromethorphan N-Oxide Hydrochloride<br />
O<br />
(A) 100 mg<br />
N<br />
x HCl<br />
O<br />
Dextropropoxyphene Hydrochloride<br />
MM 0098.01<br />
Dextropropoxyphene Hydrochloride<br />
[Controlled Substance]<br />
N<br />
O<br />
(A)<br />
50 mg<br />
O<br />
x HCl<br />
MM 0098.00<br />
Dextropropoxyphene [Controlled Substance]<br />
N (A) 50 mg<br />
O<br />
O<br />
MM 0098.06<br />
Imp. A (EP): (2S,3R)-4-(Dimethylamino)-1,2-diphenyl-3-<br />
methylbutan-2-ol<br />
N (A) 100 mg<br />
OH<br />
MM 0098.07<br />
Imp. B (EP) as Hydrochloride: (1S,2R)-1-<br />
Benzyl-3-(dimethylamino)-2-methyl-1-<br />
phenylpropyl Acetate Hydrochloride<br />
(Acetoxyphene Hydrochloride)<br />
N<br />
O<br />
O<br />
x HCl<br />
(A)<br />
100 mg<br />
New MM 0098.10 Imp. E (Pharm<strong>eu</strong>ropa): Toluene (C) 100 mg<br />
Diazepam<br />
MM 0023.00<br />
Diazepam [Controlled Substance]<br />
N<br />
O<br />
(A)<br />
100 mg<br />
Cl<br />
N<br />
MM 0023.02<br />
Imp. A (EP): 7-Chloro-5-phenyl-1,3-dihydro-2H-1,4-benzodiazepin-2-<br />
one (Nordazepam) [Controlled Substance]<br />
Cl<br />
H<br />
N<br />
N<br />
O<br />
(A)<br />
100 mg<br />
202 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
<strong>Pharmac<strong>eu</strong>tical</strong> <strong>impurities</strong><br />
Code Product Category Unit<br />
MM 0023.04<br />
Imp. B (EP): 2-Chloro-N-(4-chloro-2-benzoylphenyl)-Nmethylacetamide<br />
O<br />
N<br />
Cl (A) 100 mg<br />
Cl<br />
O<br />
MM 0023.03<br />
Imp. C (EP): 3-Amino-6-chloro-1-methyl-4-phenylquinolin-<br />
2(1H)-one<br />
N<br />
O<br />
(A)<br />
100 mg<br />
Cl<br />
NH 2<br />
MM 0023.01<br />
Imp. D (EP): [5-Chloro-2-(methylamino)phenyl]phenylmethanone<br />
(5-Chloro-2-(methylamino)benzophenone)<br />
Cl<br />
NH<br />
O<br />
(B)<br />
100 mg<br />
MM 0023.05<br />
2'-Benzoyl-2,4'-dichloroacetanilide<br />
O<br />
NH<br />
Cl (A) 100 mg<br />
Cl<br />
O<br />
Dibutyl Sebacate<br />
O O<br />
MM 0925.00 Dibutyl Sebacate<br />
(A)<br />
500 mg<br />
O<br />
O<br />
Dichlorobenzyl Alcohol<br />
MM 0739.01<br />
Bis-(2,4-dichlorobenzyl)Ether<br />
O<br />
(A)<br />
100 mg<br />
Cl<br />
Cl<br />
Cl<br />
Cl<br />
Diclofenac Sodium<br />
MM 0006.00<br />
Diclofenac Sodium<br />
O<br />
ONa<br />
(A)<br />
500 mg<br />
Cl<br />
NH<br />
Cl<br />
MM 0006.01<br />
Imp. A (EP): 1-(2,6-Dichlorophenyl)-1,3-dihydro-2H-indol-2-one<br />
Cl<br />
N<br />
O<br />
Cl<br />
(A)<br />
100 mg<br />
MM 0006.03<br />
Imp. B (EP): 2-[(2,6-Dichlorophenyl)amino]benzaldehyde<br />
O (A) 100 mg<br />
Cl<br />
NH<br />
Cl<br />
MM 0006.04<br />
Imp. C (EP): [2-[(2,6-Dichlorophenyl)amino]phenyl]methanol<br />
OH (A) 100 mg<br />
Cl<br />
NH<br />
Cl<br />
MM 0006.09<br />
Imp. D (EP): 2-[2-[(2-Bromo-6-chlorophenyl)amino]phenyl]acetic Acid<br />
OH<br />
(D)<br />
100 mg<br />
Br<br />
O<br />
NH<br />
Cl<br />
MM 0006.05<br />
Imp. D (EP) as Sodium Salt: Sodium 2-[2-[(2-Bromo-6-chlorophenyl)-<br />
amino]phenyl]acetate<br />
Br<br />
ONa<br />
O<br />
NH<br />
Cl<br />
(D)<br />
100 mg<br />
MM 0006.02<br />
Imp. E (EP): 1,3-Dihydro-2H-indol-2-one<br />
N<br />
H<br />
O<br />
(B)<br />
100 mg<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 203
<strong>Pharmac<strong>eu</strong>tical</strong> <strong>impurities</strong><br />
Code Product Category Unit<br />
MM 0006.06 1-(2-Bromo-6-chlorophenyl)indolin-2-one<br />
O<br />
N<br />
Br Cl<br />
(D) 100 mg<br />
MM 0006.10<br />
Methyl 2-[2-[(2,6-Dichlorophenyl)amino]phenyl]acetate<br />
(Methyl Ester of Diclofenac)<br />
Cl<br />
O<br />
O<br />
NH<br />
Cl<br />
(A)<br />
100 mg<br />
MM 0006.11<br />
Ethyl 2-[2-[(2,6-Dichlorophenyl)amino]phenyl]acetate<br />
(Ethyl Ester of Diclofenac)<br />
Cl<br />
O<br />
O<br />
NH<br />
Cl<br />
(A)<br />
100 mg<br />
MM 0006.26<br />
Isopropyl 2-[2-[(2,6-Dichlorophenyl)amino]phenyl]acetate<br />
(Isopropyl Ester of Diclofenac)<br />
Cl<br />
O<br />
O<br />
NH<br />
Cl<br />
(A)<br />
100 mg<br />
MM 0006.12<br />
2-(2,6-Dichlorophenylamino)benzoic Acid<br />
O<br />
(A) 100 mg<br />
OH<br />
Cl<br />
NH<br />
Cl<br />
MM 0006.15<br />
2,6-Dichlorodiphenylamine<br />
(A)<br />
100 mg<br />
Cl<br />
NH<br />
Cl<br />
MM 0006.16<br />
2-Bromo-6-chlorodiphenylamine<br />
(A)<br />
100 mg<br />
Br<br />
NH<br />
Cl<br />
MM 0006.17<br />
1-(2,6-Dichlorophenyl)indolin-2,3-dione<br />
O<br />
(A) 100 mg<br />
Cl<br />
N<br />
O<br />
Cl<br />
MM 0006.18<br />
Diclofenac Potassium<br />
Cl<br />
OK<br />
O<br />
NH<br />
Cl<br />
(A)<br />
100 mg<br />
MM 0006.19<br />
2-Chloro-N-(2,6-dichlorophenyl)-N-phenylacetamide<br />
Cl<br />
(A) 100 mg<br />
Cl<br />
N<br />
O<br />
Cl<br />
MM 0006.20<br />
2-[2-[(2,6-Dichlorophenyl)amino]phenyl]acetic Acid (Diclofenac)<br />
Cl<br />
OH<br />
O<br />
NH<br />
Cl<br />
(A)<br />
100 mg<br />
NH<br />
MM 0006.21 2,6-Dichloroaniline 2<br />
Cl Cl<br />
(B)<br />
100 mg<br />
NH<br />
MM 0006.22 2-Bromo-6-chloroaniline 2<br />
Br Cl<br />
on request<br />
MM0006.27<br />
N-Acetyl-N-phenyl-2,6-dichloroaniline<br />
O (A) 100 mg<br />
Cl<br />
N<br />
Cl<br />
MM 0006.28<br />
Diethyl Phthalate<br />
O<br />
O<br />
O<br />
(C)<br />
100 mg<br />
O<br />
204 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
<strong>Pharmac<strong>eu</strong>tical</strong> <strong>impurities</strong><br />
Code Product Category Unit<br />
Dicloxacillim Sodium<br />
MM 0229.00<br />
MM 0229.03<br />
Diflucortolone Valerate<br />
MM 0600.00<br />
Dicloxacillin Sodium Monohydrate<br />
Imp. C (EP): (2S,5R,6R)-6-Amino-3,3-dimethyl-7-oxo-4-thia-1-<br />
azabicyclo[3.2.0]-heptane-2-carboxylic Acid<br />
(6-Aminopenicillanic Acid)<br />
Diflucortolone Valerate<br />
O<br />
Cl ONa<br />
on request<br />
O<br />
N Cl N<br />
H<br />
O N<br />
S<br />
x H 2 O<br />
H<br />
O<br />
HO<br />
O<br />
O<br />
H 2N<br />
O<br />
O<br />
N<br />
S<br />
H<br />
OH (B) 100 mg<br />
O<br />
(A) 100 mg<br />
O<br />
F<br />
F<br />
Digitoxin<br />
MM 0336.01<br />
Digitoxigenin<br />
O O<br />
on request<br />
HO<br />
OH<br />
Digoxin<br />
MM 0212.00<br />
Digoxin<br />
O<br />
O<br />
(A)<br />
250 mg<br />
OH<br />
OO<br />
H<br />
OH<br />
OO<br />
OH<br />
OO<br />
OH<br />
HO<br />
OH<br />
Diltiazem Hydrochloride<br />
MM 0068.00<br />
Diltiazem Hydrochloride<br />
O<br />
(A)<br />
500 mg<br />
S<br />
N<br />
O<br />
O<br />
O<br />
N<br />
x HCl<br />
MM 0068.02<br />
Imp. B (EP): (2S,3S)-2-(4-Methoxyphenyl)-4-oxo-2,3,4,5-<br />
tetrahydro-1,5-benzothiazepin-3-yl Acetate<br />
S<br />
N<br />
H<br />
O<br />
O<br />
O<br />
(A) 100 mg<br />
O<br />
MM 0068.03<br />
Imp. D (EP) as Hydrochloride: (2S,3S)-2-(4-Methoxyphenyl(-5-<br />
[2-(methylamino)ethyl]-4-oxo-2,3,4,5-tetrahydro-1,5-<br />
benzothiazepin-3-yl Acetate Hydrochloride<br />
(N-Desmethyldiltiazem Hydrochloride)<br />
S<br />
N<br />
O<br />
O<br />
O<br />
O<br />
x HCl<br />
(A)<br />
100 mg<br />
HN<br />
MM0068.04<br />
Imp. E (EP):(2S,3S)-3-Hydroxy-2-(4-methoxyphenyl)-2,3-<br />
dihydro-1,5-benzothiazepin-4(5H)-one<br />
S<br />
N<br />
H<br />
O<br />
OH<br />
O<br />
(A) 100 mg<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 205
<strong>Pharmac<strong>eu</strong>tical</strong> <strong>impurities</strong><br />
Code Product Category Unit<br />
MM 0068.05<br />
Imp. F (EP):(2S,3S)-5-[2-(Dimethylamino)ethyl]-3-hydroxy-2-<br />
(4-methoxyphenyl)-2,3-dihydro-1,5-benzothiazepin-4(5H)-one<br />
S<br />
N<br />
O<br />
OH<br />
O<br />
(A) 100 mg<br />
N<br />
MM 0068.07<br />
Diltiazem Sulphoxide<br />
O<br />
(A)<br />
100 mg<br />
O<br />
S<br />
N<br />
O<br />
O<br />
O<br />
N<br />
MM 0068.08<br />
Diltiazem Maleate<br />
O<br />
(A)<br />
100 mg<br />
S<br />
N<br />
O<br />
O<br />
O<br />
x<br />
O<br />
OH<br />
OH<br />
O<br />
N<br />
Dimenhydrinate<br />
MM 0599.00<br />
Dimenhydrinate<br />
O<br />
N<br />
x<br />
O<br />
N<br />
O N<br />
H<br />
N<br />
N<br />
Cl<br />
(A)<br />
500 mg<br />
MM 0599.05<br />
Imp. A (Pharm<strong>eu</strong>ropa): Theophylline<br />
N<br />
O<br />
(A) 500 mg<br />
H<br />
N<br />
O<br />
N<br />
N<br />
MM 0599.04<br />
Imp. B (Pharm<strong>eu</strong>ropa): 8-[(2-(Diphenylmethoxy)-<br />
ethyl)(methlyl)amino]-1,3-dimethyl-3,7-dihydro-1Hpurine-2,6-dione<br />
O<br />
N<br />
O N<br />
H<br />
N<br />
N<br />
N<br />
O<br />
(A)<br />
100 mg<br />
MM 0599.01<br />
Diphenhydramine Hydrochloride<br />
(A)<br />
500 mg<br />
O<br />
N<br />
x HCl<br />
MM 0599.02<br />
8-Chlorotheophylline<br />
O<br />
N<br />
O N<br />
H<br />
N<br />
N<br />
Cl<br />
(B)<br />
100 mg<br />
MM 0599.03<br />
8-[N-(2-Diphenylmethoxyethyl)-N,N-dimethylaminium]-<br />
1,3-dimethylxanthine inner salt<br />
O<br />
N<br />
(A)<br />
100 mg<br />
O<br />
N<br />
N - N<br />
N + O<br />
Dimetindene Maleate<br />
MM 0595.01 Imp. A (EP): 2-Ethylpyridine<br />
N<br />
(B) 100 mg<br />
Diphemanil Metilsulfate<br />
x<br />
-<br />
S<br />
O O<br />
New MM 1163.00 Diphemanil Metilsulfate<br />
N + (D) 100 mg<br />
O O<br />
206 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
<strong>Pharmac<strong>eu</strong>tical</strong> <strong>impurities</strong><br />
Code Product Category Unit<br />
Diphenhydramine Hydrochloride<br />
MM 0490.00 Diphenhydramine Hydrochloride<br />
(A) 500 mg<br />
O<br />
N<br />
x HCl<br />
MM 0490.03<br />
Imp. A (EP) as Hydrochloride: 2-(Diphenylmethoxy)-Nmethylethanamine<br />
Hydrochloride<br />
(Nordiphenhydramine Hydrochloride)<br />
O<br />
H<br />
N<br />
x HCl<br />
(A)<br />
100 mg<br />
MM 0490.04<br />
Imp. B (EP) as Hydrochloride: 2-[(RS)(4-<br />
Methylphenyl)phenylmethoxy]-N,Ndimethylethanamine<br />
Hydrochloride<br />
O<br />
N<br />
x HCl<br />
(A)<br />
100 mg<br />
MM 0490.08<br />
Imp. C (EP) as Hydrochloride: 2-[(RS)(4-<br />
Bromophenyl)phenylmethoxy]-N,Ndimethylethanamine<br />
Hydrochloride<br />
O<br />
N<br />
x HCl<br />
(A)<br />
100 mg<br />
Br<br />
MM 0490.02<br />
Imp. D (EP): Diphenylmethanol (Benzhydrol)<br />
(B)<br />
100 mg<br />
OH<br />
MM 0490.05<br />
Imp. E (EP): Diphenylmethanone (Benzophenone)<br />
(B)<br />
100 mg<br />
O<br />
MM 0490.01<br />
Diphenhydramine N-Oxide<br />
O<br />
N O (A) 100 mg<br />
Diphenylpyraline Hydrochloride<br />
MM 0557.00<br />
Diphenylpyraline Hydrochloride<br />
O<br />
N<br />
x HCl<br />
(A)<br />
500 mg<br />
MM 0557.01<br />
Diphenylpyraline<br />
O<br />
(A)<br />
100 mg<br />
N<br />
MM 0557.02<br />
Diphenylmethanol (Benzhydrol)<br />
OH<br />
(B)<br />
100 mg<br />
MM 0557.03<br />
Diphenylmethanone (Benzophenone)<br />
O<br />
(B)<br />
100 mg<br />
MM 0557.04<br />
Diphenylpyraline N-Oxide<br />
O<br />
(A)<br />
100 mg<br />
N<br />
O<br />
Dipipanone Hydrochloride<br />
MM 0760.01 1,1-Diphenylbut-1-ene (A) 100 mg<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 207
<strong>Pharmac<strong>eu</strong>tical</strong> <strong>impurities</strong><br />
Code Product Category Unit<br />
MM 0760.02 1-(1-Methyl-3,3-diphenylpropyl)piperidine Hydrochloride<br />
(A) 100 mg<br />
N<br />
x HCl<br />
Dipotassium Clorazepate<br />
MM 0984.01<br />
Imp. A (EP): (2-Amino-5-chlorophenyl)phenylmethanone<br />
(Aminochlorobenzophenone)<br />
Cl<br />
NH 2<br />
O<br />
(B)<br />
100 mg<br />
MM 0984.02<br />
Imp. B (EP): 7-Chloro-5-phenyl-1,3-dihydro-2H-1,4-benzodiazepin-<br />
2-one<br />
(Nordazepam) [Controlled Substance]<br />
Cl<br />
H<br />
N<br />
N<br />
O<br />
(A)<br />
100 mg<br />
Diprafenon Hydrochloride<br />
MM 0428.01 2'-Hydroxy-3-phenylpropiophenone<br />
O<br />
(A)<br />
100 mg<br />
OH<br />
Disopyramide<br />
MM 0108.00<br />
Disopyramide<br />
N<br />
(A)<br />
500 mg<br />
N<br />
NH 2<br />
O<br />
Dithranol<br />
OH O OH<br />
MM 0137.00 Dithranol (A) 500 mg<br />
MM 0137.04 Imp. A (EP): Anthracen-9(10H)-one (Anthrone)<br />
O<br />
(A) 100 mg<br />
OH O OH<br />
MM 0137.01 Imp. B (EP): 1,8-Dihydroxyanthracene-9,10-dione (Danthron)<br />
(A)<br />
100 mg<br />
O<br />
MM 0137.02<br />
Imp. C (EP): 4,4',5,5'-Tetrahydroxy-9,9'-bianthracenyl-10,10'(9H,9'H)-<br />
dione (Dithranol Dimer)<br />
OH<br />
O<br />
OH<br />
(A)<br />
100 mg<br />
OH O OH<br />
208 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
<strong>Pharmac<strong>eu</strong>tical</strong> Impurities<br />
Code Product Category Unit<br />
Dobutamine Hydrochloride<br />
MM 0675.01 Imp. A (EP) as Hydrochloride: Dopamine Hydrochloride HO<br />
NH 2<br />
x HCl<br />
HO<br />
(A) 500 mg<br />
OH<br />
MM 0675.02 Imp. B (EP): 4-(4-Hydroxyphenyl)butan-2-one<br />
(C) 100 mg<br />
O<br />
Dodecylguanidinium Acetate<br />
MM 0451.03 Dodecylnitrile<br />
N<br />
(B) 100 mg<br />
MM 0451.05<br />
Dimethyldodecylamine<br />
N<br />
(B)<br />
100 mg<br />
Domperidone<br />
MM 0107.00<br />
Domperidone<br />
HN<br />
O<br />
N<br />
N<br />
O<br />
N NH<br />
(D)<br />
100 mg<br />
Cl<br />
MM 0107.06<br />
Imp. A (EP): 5-Chloro-1-(piperidin-4-yl)-1,3-dihydro-2H-benzimidazol-<br />
2-one<br />
HN<br />
O<br />
N NH<br />
(A)<br />
100 mg<br />
MM 0107.05<br />
Imp. B (EP): 4-(5-Chloro-2-oxo-2,3-dihydro-1H-benzimidazol-1-yl)-1-<br />
formylpiperidine<br />
Cl<br />
O<br />
O (A) 100 mg<br />
N<br />
N NH<br />
MM 0107.03<br />
Imp. F (EP): 1,3-Bis[3-[4-(5-chloro-2-oxo-<br />
2,3-dihydro-1H-benzimidazol-1-yl)piperidin-<br />
1-yl]propyl]-1,3-dihydro-2H-benzimidazol-2-<br />
one<br />
MM 0107.07 1,3-Dihydro-2H-benzimidazol-2-one<br />
H N<br />
O<br />
N H<br />
HN<br />
Cl<br />
O<br />
N<br />
N<br />
N<br />
O<br />
N<br />
N<br />
N<br />
O<br />
Cl<br />
NH<br />
Cl<br />
(A)<br />
(B)<br />
50 mg<br />
100 mg<br />
Donepezil Hydrochloride<br />
MM 0677.00<br />
Donepezil Hydrochloride<br />
on request<br />
O<br />
O<br />
N<br />
x HCl<br />
O<br />
MM 0677.01<br />
Donepezil<br />
on request<br />
O<br />
O<br />
N<br />
Dopamine Hydrochloride<br />
MM 0384.00 Dopamine Hydrochloride<br />
HO<br />
MM 0384.02<br />
Imp. A (EP) as Hydrochloride: 5-(2-Aminoethyl)-2-<br />
methoxyphenol Hydrochloride (4-O-Methyldopamine<br />
Hydrochloride)<br />
MM 0384.04 Imp. C (EP): 2-(3,4-Dimethoxyphenyl)ethanamine<br />
O<br />
O<br />
HO<br />
HO<br />
O<br />
NH 2<br />
NH 2<br />
x HCl<br />
x HCl<br />
(A) 500 mg<br />
(A) 100 mg<br />
NH 2<br />
(A) 100 mg<br />
O<br />
MM 0384.01 (R,S)-α-Methyldopamine Hydrobromide<br />
HO<br />
HO<br />
NH 2<br />
x HBr<br />
(A)<br />
100 mg<br />
Dosulepin Hydrochloride<br />
MM 0510.00<br />
Dosulepin Hydrochloride<br />
N<br />
(A)<br />
100 mg<br />
x HCl<br />
S<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 209
<strong>Pharmac<strong>eu</strong>tical</strong> Impurities<br />
Code Product Category Unit<br />
MM 0510.02 Imp. B (EP): Dibenzo[b,e]thiepin-11(6H)-one<br />
(A) 100 mg<br />
O<br />
S<br />
MM 0510.08<br />
Nordosulepin Hydrochloride<br />
N<br />
H<br />
(A)<br />
50 mg<br />
x HCl<br />
S<br />
Doxazosin Mesilate<br />
MM 0386.00<br />
Doxazosin Mesilate<br />
O<br />
O<br />
N N<br />
N<br />
NH 2<br />
x<br />
N<br />
O<br />
O<br />
O<br />
O O<br />
S<br />
OH<br />
(A)<br />
100 mg<br />
MM 0386.08<br />
Doxazosin<br />
N<br />
O<br />
O<br />
(A)<br />
100 mg<br />
O<br />
O<br />
N N<br />
N<br />
O<br />
MM 0386.04<br />
Imp. A (EP): (2RS)-2,3-Dihydro-1,4-benzodioxine-2-carboxylic Acid<br />
NH 2<br />
O<br />
(A) 100 mg<br />
HO O<br />
O<br />
MM 0386.05<br />
Imp. B (EP) as Hydrochloride: 1-[(2RS)-2,3-Dihydro-1,4-<br />
benzodioxin-2-ylcarbonyl]piperazine Hydrochloride<br />
HN<br />
N<br />
O<br />
O<br />
O<br />
x HCl<br />
(A)<br />
100 mg<br />
MM 0386.06<br />
Imp. C (EP): 1,4-Bis(2,3-dihydro-1,4-benzodioxin-<br />
2-ylcarbonyl)piperazine<br />
O<br />
O<br />
N<br />
N<br />
O<br />
O<br />
O<br />
(A)<br />
100 mg<br />
O<br />
MM 0386.10<br />
Imp. D (EP): 6,7-Dimethoxyquinazoline-2,4(1H,3H)-dione<br />
O<br />
H<br />
N<br />
O<br />
(C)<br />
100 mg<br />
MM 0386.09<br />
Imp. E (EP): 2,4-Dichloro-6,7-dimethoxyquinazoline<br />
O N<br />
MM 0386.01 Imp. F (EP): 2-Chloro-6,7-dimethoxyquinazolin-4-amine<br />
New MM 0386.12<br />
Imp. F (EP) as Mesilate: 2-Chloro-6,7-dimethoxyquinazolin-4-amine<br />
Mesilate<br />
O<br />
O<br />
N<br />
O<br />
O<br />
O<br />
N<br />
O<br />
Cl<br />
x<br />
O<br />
N<br />
NH<br />
N<br />
Cl<br />
Cl<br />
Cl<br />
N<br />
O<br />
NH 2<br />
O<br />
S<br />
OH<br />
(A)<br />
(A)<br />
(A)<br />
100 mg<br />
100 mg<br />
100 mg<br />
NH 2<br />
MM 0386.02<br />
Imp. G (EP): 6,7-Dimethoxy-2-(piperazin-1-yl)quinazolin-4-<br />
amine<br />
O<br />
O<br />
NH (A) 100 mg<br />
N N<br />
N<br />
NH 2<br />
MM 0386.03<br />
Imp. H (EP): 2,2'-(Piperazine-1,4-diyl)bis(6,7-<br />
dimethoxyquinazolin-4-amine)<br />
NH 2<br />
(D) 100 mg<br />
O<br />
N<br />
O<br />
O<br />
N N<br />
N N<br />
N<br />
NH 2<br />
O<br />
210 All your need for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
<strong>Pharmac<strong>eu</strong>tical</strong> Impurities<br />
Code Product Category Unit<br />
Doxepin Hydrochloride<br />
MM 0032.00 Doxepin Hydrochloride<br />
N<br />
(A) 500 mg<br />
O<br />
x HCl<br />
Doxycycline Hydrochloride<br />
MM 0538.00 Doxycycline Hydrochloride<br />
OH O OH O<br />
OH<br />
O<br />
(A)<br />
500 mg<br />
H<br />
H<br />
OH<br />
N<br />
OH<br />
NH 2<br />
x HCl<br />
Doxylamine Hydrogen Succinate<br />
MM 0101.00<br />
Doxylamine Hydrogen Succinate<br />
O<br />
(A)<br />
500 mg<br />
N<br />
O<br />
N<br />
x<br />
OH<br />
OH<br />
MM 0101.04<br />
Imp. D (EP): Phenyl(pyridin-2-yl)methanone<br />
(2-Benzoylpyridine)<br />
O<br />
(A)<br />
100 mg<br />
N<br />
O<br />
New MM 0101.05<br />
Doxylamine N-Oxide Dihydrochloride<br />
(A)<br />
100 mg<br />
N<br />
O<br />
N O<br />
x 2 HCl<br />
Drofenine Hydrochloride<br />
MM 0768.00<br />
Drofenine Hydrochloride<br />
(A)<br />
500 mg<br />
O<br />
O<br />
N<br />
x HCl<br />
MM 0768.01<br />
Drofenine N-Oxide Hydrochloride<br />
(A)<br />
100 mg<br />
O<br />
O<br />
N<br />
O<br />
x HCl<br />
Droperidol<br />
New MM 0138.04<br />
Imp. D (EP) as Hydrochloride: (1RS)-<br />
1-[4-(4-Fluorophenyl)-4-oxobutyl]-<br />
4-(2-oxo-2,3-dihydro-1H-benzimidazol-<br />
1-yl)-1,2,3,6-tetrahydropyridine 1-Oxide<br />
Hydrochloride<br />
F<br />
O<br />
O<br />
N<br />
O<br />
N<br />
NH<br />
x HCl<br />
(A)<br />
100 mg<br />
Dropropizine<br />
MM 1017.00<br />
Dropropizine<br />
N<br />
N<br />
OH<br />
OH (A) 500 mg<br />
Ebastine<br />
MM 0468.00<br />
Ebastine<br />
(A)<br />
100 mg<br />
O<br />
N<br />
O<br />
New MM 0468.02<br />
Imp. A (EP): Diphenylmethanol (Benzhydrol)<br />
(B)<br />
100 mg<br />
OH<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 211
<strong>Pharmac<strong>eu</strong>tical</strong> Impurities<br />
Code Product Category Unit<br />
Econazole Nitrate<br />
MM 0524.00<br />
Econazole Nitrate<br />
Cl<br />
(A) 500 mg<br />
Cl<br />
x HNO 3<br />
O<br />
Cl<br />
N<br />
N<br />
MM 0524.01<br />
Imp. A (EP): (1RS)-1-(2,4-Dichlorophenyl)-2-(1H-imidazol-1-yl)ethanol<br />
Cl<br />
(A) 100 mg<br />
Cl<br />
HO<br />
N<br />
MM 0524.02<br />
Imp. B (EP) as Nitrate: (2RS)-2-[(4-Chlorobenzyl)oxy]-2-<br />
(2,4-dichlorophenyl) ethanamine Nitrate<br />
N<br />
Cl<br />
(D) 100 mg<br />
Cl<br />
O<br />
x HNO 3<br />
Cl<br />
NH 2<br />
Enalapril Maleate<br />
MM 0010.00<br />
Enalapril Maleate<br />
O<br />
H<br />
N<br />
O<br />
O<br />
N<br />
O<br />
OH O (A) 100 mg<br />
OH<br />
x<br />
OH<br />
O<br />
MM 0010.05<br />
Imp. B (EP): (2S)-2-[[(1S)-1-(Ethoxycarbonyl)-3-<br />
phenylpropyl]amino]propanoic Acid<br />
H<br />
N<br />
O (A) 100 mg<br />
OH<br />
O<br />
O<br />
MM 0010.01<br />
Imp. C (EP): (2S)-1-[(2S)-2-[[(1S)-1-Carboxy-<br />
3-phenylpropyl]amino]propanoyl]pyrrolidine-2-<br />
carboxylic Acid (Enalaprilat)<br />
H<br />
N<br />
O<br />
O<br />
N<br />
OH on request<br />
HO<br />
O<br />
MM 0010.06<br />
Imp. D (EP): Ethyl (2S)-2-[(3S,8aS)-3-Methyl-1,4-dioxooctahydropyrrolo[1,2-α]pyrazin-2-yl]-4-phenylbutanoate<br />
(Enalapril diketopiperazine)<br />
H<br />
(A) 100 mg<br />
O<br />
N<br />
N<br />
O<br />
O<br />
O<br />
MM 0010.14<br />
Imp. I (EP): 1H-Imidazole<br />
H<br />
N (B) 100 mg<br />
N<br />
MM 0010.15<br />
(2S)-2[[(1S)-1-(Ethoxycarbonyl)-3-<br />
phenylpropyl]amino]propanoic Acid Ethyl Ester<br />
Hydrochloride<br />
O<br />
H<br />
N<br />
O<br />
O<br />
O<br />
x HCl<br />
(A)<br />
100 mg<br />
Enilconazole<br />
New MM 1228.05<br />
Imp. E (EP): (1RS)-1-(2,4-Dichlorophenyl)-2-(1H-imidazol-1-yl)ethanol<br />
Cl<br />
(A) 100 mg<br />
Cl<br />
HO<br />
N<br />
N<br />
Enrofloxacin<br />
MM 0395.00<br />
Enrofloxacin<br />
N<br />
(A)<br />
100 mg<br />
N<br />
N<br />
F<br />
O<br />
OH<br />
O<br />
212 All your need for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
<strong>Pharmac<strong>eu</strong>tical</strong> Impurities<br />
Code Product Category Unit<br />
New MM 0395.04<br />
New MM 0395.05<br />
MM 0395.01<br />
MM 0395.03<br />
Imp. A (Pharm<strong>eu</strong>ropa): 7-Chloro-1-cyclopropyl-6-fluoro-4-oxo-1,4-dihydroquinoline-<br />
3-carboxylic Acid<br />
Imp. B (Pharm<strong>eu</strong>ropa) as Hydrochloride<br />
Monohydrate: 1-Cyclopropyl-6-fluoro-4-<br />
oxo-7-piperazin-1-yl-1,4-dihydroquinoline-<br />
3-carboxylic Acid Hydrochloride Monohydrate<br />
Imp. C (Pharm<strong>eu</strong>ropa) as Hydrochloride:<br />
1-Cyclopropyl-7-(4-ethylpiperazin-1-yl)-4-<br />
oxo-1,4-dihydroquinoline-3-carboxylic Acid<br />
Hydrochloride (Desfluoroenrofloxacin<br />
Hydrochloride)<br />
Enrofloxacin N-Oxide<br />
HN<br />
N<br />
N<br />
F<br />
N<br />
N<br />
Cl<br />
F<br />
N<br />
N<br />
O<br />
N<br />
O<br />
O<br />
N<br />
O<br />
OH<br />
O<br />
N<br />
OH<br />
O<br />
OH<br />
x HCl<br />
x H 2 O<br />
x HCl<br />
(A)<br />
(A)<br />
(A)<br />
100 mg<br />
500 mg<br />
100 mg<br />
O<br />
(A) 100 mg<br />
F<br />
O<br />
O<br />
OH<br />
Ephedrine Hydrochloride<br />
MM 0652.00 Ephedrine Hydrochloride [Controlled Substance]<br />
OH<br />
H<br />
N<br />
x HCl<br />
(A)<br />
500 mg<br />
MM 0652.02<br />
Imp. B (EP) as Hydrochloride: Ps<strong>eu</strong>doephedrine Hydrochloride<br />
[Controlled Substance]<br />
OH<br />
H<br />
N<br />
x HCl<br />
(A)<br />
500 mg<br />
Ephedrine Sulphate<br />
New MM1147.00<br />
Ephedrine Sulphate [Controlled Substance]<br />
OH<br />
H<br />
N<br />
x H 2 SO 4<br />
(A) 250 mg<br />
2<br />
Erdosteine<br />
MM 0544.00<br />
Erdosteine<br />
S<br />
O<br />
(A) 100 mg<br />
N<br />
H<br />
O<br />
S<br />
O<br />
OH<br />
MM 0544.01<br />
2-Chloro-N-(2-oxotetrahydrothiophen-3-yl)acetamide<br />
S<br />
O<br />
(A) 100 mg<br />
N<br />
H<br />
O<br />
Cl<br />
Erythromycin<br />
MM 0132.10<br />
Imp. E (EP): Erythromycin A Enol Ether<br />
(A)<br />
50 mg<br />
N<br />
OO<br />
OH<br />
OH<br />
O<br />
OO<br />
O OH<br />
HO<br />
O<br />
O<br />
Esomeprazole Magnesium Trihydrate<br />
MM 1036.02<br />
Imp. A (Pharm<strong>eu</strong>ropa): 5-Methoxy-1H-benzimidazole-2-thiol<br />
O<br />
(A) 100 mg<br />
NH<br />
MM 1036.03<br />
MM 1036.04<br />
MM 1036.05<br />
Imp. B (Pharm<strong>eu</strong>ropa): 2-[(RS)-[(3,5-Dimethylpyridin-2-<br />
yl)methyl]sulphinyl]-<br />
5-methoxy-1H-benzimidazole<br />
Imp. C (Pharm<strong>eu</strong>ropa): 5-Methoxy-2-[[(4-methoxy-3,5-<br />
dimethylpyridin-2-yl)-methyl]sulphanyl]-1H-benzimidazole<br />
(Ufiprazole)<br />
Imp. D (Pharm<strong>eu</strong>ropa): 5-Methoxy-2-[[(4-methoxy-3,5-<br />
dimethylpyridin-2-yl)methyl]sulphonyl]-1H-benzimidazole<br />
(Omeprazole Sulphone)<br />
NH<br />
N S<br />
O N<br />
N SH<br />
O<br />
(A) 100 mg<br />
O<br />
(A) 100 mg<br />
NH<br />
O<br />
N S<br />
N<br />
O<br />
NH<br />
O<br />
N S<br />
O O N<br />
(A) 100 mg<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 213
<strong>Pharmac<strong>eu</strong>tical</strong> Impurities<br />
Code Product Category Unit<br />
MM 1036.06 Imp. E (Pharm<strong>eu</strong>ropa): 4-Methoxy-2-[[(RS)-(5-methoxy-<br />
O<br />
(A) 100 mg<br />
NH<br />
1H-benzimidazol-2-yl)sulphinyl]methyl]-3,5-<br />
O<br />
N<br />
dimethylpyridine 1-Oxide (Omeprazole N-Oxide)<br />
S<br />
O N<br />
O<br />
Estradiol Benzoate<br />
MM 0301.00 Estradiol Benzoate<br />
OH<br />
(A)<br />
500 mg<br />
O<br />
O<br />
MM 0301.04 Imp. A (EP) as Hemihydrate: Estradiol Hemihydrate<br />
OH<br />
(A)<br />
500 mg<br />
x 1 / 2 H 2 O<br />
HO<br />
MM 0301.02<br />
Imp. C (EP): Estra-1,3,5(10)-triene-3,17β-diyl<br />
Dibenzoate (Estradiol 3,17-Dibenzoate)<br />
O<br />
O<br />
(A) 100 mg<br />
O<br />
O<br />
MM 0301.07<br />
Imp. D (EP): 3-Hydroxyestra-1,3,5(10)-trien-17β-yl<br />
Benzoate (Estradiol 17-Benzoate)<br />
O<br />
O<br />
(A) 100 mg<br />
HO<br />
MM 0301.03<br />
Imp. E (EP): 17α-Hydroxyestra-1,3,5(10)-trien-3-yl Benzoate<br />
(17-epi-Estradiol Benzoate)<br />
O<br />
OH<br />
(D)<br />
100 mg<br />
O<br />
MM 0301.08<br />
Imp. G (Pharm<strong>eu</strong>ropa): 17-Oxo-estra-1,3,5(10)trien-3-yl<br />
Benzoate<br />
O<br />
(A)<br />
100 mg<br />
O<br />
O<br />
MM 0301.05<br />
Benzoic Acid<br />
O<br />
(B) 100 mg<br />
OH<br />
Estradiol Enanthate<br />
MM 0473.00<br />
Estradiol Enanthate<br />
O<br />
O<br />
(A) 100 mg<br />
Estradiol Hemihydrate<br />
MM 0300.00 Estradiol Hemihydrate<br />
OH<br />
HO<br />
(A)<br />
500 mg<br />
MM 0300.05 Imp. A (EP): 3-Hydroxyestra-1,3,5(10)-trien-17-one (Estrone)<br />
O<br />
HO<br />
x 1 / 2 H 2 O<br />
(A)<br />
500 mg<br />
HO<br />
MM 0300.01 Imp. B (EP): Estra-1,3,5(10)-triene-3,17α-diol (17α-Estradiol; 17-<br />
epi-Estradiol)<br />
OH<br />
(A)<br />
100 mg<br />
HO<br />
MM 0300.06 Imp. C (EP): 4-Methylestra-1,3,5(10)-triene-3,17β-diol (4-<br />
Methylestradiol)<br />
OH<br />
(A)<br />
100 mg<br />
HO<br />
214 All your need for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
<strong>Pharmac<strong>eu</strong>tical</strong> Impurities<br />
Code Product Category Unit<br />
MM 0300.02 Imp. D (EP): Estra-1,3,5(10),9(11)-tetraene-3,17β-diol (9,11-<br />
Didehydroestradiol)<br />
OH<br />
(D)<br />
100 mg<br />
MM 0300.03 6β-Hydroxyestradiol<br />
OH<br />
HO<br />
(D)<br />
50 mg<br />
MM 0300.08 6-Ketoestradiol<br />
OH<br />
HO<br />
OH<br />
(A)<br />
100 mg<br />
Estradiol Valerate<br />
MM 0209.00<br />
Estradiol Valerate<br />
HO<br />
O<br />
O<br />
O<br />
(A) 500 mg<br />
MM 0209.05 Imp. A (EP) as Hemihydrate:Estradiol Hemihydrate<br />
OH<br />
HO<br />
(A)<br />
500 mg<br />
x 1 / 2 H 2 O<br />
HO<br />
MM 0209.06<br />
Imp. B (EP): 17β-Hydroxyestra-1,3,5(10)-trien-3-yl<br />
Pentanoate (Estradiol 3-Valerate)<br />
OH<br />
(A)<br />
100 mg<br />
O<br />
O<br />
MM 0209.01<br />
Imp. C (EP): 3-Hydroxyestra-1,3,5(10),9(11)-tetraen-17β-yl<br />
Pentanoate (9,11-Didehydroestradiol Valerate)<br />
O<br />
O<br />
(D) 100 mg<br />
HO<br />
MM 0209.07<br />
Imp. D (EP): 3-Hydroxy-4-methylestra-1,3,5(10)-trien-<br />
17β-yl Pentanoate<br />
(4-Methylestradiol Valerate)<br />
O<br />
O<br />
(D) 100 mg<br />
HO<br />
MM 0209.02<br />
Imp. E (EP): Estra-1,3,5(10)-trien-3,17β-diyl<br />
Dipentanoate (Estradiol 3,17-Divalerate)<br />
O<br />
O<br />
(A)<br />
100 mg<br />
O<br />
O<br />
MM 0209.04<br />
Imp. F (EP): 3-Hydroxyestra-1,3,5(10)-trien-17β-yl Butanoate<br />
(Estradiol Butyrate)<br />
O<br />
O<br />
(A) 100 mg<br />
HO<br />
MM 0209.03<br />
17-epi-Estradiol Valerate (17α-Estradiol Valerate)<br />
O<br />
O<br />
(D) 100 mg<br />
HO<br />
Estramustine Sodium Phosphate<br />
New MM 0100.01 Estramustine<br />
OH<br />
(D)<br />
100 mg<br />
Cl<br />
Cl<br />
N<br />
O<br />
O<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 215
<strong>Pharmac<strong>eu</strong>tical</strong> Impurities<br />
Code Product Category Unit<br />
Estriol<br />
MM 0130.00 Estriol<br />
OH<br />
(A) 100 mg<br />
OH<br />
HO<br />
MM 0130.06 Imp. A (EP): Estra-1,3,5(10),9(11)-tetraene-3,16α,17β-triol (9,11-<br />
Didehydroestriol)<br />
OH<br />
OH<br />
(D)<br />
100 mg<br />
MM 0130.19 Imp. B (EP): 3-Hydroxyestra-1,3,5(10)-trien-17-one (Estrone)<br />
O<br />
HO<br />
(A)<br />
500 mg<br />
HO<br />
MM 0130.01<br />
Imp. C (EP): 3-Methoxyestra-1,3,5(10)-triene-16α,17β-diol<br />
(Estriol 3-Methyl Ether)<br />
OH<br />
OH<br />
(D)<br />
100 mg<br />
MM 0130.20 Imp. D (EP) as Hemihydrate: Estradiol Hemihydrate<br />
OH<br />
O<br />
(A)<br />
500 mg<br />
x 1 / 2 H 2 O<br />
HO<br />
MM 0130.05<br />
Imp. E (EP): Estra-1,3,5(10)-triene-3,16α,17α-triol<br />
(17-epi-Estriol)<br />
OH<br />
OH<br />
(D)<br />
100 mg<br />
HO<br />
MM 0130.04<br />
Imp. F (EP): Estra-1,3,5(10)-triene-3,16β,17β-triol<br />
(16-epi-Estriol)<br />
OH<br />
OH<br />
(D)<br />
100 mg<br />
HO<br />
MM 0130.03<br />
Imp. G (EP): Estra-1,3,5(10)-triene-3,16β,17α-triol<br />
(16,17-epi-Estriol)<br />
OH<br />
OH<br />
(D)<br />
100 mg<br />
HO<br />
MM 0130.22<br />
Imp. I (EP): 3-Hydroxy-17-oxa-D-homoestra-1,3,5(10)-trien-17aone<br />
O<br />
on request<br />
O<br />
MM 0130.02 6α-Hydroxyestriol<br />
OH<br />
HO<br />
OH<br />
(D)<br />
100 mg<br />
HO<br />
OH<br />
MM 0130.14<br />
Estriol 16,17-Diacetate<br />
O<br />
O<br />
(D)<br />
100 mg<br />
O<br />
O<br />
HO<br />
MM 0130.15<br />
Estriol Triacetate<br />
O<br />
O<br />
(D)<br />
100 mg<br />
O<br />
O<br />
O<br />
MM 0130.16 Estriol 3-Benzyl Ether<br />
OH<br />
O<br />
OH<br />
(D)<br />
100 mg<br />
MM 0130.17 16-Oxoestradiol<br />
OH<br />
O<br />
O<br />
(D)<br />
100 mg<br />
MM 0130.18 6-Oxoestriol<br />
OH<br />
HO<br />
OH<br />
(D)<br />
100 mg<br />
HO<br />
O<br />
216 All your need for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
<strong>Pharmac<strong>eu</strong>tical</strong> Impurities<br />
Code Product Category Unit<br />
Estrone<br />
MM 0282.00 Estrone<br />
O<br />
(A) 500 mg<br />
MM 0282.01 Estrone 3-Methyl Ether<br />
O<br />
HO<br />
(A)<br />
100 mg<br />
Ethacridine Lactate Monohydrate<br />
MM 0798.00 Ethacridine Lactate Monohydrate<br />
Ethinylestradiol<br />
O<br />
NH 2<br />
O<br />
O<br />
x OH x H 2O<br />
H 2 N<br />
N<br />
OH<br />
MM 0123.00 Ethinylestradiol<br />
OH<br />
(A)<br />
on request<br />
500 mg<br />
HO<br />
MM 0123.02<br />
Imp. B (EP): 19-Nor-17α-pregna-1,3,5(10),9(11)-tetraen-20-<br />
yne-3,17-diol (9,11-Didehydroethinylestradiol)<br />
OH<br />
(D)<br />
50 mg<br />
MM 0123.03 Imp. C (EP): 3-Hydroxyestra-1,3,5(10)-trien-17-one (Estrone)<br />
O<br />
HO<br />
(A)<br />
500 mg<br />
HO<br />
MM 0123.04<br />
Imp. D (EP) as Hemihydrate:<br />
Estradiol Hemihydrate<br />
OH<br />
x 1 / 2 H 2 O<br />
(A)<br />
500 mg<br />
MM 0123.05 6-Ketoethinylestradiol<br />
OH<br />
HO<br />
(D)<br />
100 mg<br />
MM 0123.06 6β-Hydroxyethinylestradiol<br />
OH<br />
HO<br />
O<br />
(D)<br />
25 mg<br />
MM 0123.07 6α-Hydroxyethinylestradiol<br />
OH<br />
HO<br />
OH<br />
(D)<br />
100 mg<br />
HO<br />
OH<br />
MM 0123.08<br />
6,7-Didehydroethinylestradiol<br />
OH (D) 50 mg<br />
HO<br />
Ethionamide<br />
MM 0845.00<br />
Ethionamide<br />
S<br />
(A) 250 mg<br />
NH 2<br />
N<br />
MM 0845.01<br />
Ethionamide Sulphoxide<br />
S<br />
O<br />
(D) 100 mg<br />
NH 2<br />
N<br />
Ethosuximide<br />
MM 0750.00 Ethosuximide<br />
H<br />
O N<br />
O<br />
(A)<br />
500 mg<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 217
<strong>Pharmac<strong>eu</strong>tical</strong> Impurities<br />
Code Product Category Unit<br />
Ethyl Parahydroxybenzoate<br />
MM 0498.00<br />
Ethyl Parahydroxybenzoate<br />
O<br />
(A) 500 mg<br />
O<br />
HO<br />
MM 0498.05<br />
Sodium Ethyl Parahydroxybenzoate<br />
O<br />
(A) 500 mg<br />
O<br />
NaO<br />
MM 0498.01<br />
Imp. A (EP): 4-Hydroxybenzoic Acid<br />
O<br />
(B) 100 mg<br />
OH<br />
HO<br />
MM 0498.02<br />
Imp. B (EP): Methyl 4-Hydroxybenzoate<br />
O<br />
(A) 500 mg<br />
O<br />
HO<br />
MM 0498.03<br />
Imp. C (EP): Propyl 4-Hydroxybenzoate<br />
O<br />
(A) 500 mg<br />
O<br />
HO<br />
MM 0498.04<br />
Imp. D (EP): Butyl 4-Hydroxybenzoate<br />
O<br />
(A) 500 mg<br />
O<br />
HO<br />
Ethylmorphine Hydrochloride<br />
MM 0799.02<br />
Imp. B (EP) as Hydrochloride Trihydrate: Morphine<br />
Hydrochloride Trihydrate<br />
[Controlled Substance]<br />
N<br />
x HCl<br />
x 3 H 2 O<br />
(A)<br />
250 mg<br />
HO<br />
O<br />
OH<br />
MM 0799.03<br />
Imp. B (EP) as Hemisulphate Pentahemihydrate: Morphine<br />
Hemisulphate Pentahemihydrate [Controlled Substance]<br />
N<br />
x H 2 SO 4<br />
x 5 H 2 O<br />
(A)<br />
250 mg<br />
HO<br />
O<br />
OH<br />
2<br />
MM 0799.04<br />
Imp. C (EP) as Monohydrate: Codeine Monohydrate<br />
[Controlled Substance]<br />
N<br />
x H 2 O<br />
(A)<br />
100 mg<br />
O<br />
O<br />
OH<br />
MM 0799.05<br />
Imp. C (EP) as Phosphate Hemihydrate: Codeine<br />
Phosphate Hemihydrate<br />
[Controlled Substance]<br />
N<br />
x H 3 PO 4<br />
x 1/2 H 2 O<br />
(A)<br />
100 mg<br />
O<br />
O<br />
OH<br />
Etilefrine Hydrochloride<br />
MM 0035.00<br />
Etilefrine Hydrochloride<br />
HO<br />
OH HN<br />
x HCl<br />
(A)<br />
500 mg<br />
MM 0035.02<br />
MM 0035.03<br />
MM 0035.05<br />
Imp. B (EP) as Hydrochloride: (1RS)-1-(3-Hydroxyphenyl)-2-<br />
(methylamino)ethanol Hydrochloride<br />
(Phenylephrine Hydrochloride)<br />
Imp. C (EP) as Hydrochloride: (1RS)-2-Amino-1-(3-<br />
hydroxyphenyl)ethanol Hydrochloride (Norfenefrine<br />
Hydrochloride)<br />
Imp. E (EP): 1-(3-Hydroxyphenyl)ethanone (3-Hydroxyacetophenone)<br />
HO<br />
HO<br />
OH<br />
HN<br />
x HCl<br />
OH<br />
HO<br />
(A) 500 mg<br />
NH<br />
(A) 500 mg<br />
O<br />
(C) 100 mg<br />
MM 0035.06<br />
Imp. F (EP): N-Benzylethanamine (Benzylethylamine)<br />
(C)<br />
100 mg<br />
HN<br />
MM 0035.50<br />
3-Benzoyloxyacetophenone<br />
O<br />
O<br />
(A)<br />
100 mg<br />
O<br />
MM 0035.51<br />
3-Benzoyloxy-α-bromoacetophenone<br />
O<br />
O<br />
Br<br />
on request<br />
O<br />
218 All your need for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
<strong>Pharmac<strong>eu</strong>tical</strong> Impurities<br />
Code Product Category Unit<br />
Etodolac<br />
MM 0911.00<br />
Etodolac<br />
H<br />
N<br />
O<br />
O<br />
OH<br />
(A)<br />
250 mg<br />
New MM 0911.02<br />
Imp. B (EP): 2-[(1RS)-1-Ethyl-8-methyl-1,3,4,9-<br />
tetrahydropyrano[3,4-b]indol-1-yl]acetic Acid<br />
(8-Methyl Etodolac)<br />
H<br />
N<br />
O<br />
O<br />
OH<br />
(A)<br />
100 mg<br />
New MM 0911.08<br />
Imp. H (EP): 2-(7-Ethylindol-3-yl)ethanol<br />
H<br />
N (A) 100 mg<br />
OH<br />
New MM 0911.11<br />
Imp. K (EP): Methyl 2-[(1RS)-1,8-Diethyl-1,3,4,9-<br />
tetrahydropyrano[3,4-b]indol-1-yl]acetate<br />
(Etodolac Methyl Ester)<br />
H<br />
N<br />
O<br />
O<br />
O<br />
(A)<br />
100 mg<br />
Etofenamate<br />
MM 0105.01<br />
Imp. A (EP): 2-[[3-(Trifluoromethyl)phenyl]-amino]benzoic Acid<br />
(Flufenamic Acid)<br />
O<br />
OH<br />
(A)<br />
500 mg<br />
NH<br />
F<br />
MM 0105.02<br />
Imp. B (EP): Butyl 2-[[3-(Trifluoromethyl)phenyl]-amino]benzoate<br />
(Butyl Flufenamate)<br />
O<br />
O<br />
F<br />
F<br />
(A)<br />
100 mg<br />
NH<br />
F<br />
MM 0105.04<br />
Imp. D (EP): 2,2'-Oxybis(ethylene) Bis[2-[[3-<br />
(trifluoromethyl)phenyl] amino]benzoate]<br />
O<br />
O<br />
O<br />
F F<br />
O<br />
O<br />
(A)<br />
100 mg<br />
NH<br />
HN<br />
F<br />
F<br />
F F F F<br />
MM 0105.07 Imp. G (EP): 2-Hydroxyethyl 2-[[3-<br />
(Trifluoromethyl)phenyl]amino]benzoate<br />
O<br />
O<br />
OH<br />
(A)<br />
100 mg<br />
NH<br />
F<br />
F F<br />
MM 0105.08 Etofenamate Myristate<br />
O<br />
O<br />
O<br />
O<br />
O<br />
(A)<br />
100 mg<br />
NH<br />
F<br />
F<br />
F<br />
MM 0105.09 Etofenamate Palmitate<br />
O<br />
O<br />
O<br />
O<br />
O<br />
(A)<br />
100 mg<br />
NH<br />
F<br />
F<br />
F<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 219
<strong>Pharmac<strong>eu</strong>tical</strong> Impurities<br />
Code Product Category Unit<br />
MM 0105.10 Etofenamate Stearate<br />
O<br />
O<br />
O<br />
O<br />
NH<br />
O<br />
(A) 100 mg<br />
F<br />
F<br />
F<br />
MM 0105.11 Triethylene Glycol Flufenamate<br />
O<br />
O<br />
O<br />
O<br />
OH<br />
(A)<br />
100 mg<br />
NH<br />
F<br />
F<br />
F<br />
Etofylline<br />
MM 0603.00<br />
Etofylline<br />
N<br />
O<br />
N<br />
OH<br />
(A)<br />
500 mg<br />
O<br />
N<br />
N<br />
Etoposide<br />
MM 0492.00<br />
Etoposide<br />
O<br />
O<br />
on request<br />
O<br />
OH<br />
O<br />
O O<br />
H<br />
OH<br />
O<br />
O<br />
H<br />
O<br />
O<br />
OH<br />
Famotidine<br />
MM 0029.00<br />
Famotidine<br />
MM 0029.06 Imp. A (EP) as Hydrochloride: 3-[[[2-<br />
[(Diaminomethylene)amino]thiazol-4-yl]-<br />
methyl]sulphanyl]propanimidamide Hydrochloride<br />
NH 2<br />
NH 2<br />
H 2 N N<br />
S<br />
N<br />
N<br />
S NH 2<br />
S<br />
O O<br />
NH 2<br />
NH<br />
H 2 N N<br />
N<br />
S NH 2 x HCl<br />
S<br />
(A)<br />
(A)<br />
250 mg<br />
100 mg<br />
MM 0029.05<br />
Imp. B (EP) as Dimaleate: 3,5-Bis[2-[[[2-<br />
[(diaminomethylene)amino]thiazol-4-yl]-<br />
methyl]sulphanyl]ethyl]-4H-1,2,4,6-<br />
thiatriazine 1,1-Dioxide Dimaleate<br />
H 2 N<br />
O O<br />
S<br />
NH N N<br />
2 H 2 N<br />
N<br />
S N S<br />
N NH 2<br />
N<br />
H<br />
N<br />
S<br />
S<br />
O<br />
(D)<br />
50 mg<br />
x 2<br />
OH<br />
OH<br />
MM 0029.01<br />
MM 0029.02<br />
MM 0029.07<br />
MM 0029.03<br />
MM 0029.09<br />
MM 0029.04<br />
Imp. C (EP) as Hydrochloride:<br />
3-[[[2-[(Diaminomethylene)amino]thiazol-4-<br />
yl]methyl]sulphanyl]-N-sulphamoylpropanamide<br />
Hydrochloride<br />
H 2 N<br />
O<br />
NH<br />
O<br />
2<br />
O O<br />
N<br />
S<br />
S<br />
N NH2<br />
N<br />
H<br />
S<br />
x HCl<br />
(A)<br />
100 mg<br />
Imp. D (EP): 3-[[[2-[(Diaminomethylene)amino]thiazol-4-<br />
NH<br />
O<br />
2 (A) 100 mg<br />
H<br />
yl]methyl]sulphanyl]propanamide 2 N N<br />
S NH 2<br />
Imp. E (EP): 2,2'-[Disulphanediylbis-<br />
(methylenethiazole-4,2-diyl)]diguanidine<br />
H 2N<br />
N<br />
NH 2<br />
N<br />
N<br />
S<br />
S<br />
S S<br />
N<br />
S<br />
H 2N<br />
(A) 100 mg<br />
Imp. F (EP): 3-[[[2-[(Diaminomethylene)amino]thiazol-4-<br />
NH<br />
O<br />
2 (A) 100 mg<br />
H<br />
yl]methyl]sulphanyl]propanoic Acid 2 N N<br />
S OH<br />
Imp. G (EP) as Maleate: N-Cyano-3-[[[2-<br />
(diaminomethylene)amino]thiazol-4-<br />
yl]methyl]sulphanyl]propanimidamide Maleate<br />
Famotidine Sulphoxide<br />
H 2N<br />
H 2 N<br />
N<br />
S<br />
N<br />
NH 2<br />
O<br />
NH NH<br />
2 N<br />
N<br />
OH<br />
S N x<br />
N<br />
H<br />
OH<br />
S<br />
O<br />
NH<br />
NH 2<br />
2<br />
N<br />
S<br />
N<br />
N<br />
S NH 2<br />
O<br />
S<br />
O O<br />
(A)<br />
(A)<br />
100 mg<br />
100 mg<br />
220 All your need for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
<strong>Pharmac<strong>eu</strong>tical</strong> Impurities<br />
Code Product Category Unit<br />
MM 0029.10<br />
MM 0029.51<br />
O<br />
3-[[[2-[(Diaminomethylene)amino]thiazol-4-<br />
yl]methyl]sulphinyl]-N-sulphamoylpropanamide<br />
H 2 N N<br />
S N<br />
H<br />
2-[(Diaminomethylene)amino]-4-(4-cyanobutyl)thiazole<br />
Hydrochloride<br />
NH 2<br />
S<br />
NH2<br />
N<br />
H 2N<br />
S<br />
N<br />
N<br />
S<br />
NH 2<br />
O<br />
O<br />
O<br />
N<br />
x HCl<br />
(D)<br />
(A)<br />
50 mg<br />
100 mg<br />
Felodipine<br />
MM 0139.00 Felodipine<br />
H<br />
N<br />
(A)<br />
100 mg<br />
O<br />
O<br />
O<br />
O<br />
Cl<br />
Cl<br />
MM 0139.01<br />
Imp. A (EP): Ethyl Methyl 4-(2,3-Dichlorophenyl)-2,6-<br />
dimethylpyridine-3,5-dicarboxylate<br />
O<br />
N<br />
O<br />
(D)<br />
50 mg<br />
O<br />
O<br />
Cl<br />
Cl<br />
MM 0139.02<br />
Imp. B (EP): Dimethyl 4-(2,3-Dichlorophenyl)-2,6-dimethyl-1,4-<br />
dihydropyridine-3,5-dicarboxylate<br />
O<br />
H<br />
N<br />
O<br />
(A)<br />
100 mg<br />
O<br />
O<br />
Cl<br />
Cl<br />
MM 0139.03<br />
Imp. C (EP): Diethyl 4-(2,3-Dichlorophenyl)-2,6-dimethyl-1,4-<br />
dihydropyridine-3,5-dicarboxylate<br />
O<br />
H<br />
N<br />
O<br />
(A)<br />
100 mg<br />
O<br />
O<br />
Cl<br />
Fenbendazole<br />
MM 0518.03<br />
MM 0518.01<br />
MM 0518.02<br />
Fenbufen<br />
Imp. A (EP): Methyl (1H-Benzimidazol-2-yl)carbamate<br />
(Carbendazim)<br />
Fenbendazole Sulphoxide (Oxfendazole)<br />
Fenbendazole Sulphone<br />
MM 0918.00 Fenbufen<br />
O<br />
S<br />
O<br />
S<br />
O O<br />
H<br />
N<br />
N<br />
H<br />
N<br />
N<br />
H<br />
N<br />
N<br />
Cl<br />
O<br />
(A) 100 mg<br />
O<br />
NH<br />
O<br />
NH<br />
O<br />
NH<br />
O<br />
O<br />
O<br />
OH<br />
(A)<br />
(A)<br />
(A)<br />
100 mg<br />
100 mg<br />
500 mg<br />
MM 0918.03 Imp. C (EP): Biphenyl (A) 100 mg<br />
MM 0918.05<br />
Fenfluramine Hydrochloride<br />
4-(4-Chlorophenyl)-4-oxobutanoic Acid<br />
(3-(4-Chlorobenzoyl)propionic Acid)<br />
MM 0608.00 Fenfluramine Hydrochloride<br />
H<br />
N<br />
x HCl<br />
Cl<br />
O<br />
O<br />
OH<br />
(A)<br />
(A)<br />
100 mg<br />
500 mg<br />
MM 0608.01<br />
Norfenfluramine Hydrochloride<br />
F<br />
F<br />
F<br />
NH 2<br />
(A)<br />
100 mg<br />
F<br />
F<br />
F<br />
x HCl<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 221
<strong>Pharmac<strong>eu</strong>tical</strong> Impurities<br />
Code Product Category Unit<br />
MM 0608.02 N-Nitrosofenfluramine<br />
N O (A) 100 mg<br />
N<br />
F<br />
F<br />
F<br />
Fenofibrate<br />
MM 0505.00<br />
Fenofibrate<br />
Cl<br />
O<br />
O<br />
(A) 500 mg<br />
O<br />
O<br />
MM 0505.01 Imp. A (EP): (4-Chlorophenyl)(4-hydroxyphenyl)methanone<br />
Cl<br />
OH<br />
(C) 100 mg<br />
O<br />
New MM 0505.03<br />
Imp. C (EP): (3RS)-3-[4-(4-Chlorobenzoyl)-<br />
phenoxy]butan-2-one<br />
Cl<br />
O<br />
O<br />
(A) 100 mg<br />
O<br />
New MM 0505.04<br />
Imp. D (EP): Methyl 2-[4-(4-Chlorobenzoyl)-<br />
phenoxy]-2-methylpropanoate<br />
Cl<br />
O<br />
O<br />
(A) 100 mg<br />
O<br />
O<br />
New MM 0505.05<br />
Imp. E (EP): Ethyl 2-[4-(4-Chlorobenzoyl)-<br />
phenoxy]-2-methylpropanoate<br />
Cl<br />
O<br />
O<br />
(A) 100 mg<br />
O<br />
O<br />
New MM 0505.06<br />
Imp. F (EP): (4-Chlorophenyl)[4-(1-methylethoxy)phenyl]methanone<br />
Cl<br />
O<br />
(A) 100 mg<br />
O<br />
Fenoprofen Calcium<br />
MM 0790.00<br />
Fenoprofen Calcium Dihydrate<br />
O O -<br />
O<br />
2<br />
Ca 2+<br />
x 2 H 2 O<br />
(A)<br />
500 mg<br />
Fentanyl<br />
MM 0528.00<br />
Fentanyl [Controlled Substance]<br />
(A)<br />
100 mg<br />
O<br />
N<br />
N<br />
MM 0528.01<br />
Imp. A (EP): N-Phenyl-N-[cis,trans-1-oxido-1-<br />
(2-phenylethyl)piperidin-4-yl]propanamide<br />
(Fentanyl N-Oxide)<br />
O<br />
N<br />
O<br />
N<br />
(A)<br />
100 mg<br />
MM 0528.08 Imp. B (EP): N-Phenyl-N-(piperidin-4-yl)propanamide O NH (A) 100 mg<br />
N<br />
MM 0528.03<br />
Imp. C (EP): N-phenyl-N-[1-(2-phenylethyl)-<br />
piperidin-4-yl]acetamide<br />
O<br />
N<br />
(A)<br />
100 mg<br />
N<br />
MM 0528.04<br />
Imp. D (EP): N-phenyl-1-(2-phenylethyl)piperidin-4-amine<br />
(A)<br />
100 mg<br />
N<br />
HN<br />
222 All your need for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
<strong>Pharmac<strong>eu</strong>tical</strong> Impurities<br />
Code Product Category Unit<br />
MM 0528.05 Imp. E (EP): Benzaldehyde<br />
O<br />
(B) 100 mg<br />
MM 0528.06 Imp. F (EP): Aniline (Phenylamine)<br />
NH 2<br />
(B) 100 mg<br />
MM 0528.07<br />
Imp. G (EP): N-Phenylpropanamide<br />
O<br />
(A) 100 mg<br />
NH<br />
Fexofenadine Hydrochloride<br />
MM 0507.05<br />
Imp. E (EP): Diphenyl(piperidin-4-yl)methanol<br />
(B)<br />
100 mg<br />
OH<br />
Finasteride<br />
MM 0415.00<br />
Finasteride<br />
NH<br />
O H<br />
N (A) 100 mg<br />
O<br />
N<br />
H<br />
Flavoxate Hydrochloride<br />
MM 0156.00<br />
Flavoxate Hydrochloride<br />
O<br />
(A)<br />
100 mg<br />
O<br />
O<br />
O<br />
N<br />
x HCl<br />
MM 0156.01<br />
Imp. A (EP): 3-Methyl-4-oxo-2-phenyl-4H-1-<br />
benzopyran-8-carboxylic Acid (3-Methylflavone-8-carboxylic<br />
Acid)<br />
O<br />
(A) 100 mg<br />
O<br />
MM 0156.02<br />
Imp. B (EP): Ethyl 3-Methyl-4-oxo-2-phenyl-<br />
4H-1-benzopyran-8-carboxylate (3-Methylflavone-8-carboxylic<br />
Acid Ethyl Ester)<br />
O<br />
O OH<br />
O<br />
(A) 100 mg<br />
O<br />
O<br />
Flubendazole<br />
MM 0463.00<br />
Flubendazole<br />
F<br />
H<br />
N<br />
N<br />
O<br />
(A) 100 mg<br />
O<br />
NH<br />
O<br />
MM 0463.02<br />
Imp. B (EP): (2-Amino-1H-benzimidazol-5-yl)(4-<br />
fluorophenyl)methanone<br />
F<br />
O<br />
H<br />
N<br />
N<br />
NH 2<br />
(A) 100 mg<br />
MM 0463.03<br />
Imp. C (EP): (4-Fluorophenyl)(2-hydroxy-1H-benzimidazol-5-<br />
yl)methanone<br />
F<br />
O<br />
H<br />
N<br />
N<br />
OH<br />
(A)<br />
100 mg<br />
MM 0463.04<br />
Imp. D (EP): (1H-Benzimidazol-5-yl)(4-fluorophenyl)methanone<br />
H<br />
F on request<br />
N<br />
N<br />
O<br />
MM 0463.05<br />
Imp. E (EP): Methyl [5-(2-Fluorobenzoyl)-1H-benzimidazol-2-<br />
yl]carbamate<br />
F<br />
O<br />
H<br />
N<br />
N<br />
O<br />
O<br />
NH<br />
(A)<br />
100 mg<br />
MM 0463.06<br />
Imp. F (EP): Methyl [5-(4-Fluorobenzoyl)-1-methyl-1Hbenzimidazol-2-yl]carbamate<br />
F<br />
O<br />
N<br />
N<br />
O<br />
(A) 100 mg<br />
O<br />
NH<br />
MM 0463.07<br />
Imp. G (EP): Methyl [5-[4-(1-Methylethoxy)benzoyl]-1Hbenzimidazol-2-yl]carbamate<br />
O<br />
O<br />
H<br />
N<br />
N<br />
O<br />
(D) 100 mg<br />
O<br />
NH<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 223
<strong>Pharmac<strong>eu</strong>tical</strong> Impurities<br />
Code Product Category Unit<br />
Flucloxacillin Sodium<br />
MM 0489.00<br />
MM 0489.01<br />
Flucloxacillin Sodium Hydrate<br />
Imp. A (EP) as Disodium Salt: (4S)-2-[Carboxy[[[3-(2-chloro-<br />
6-fluorophenyl)-5-methylisoxazol-4-yl]carbonyl]amino]methyl]-<br />
5,5-dimethylthiazolidine-4-carboxylic Acid Disodium Salt<br />
(Penicilloic Acids of Flucloxacillin Disodium Salt)<br />
Cl<br />
N<br />
O<br />
O<br />
O<br />
F<br />
H<br />
N<br />
Cl<br />
N<br />
O<br />
N<br />
H<br />
O<br />
F<br />
H<br />
N<br />
S<br />
HN<br />
ONa<br />
O<br />
S<br />
O<br />
O ONa<br />
x H 2 O<br />
ONa<br />
(A)<br />
(A)<br />
500 mg<br />
100 mg<br />
MM 0489.02<br />
Imp. B (EP): (2RS,4S)-2-[[[[3-(2-Chloro-6-fluorophenyl)-5-<br />
methylisoxazol-4-yl]-carbonyl]amino]methyl]-5,5-dimethylthiazolidine-4-carboxylic<br />
Acid (Penilloic Acids of Flucloxacillin)<br />
Cl<br />
N<br />
O<br />
O<br />
O<br />
F HN<br />
NH<br />
S<br />
OH<br />
(A)<br />
50 mg<br />
MM 0489.04<br />
Imp. C (EP): (2S,5R,6R)-6-Amino-3,3-dimethyl-7-oxo-4-thia-1-<br />
azabicyclo[3.2.0]-heptane-2-carboxylic Acid (6-Aminopenicillanic Acid)<br />
O<br />
N<br />
O<br />
OH (B) 100 mg<br />
H 2 N<br />
S<br />
H<br />
MM0489.03<br />
Imp. D (EP): 3-(2-Chloro-6-fluorophenyl)-5-methylisoxazole-4-carboxylic<br />
Acid<br />
Cl<br />
N<br />
O<br />
F<br />
OH<br />
(C)<br />
100 mg<br />
O<br />
Fluconazole<br />
MM 0235.00<br />
Fluconazole<br />
F<br />
(A) 100 mg<br />
N<br />
N<br />
N<br />
F<br />
HO<br />
MM 0235.13<br />
Imp. C (EP): 1,1'-(1,3-Phenylene)di-1H-1,2,4-triazole<br />
N<br />
N<br />
N<br />
N N (A) 50 mg<br />
N<br />
MM 0235.02<br />
Imp. F (EP): (2RS)-2-(2,4-Difluorophenyl)-3-(1H-1,2,4-triazol-1-<br />
yl)propane-1,2-diol<br />
N<br />
N<br />
N<br />
F<br />
N<br />
HO<br />
N<br />
N<br />
F<br />
(A) 50 mg<br />
OH<br />
MM 0235.01<br />
2-(2,4-Difluorophenyl)propane-1,2,3-triol<br />
F<br />
(A) 100 mg<br />
HO<br />
F<br />
HO<br />
MM 0235.03 1H-1,2,4-Triazol<br />
H<br />
N<br />
MM 0235.04 2-Chloro-2',4'-difluoroacetophenone<br />
OH<br />
N<br />
N<br />
F<br />
F<br />
(B)<br />
(C)<br />
100 mg<br />
100 mg<br />
MM 0235.06<br />
1-(2,4-Difluorophenyl)-2-(1H-1,2,4-triazol-1-yl)ethanol<br />
O<br />
F<br />
Cl<br />
(A)<br />
100 mg<br />
F<br />
HO N<br />
N<br />
N<br />
MM 0235.09 4-Amino-1,2,4-triazole<br />
NH 2<br />
N<br />
N<br />
N<br />
(C)<br />
100 mg<br />
224 All your need for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
<strong>Pharmac<strong>eu</strong>tical</strong> Impurities<br />
Code Product Category Unit<br />
Flufenamic Acid<br />
O<br />
MM 0410.00 Flufenamic Acid (A) 500 mg<br />
OH<br />
NH<br />
F<br />
F<br />
F<br />
Flumetasone Pivalate<br />
MM 0427.01<br />
Imp. A (EP): 6α,9-Difluoro-11β,17,21-trihydroxy-16αmethylpregna-1,4-diene-3,20-dione<br />
(Flumetasone)<br />
HO<br />
O<br />
OH<br />
OH<br />
(A)<br />
100 mg<br />
F<br />
O<br />
F<br />
Flunarizine Dihydrochloride<br />
MM 0175.00<br />
Flunarizine Dihydrochloride<br />
F<br />
N<br />
N<br />
(A)<br />
500 mg<br />
x 2 HCl<br />
F<br />
MM 0175.04<br />
Imp. A (EP) : 1-[Bis(4-fluorophenyl)methyl]piperazine<br />
F<br />
N<br />
NH (A) 100 mg<br />
F<br />
MM 0175.03<br />
Imp. C (EP) as Dihydrochloride: 1-[(RS)-(2-<br />
Fluorophenyl)(4-fluorophenyl)methyl]-4-[(2E)-3-<br />
phenylprop-2-enyl]piperazine Dihydrochloride<br />
F<br />
N<br />
F<br />
N<br />
x 2 HCl<br />
(A)<br />
100 mg<br />
MM 0175.02 Chlorobis-(4-fluorophenyl)methane<br />
Cl<br />
(B)<br />
100 mg<br />
F<br />
F<br />
MM 0175.05<br />
1-Bis(4-fluorophenyl)methyl-4-(ethoxycarbonyl)piperazine<br />
O O<br />
(A) 100 mg<br />
N<br />
N<br />
F<br />
F<br />
MM 0175.06<br />
Flunarizine N-Oxide Dihydrochloride<br />
F<br />
N<br />
O<br />
on request<br />
N<br />
x 2 HCl<br />
F<br />
Flunitrazepam<br />
MM 0069.00<br />
Flunitrazepam [Controlled Substance]<br />
N<br />
O<br />
on request<br />
O 2N<br />
N<br />
F<br />
MM 0069.02<br />
Imp. B (EP): 5-(2-Fluorophenyl)-7-nitro-1,3-dihydro-2H-1,4-<br />
benzodiazepin-2-one (Demethylflunitrazepam)<br />
O 2N<br />
H<br />
N<br />
N<br />
O<br />
(A)<br />
100 mg<br />
F<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 225
<strong>Pharmac<strong>eu</strong>tical</strong> Impurities<br />
Code Product Category Unit<br />
Flunixin Meglumine<br />
MM 0915.00<br />
Flunixin Meglumine<br />
F F<br />
(A) 100 mg<br />
F<br />
N<br />
NH<br />
OH<br />
x<br />
HO<br />
HO<br />
OH<br />
OH<br />
H<br />
N<br />
OH<br />
MM 0915.01 Imp. A (EP): 2-Chloropyridine-3-carboxylic Acid<br />
N<br />
MM 0915.03 Imp. C (EP): Ethyl 2-Chloropyridine-3-carboxylate<br />
N<br />
O<br />
Cl<br />
(A) 100 mg<br />
OH<br />
O<br />
Cl<br />
(A) 100 mg<br />
O<br />
O<br />
Fluorouracil<br />
MM 0593.00<br />
Fluorouracil<br />
HN<br />
O<br />
F<br />
(A)<br />
500 mg<br />
O<br />
N<br />
H<br />
MM 0593.02<br />
Imp. A (EP): Pyrimidine-2,4,6-(1H,3H,5H)-<br />
trione (Barbituric Acid)<br />
HN<br />
O<br />
(C)<br />
100 mg<br />
MM 0593.01<br />
Imp. B (EP): Dihydropyrimidine-2,4,5(3H)-<br />
trione (Isobarbituric Acid or 5-Hydroxyuracil)<br />
O<br />
HN<br />
N<br />
H<br />
O<br />
O<br />
O<br />
(A)<br />
100 mg<br />
MM 0593.03<br />
Imp. C (EP): Pyrimidine-2,4(1H,3H)-dione (Uracil)<br />
O<br />
N<br />
H<br />
O<br />
(C) 100 mg<br />
HN<br />
MM 0593.05<br />
Imp. E (EP): 5-Chloropyrimidine-2,4(1H,3H)dione (5-Chlorouracil)<br />
HN<br />
O<br />
O<br />
N<br />
H<br />
Cl<br />
(A)<br />
100 mg<br />
MM 0593.06<br />
Imp. F (EP): 2-Ethoxy-5-fluoropyrimidin-<br />
4(1H)-one (2-Ethoxy-5-fluorouracil)<br />
O<br />
N<br />
N<br />
H<br />
O<br />
F<br />
(A)<br />
100 mg<br />
O<br />
N<br />
H<br />
Fluoxetine Hydrochloride<br />
MM 0256.00 Fluoxetine Hydrochloride O<br />
H<br />
N<br />
(A)<br />
50 mg<br />
F<br />
F<br />
F<br />
x HCl<br />
MM 0256.01 Imp. A (EP): (1RS)-3-(Methylamino)-1-phenylpropan-1-ol HO<br />
H<br />
N (A) 100 mg<br />
MM 0256.02<br />
Imp. B (EP) as Hydrochloride: N-Methyl-3-<br />
phenylpropan-1-amine Hydrochloride<br />
(Methyl-3-phenylpropylamine Hydrochloride)<br />
[Controlled Substance]<br />
H<br />
N (A) 100 mg<br />
x HCl<br />
MM 0256.03<br />
Imp. C (EP) as Hydrochloride:(3RS)-N-Methyl-3-phenyl-3-<br />
[3-(trifluoromethyl]phenoxy]propan-1-amine Hydrochloride<br />
O<br />
H<br />
N<br />
x HCl<br />
(A)<br />
100 mg<br />
F<br />
F<br />
F<br />
MM 0256.05 4-Hydroxybenzotrifluoride<br />
OH<br />
F<br />
F F<br />
MM 0256.06 4-Chlorobenzotrifluoride<br />
Cl<br />
F<br />
F F<br />
(B)<br />
(B)<br />
100 mg<br />
100 mg<br />
226 All your need for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
<strong>Pharmac<strong>eu</strong>tical</strong> Impurities<br />
Code Product Category Unit<br />
MM 0256.10 3-Dimethylamino-1-phenylpropan-1-ol<br />
OH<br />
(A) 100 mg<br />
N<br />
Fluoxymesterone<br />
MM 0959.00<br />
Fluoxymesterone<br />
HO<br />
OH<br />
(A)<br />
100 mg<br />
F<br />
O<br />
Flupentixol Decanoate<br />
MM 0182.00<br />
Flupentixol Decanoate<br />
N<br />
N<br />
CF 3<br />
O<br />
O<br />
on request<br />
S<br />
MM 0182.08<br />
Imp. B (BP): 2-Trifluoromethylthioxanthone<br />
O<br />
(A) 100 mg<br />
CF 3<br />
S<br />
MM 0182.05 1-(2-Hydroxyethyl)piperazine<br />
HN<br />
N<br />
OH (B) 100 mg<br />
MM 0182.06<br />
cis/trans-3-[2-(Trifluoromethyl)-9H-thioxanthen-9-ylidene]propene<br />
on request<br />
CF 3<br />
MM 0182.07 4-Chloro-3-nitrobenzotrifluoride<br />
O 2N CF 3<br />
S<br />
(B)<br />
100 mg<br />
MM 0182.09<br />
4-Fluoro-3-nitrobenzotrifluoride<br />
Cl<br />
O 2 N CF 3 (B) 100 mg<br />
F<br />
Flupentixol Dihydrochloride<br />
MM 0223.02<br />
Imp. G (EP): 2-(Trifluoromethyl)-9H-thioxanthen-9-one<br />
O<br />
(A) 100 mg<br />
CF 3<br />
S<br />
MM 0223.03 1-(2-Hydroxyethyl)piperazine<br />
HN<br />
N<br />
OH (B) 100 mg<br />
MM 0223.04<br />
cis/trans-3-[2-(Trifluoromethyl)-9H-thioxanthen-9-ylidene]propene<br />
on request<br />
CF 3<br />
O CF<br />
MM 0223.05 4-Chloro-3-nitrobenzotrifluoride 2 N<br />
3<br />
Fluphenazine Hydrochloride<br />
MM 0114.00<br />
Fluphenazine Dihydrochloride<br />
S<br />
Cl<br />
(B)<br />
(A)<br />
100 mg<br />
500 mg<br />
S<br />
N<br />
F<br />
N<br />
N<br />
OH<br />
x 2 HCl<br />
MM 0114.01<br />
Imp. A (EP): 2-[4-[3-[5-Oxo-2-(trifluoromethyl)-<br />
10H-5 4 -phenothiazin-10-yl]propyl]piperazin-1-<br />
yl]ethanol (Fluphenazine S-Oxide)<br />
F<br />
S<br />
O<br />
F<br />
N<br />
F<br />
N<br />
N<br />
OH<br />
(A)<br />
100 mg<br />
MM 0114.04<br />
Fluphenazine N,N',S-Trioxide Dihydrochloride<br />
S<br />
O<br />
N<br />
F<br />
F<br />
O<br />
N<br />
F<br />
N<br />
O<br />
OH<br />
x 2 HCl<br />
on request<br />
F F<br />
Flurazepam Monohydrochloride<br />
MM 0070.01<br />
Imp. A (EP): [5-Chloro-2-[[2-(diethylamino)ethyl]amino]phenyl]-(2-<br />
fluorophenyl)methanone<br />
Cl<br />
H<br />
N<br />
O<br />
F<br />
N<br />
on request<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 227
<strong>Pharmac<strong>eu</strong>tical</strong> Impurities<br />
Code Product Category Unit<br />
MM 0070.02 Imp. B (EP): 7-Chloro-5-(2-fluorophenyl)-1,3-dihydro-2H-1,4-<br />
H<br />
N<br />
O<br />
(A) 100 mg<br />
benzodiazepin-2-one<br />
Cl<br />
N<br />
F<br />
MM 0070.03<br />
2-Chloro-10-(2-diethylaminoethyl)-9,10-dihydroacridin-9-one<br />
N (A) 100 mg<br />
N<br />
Cl<br />
O<br />
MM0070.06<br />
Flurazepam [Controlled Substance]<br />
N (A) 100 mg<br />
N<br />
O<br />
Cl<br />
N<br />
F<br />
Flutamide<br />
MM 0161.00<br />
Flutamide<br />
O<br />
H<br />
N<br />
F F<br />
(A) 500 mg<br />
F<br />
NO 2<br />
MM 0161.03<br />
Imp. A (EP): 4-Nitro-3-(trifluoromethyl)aniline<br />
H 2 N<br />
F F<br />
(A) 100 mg<br />
F<br />
NO 2<br />
MM 0161.04<br />
Imp. B (EP): N-[4-Nitro-3-(trifluoromethyl)phenyl]acetamide<br />
O<br />
H<br />
N<br />
F F<br />
(A) 100 mg<br />
F<br />
NO 2<br />
MM 0161.05<br />
Imp. C (EP): N-[4-Nitro-3-(trifluoromethyl)phenyl]propanamide<br />
O<br />
H<br />
N<br />
F F<br />
(A) 100 mg<br />
F<br />
NO 2<br />
MM 0161.06<br />
Imp. D (EP): 3-(Trifluoromethyl)aniline<br />
H 2 N<br />
F F<br />
(B) 100 mg<br />
F<br />
MM 0161.07 Imp. E (EP): 2-Methyl-N-[3-(trifluoromethyl)phenyl]propanamide H<br />
N<br />
MM 0161.08<br />
MM 0161.01<br />
MM 0161.09<br />
Imp. F (EP): 2-Methyl-N-[2-nitro-5-<br />
(trifluoromethyl)phenyl]propanamide<br />
2-Hydroxy-2-methyl-N-[4-nitro-3-(trifluoromethyl)-<br />
phenyl]propanamide (2-Hydroxyflutamide)<br />
Trifluoromethylbenzene<br />
O<br />
H<br />
N<br />
O<br />
O 2 N<br />
O<br />
H<br />
N<br />
F F<br />
(A) 100 mg<br />
F<br />
F F<br />
(D) 100 mg<br />
F<br />
HO<br />
(A) 100 mg<br />
F F<br />
F<br />
NO 2<br />
F F<br />
(B) 100 mg<br />
F<br />
MM 0161.10<br />
3-Nitrobenzotrifluoride<br />
O 2 N<br />
F F<br />
(B) 100 mg<br />
F<br />
MM 0161.12<br />
3-Trifluoromethyl-4-nitrophenol<br />
HO<br />
F F<br />
(A) 100 mg<br />
F<br />
NO 2<br />
Fluvastatin Sodium<br />
MM 0676.00<br />
Fluvastatin Sodium<br />
F<br />
(D)<br />
100 mg<br />
N<br />
OH<br />
OH<br />
O<br />
ONa<br />
228 All your need for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
<strong>Pharmac<strong>eu</strong>tical</strong> Impurities<br />
Code Product Category Unit<br />
Folic Acid<br />
MM 0621.00 Folic Acid<br />
O OH<br />
O<br />
(A) 500 mg<br />
MM 0621.01<br />
MM 0621.02<br />
MM 0621.04<br />
MM 0621.07<br />
O<br />
N<br />
H 2 N N<br />
H<br />
Imp. A (EP): (2S)-2-[(4-Aminobenzoyl)amino]pentanedioic Acid<br />
(N-(4-Aminobenzoyl)-L-glutamic Acid)<br />
Imp. B (EP) as Sulphate: 2,5,6-Triaminopyrimidin-4(1H)-one<br />
Sulphate<br />
Imp. D (EP): 4-[[(2-Amino-4-oxo-1,4-dihydropteridin-6-<br />
yl)methyl]amino]benzoic Acid (Pteroic Acid)<br />
4-Aminobenzoic Acid<br />
H 2 N<br />
N<br />
N<br />
N<br />
O<br />
N<br />
H<br />
N<br />
H<br />
H 2 N<br />
O<br />
N<br />
H 2 N N<br />
H<br />
N<br />
N<br />
N<br />
H<br />
O<br />
H 2 N<br />
N<br />
H<br />
N<br />
H<br />
OH<br />
O<br />
O OH<br />
(A) 100 mg<br />
OH<br />
O<br />
(A) 100 mg<br />
NH 2<br />
x H SO<br />
O<br />
(D) 50 mg<br />
OH<br />
O<br />
(B) 100 mg<br />
OH<br />
MM 0621.08<br />
L-Glutamine<br />
H 2 N<br />
OH<br />
(A)<br />
500 mg<br />
NH 2<br />
O<br />
O<br />
Formoterol Fumarate Dihydrate<br />
MM 0447.00<br />
Formoterol Fumarate Dihydrate<br />
(D)<br />
50 mg<br />
OH<br />
HN<br />
O<br />
Furosemide<br />
HO<br />
HN<br />
x HO<br />
O<br />
O<br />
<strong>and</strong> enantiomer<br />
MM 0014.00 Furosemide<br />
O OH<br />
MM 0014.02<br />
Imp. A (EP): 2-Chloro-4-[(furan-2-ylmethyl)amino]-5-<br />
sulphamoylbenzoic Acid<br />
O<br />
H 2 N<br />
S<br />
O O<br />
Cl<br />
O<br />
x 2 H<br />
OH 2 O<br />
H<br />
N<br />
H 2 N<br />
S<br />
O O<br />
HN<br />
MM 0014.03 Imp. B (EP): 2,4-Dichloro-5-sulphamoylbenzoic Acid<br />
O OH<br />
OH<br />
Cl<br />
H 2 N<br />
S<br />
O O<br />
Cl<br />
MM 0014.01 Imp. C (EP): 2-Amino-4-chloro-5-sulphamoylbenzoic Acid<br />
O OH<br />
H 2 N<br />
S<br />
O O<br />
Cl<br />
MM 0014.05 Imp. E (EP): 2,4-Dichlorobenzoic Acid<br />
O OH<br />
O<br />
O<br />
2<br />
Cl<br />
NH 2<br />
Cl<br />
(A)<br />
(A)<br />
(B)<br />
(A)<br />
(B)<br />
500 mg<br />
100 mg<br />
100 mg<br />
100 mg<br />
100 mg<br />
MM 0014.50 Ethyl 2,4-Dichloro-5-sulphamoylbenzoate<br />
O O<br />
Cl<br />
Cl<br />
(A)<br />
100 mg<br />
H 2 N<br />
S<br />
O O<br />
Cl<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 229
<strong>Pharmac<strong>eu</strong>tical</strong> Impurities<br />
Code Product Category Unit<br />
Gabapentin<br />
MM 0684.01 3,3-Pentamethylene-4-butyrolactam<br />
O (A) 100 mg<br />
NH<br />
Ganciclovir<br />
New MM 0485.07<br />
Imp. F (Pharm<strong>eu</strong>ropa): 2-Amino-1,9-dihydro-6H-purin-6-one (Guanine)<br />
O<br />
HN<br />
H 2 N N<br />
N<br />
H<br />
N<br />
(B)<br />
100 mg<br />
Gemfibrozil<br />
MM 0641.00 Gemfibrozil<br />
O OH<br />
O<br />
(A)<br />
250 mg<br />
MM 0641.08 Imp. A (EP): 2,5-Dimethylphenol (p-Xylenol)<br />
OH<br />
(A) 100 mg<br />
O O<br />
MM 0641.02 Imp. H (EP): 1,3-Bis(2,5-dimethylphenoxy)propane (A) 100 mg<br />
MM 0641.01<br />
3-(2,5-Dimethylphenoxy)propyl Chloride<br />
(3-(2,5-Xylyloxy)propyl Chloride)<br />
MM 0641.03 Gemfibrozil Isobutyl Ester<br />
O O<br />
O Cl<br />
(A) 100 mg<br />
O<br />
(A)<br />
100 mg<br />
Glibenclamide<br />
MM 0008.00<br />
Glibenclamide<br />
O<br />
O O<br />
(A)<br />
500 mg<br />
Cl<br />
O<br />
O<br />
N<br />
H<br />
S N<br />
H<br />
N<br />
H<br />
MM 0008.01<br />
Imp. A (EP): 5-Chloro-2-methoxy-N-(2-(4-<br />
sulfamoylphenyl)ethyl)benzamide<br />
Cl<br />
O<br />
N<br />
H<br />
O<br />
O O<br />
S NH2<br />
(A)<br />
100 mg<br />
MM 0008.02<br />
Imp. B (EP): Methyl [[4-[2-[(5-Chloro-2-<br />
methoxybenzoyl)amino]ethyl]phenyl]-<br />
sulphonyl]carbamate<br />
Cl<br />
O<br />
N<br />
H<br />
O<br />
O O O<br />
S NH O<br />
(A)<br />
100 mg<br />
MM 0008.03<br />
5-Chloro-2-methoxybenzoic Acid<br />
Cl<br />
O<br />
OH<br />
(B)<br />
100 mg<br />
O<br />
MM 0008.04<br />
5-Chloro-N-(2-phenylethyl)-2-methoxybenzamide<br />
Cl<br />
O<br />
N<br />
H<br />
O<br />
(A)<br />
100 mg<br />
Gliclazide<br />
MM 0325.00<br />
Gliclazide<br />
O O<br />
S<br />
N<br />
H<br />
O<br />
N<br />
H<br />
N<br />
(A)<br />
500 mg<br />
MM 0325.01<br />
Imp. A (EP): 4-Methylbenzenesulphonamide<br />
O O<br />
(C) 100 mg<br />
S<br />
NH 2<br />
New MM 0325.02<br />
Imp. B (EP): 2-Nitroso-octahydrocyclopenta[c]pyrrole<br />
(A)<br />
100 mg<br />
New MM 0325.09<br />
Methyl N-Methyl-p-tolylsulphoncarbamate<br />
N<br />
N<br />
O<br />
O O O<br />
(A) 100 mg<br />
S<br />
N O<br />
Glimepiride<br />
MM 0647.00<br />
Glimepiride<br />
O<br />
O<br />
O (D) 100 mg<br />
O<br />
N<br />
S<br />
NH<br />
N<br />
H<br />
O<br />
N<br />
H<br />
230 All your need for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
<strong>Pharmac<strong>eu</strong>tical</strong> Impurities<br />
Code Product Category Unit<br />
MM 0647.02<br />
Imp. A (EP): 1-[[4-[2-[[(3-Ethyl-4-methyl-2-oxo-2,3-<br />
dihydro-1H-pyrrol-1-yl)carbonyl]-<br />
amino]ethyl]phenyl]sulphonyl]-3-(cis-4-<br />
methylcyclohexyl)urea (cis-Glimepiride)<br />
O<br />
N<br />
O O O<br />
(D) 100 mg<br />
S<br />
NH N<br />
H<br />
O<br />
N<br />
H<br />
MM 0647.01<br />
Imp. B (EP): 3-Ethyl-4-methyl-2-oxo-N-[2-(4-<br />
sulphamoylphenyl)ethyl]-2,3-dihydro-1H-pyrrole-1-<br />
carboxamide (Glimepiride Sulphonamide)<br />
N<br />
O<br />
N<br />
H<br />
O O<br />
S<br />
NH2<br />
(A)<br />
100 mg<br />
O<br />
MM 0647.03<br />
Imp. C (EP): Methyl [[4-[2-[[(3-Ethyl-4-methyl-2-oxo-<br />
2,3-dihydro-1H-pyrrol-1-yl)<br />
carbonyl]amino]ethyl]phenyl]-<br />
sulphonyl]carbamate (Glimepiride Carbamate)<br />
N<br />
O<br />
N<br />
H<br />
O O<br />
S<br />
NH<br />
O<br />
(A) 100 mg<br />
O<br />
O<br />
MM 0647.08<br />
cis-4-Methylcyclohexylamine Hydrochloride<br />
x HCl<br />
(A)<br />
100 mg<br />
H 2 N<br />
Glipizide<br />
MM 0942.01<br />
Imp. A (EP): 5-Methyl-N-[2-(4-<br />
sulphamoylphenyl)ethyl]pyrazine-2-carboxamide<br />
O<br />
O O<br />
(A) 100 mg<br />
S<br />
NH2<br />
N<br />
N<br />
H<br />
N<br />
New MM 0942.02<br />
Imp. B (EP): Cyclohexanamine<br />
(C)<br />
100 mg<br />
H 2 N<br />
MM 0942.04<br />
Imp. D (EP): 6-Methyl-N-[2-(4-<br />
sulphamoylphenyl)ethyl]pyrazine-2-carboxamide<br />
O<br />
O O<br />
(A) 100 mg<br />
S<br />
NH2<br />
N<br />
N<br />
H<br />
N<br />
Glutamine<br />
MM 0169.00<br />
L-Glutamine<br />
H 2 N<br />
OH<br />
(A)<br />
500 mg<br />
NH 2<br />
O<br />
O<br />
MM 0169.01<br />
N-Phenylacetyl-L-glutamine<br />
(Phenylacetylglutamine)<br />
O<br />
HN<br />
(A)<br />
100 mg<br />
H 2 N<br />
OH<br />
O<br />
O<br />
MM 0169.02 Phenylacetamide<br />
NH 2<br />
O<br />
(A)<br />
100 mg<br />
MM 0169.03<br />
D-Glutamine<br />
H 2 N<br />
OH<br />
(A)<br />
100 mg<br />
NH 2<br />
O<br />
O<br />
Glycopyrronium Bromide<br />
MM 0834.00<br />
Glycopyrronium Bromide<br />
O<br />
N + (A) 100 mg<br />
O<br />
OH<br />
Br -<br />
MM 0834.05<br />
Imp. B (Pharm<strong>eu</strong>ropa): 2-Oxo-2-phenylethanoic Acid (Benzoylformic<br />
Acid)<br />
O<br />
OH<br />
(A)<br />
100 mg<br />
O<br />
MM 0834.03<br />
Imp. D (Pharm<strong>eu</strong>ropa): Benzoic Acid<br />
(B)<br />
100 mg<br />
OH<br />
O<br />
MM 0834.04<br />
Imp. F (Pharm<strong>eu</strong>ropa): Benzaldehyde<br />
(B)<br />
100 mg<br />
O<br />
MM 0834.07<br />
Imp. H (Pharm<strong>eu</strong>ropa): Methyl 2-Oxo-2-phenylethanoate (Methyl<br />
Benzoylformate)<br />
O<br />
O<br />
(A)<br />
100 mg<br />
O<br />
MM 0834.01<br />
Imp. J (Pharm<strong>eu</strong>ropa): 2-(RS)-Cyclopentyl-2-hydroxy-2-phenylethanoic<br />
Acid (α-Cyclopentylm<strong>and</strong>elic Acid)<br />
O<br />
OH<br />
(A)<br />
100 mg<br />
OH<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 231
<strong>Pharmac<strong>eu</strong>tical</strong> Impurities<br />
Code Product Category Unit<br />
MM 0834.08 Imp. K (Pharm<strong>eu</strong>ropa): 2-(RS)-Cyclopentyl-2-phenylethanoic Acid<br />
O (A) 100 mg<br />
OH<br />
MM 0834.06<br />
Imp. M (Pharm<strong>eu</strong>ropa): Cyclopentyl Phenyl Ketone<br />
O<br />
(A)<br />
100 mg<br />
Granisetron Hydrochloride<br />
MM 0398.00<br />
Granisetron Hydrochloride<br />
H<br />
on request<br />
N<br />
N<br />
HN<br />
N<br />
x HCl<br />
O<br />
H<br />
Griseofulvin<br />
MM 0582.00<br />
Griseofulvin<br />
O<br />
Cl<br />
O<br />
O<br />
O<br />
(A)<br />
500 mg<br />
O<br />
O<br />
Guaiacol<br />
MM 0814.00 Guaiacol<br />
OH<br />
(A)<br />
500 mg<br />
MM 0814.04<br />
Imp. A (EP): Benzene-1,2-diol<br />
(Pyrocatechol)<br />
O<br />
OH<br />
OH<br />
(C)<br />
100 mg<br />
MM 0814.05 Imp. B (EP): Phenol<br />
OH<br />
(B) 100 mg<br />
MM 0814.06<br />
MM 0814.08<br />
Imp. C (EP): 1,2-Dimethoxybenzene<br />
(Veratrole)<br />
Imp. E (EP): Methyl Benzoate<br />
O<br />
O<br />
O<br />
(C) 100 mg<br />
O<br />
(C) 100 mg<br />
New MM 0814.11 Imp. G (Pharm<strong>eu</strong>ropa): 4-Methoxyphenol<br />
OH<br />
New MM 0814.12 Imp. H (Pharm<strong>eu</strong>ropa): 3-Methoxyphenol<br />
OH<br />
O<br />
(A)<br />
(B)<br />
500 mg<br />
100 mg<br />
O<br />
Guaifenesin<br />
MM 0354.00<br />
Guaifenesin<br />
O<br />
OH<br />
OH<br />
(A)<br />
500 mg<br />
O<br />
MM 0354.04<br />
Imp. A (EP): 2-Methoxyphenol (Guaiacol)<br />
OH<br />
(A) 500 mg<br />
O<br />
MM 0354.01<br />
Imp. B (EP): 2-(2-Methoxyphenoxy)propane-1,3-diol<br />
(B-Isomer)<br />
HO OH (A) 100 mg<br />
O<br />
O<br />
MM 0354.02<br />
Imp. C (EP): 1,1'-Oxybis[3-(2-<br />
methoxyphenoxy)propan-2-ol](Bisether)<br />
O<br />
OH<br />
O<br />
OH<br />
O<br />
(A)<br />
100 mg<br />
O<br />
O<br />
MM 0354.03<br />
Imp. D (EP): 1,3-Bis(2-methoxyphenoxy)propan-2-ol<br />
O<br />
OH<br />
O<br />
(A)<br />
100 mg<br />
O<br />
O<br />
232 All your need for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
<strong>Pharmac<strong>eu</strong>tical</strong> Impurities<br />
Code Product Category Unit<br />
Halofantrine Hydrochloride<br />
MM0433.00 Halofantrine Hydrochloride<br />
Cl<br />
F<br />
F<br />
Cl<br />
F<br />
x HCl<br />
(A) 100 mg<br />
HO<br />
N<br />
Harpagoside<br />
MM 0370.01<br />
Methyl trans-Cinnamate<br />
O<br />
(B) 100 mg<br />
O<br />
Heptaminol Hydrochloride<br />
MM 0653.00 Heptaminol Hydrochloride<br />
NH 2<br />
Hexetidine<br />
MM 0337.03<br />
Hexylresorcinol<br />
Imp. C (EP): 2,6-Bis(2-ethylhexyl)-7amethylhexahydro-1H-imidazo[1,5-c]imidazole<br />
(Hexedine)<br />
N<br />
HO<br />
N<br />
N<br />
x HCl<br />
on request<br />
(A)<br />
100 mg<br />
MM 0111.00 Hexylresorcinol<br />
HO OH<br />
(A) 500 mg<br />
MM 0111.01 Imp. A (EP): Phenol<br />
OH<br />
(B) 100 mg<br />
MM 0111.02 Imp. B (EP): Resorcinol<br />
HO OH<br />
(B) 100 mg<br />
Homatropine Methylbromide<br />
MM 0792.00 Homatropine Methylbromide<br />
MM 0792.03 Imp. C (EP): (2RS)-2-Hydroxy-2-phenylacetic Acid (M<strong>and</strong>elic Acid)<br />
H<br />
O<br />
H<br />
N +<br />
O<br />
OH<br />
H<br />
<strong>and</strong> enantiomer<br />
Br -<br />
(A) 250 mg<br />
O (A) 100 mg<br />
MM 0792.04<br />
MM 0792.06<br />
Hydrochlorothiazide<br />
MM 0011.00<br />
Imp. D (EP) as Bromide: (1R,2R,4S,5S,7s)-7-[[(2S)-3-<br />
Hydroxy-2-phenylpropanoyl]oxy]-9,9-dimethyl-3-oxa-<br />
9-azoniatricyclo<br />
[3.3.1.0 2,4 ]nonane Bromide<br />
(Methylhyoscine Bromide)<br />
Imp. F (EP): Methyl (2RS)-2-Hydroxy-2-phenylacetate (Methyl<br />
M<strong>and</strong>elate)<br />
Hydrochlorothiazide<br />
O<br />
H<br />
O<br />
OH<br />
OH<br />
OH<br />
H H<br />
N + O<br />
H H<br />
S<br />
H 2 N<br />
O<br />
OH<br />
Br - (A) 100 mg<br />
O (A) 100 mg<br />
O O<br />
(A) 500 mg<br />
O O<br />
S<br />
NH<br />
MM 0011.03<br />
MM 0011.01<br />
Imp. A (EP): Chlorothiazide<br />
Imp. B (EP): 4-Amino-6-chlorobenzene-1,3-disulphonamide<br />
(Salamide)<br />
Cl<br />
S<br />
H 2 N<br />
Cl<br />
S<br />
H 2N<br />
Cl<br />
N<br />
H<br />
O O<br />
(A) 500 mg<br />
O O<br />
S<br />
NH<br />
N<br />
O O<br />
S<br />
NH 2<br />
NH 2<br />
O O<br />
(B) 100 mg<br />
Hydrocodone Hydrogen Tartrate 2.5-Hydrate<br />
MM 1113.01<br />
Imp. A (EP) as Hydrochloride Trihydrate: Morphine<br />
Hydrochloride Trihydrate [Controlled Substance]<br />
N<br />
x HCl<br />
x 3 H 2 O<br />
(A)<br />
250 mg<br />
HO<br />
O<br />
OH<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 233
<strong>Pharmac<strong>eu</strong>tical</strong> Impurities<br />
Code Product Category Unit<br />
MM 1113.02<br />
Imp. A (EP) as Hemisulphate Pentahemihydrate: Morphine<br />
Hemisulphate Pentahemihydrate [Controlled Substance]<br />
N<br />
x H 2 SO 4<br />
x 5 H 2 O<br />
(A)<br />
250 mg<br />
HO<br />
O<br />
OH<br />
2<br />
MM 1113.04<br />
Imp. C (EP) as Monohydrate: Codeine Monohydrate<br />
[Controlled Substance]<br />
N<br />
x H 2 O<br />
(A)<br />
100 mg<br />
MM 1113.05<br />
Imp. C (EP) as Phosphate Hemihydrate: Codeine<br />
Phosphate Hemihydrate [Controlled Substance]<br />
O<br />
O<br />
N<br />
OH<br />
x H 3 PO 4<br />
x 1/2 H 2 O<br />
(A)<br />
100 mg<br />
MM 1113.06<br />
MM 1113.07<br />
Imp. D (EP) as Hydrochloride: 4,5α-Epoxy-14-hydroxy-3-<br />
methoxy-17-methyl-morphinan-6-one Hydrochloride<br />
(Oxycodone Hydrochloride)<br />
[Controlled Substance]<br />
Imp. E (EP): 7,8-Didehydro-4,5α-epoxy-3-methoxy-17-<br />
methylmorphinan-6-one (Codeinone)<br />
O<br />
O<br />
O<br />
HO<br />
O<br />
OH<br />
N<br />
x HCl<br />
O<br />
(A) 100 mg<br />
N (A) 100 mg<br />
MM 1113.08<br />
Imp. F (EP): 7,8-Didehydro-4,5α-epoxy-3,6α-dimethoxy-17-<br />
methylmorphinan (Methylcodeine) [Controlled Substance]<br />
O<br />
O<br />
O<br />
N (A) 100 mg<br />
O O O<br />
MM 1113.10 Imp. H (EP): Diphenylmethanone (Benzophenone)<br />
O<br />
(B) 100 mg<br />
Hydrocortisone<br />
MM 0185.00<br />
Hydrocortisone (Cortisol)<br />
HO<br />
O<br />
OH<br />
OH<br />
(A)<br />
500 mg<br />
O<br />
MM 0185.20<br />
Imp. A (EP): Prednisolone<br />
HO<br />
O<br />
OH<br />
OH<br />
(A)<br />
500 mg<br />
O<br />
MM 0185.21<br />
Imp. B (EP): Cortisone<br />
O<br />
O<br />
OH<br />
OH<br />
(A)<br />
500 mg<br />
O<br />
MM 0185.22<br />
Imp. C (EP): Hydrocortisone Acetate<br />
HO<br />
O<br />
O<br />
OH<br />
O<br />
(A) 500 mg<br />
O<br />
MM 0185.06<br />
Imp. D (EP): 6β,11β,17,21-Tetrahydroxy-pregn-4-ene-3,20-dione<br />
(6β-Hydroxyhydrocortisone)<br />
HO<br />
O<br />
OH<br />
OH<br />
(A)<br />
100 mg<br />
O<br />
OH<br />
MM 0185.07<br />
Imp. E (EP): 11β,17,21-Trihydroxypregna-4,6-diene-3,20-dione<br />
(∆6-Hydrocortisone)<br />
HO<br />
O<br />
OH<br />
OH<br />
(D)<br />
100 mg<br />
O<br />
MM 0185.08<br />
Imp. F (EP): 17,21-Dihydroxypregn-4-ene-3,20-dione<br />
(Reichstein's Substance S)<br />
O<br />
OH<br />
OH<br />
(A)<br />
100 mg<br />
O<br />
234 All your need for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
<strong>Pharmac<strong>eu</strong>tical</strong> Impurities<br />
Code Product Category Unit<br />
MM 0185.13 6α-Hydroxyhydrocortisone<br />
O<br />
OH<br />
HO<br />
OH<br />
(D) 50 mg<br />
O<br />
OH<br />
Hydrocortisone Acetate<br />
MM 0187.00<br />
Hydrocortisone Acetate<br />
HO<br />
O<br />
O<br />
OH<br />
O<br />
(A) 500 mg<br />
O<br />
MM 0187.06<br />
Hydrocortisone 11,17,21-Triacetate<br />
O<br />
O<br />
O<br />
O<br />
O<br />
O<br />
(A)<br />
100 mg<br />
O<br />
O<br />
MM 0187.09<br />
11β,17,21-Trihydroxypregna-4,6-diene-3,20-dione 21-Acetate<br />
HO<br />
O<br />
O<br />
OH<br />
O<br />
(D) 100 mg<br />
O<br />
Hydrocortisone 17-Butyrate<br />
MM 0188.00<br />
Hydrocortisone 17-Butyrate<br />
HO<br />
O<br />
OH<br />
O<br />
(A)<br />
500 mg<br />
O<br />
O<br />
MM 0188.01<br />
Hydrocortisone 21-Butyrate<br />
HO<br />
O<br />
O<br />
OH<br />
O<br />
(A) 100 mg<br />
O<br />
Hydrocortisone Hydrogen Succinate<br />
MM 0275.00<br />
Hydrocortisone Hydrogen Succinate<br />
HO<br />
O<br />
O<br />
OH<br />
O<br />
OH<br />
O<br />
on request<br />
O<br />
MM 0275.01<br />
Imp. A (EP): Hydrocortisone<br />
HO<br />
O<br />
OH<br />
OH<br />
(A)<br />
500 mg<br />
O<br />
MM 0275.02<br />
Imp. B (EP): Hydrocortisone Acetate<br />
HO<br />
O<br />
O<br />
OH<br />
O<br />
(A) 500 mg<br />
O<br />
Hydroxychloroquine Sulphate<br />
Cl<br />
N<br />
MM 0764.00 Hydroxychloroquine Sulphate<br />
x H 2 SO 4<br />
(A) 500 mg<br />
HN<br />
N<br />
OH<br />
Cl<br />
N<br />
MM 0764.02 Desethylhydroxychloroquine Dihydrochloride<br />
x 2 HCl<br />
on request<br />
HN<br />
N<br />
H<br />
OH<br />
Cl<br />
N<br />
MM 0764.04 O-Acetylhydroxychloroquine<br />
(A)<br />
100 mg<br />
HN<br />
N<br />
O<br />
O<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 235
<strong>Pharmac<strong>eu</strong>tical</strong> Impurities<br />
Code Product Category Unit<br />
Cl<br />
N<br />
MM 0764.05 Hydroxychloroquine N-Oxide Dihydrochloride<br />
(A)<br />
100 mg<br />
HN<br />
N<br />
O<br />
OH<br />
x 2 HCl<br />
Hydroxyethyl Salicylate<br />
MM 0112.00<br />
Hydroxyethyl Salicylate<br />
O<br />
O<br />
OH<br />
(A)<br />
500 mg<br />
OH<br />
MM 0112.01<br />
Imp. A (EP): Salicylic Acid<br />
O<br />
(A) 500 mg<br />
OH<br />
OH<br />
Hydroxyzine Hydrochloride<br />
MM 0852.00 Hydroxyzine Hydrochloride<br />
Cl<br />
N<br />
N<br />
O<br />
OH<br />
x 2 HCl<br />
(A)<br />
250 mg<br />
MM 0852.01 Imp. A (EP): (RS)-1-[(4-Chlorophenyl)phenylmethyl]piperazine<br />
Cl<br />
N<br />
NH (A) 100 mg<br />
Hymechromone<br />
MM 0294.00 Hymecromone<br />
HO O O<br />
(A) 500 mg<br />
MM 0294.01 Imp. A (EP): 1,3-Dihydroxybenzene (Resorcinol)<br />
HO OH<br />
(B) 100 mg<br />
MM 0294.02 Imp. B (EP): 7-Hydroxy-2-methyl-4H-1-benzopyran-4-one<br />
HO O<br />
(A)<br />
100 mg<br />
MM 0294.03 2,4-Dihydroxyacetophenone<br />
HO<br />
O<br />
OH<br />
(B) 100 mg<br />
O<br />
MM 0294.04 Hymecromone Acetate O O O<br />
O<br />
(A)<br />
100 mg<br />
MM 0294.50 7-Acetoxy-3-acetyl-2-4H-1-benzopyran-4-one<br />
O O<br />
O<br />
(A)<br />
100 mg<br />
O<br />
O<br />
Hyoscine Butylbromide<br />
MM 0683.00<br />
Hyoscine Butylbromide<br />
O<br />
H<br />
O<br />
H<br />
+<br />
N<br />
O<br />
Br<br />
(A)<br />
500 mg<br />
OH<br />
H<br />
MM 0683.01<br />
Imp. A (EP) as Hydrobromide Trihydrate: Hyoscine<br />
Hydrobromide Trihydrate<br />
O<br />
H<br />
O<br />
H<br />
N<br />
H<br />
O<br />
x HBr<br />
x 3 H 2 O<br />
(A)<br />
500 mg<br />
OH<br />
H<br />
H<br />
MM 0683.02<br />
Imp. B (EP): (2RS)-3-Hydroxy-2-phenylpropanoic Acid (DL-Tropic<br />
Acid)<br />
O<br />
OH<br />
(A)<br />
100 mg<br />
OH<br />
Hyoscine Hydrobromide<br />
MM 0546.00<br />
Hyoscine Hydrobromide Trihydrate<br />
O<br />
H<br />
O<br />
H<br />
N<br />
H<br />
O<br />
x HBr<br />
x 3 H 2 O<br />
(A)<br />
500 mg<br />
OH<br />
H<br />
H<br />
236 All your need for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
<strong>Pharmac<strong>eu</strong>tical</strong> Impurities<br />
Code Product Category Unit<br />
New MM 0546.06<br />
MM 0546.05<br />
Imp. C (EP): (1R,2R,4S,5S,7s)-9-Methyl-3-oxa-<br />
9-azatricyclo[3.3.1.0 2,4 ]non-7-yl 2-Phenylprop-<br />
2-enoate (Apohyoscine)<br />
Imp. D (EP): (2RS)-3-Hydroxy-2-phenylpropanoic Acid<br />
(DL-Tropic Acid)<br />
O<br />
H<br />
O<br />
H<br />
H<br />
N<br />
H<br />
H<br />
O<br />
OH<br />
(A)<br />
100 mg<br />
O (A) 100 mg<br />
OH<br />
Hyoscyamine Sulphate<br />
MM 0794.01<br />
Imp. A (EP): (2RS)-3-Hydroxy-2-phenylpropanoic Acid<br />
(DL-Tropic Acid)<br />
O<br />
OH<br />
(A)<br />
100 mg<br />
OH<br />
MM 0794.04<br />
Imp. D (EP) as Hydrobromide Trihydrate: Hyoscine<br />
Hydrobromide Trihydrate<br />
O<br />
H<br />
O<br />
H<br />
N<br />
H<br />
O<br />
x HBr<br />
x 3 H 2 O<br />
(A)<br />
500 mg<br />
OH<br />
H<br />
H<br />
MM 0794.07<br />
Imp. G (EP) as Hydrochloride: (1R,3r,5S)-8-Methyl-8-<br />
azabicyclo[3.2.1]oct-3-yl 2-Phenylprop-2-enoate<br />
Hydrochloride (Apoatropine Hydrochloride)<br />
O<br />
H<br />
O<br />
H<br />
(D) 100 mg<br />
N<br />
x HCl<br />
H<br />
Ibuprofen<br />
MM 0002.00<br />
Ibuprofen<br />
OH<br />
(A)<br />
500 mg<br />
O<br />
MM 0002.13<br />
Imp. A (EP): (2RS)-2-[3-(2-Methylpropyl)phenyl]propanoic Acid<br />
OH<br />
(A)<br />
100 mg<br />
O<br />
MM 0002.01<br />
Imp. B (EP):(2RS)-2-(4-Butylphenyl)propanoic Acid<br />
OH<br />
(A)<br />
100 mg<br />
O<br />
MM 0002.10<br />
Imp. C (EP): (2RS)-2-[4-(Methylpropyl)phenyl]propanamide<br />
NH 2<br />
(A)<br />
100 mg<br />
O<br />
MM 0002.11<br />
Imp. D (EP): (2RS)-2-(4-Methylphenyl)propanoic Acid<br />
OH<br />
(A)<br />
100 mg<br />
MM 0002.04 Imp. E (EP): 1-[4-(2-Methylpropyl)phenyl]ethanone<br />
O<br />
(A) 100 mg<br />
O<br />
MM 0002.28<br />
Imp. F (EP): 3-[4-(2-Methylpropyl)phenyl]propanoic Acid<br />
O<br />
(A) 100 mg<br />
OH<br />
MM 0002.38<br />
Imp. G (EP): cis-7-(2-Methylpropyl)-1-[4-(2-<br />
methylpropyl)phenyl]-1,2,3,4-tetrahydronaphthalene-1,4-<br />
dicarboxylic Acid<br />
O OH<br />
(D) 50 mg<br />
HO<br />
O<br />
MM 0002.30<br />
Imp. H (EP):(3RS)-1,3-Bis[4-(2-methylpropyl)phenyl]butan-<br />
1-one<br />
O<br />
(D) 100 mg<br />
MM 0002.31 Imp. I (EP):(3RS)-1,3-Bis[4-(2-methylpropyl)phenyl]butane (A) 50 mg<br />
MM 0002.02<br />
Imp. J (EP): (2RS)-2-[4-(2-Methylpropanoyl)phenyl]propanoic Acid<br />
OH<br />
(A)<br />
100 mg<br />
O<br />
O<br />
MM 0002.26<br />
Imp. K (EP): (2RS)-2-(4-Formylphenyl)propanoic Acid<br />
OH<br />
(A)<br />
100 mg<br />
O<br />
O<br />
MM 0002.24<br />
Imp. L (EP): 2-[4-(1-Hydroxy-2-methylpropyl)phenyl]propanoic Acid<br />
(1-Hydroxyibuprofen)<br />
OH<br />
O<br />
(A)<br />
100 mg<br />
OH<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 237
<strong>Pharmac<strong>eu</strong>tical</strong> Impurities<br />
Code Product Category Unit<br />
MM 0002.34<br />
Imp. M (EP): (2RS)-2-Hydroxy-2-[4-(2-<br />
methylpropyl)phenyl]propanoic Acid<br />
OH<br />
(A) 100 mg<br />
OH<br />
O<br />
MM 0002.35 Imp. N (EP): (2RS)-2-(4-Ethylphenyl)propanoic Acid<br />
OH<br />
O<br />
(A)<br />
100 mg<br />
MM 0002.33<br />
Imp. O (EP): 2-[4-(1-Methylpropyl)phenyl]propanoic Acid<br />
OH<br />
(A)<br />
100 mg<br />
O<br />
MM 0002.19 Imp. P (EP):(2RS)-2-[4-(2-Methylpropyl)phenyl]propan-1-ol<br />
OH<br />
(A)<br />
100 mg<br />
MM 0002.36 Imp. Q (EP): 2-[4-(2-Methylpropyl)phenyl]ethanol<br />
OH<br />
(A) 100 mg<br />
MM 0002.37 Imp. R (EP):1,1-Bis[4-(2-methylpropyl)phenyl]ethane (A) 100 mg<br />
MM 0002.03<br />
4-Isobutylbenzoic Acid<br />
O<br />
(A) 100 mg<br />
OH<br />
MM 0002.07<br />
2-(4-Isobutyrylphenyl)propanamide<br />
NH 2<br />
(A)<br />
100 mg<br />
O<br />
O<br />
MM 0002.08<br />
4-Acetylbenzoic Acid<br />
O<br />
OH<br />
(A)<br />
100 mg<br />
MM 0002.09 4-Isobutyrylacetophenone<br />
O<br />
O<br />
(A)<br />
100 mg<br />
O<br />
MM 0002.14<br />
2-(4-Isobutyrylphenyl)propane<br />
(A)<br />
100 mg<br />
O<br />
MM 0002.15<br />
2-Hydroxypropyl 2-(4-Isobutylphenyl)propanoate<br />
O<br />
OH<br />
on request<br />
O<br />
MM 0002.16<br />
1-Hydroxyprop-2-yl 2-(4-Isobutylphenyl)propanoate<br />
O<br />
O<br />
OH<br />
on request<br />
MM 0002.17<br />
2,3-Dihydroxypropyl 2-(4-Isobutylphenyl)propanoate<br />
O<br />
OH<br />
on request<br />
OH<br />
O<br />
MM 0002.18<br />
1,3-Dihydroxyprop-2-yl 2-(4-Isobutylphenyl)propanonate<br />
O<br />
O<br />
OH<br />
OH<br />
on request<br />
MM 0002.20<br />
2-(4-n-Propylphenyl)propanoic Acid<br />
OH<br />
(A)<br />
100 mg<br />
O<br />
MM 0002.21<br />
2-(4-Isobutylphenyl)propionitrile<br />
(A)<br />
100 mg<br />
N<br />
MM 0002.23<br />
Isopropyl 2-(4-Isobutylphenyl)propanonate<br />
O<br />
(A)<br />
100 mg<br />
MM 0002.25 1-Ethyl-4-isobutylbenzene (A) 100 mg<br />
O<br />
MM 0002.29<br />
trans-7-(2-Methylpropyl)-1-[4-(2-methylpropyl)phenyl]-1,2,3,4-<br />
tetrahydronaphthalene-1,4-dicarboxylic Acid<br />
O OH<br />
(D) 100 mg<br />
HO<br />
O<br />
MM 0002.32 2-[4-(2-Hydroxy-2-methylpropyl)phenyl]propanoic Acid (2-<br />
Hydroxyibuprofen)<br />
HO<br />
OH<br />
O<br />
(A)<br />
100 mg<br />
238 All your need for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
<strong>Pharmac<strong>eu</strong>tical</strong> Impurities<br />
Code Product Category Unit<br />
MM 0002.45<br />
MM 0002.46<br />
(2SR)-2-(4-Isobutylphenyl)-N-((SR)-1-<br />
phenylethyl)propanamide<br />
(2SR)-2-(4-Isobutylphenyl)-N-((RS)-1-<br />
phenylethyl)propanamide<br />
O<br />
<strong>and</strong> enantiomer<br />
O<br />
<strong>and</strong> enantiomer<br />
H<br />
N<br />
H<br />
N<br />
(A)<br />
(A)<br />
100 mg<br />
100 mg<br />
MM 0002.48 4-Isobutylstyrene (A) 100 mg<br />
MM 0002.50<br />
1-(4-Isobutylphenyl)ethanol<br />
OH<br />
(A)<br />
100 mg<br />
MM 0002.51 4-(1-Hydroxy-2-methylpropyl)acetophenone<br />
O<br />
(A)<br />
100 mg<br />
OH<br />
MM 0002.53<br />
Ibuprofen Methyl Ester<br />
O<br />
(A)<br />
100 mg<br />
O<br />
MM 0002.57<br />
1-(4-Isopropylphenyl)ethanone<br />
(4-Isopropylacetophenone)<br />
O<br />
(A) 100 mg<br />
MM 0002.59<br />
2-(4-Isopropylphenyl)acrylic Acid<br />
OH<br />
(A)<br />
100 mg<br />
O<br />
Idoxuridine<br />
MM 0791.00<br />
Idoxuridine<br />
HO<br />
O<br />
HN<br />
O N<br />
O<br />
I<br />
(A)<br />
500 mg<br />
OH<br />
Imidocarb Dipropionate<br />
MM 0742.00 Imidocarb Dipropionate O<br />
H<br />
N<br />
N<br />
N<br />
H<br />
N<br />
H<br />
N<br />
H<br />
N<br />
x 2<br />
O<br />
OH<br />
(A)<br />
100 mg<br />
Imipramine Hydrochloride<br />
MM 0077.00<br />
Imipramine Hydrochloride<br />
(A)<br />
500 mg<br />
N<br />
N<br />
x HCl<br />
MM 0077.09<br />
Desipramine Hydrochloride<br />
(A)<br />
250 mg<br />
N<br />
N<br />
H<br />
x HCl<br />
MM 0077.03<br />
N-[3-(10,11-Dihydro-5H-dibenzo-[b,f]azepin-5-yl)propyl]-<br />
N,N',N'-trimethylpropane-1,3-diamine Dihydrochloride<br />
N<br />
N<br />
N<br />
(A)<br />
100 mg<br />
x 2 HCl<br />
MM 0077.04<br />
10-Hydroxyimipramine<br />
(A)<br />
100 mg<br />
N<br />
N<br />
HO<br />
MM 0077.05<br />
10,11-Dehydroimipramine<br />
(A)<br />
100 mg<br />
N<br />
N<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 239
<strong>Pharmac<strong>eu</strong>tical</strong> Impurities<br />
Code Product Category Unit<br />
MM 0077.10<br />
Iminodibenzyl<br />
(B)<br />
100 mg<br />
NH<br />
MM 0077.08<br />
10-[3-(Dimethylamino)propyl]- 9-acridanone Hydrochloride<br />
(A)<br />
100 mg<br />
N<br />
N<br />
x HCl<br />
O<br />
MM 0077.12<br />
Imipramine N-Oxide<br />
(A)<br />
100 mg<br />
N<br />
N<br />
O<br />
Indanazoline Hydrochloride<br />
MM 0588.02<br />
4-Aminoindan Hydrochloride<br />
(A)<br />
100 mg<br />
x HCl<br />
NH 2<br />
Indapamide<br />
MM 0477.00<br />
Indapamide<br />
O<br />
O<br />
S<br />
H 2 N<br />
Cl<br />
O<br />
N<br />
H<br />
N<br />
(A)<br />
250 mg<br />
New MM 0477.01<br />
Imp. A (EP): (2RS)-2-Methyl-1-nitroso-<br />
(A) 100 mg<br />
2,3-dihydro-1H-indole<br />
ON N<br />
MM 0477.02<br />
Imp. B (EP): 4-Chloro-N-(2-methyl-1H-indol-1-yl)-3-sulphamoylbenzamide<br />
O<br />
O<br />
S<br />
H 2N<br />
Cl<br />
O<br />
N<br />
H<br />
N<br />
(A)<br />
100 mg<br />
MM 0477.04<br />
4-Chloro-3-sulfamoylbenzoic Acid<br />
O<br />
O<br />
S<br />
H 2 N<br />
O<br />
(C) 100 mg<br />
OH<br />
Cl<br />
MM 0477.05<br />
N-(4-Chloro-3-sulfamoylbenzoyl)-2-methylindoline<br />
O<br />
O<br />
S<br />
H 2 N<br />
O<br />
N<br />
(D)<br />
100 mg<br />
Cl<br />
MM 0477.07<br />
Triethylamine<br />
N<br />
(C)<br />
100 mg<br />
MM 0477.08<br />
2-Methylindoline<br />
(A)<br />
100 mg<br />
HN<br />
MM 0477.09<br />
1-Amino-2-methylindoline Hydrochloride<br />
H 2 N N<br />
x HCl<br />
(D)<br />
100 mg<br />
Indometacin<br />
MM 0584.00<br />
Indometacin<br />
O<br />
N<br />
OH<br />
(A)<br />
500 mg<br />
Cl<br />
O<br />
O<br />
MM 0584.01<br />
Imp. A (EP): 4-Chlorobenzoic Acid<br />
O<br />
(B)<br />
100 mg<br />
OH<br />
Cl<br />
Indoramin Hydrochloride<br />
MM 0802.01 Indoramin<br />
H<br />
N<br />
N<br />
H<br />
N<br />
(A)<br />
100 mg<br />
O<br />
Ipecacuanha<br />
MM 0131.02 Emetine Dihydrochloride N<br />
x 2 HCl<br />
(A)<br />
100 mg<br />
O<br />
O<br />
H<br />
HN<br />
O<br />
O<br />
240 All your need for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
<strong>Pharmac<strong>eu</strong>tical</strong> Impurities<br />
Code Product Category Unit<br />
Iprindole Hydrochloride<br />
MM 0478.00 Iprindole Hydrochloride<br />
N<br />
N<br />
x HCl<br />
(A) 100 mg<br />
Isoamyl Benzoate<br />
MM 1086.00<br />
Isoamyl Benzoate<br />
O<br />
(A) 500 mg<br />
O<br />
Isoconazol Nitrate<br />
MM 0541.00<br />
Isoconazole Nitrate<br />
Cl<br />
(A)<br />
100 mg<br />
Cl<br />
Cl<br />
x HNO 3<br />
O<br />
Cl<br />
N<br />
N<br />
MM 0541.01<br />
Imp. A (EP): (1RS)-1-(2,4-Dichlorophenyl)-2-(1H-imidazol-1-yl) ethanol<br />
N<br />
N<br />
(A) 100 mg<br />
HO<br />
Cl<br />
Cl<br />
MM 0541.02<br />
Imp. B (EP) as Nitrate: (2RS)-2-[(2,6-Dichlorobenzyl)oxy]-2-<br />
(2,4-dichlorophenyl)ethanamine Nitrate<br />
Cl<br />
(D)<br />
100 mg<br />
Cl<br />
Cl<br />
x HNO 3<br />
O<br />
MM 0541.03<br />
Isoflurane<br />
MM 0500.02<br />
MM 0500.03<br />
MM 0500.04<br />
MM 0500.05<br />
Imp. C (EP) as Nitrate: 1-[(2RS)-2-[(2,4-<br />
Dichlorobenzyl)oxy]-2-(2,4-dichlorophenyl)ethyl]-1Himidazole<br />
Nitrate (Miconazole Nitrate)<br />
Imp. B (EP): 2-(Difluoromethoxy)-1,1,1-trifluoroethane<br />
Imp. C (EP): (2RS)-2-Chloro-2-(chlorodifluoromethoxy)-<br />
1,1,1-trifluoroethane<br />
Imp. D (EP): 1,1-Dichloro-1-(difluoromethoxy)-2,2,2-trifluoroethane<br />
Imp. E (EP): 1,1-Dichloro-1-(chlorodifluoromethoxy)-2,2,2-<br />
trifluoroethane<br />
Cl<br />
Cl<br />
Cl<br />
Cl<br />
O<br />
Cl<br />
F<br />
F<br />
F<br />
F<br />
NH 2<br />
N<br />
F<br />
F<br />
N<br />
F<br />
F<br />
Cl<br />
Cl<br />
F<br />
x HNO 3<br />
O<br />
O<br />
Cl<br />
F<br />
O<br />
F<br />
F<br />
F<br />
F<br />
Cl<br />
F<br />
Cl Cl F F<br />
F<br />
O Cl<br />
F F<br />
(A)<br />
(A)<br />
(A)<br />
(A)<br />
(A)<br />
500 mg<br />
100 mg<br />
100 mg<br />
100 mg<br />
100 mg<br />
MM 0500.06 Imp. F (EP): Acetone<br />
O<br />
(C) 100 mg<br />
Isoproturon<br />
MM 2503.02 3-(2-Isopropylphenyl)-1,1-dimethylurea<br />
H<br />
N N<br />
(A)<br />
100 mg<br />
MM 2503.03 3-(3-Isopropylphenyl)-1,1-dimethylurea H<br />
N N<br />
O<br />
O<br />
(A)<br />
100 mg<br />
Isosorbide Dinitrate<br />
MM 0126.00<br />
Isosorbide Dinitrate<br />
(contains approx. 60% Lactose)<br />
O<br />
H<br />
O<br />
NO 2<br />
on request<br />
O 2 N<br />
O<br />
H<br />
O<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 241
<strong>Pharmac<strong>eu</strong>tical</strong> Impurities<br />
Code Product Category Unit<br />
MM 0126.05 Imp. B (EP): Isosorbide 2-Nitrate<br />
H<br />
O<br />
O<br />
NO 2<br />
(A) 100 mg<br />
MM 0126.06<br />
Imp. C (EP): Isosorbide Mononitrate (Isosorbide 5-Nitrate)<br />
HO<br />
O<br />
H<br />
H<br />
O<br />
OH<br />
(A)<br />
500 mg<br />
O 2 N<br />
O<br />
H<br />
O<br />
MM 0126.01<br />
2-Monomethyl Isosorbide<br />
O<br />
H<br />
O<br />
on request<br />
MM 0126.02<br />
Dimethyl Isosorbide<br />
HO<br />
O<br />
O<br />
H<br />
H<br />
O<br />
(B) 100 mg<br />
MM 0126.03<br />
Isosorbide<br />
O<br />
O<br />
H<br />
H<br />
OH<br />
(A) 500 mg<br />
O<br />
MM 0126.04<br />
Isomannit Dinitrate<br />
HO<br />
H<br />
O<br />
H<br />
O<br />
O<br />
NO 2<br />
(A)<br />
100 mg<br />
O 2 N<br />
O<br />
H<br />
O<br />
Isosorbide Mononitrate<br />
MM 0502.00<br />
Isosorbide Mononitrate<br />
O<br />
H<br />
OH<br />
(A)<br />
500 mg<br />
O 2 N<br />
O<br />
H<br />
O<br />
MM 0502.02<br />
Imp. B (EP): Isosorbide Dinitrate (contains approx. 60% Lactose)<br />
O<br />
H<br />
O<br />
NO 2<br />
(A)<br />
500 mg<br />
O 2 N<br />
O<br />
H<br />
O<br />
MM 0502.03<br />
Imp. C (EP): Isosorbide 2-Nitrate<br />
O<br />
H<br />
O<br />
NO 2<br />
(A) 100 mg<br />
MM 0502.04<br />
Isosorbide<br />
HO<br />
O<br />
H<br />
H<br />
OH<br />
(A) 500 mg<br />
O<br />
HO<br />
H<br />
O<br />
Isoxsuprine Hydrochloride<br />
MM 0576.00<br />
Isoxsuprine Hydrochloride<br />
OH<br />
H<br />
N<br />
(A)<br />
500 mg<br />
O<br />
x HCl<br />
HO<br />
<strong>and</strong> enantiomere<br />
Itraconazole<br />
MM 0258.00<br />
Itraconazole<br />
(A)<br />
100 mg<br />
N<br />
N<br />
N<br />
O<br />
N<br />
N<br />
<strong>and</strong> enantiomer<br />
O<br />
Cl<br />
Cl<br />
O<br />
O<br />
N<br />
N<br />
N<br />
242 All your need for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
<strong>Pharmac<strong>eu</strong>tical</strong> Impurities<br />
Code Product Category Unit<br />
New MM 0258.04<br />
Imp. C (EP): 4-[4-[4-[4-[[cis-2-(2,4-Dichlorophenyl)-<br />
2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]-<br />
methoxy]phenyl]piperazin-1-yl]phenyl]-2-propyl-<br />
2,4-dihydro-3H-1,2,4-triazol-3-one<br />
N<br />
N<br />
N<br />
O<br />
(A)<br />
100 mg<br />
N<br />
N<br />
<strong>and</strong> enantiomer<br />
O<br />
Cl<br />
Cl<br />
New MM 0258.05<br />
Imp. D (EP): 4-[4-[4-[4-[[cis-2-(2,4-Dichlorophenyl)-<br />
2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]-<br />
methoxy]phenyl]piperazin-1-yl]phenyl]-2-(1-<br />
methylethyl)-2,4-dihydro-3H-1,2,4-triazol-3-one<br />
O<br />
N N<br />
N<br />
O<br />
O<br />
N<br />
N<br />
N<br />
(A)<br />
100 mg<br />
N<br />
N<br />
<strong>and</strong> enantiomer<br />
Cl<br />
Cl<br />
O<br />
New MM 0258.07<br />
Imp. F (EP): 2-Butyl-4-[4-[4-[4-[[cis-2-(2,4-dichlorophenyl)-2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-<br />
4-yl]methoxy]phenyl]piperazin-1-yl]phenyl]-2,4-<br />
dihydro-3H-1,2,4-triazol-3-one<br />
O<br />
N N<br />
N<br />
O<br />
O<br />
N<br />
N<br />
N<br />
(A)<br />
100 mg<br />
N<br />
N<br />
<strong>and</strong> enantiomer<br />
Cl<br />
Cl<br />
O<br />
MM 0258.10<br />
2,4-Dihydro-4-[4-[4-(4-methoxyphenyl)-1-piperazinyl]phenyl]-<br />
3H-1,2,4-triazol-3-one<br />
O<br />
O<br />
N<br />
N<br />
N<br />
N NH<br />
N<br />
O<br />
(A)<br />
100 mg<br />
N<br />
N<br />
O<br />
MM 0258.11<br />
cis-2-(2,4-Dichlorophenyl)-2-(1H-1,2,4-triazol-1-ylmethyl)-<br />
1,3-dioxolane-4-methanol Mesilate<br />
<strong>and</strong> enantiomer<br />
Cl<br />
Cl<br />
(A)<br />
100 mg<br />
O<br />
O<br />
S<br />
O O<br />
O<br />
N<br />
N<br />
N<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 243
<strong>Pharmac<strong>eu</strong>tical</strong> Impurities<br />
Code Product Category Unit<br />
Josamycin<br />
OH<br />
MM 0443.00 Josamycin (A) 100 mg<br />
O<br />
N<br />
OO<br />
O<br />
O<br />
O<br />
O OO<br />
OH<br />
OH<br />
O<br />
O<br />
O<br />
Ketamine Hydrochloride<br />
MM0144.00 Ketamine Hydrochloride O<br />
NH<br />
x HCl<br />
(A)<br />
500 mg<br />
Cl<br />
Ketoconazole<br />
MM 0145.00<br />
Ketoconazole<br />
Cl<br />
(A)<br />
500 mg<br />
Cl<br />
O<br />
N<br />
N<br />
O<br />
O<br />
N<br />
N<br />
O<br />
MM 0145.04<br />
Imp. D (EP): 1-[4-[[(2RS,4SR)-2-(2,4-Dichlorophenyl)-2-<br />
(1H-imidazol-1-ylmethyl)-1,3-dioxolan-4-<br />
yl]methoxy]phenyl]piperazine<br />
HN<br />
N<br />
O<br />
Cl<br />
O<br />
O<br />
Cl<br />
N<br />
N<br />
(A)<br />
100 mg<br />
Ketoprofen<br />
MM 0001.00<br />
Ketoprofen<br />
O<br />
OH<br />
(A)<br />
500 mg<br />
O<br />
MM 0001.01<br />
Imp. A (EP):1-(3-Benzoylphenyl)ethanone<br />
(3-Acetylbenzophenone)<br />
O O<br />
(A) 100 mg<br />
MM 0001.03<br />
Imp. B (EP): (3-Benzoylphenyl)acetic Acid<br />
O<br />
OH<br />
(A)<br />
100 mg<br />
O<br />
MM 0001.07<br />
Imp. C (EP):3-[(1RS)-1-Carboxylethyl]benzoic Acid<br />
O<br />
HO<br />
OH<br />
O<br />
(A)<br />
100 mg<br />
MM 0001.12<br />
Imp. D (EP): (2RS)-2-[3-(4-Methylbenzoyl)phenyl]propanoic<br />
Acid<br />
O<br />
OH<br />
O<br />
(D)<br />
100 mg<br />
MM 0001.05<br />
Imp. E (EP):(2RS)-2-(3-Benzoylphenyl)propanamide<br />
O<br />
NH 2<br />
(A)<br />
100 mg<br />
O<br />
MM 0001.04 Imp. F (EP): (2RS)-2-(3-Benzoylphenyl)propanenitrile<br />
O<br />
(A)<br />
100 mg<br />
N<br />
MM 0001.20<br />
Imp. G (EP): 3-[(1RS)-1-Cyanoethyl]benzoic Acid<br />
O<br />
HO<br />
N<br />
(A)<br />
100 mg<br />
MM 0001.22<br />
Imp. H (EP): 3-(Cyanomethyl)benzoic Acid<br />
O<br />
(A)<br />
100 mg<br />
HO<br />
N<br />
MM 0001.14 Imp. I (EP): (3-Benzoylphenyl)ethanenitrile<br />
O<br />
(A)<br />
100 mg<br />
N<br />
MM 0001.23<br />
Imp. J (EP): (2RS)-2-[3-(2,4-<br />
Dimethylbenzoyl)phenyl]propanoic Acid<br />
O<br />
O<br />
OH<br />
(D)<br />
100 mg<br />
MM 0001.02 3-Ethylbenzophenone<br />
O<br />
(A) 100 mg<br />
244 All your need for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
<strong>Pharmac<strong>eu</strong>tical</strong> Impurities<br />
Code Product Category Unit<br />
MM 0001.11 3-(1-Hydroxyethyl)benzophenone<br />
O OH<br />
(A) 100 mg<br />
MM 0001.13 3-Methylbenzophenone<br />
O<br />
(B) 100 mg<br />
MM 0001.17 3-(1-Methoxyethyl)benzophenone O O (A) 100 mg<br />
MM 0001.18 2-[3-(α-Hydroxybenzyl)phenyl]propanoic Acid<br />
OH<br />
OH<br />
(A)<br />
100 mg<br />
O<br />
MM 0001.19 Ethyl 2-(3-Benzoylphenyl)propionate<br />
O<br />
O<br />
(A)<br />
100 mg<br />
O<br />
MM 0001.21 Isopropyl 2-(3-Benzoylphenyl)propionate<br />
O<br />
O<br />
(A)<br />
100 mg<br />
O<br />
MM 0001.50 3-(1-Acetoxyethyl)benzophenone<br />
O<br />
O<br />
O<br />
(A) 100 mg<br />
Ketorolac Trometamol<br />
MM 0851.00<br />
Ketorolac Trometamol<br />
O<br />
N<br />
O<br />
OH<br />
x<br />
HO<br />
OH<br />
NH 2OH<br />
(A)<br />
250 mg<br />
Ketotifen Hydrogen Fumarate<br />
MM 0180.00<br />
Ketotifen Hydrogen Fumarate<br />
O<br />
S<br />
N<br />
x<br />
HO<br />
O<br />
O<br />
OH<br />
(A)<br />
250 mg<br />
MM 0180.04 Ketotifen S<br />
N (A) 100 mg<br />
O<br />
MM 0180.07<br />
Imp. D (EP): 4-[(aRaS)-1-Methylpiperidin-4-<br />
ylidene]-4,9-dihydro-10H-benzo[4,5]-<br />
cyclohepta[1,2-b]thiophen-10-one N-Oxide<br />
(Ketotifen N-Oxide)<br />
O<br />
S<br />
O<br />
(A) 100 mg<br />
N<br />
MM 0180.11 10-Methoxy-4H-benzo[4,5]cyclohepta[1,2-b]thiophen-4-one S<br />
O<br />
O<br />
(A)<br />
100 mg<br />
Labetalol Hydrochloride<br />
Code Product Category Unit<br />
MM 0438.00 Labetalol Hydrochloride<br />
OH<br />
HN<br />
(A) 500 mg<br />
Lacidipine<br />
x HCl<br />
HO<br />
O NH 2<br />
MM 0407.00 Lacidipine<br />
H<br />
N<br />
(A)<br />
100 mg<br />
O<br />
O<br />
O<br />
O<br />
O<br />
O<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 245
<strong>Pharmac<strong>eu</strong>tical</strong> Impurities<br />
Code Product Category Unit<br />
New MM 0407.01<br />
Imp. A (BP): Ethyl Methyl (E)-4-{2-[2-(tert-Butoxycarbonyl)vinyl]phenyl}-1,4-dihydro-2,6-dimethylpyridine-3,5-dicarboxylate<br />
O<br />
O<br />
H<br />
N<br />
O<br />
O<br />
O<br />
O<br />
(A)<br />
100 mg<br />
New MM 0407.02<br />
Imp. B (BP): Diethyl (E)-4-{2-[2-(tert-Butoxycarbonyl)vinyl]phenyl}-2,6-dimethylpyridine-<br />
3,5-dicarboxylate<br />
O<br />
O<br />
N<br />
O<br />
O<br />
O<br />
(A)<br />
100 mg<br />
O<br />
Lamivudine<br />
MM 0749.03<br />
Imp. C (EP): Salicylic Acid<br />
O<br />
(A)<br />
500 mg<br />
OH<br />
OH<br />
MM 0749.05<br />
Imp. E (EP): 4-Aminopyrimidin-2(1H)-one(Cytosine)<br />
NH 2<br />
(A)<br />
100 mg<br />
N<br />
MM 0749.06<br />
Imp. F (EP): Pyrimidine-2,4(1H,3H)-dione (Uracil)<br />
O<br />
N<br />
H<br />
O<br />
(C)<br />
100 mg<br />
HN<br />
Lamotrigine<br />
MM 0922.00 Lamotrigine N N NH 2<br />
(A) 100 mg<br />
N<br />
NH 2<br />
MM 0922.01<br />
Imp. A (Pharm<strong>eu</strong>ropa): 3-Amino-6-(2,3-dichlorophenyl)-1,2,4-triazin-<br />
5(4H)-one<br />
Cl<br />
Cl<br />
O<br />
N N NH<br />
N<br />
H<br />
NH 2<br />
(A)<br />
100 mg<br />
MM 0922.03<br />
Imp. C (Pharm<strong>eu</strong>ropa): (Z)-2-(2,3-Dichlorophenyl)-2-<br />
(guanidinimino)acetonitrile<br />
Cl<br />
Cl<br />
O<br />
Cl<br />
N N NH 2<br />
N<br />
Cl<br />
MM 0922.05 Imp. E (Pharm<strong>eu</strong>ropa): 2,3-Dichlorobenzoic Acid<br />
O<br />
NH 2<br />
OH<br />
(A)<br />
(A)<br />
100 mg<br />
100 mg<br />
Cl<br />
Cl<br />
Lansoprazole<br />
MM 0474.00<br />
Lansoprazole<br />
NH<br />
N S<br />
O<br />
N<br />
O<br />
F<br />
F<br />
F<br />
(A)<br />
100 mg<br />
MM 0474.07<br />
Imp. A (EP): 2-[(RS)-[[3-Methyl-1-oxido-<br />
4-(2,2,2-trifluoroethoxy)pyridin-2-yl]methyl]-<br />
sulphinyl]-1H-benzimidazole (Lansoprazole<br />
N-Oxide)<br />
NH<br />
N S<br />
O N<br />
O<br />
O<br />
F<br />
F<br />
F<br />
(D)<br />
100 mg<br />
MM 0474.01<br />
Imp. B (EP): 2-[[[3-Methyl-4-(2,2,2-trifluoroethoxy)pyridin-2-yl]methyl]sulphonyl]-1Hbenzimidazole<br />
(Lansoprazole Sulphone)<br />
NH<br />
N S<br />
O O<br />
N<br />
O<br />
F<br />
F<br />
F<br />
(A)<br />
100 mg<br />
MM 0474.06<br />
Imp. C (EP): 2-[[[3-Methyl-4-(2,2,2-trifluoroethoxy)pyridin-2-yl]methyl]sulphanyl]-1Hbenzimidazole<br />
NH<br />
N S<br />
N<br />
O<br />
F<br />
F<br />
F<br />
(A)<br />
100 mg<br />
MM 0474.03<br />
Imp. D (EP): 1H-Benzimidazol-2-ol<br />
NH<br />
(B)<br />
100 mg<br />
N<br />
OH<br />
246 All your need for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
<strong>Pharmac<strong>eu</strong>tical</strong> Impurities<br />
Code Product Category Unit<br />
MM 0474.05 Imp. E (EP): 1H-Benzimidazole-2-thiol<br />
NH<br />
(A) 100 mg<br />
MM 0474.04 4-Ethoxyacetophenone O<br />
N<br />
SH<br />
(C)<br />
100 mg<br />
O<br />
MM 0474.08<br />
MM 0474.09<br />
Lansoprazole Sulphone N-Oxide<br />
2-Chloromethyl-3-methyl-4-(2,2,2-trifluoroethoxy)pyridine<br />
Hydrochloride<br />
Cl<br />
NH<br />
N S<br />
O O N<br />
O<br />
N<br />
O<br />
F<br />
O<br />
F<br />
F<br />
F F<br />
F<br />
x HCl<br />
(A)<br />
(A)<br />
100 mg<br />
100 mg<br />
Leflunomide<br />
MM 0859.00<br />
Leflunomide<br />
N<br />
O<br />
H<br />
N<br />
(D)<br />
100 mg<br />
O<br />
F<br />
Levamisole Hydrochloride<br />
MM 0706.04<br />
Imp. D (EP): 6-Phenyl-2,3-dihydroimidazo[2,1-b]thiazole<br />
F<br />
N<br />
F<br />
N S<br />
(A) 100 mg<br />
Levocetirizine Dihydrochloride<br />
New MM 1035.00<br />
Levocetirizine Dihydrochloride<br />
Cl<br />
N<br />
N<br />
O<br />
O<br />
OH<br />
on request<br />
x 2 HCl<br />
Levodopa<br />
MM 0262.00<br />
New MM 0262.12<br />
Levodopa<br />
Imp. B (EP): (2S)-2-Amino-3-(4-hydroxyphenyl)propanoic<br />
Acid (Tyrosine)<br />
HO<br />
HO<br />
HO<br />
O<br />
(A) 500 mg<br />
NH 2<br />
OH<br />
O<br />
(A) 100 mg<br />
NH 2<br />
OH<br />
MM 0262.05<br />
Imp. C (EP): (2RS)-2-Amino-3-(4-hydroxy-3-<br />
methoxyphenyl)propanoic Acid (3-Methoxy-DL-tyrosine; (DL)-3-<br />
O-Methyldopa)<br />
HO<br />
O<br />
O<br />
OH<br />
NH 2<br />
(A)<br />
100 mg<br />
MM 0262.06<br />
4-Hydroxy-3-methoxym<strong>and</strong>elic Acid<br />
OH<br />
OH<br />
(A)<br />
100 mg<br />
HO<br />
O<br />
O<br />
Levofloxacin<br />
MM 0846.00<br />
Levofloxacin<br />
N<br />
N<br />
O<br />
N<br />
(A)<br />
100 mg<br />
Levomenthol<br />
OH<br />
F<br />
O O<br />
MM0388.00 Levomenthol<br />
OH<br />
(A) 500 mg<br />
Levomepromazine Hydrochloride<br />
MM 0266.00<br />
Levomepromazine Hydrochloride<br />
(A)<br />
500 mg<br />
S<br />
N<br />
N<br />
x HCl<br />
O<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 247
<strong>Pharmac<strong>eu</strong>tical</strong> Impurities<br />
Code Product Category Unit<br />
Levomepromazine Maleate<br />
MM 0019.00 Levomepromazine Maleate O (A) 100 mg<br />
S<br />
N<br />
N<br />
x<br />
OH<br />
OH<br />
MM 0019.02<br />
Imp. A (EP): 2-Methoxyphenothiazine<br />
O<br />
O<br />
(A)<br />
100 mg<br />
S<br />
NH<br />
O<br />
MM 0019.01<br />
Imp. B (EP): 10-[(2R)-3-(Dimethylamino)-2-methylpropyl]-2-<br />
methoxy-10H-phenothiazine 5-Oxide (Levomepromazine S-Oxide)<br />
S<br />
O<br />
N<br />
N<br />
(A)<br />
100 mg<br />
O<br />
MM 0019.07<br />
N-Demethyllevomepromazine Hydrochloride<br />
(D)<br />
100 mg<br />
S<br />
N<br />
N<br />
H<br />
x HCl<br />
O<br />
MM 0019.09<br />
Levomepromazine Sulphone Hydrochloride<br />
(A)<br />
100 mg<br />
Levonorgestrel<br />
N<br />
N<br />
x HCl<br />
O S<br />
O<br />
O<br />
MM 0121.00 Levonorgestrel OH<br />
(A)<br />
250 mg<br />
MM 0121.01 6β-Hydroxylevonorgestrel<br />
OH<br />
O<br />
(D)<br />
100 mg<br />
MM 0121.02 6-Ketolevonorgestrel OH<br />
O<br />
OH<br />
(D)<br />
100 mg<br />
MM 0121.08 6α-Hydroxylevonorgestrel OH<br />
O<br />
O<br />
(D)<br />
50 mg<br />
O<br />
OH<br />
Lidocaine Hydrochloride<br />
MM 0102.04<br />
Lidocaine Hydrochloride Monohydrate<br />
H<br />
N<br />
O<br />
N<br />
x HCl<br />
x H 2 O<br />
(A)<br />
500 mg<br />
MM 0102.00<br />
Lidocaine<br />
H<br />
N<br />
O<br />
N<br />
(A)<br />
500 mg<br />
MM 0102.02<br />
Imp. A (EP): 2,6-Dimethylaniline<br />
NH 2<br />
(B) 100 mg<br />
MM 0102.01<br />
Imp. B (EP): 2-(Diethylazinoyl)-N-(2,6-<br />
dimethylphenyl)acetamide (Lidocaine N 2 -<br />
Oxide)<br />
H<br />
N<br />
O<br />
O (A) 100 mg<br />
N<br />
MM 0102.10<br />
Imp. F (EP) as Hydrochloride: 2-(Diethylamino)-N-(2,3-dimethylphenyl)acetamide<br />
Hydrochloride<br />
H<br />
N<br />
O<br />
N<br />
x HCl<br />
(A)<br />
100 mg<br />
MM 0102.11<br />
Imp. G (EP) as Hydrochloride: N-(2,6-<br />
Dimethylphenyl)-2-[(1-methylethyl)amino]-<br />
acetamide Hydrochloride<br />
H<br />
N<br />
O<br />
N<br />
H<br />
x HCl<br />
(A)<br />
100 mg<br />
248 All your need for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
<strong>Pharmac<strong>eu</strong>tical</strong> Impurities<br />
Code Product Category Unit<br />
MM 0102.03 Imp. H (EP): 2-Chloro-N-(2,6-dimethylphenyl)acetamide H<br />
N<br />
(B) 100 mg<br />
Cl<br />
O<br />
Liothyronine Sodium<br />
MM 0626.00<br />
Liothyronine Sodium<br />
HO<br />
I<br />
O<br />
I<br />
I<br />
NH 2<br />
(A) 50 mg<br />
ONa<br />
O<br />
MM 0626.01<br />
Liothyronine<br />
HO<br />
I<br />
O<br />
I<br />
I<br />
NH 2<br />
(A) 100 mg<br />
OH<br />
O<br />
Lisinopril Dihydrate<br />
MM 0598.00<br />
Lisinopril Dihydrate<br />
H<br />
N<br />
O<br />
N<br />
O<br />
OH<br />
x 2 H 2 O<br />
(A)<br />
100 mg<br />
HO<br />
O<br />
H 2 N<br />
MM 0598.01<br />
Imp. A (EP): (2RS)-2-Amino-4-phenylbutanoic Acid<br />
(A)<br />
100 mg<br />
NH 2<br />
HO<br />
O<br />
MM 0598.02<br />
Imp. B (EP) as Hydrate: 4-Methylbenzenesulphonic Acid Hydrate<br />
O O<br />
S OH<br />
x H 2 O<br />
(C)<br />
100 mg<br />
Loperamide Hydrochloride<br />
MM 0025.00 Loperamide Hydrochloride<br />
Cl<br />
(A)<br />
500 mg<br />
OH<br />
N<br />
x HCl<br />
N<br />
O<br />
MM 0025.15<br />
Imp. B (EP) as Bromide: 4-(4-Chlorophenyl)-<br />
1,1-bis[4-(dimethylamino)-4-oxo-3,3-diphenylbutyl]-4-hydroxypiperidinium<br />
Bromide<br />
Cl<br />
OH<br />
N +<br />
N<br />
O<br />
Br - (A) 100 mg<br />
N<br />
O<br />
MM 0025.04 Imp. C (EP): 4-(4-Chlorophenyl)piperidin-4-ol<br />
Cl<br />
(B)<br />
100 mg<br />
OH<br />
N<br />
H<br />
MM 0025.05<br />
Imp. D (EP): 4-(4-Hydroxy-4-phenylpiperidin-1-yl)-N,N-dimethyl-2,2-<br />
diphenylbutanamide<br />
OH<br />
(A)<br />
100 mg<br />
N<br />
N<br />
O<br />
MM 0025.09<br />
Imp. F (EP): Loperamide Oxide<br />
OH<br />
Cl<br />
(A)<br />
100 mg<br />
N<br />
O<br />
N<br />
O<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 249
<strong>Pharmac<strong>eu</strong>tical</strong> Impurities<br />
Code Product Category Unit<br />
MM 0025.11 Imp. H (EP): 4-[4-(4-Chlorophenyl)-3,6-dihydropyridin-1(2H)-yl]-N,Ndimethyl-2,2-diphenylbutanamide<br />
Cl<br />
(A) 100 mg<br />
N<br />
O<br />
N<br />
MM 0025.07<br />
Ethyl Diphenylacetate<br />
(A)<br />
100 mg<br />
O<br />
MM 0025.08 α,α-Diphenyl-γ-butyrolactone O<br />
O<br />
(A)<br />
100 mg<br />
O<br />
MM 0025.10<br />
Dimethyl-(tetrahydro-3,3-diphenyl-2-furilidine)ammonium Bromide<br />
O (A) 100 mg<br />
Br -<br />
N +<br />
Loratadine<br />
MM 0257.00<br />
Loratadine<br />
O<br />
Cl (A) 100 mg<br />
N O<br />
N<br />
MM 0257.02<br />
Imp. B (EP): 8-Chloro-5,6-dihydro-11H-benzo[5.6]cyclohepta[1,2-<br />
b]pyridin-11-one<br />
Cl<br />
(A) 100 mg<br />
O<br />
N<br />
MM 0257.01<br />
Imp. D (EP): 8-Chloro-11-(piperidin-4-ylidene)-6,11-dihydro-5Hbenzo[5,6]cyclohepta[1,2-b]pyridine<br />
(Descarboethoxyloratadine;Desloratadine)<br />
Cl<br />
(A) 50 mg<br />
N<br />
NH<br />
MM 0257.05<br />
Imp. G (EP): 8-Chloro-11-(1-methylpiperidin-4-<br />
ylidene)-6,11-dihydro-5H-benzo[5,6]cyclohepta-<br />
[1,2-b]pyridine<br />
Cl<br />
(A) 100 mg<br />
N<br />
N<br />
MM 0257.07<br />
Imp. H (EP): Ethyl 4-Oxopiperidine-1-carboxylate<br />
O<br />
(A)<br />
100 mg<br />
N<br />
O<br />
O<br />
Lorazepam<br />
MM 0071.00<br />
Lorazepam [Controlled Substance]<br />
H<br />
N<br />
O<br />
(A)<br />
100 mg<br />
Cl<br />
N<br />
OH<br />
Cl<br />
MM 0071.01 Imp. A (EP): (2-Amino-5-chlorophenyl)(2-chlorophenyl)methanone (2-<br />
Amino-2',5-dichlorobenzophenone)<br />
Cl<br />
NH 2<br />
O<br />
Cl<br />
(B)<br />
100 mg<br />
MM 0071.07<br />
Imp. B (EP): (3RS)-7-Chloro-5-(2-chlorophenyl)-<br />
2-oxo-2,3-dihydro-1H-1,4-benzodiazepin-3-yl<br />
Acetate (Lorazepam Acetate)<br />
[Controlled Substance]<br />
Cl<br />
H O<br />
N<br />
O<br />
N<br />
O<br />
Cl<br />
(A)<br />
100 mg<br />
250 All your need for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
<strong>Pharmac<strong>eu</strong>tical</strong> Impurities<br />
Code Product Category Unit<br />
MM 0071.06<br />
Imp. C (EP): 7-Chloro-5-(2-chlorophenyl)-<br />
1,3-dihydro-2H-1,4-benzodiazepin-2-one<br />
4-Oxide<br />
Cl<br />
H<br />
N<br />
O<br />
N<br />
O<br />
Cl<br />
(A)<br />
100 mg<br />
MM 0071.03<br />
Imp. D (EP): (5RS)-7-Chloro-5-(2-chlorophenyl)-<br />
4,5-dihydro-1H-1,4-benzodiazepine-2,3-dione<br />
Cl<br />
H<br />
N<br />
O<br />
NH<br />
O<br />
(A)<br />
100 mg<br />
Cl<br />
MM 0071.02<br />
Imp. E (EP): 6-Chloro-4-(2-chlorophenyl)-<br />
quinazoline-2-carbaldehyde<br />
Cl<br />
N<br />
N<br />
Cl<br />
O<br />
(A) 100 mg<br />
MM 0071.04<br />
6-Chloro-4-(2-chlorophenyl)-2-quinazolinecarboxylic Acid<br />
Cl<br />
O<br />
N<br />
OH<br />
N<br />
Cl<br />
(A)<br />
100 mg<br />
MM 0071.08<br />
6-Chloro-4-(2-chlorophenyl)-2-quinazolinemethanol<br />
N<br />
OH<br />
(A) 100 mg<br />
Cl<br />
N<br />
Cl<br />
MM 0071.09<br />
6-Chloro-4-(2-chlorophenyl)-2(1H)-quinazolinone<br />
H<br />
N<br />
O<br />
(A)<br />
100 mg<br />
Cl<br />
N<br />
Cl<br />
Losartan Potassium<br />
MM 0168.00<br />
Losartan<br />
Cl<br />
OH<br />
N<br />
N<br />
N N<br />
N NH<br />
on request<br />
MM 0168.08<br />
Imp. D (Pharm<strong>eu</strong>ropa) : 2-Butyl-4-chloro-<br />
1H-imidazole-5-carbaldehyde<br />
Cl<br />
N<br />
O<br />
NH<br />
(A)<br />
100 mg<br />
New MM 0168.09<br />
Imp. G (Pharm<strong>eu</strong>ropa) : Triphenylmethanol<br />
OH<br />
(A)<br />
100 mg<br />
Lovastatin<br />
MM 0050.00<br />
Lovastatin<br />
O<br />
O<br />
(A)<br />
100 mg<br />
H O<br />
O<br />
OH<br />
MM 0050.05<br />
Imp. A (EP): (1S,7S,8S,8aR)-8-[2-[(2R,4R)-4-Hydroxy-6-<br />
oxotetrahydro-2H-pyran-2-yl]ethyl]-7-methyl-1,2,3,7,8,8ahexahydronaphthalen-1-yl<br />
(2S)-2-Methylbutanoate (Mevastatin)<br />
O<br />
O<br />
O O<br />
OH<br />
(A)<br />
100 mg<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 251
<strong>Pharmac<strong>eu</strong>tical</strong> Impurities<br />
Code Product Category Unit<br />
MM 0050.01 Imp. B (EP) as Sodium Salt: (3R,5R)-7-[(1S,2S,6R,8S,8aR)-2,6-<br />
O<br />
(A) 100 mg<br />
Dimethyl-8-[[(2S)-2-methylbutanoyl]oxy]-1,2,6,7,8,8ahexahydronaphthalen-1-yl]-3,5-dihydroxyheptanoic<br />
OH ONa<br />
Acid Sodium<br />
OH<br />
H<br />
Salt (Lovastatin Hydroxy Acid Sodium Salt)<br />
O O<br />
MM 0050.03<br />
O<br />
Imp. C (EP): (1S,3R,7S,8S,8aR)-3,7-Dimethyl-8-[2-[(2R)-6-oxo-3,6-<br />
(A) 100 mg<br />
dihydro-2H-pyran-2-yl]ethyl]-1,2,3,7,8,8a-hexahydronaphthalen-1-yl<br />
O<br />
(2S)-2-Methylbutanoate (Dehydrolovastatin)<br />
H O O<br />
Maprotiline Hydrochloride<br />
MM 0820.00<br />
Maprotiline Hydrochloride<br />
(A)<br />
250 mg<br />
N<br />
H<br />
x HCl<br />
MM 0820.01<br />
Imp. A (EP): 3-(9,10-Ethanoanthracen-9(10H)-yl)prop-2-enal<br />
(D)<br />
100 mg<br />
O<br />
MM 0820.02 Imp. B (EP) as Hydrochloride: 3-(9,10-<br />
Ethanoanthracen-9(10H)-yl)-N-[3-(9,10-<br />
ethanoanthracen-9(10H)-yl)propyl]-Nmethylpropan-1-amine<br />
Hydrochloride<br />
N<br />
x HCl<br />
(D)<br />
100 mg<br />
MM 0820.03<br />
NH 2 x HCl<br />
Imp. C (EP) as Hydrochloride: 3-(9,10-Ethanoanthracen-<br />
(D) 100 mg<br />
9(10H)-yl)propan-1-amine Hydrochloride<br />
MM 0820.04<br />
Imp. D (EP) as Hydrochloride: 3-(9,10-Ethanoanthracen-<br />
9(10H)-yl)-N-methylprop-2-en-1-amine Hydrochloride<br />
(Dehydromaprotiline Hydrochloride)<br />
N<br />
H<br />
x HCl<br />
(D)<br />
100 mg<br />
MM 0820.05<br />
Imp. E (EP) as Hydrochloride: 3-(9,10-Ethanoanthracen-<br />
9(10H)-yl)-N,N-dimethylpropan-1-amine Hydrochloride<br />
N<br />
x HCl<br />
(A)<br />
100 mg<br />
Mebeverine Hydrochloride<br />
MM 0319.00<br />
Mebeverine Hydrochloride<br />
N<br />
O<br />
O<br />
(A)<br />
100 mg<br />
O<br />
x HCl<br />
O<br />
O<br />
MM 0319.02<br />
Imp. A (Pharm<strong>eu</strong>ropa): 4-Methoxyphenylacetone<br />
O<br />
(B) 100 mg<br />
O<br />
MM 0319.03<br />
MM 0319.01<br />
Imp. B (Pharm<strong>eu</strong>ropa) as Hydrochloride: N-[(1RS)-<br />
1-[(4-Methoxyphenyl)methyl]ethyl]ethanamine<br />
Hydrochloride<br />
Imp. D (Pharm<strong>eu</strong>ropa): 3,4-Dimethoxybenzoic Acid (Veratric Acid)<br />
O<br />
O<br />
NH<br />
x HCl<br />
(A)<br />
(B)<br />
100 mg<br />
100 mg<br />
HO<br />
O<br />
O<br />
Mechlorethamine Hydrochloride<br />
MM 0823.00 Mechlorethamine Hydrochloride<br />
N<br />
Cl<br />
Cl<br />
x HCl (A) 500 mg<br />
252 All your need for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
<strong>Pharmac<strong>eu</strong>tical</strong> Impurities<br />
Code Product Category Unit<br />
Meclofenoxate Hydrochloride<br />
MM 0044.00 Meclofenoxate Hydrochloride<br />
O<br />
O<br />
N<br />
O<br />
x HCl<br />
(A) 500 mg<br />
Cl<br />
MM 0044.02<br />
(4-Chlorophenoxy)acetic Acid<br />
O<br />
O<br />
(B) 100 mg<br />
OH<br />
Cl<br />
Meclozine Hydrochloride<br />
MM 0586.00<br />
Meclozine Dihydrochloride<br />
Cl<br />
N<br />
N<br />
(A)<br />
500 mg<br />
x 2 HCl<br />
MM 0586.03<br />
Imp. B (Pharm<strong>eu</strong>ropa): (RS)-(4-Chlorophenyl)-(phenyl)methanol<br />
Cl<br />
(B) 100 mg<br />
OH<br />
MM 0586.04<br />
Imp. C (Pharm<strong>eu</strong>ropa): (4-Chlorophenyl)(phenyl)methanone<br />
Cl<br />
(B) 100 mg<br />
O<br />
MM 0586.01 N-(3-Methylbenzyl)piperazine N<br />
HN<br />
(A)<br />
100 mg<br />
MM 0586.02<br />
(RS)-1-[(4-Chlorophenyl)phenylmethyl]piperazine<br />
Cl<br />
(A) 100 mg<br />
N<br />
NH<br />
MM 0586.05<br />
Meclozine N-Oxide<br />
Cl<br />
N<br />
O<br />
(A) 100 mg<br />
N<br />
Medroxyprogesterone<br />
MM 0635.00<br />
Medroxyprogesterone<br />
O<br />
OH<br />
(A)<br />
100 mg<br />
O<br />
Medroxyprogesterone Acetate<br />
MM 0532.00<br />
Medroxyprogesterone Acetate<br />
O<br />
O<br />
(A)<br />
100 mg<br />
O<br />
O<br />
MM 0532.01<br />
Imp. A (EP): 6β-Hydroxy-6-methyl-3,20-dioxopregn-4-en-17-yl<br />
Acetate (6β-Hydroxymedroxyprogesterone Acetate)<br />
O<br />
O<br />
O<br />
(D)<br />
100 mg<br />
O<br />
OH<br />
MM 0532.02<br />
Imp. B (EP):17-Hydroxy-6α-methylpregn-4-ene-3,20-dione<br />
(Medroxyprogesterone)<br />
O<br />
OH<br />
(A)<br />
100 mg<br />
O<br />
MM 0532.05<br />
Imp. E (EP): 6-Methylidene-3,20-dioxopregn-4-en-17-yl<br />
Acetate (6-Methylenehydroxyprogesterone Acetate)<br />
O<br />
O<br />
O<br />
(A)<br />
100 mg<br />
O<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 253
<strong>Pharmac<strong>eu</strong>tical</strong> Impurities<br />
Code Product Category Unit<br />
MM 0532.06 Imp. F (EP): 6α-Methyl-3,20-dioxo-5β-pregnan-17-yl Acetate<br />
O<br />
(D) 50 mg<br />
(4,5β-Dihydromedroxyprogesterone Acetate)<br />
O<br />
O<br />
O<br />
H<br />
MM 0532.07<br />
Imp. G (EP): 6-Methyl-3,20-dioxopregna-4,6-dien-17-yl<br />
Acetate (Megestrol Acetate)<br />
O<br />
O<br />
O<br />
(A)<br />
250 mg<br />
O<br />
MM 0532.09<br />
Imp. H (EP): 3,20-Dioxopregn-4-en-17-yl Acetate<br />
(Hydroxyprogesterone Acetate)<br />
O<br />
O<br />
(A)<br />
100 mg<br />
O<br />
O<br />
Mefenamic Acid<br />
MM 0327.00<br />
Mefenamic Acid<br />
O<br />
(A)<br />
500 mg<br />
OH<br />
NH<br />
MM 0327.01 Imp. A (EP): 2,3-Dimethylaniline<br />
NH 2<br />
(B) 100 mg<br />
MM 0327.02<br />
Imp. B (EP): N-(2,3-Dimethylphenyl)-2-[(2,3-<br />
dimethylphenyl)amino]benzamide<br />
O<br />
(A)<br />
100 mg<br />
N<br />
H<br />
NH<br />
New MM 0327.05<br />
Imp. C (Pharm<strong>eu</strong>ropa): 2-Chlorobenzoic Acid<br />
O<br />
(A)<br />
100 mg<br />
OH<br />
New MM 0327.06<br />
Imp. D (Pharm<strong>eu</strong>ropa): Benzoic Acid<br />
Cl<br />
O<br />
(B) 100 mg<br />
OH<br />
Mefloquine Hydrochloride<br />
New MM 1198.01<br />
2,8-Bis-(trifluoromethyl)-4-quinolinol<br />
F<br />
F<br />
F<br />
N<br />
F<br />
F<br />
F<br />
(A)<br />
100 mg<br />
OH<br />
Megestrol Acetate<br />
MM 0573.00<br />
Megestrol Acetate<br />
O<br />
(A)<br />
250 mg<br />
O<br />
O<br />
O<br />
MM 0573.01<br />
Imp. A (EP): 6α-Methyl-3,20-dioxopregn-4-en-17-yl Acetate<br />
(Medroxyprogesterone Acetate)<br />
O<br />
O<br />
(A)<br />
100 mg<br />
O<br />
O<br />
Meloxicam<br />
MM 0246.00<br />
Meloxicam<br />
O O<br />
S<br />
N<br />
H<br />
N<br />
N<br />
(A)<br />
500 mg<br />
OH<br />
O<br />
S<br />
254 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
<strong>Pharmac<strong>eu</strong>tical</strong> Impurities<br />
Code Product Category Unit<br />
MM 0246.02<br />
Imp. A (BP): Ethyl 4-Hydroxy-2-methyl-2H-1,2-benzothiazine-3-<br />
carboxylate 1,1-Dioxide<br />
O O<br />
S<br />
N<br />
O<br />
(A)<br />
100 mg<br />
MM 0246.01<br />
Imp. B (BP): 5-Methyl-1,3-thiazol-2-amine<br />
OH<br />
O<br />
H 2 N<br />
N (A) 100 mg<br />
S<br />
MM 0246.04<br />
Imp. E (BP): Methyl 4-Hydroxy-2-methyl-<br />
2H-1,2-benzothiazine-3-carboxylate 1,1-<br />
Dioxide<br />
O O<br />
S<br />
N<br />
OH<br />
O<br />
O<br />
(A)<br />
100 mg<br />
Melperone<br />
MM 0321.00<br />
Melperone<br />
N<br />
O<br />
(A)<br />
100 mg<br />
Memantine Hydrochloride<br />
New MM 1045.01 1-Hydroxy-3,5-dimethyladamantane<br />
OH<br />
(A) 100 mg<br />
F<br />
Mephenesin<br />
MM 0810.00<br />
Mephenesin<br />
O<br />
OH<br />
OH<br />
(A)<br />
500 mg<br />
Mephentermine Hemisulphate<br />
MM 0740.00 Mephentermine Hemisulfate H<br />
N<br />
x ½ H 2 SO 4<br />
(A) 500 mg<br />
Mepivacaine Hydrochloride<br />
MM 0368.00<br />
Mepivacaine Hydrochloride<br />
H<br />
N<br />
O<br />
N<br />
x HCl<br />
(A)<br />
500 mg<br />
MM 0368.01<br />
Imp. A (EP): 2,6-Dimethylaniline<br />
NH 2<br />
(B) 100 mg<br />
MM 0368.03<br />
Imp. C (EP): N-(2,6-Dimethylphenyl)pyridine-2-carboxamide<br />
H<br />
N<br />
O<br />
N<br />
(A)<br />
100 mg<br />
MM 0368.06<br />
Mepivacaine N-Oxide<br />
H<br />
N<br />
O<br />
N<br />
O<br />
(A) 100 mg<br />
Mepyramine Maleate<br />
MM 0559.00 Mepyramine Maleate<br />
O<br />
N<br />
N<br />
OH<br />
x<br />
O N<br />
OH<br />
O<br />
MM 0559.02 Imp. A (EP): N-(4-Methoxybenzyl)pyridin-2-amine NH<br />
(A)<br />
(A)<br />
500 mg<br />
100 mg<br />
O<br />
N<br />
MM 0559.03<br />
Imp. B (EP): 4-Methoxybenzaldehyde (Anisaldehyde)<br />
O (C) 100 mg<br />
O<br />
MM 0559.04<br />
Imp. C (EP): Pyridin-2-amine<br />
NH 2<br />
(B) 100 mg<br />
N<br />
MM 0559.05<br />
Mepyramine N-Oxide Dihydrochloride<br />
O<br />
N<br />
N<br />
O<br />
N<br />
x 2 HCl<br />
(A)<br />
100 mg<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 255
<strong>Pharmac<strong>eu</strong>tical</strong> Impurities<br />
Code Product Category Unit<br />
Mequinol<br />
O<br />
MM 1131.00 Mequinol<br />
(A) 500 mg<br />
HO<br />
Mesalazine<br />
MM 0217.00<br />
Mesalazine<br />
H 2 N<br />
O<br />
(A) 500 mg<br />
OH<br />
OH<br />
MM 0217.04 Imp. A (EP): 4-Aminophenol<br />
H 2 N<br />
(B)<br />
100 mg<br />
OH<br />
MM 0217.01<br />
Imp. B (EP): 3-Aminophenol<br />
(B)<br />
100 mg<br />
H 2 N<br />
OH<br />
MM 0217.06<br />
Imp. C (EP): 2-Aminophenol<br />
(A) 100 mg<br />
OH<br />
NH 2<br />
MM 0217.07<br />
Imp. D (EP): 3-Aminobenzoic Acid<br />
O<br />
(A) 100 mg<br />
OH<br />
NH 2<br />
MM 0217.08<br />
Imp. E (EP): 4-Amino-2-hydroxybenzoic Acid<br />
(4-Aminosalicylic Acid)<br />
O<br />
OH<br />
(A)<br />
100 mg<br />
H 2 N<br />
OH<br />
MM 0217.09<br />
Imp. F (EP): 3-Amino-2-hydroxybenzoic<br />
Acid (3-Aminosalicylic Acid)<br />
O<br />
(A) 100 mg<br />
OH<br />
OH<br />
NH 2<br />
MM 0217.10<br />
Imp. G (EP): 2,5-Dihydroxybenzoic Acid<br />
HO<br />
O<br />
OH<br />
(A)<br />
100 mg<br />
OH<br />
MM 0217.11<br />
Imp. H (EP): 2-Hydroxybenzoic Acid<br />
(Salicylic Acid)<br />
O<br />
OH<br />
(A)<br />
500 mg<br />
MM 0217.13 Imp. K (EP): Aniline<br />
H 2 N<br />
(B) 100 mg<br />
OH<br />
MM 0217.14<br />
Imp. L (EP): 2-Chlorobenzoic Acid<br />
O<br />
(A)<br />
100 mg<br />
OH<br />
Cl<br />
MM 0217.15<br />
Imp. M (EP): 2-Chloro-5-nitrobenzoic Acid<br />
O 2 N<br />
O<br />
OH<br />
(A)<br />
100 mg<br />
Cl<br />
MM 0217.16<br />
Imp. N (EP): 2-Hydroxy-5-nitrobenzoic Acid<br />
(5-Nitrosalicylic Acid)<br />
O 2 N<br />
O<br />
OH<br />
(A)<br />
100 mg<br />
OH<br />
MM 0217.02<br />
5-Acetaminosalicylic Acid<br />
O<br />
O<br />
OH<br />
OH<br />
(A)<br />
100 mg<br />
N<br />
H<br />
Metamizole Sodium<br />
MM 0052.00<br />
Metamizole Sodium Monohydrate<br />
O<br />
N<br />
N<br />
N<br />
O<br />
S<br />
O<br />
ONa<br />
x H2 O<br />
(A)<br />
500 mg<br />
MM 0052.02<br />
Imp. A (EP): 4-Formylamino-1,5-dimethyl-2-phenyl-1,2-dihydro-3Hpyrazol-3-one<br />
(4-Formylaminophenazone)<br />
O H N O<br />
(A) 100 mg<br />
N<br />
N<br />
MM 0052.04<br />
Imp. B (EP): 4-Amino-1,5-dimethyl-2-phenyl-1,2-dihydro-3H-pyrazol-<br />
3-one (Ampyrone)<br />
O<br />
N<br />
N<br />
NH 2<br />
(A) 100 mg<br />
256 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
<strong>Pharmac<strong>eu</strong>tical</strong> Impurities<br />
Code Product Category Unit<br />
O<br />
MM 0052.10 Imp. C (EP) as Hydrochloride: 4-Methylamino-1,5-dimethyl-2-<br />
H<br />
(A) 100 mg<br />
N<br />
phenyl-1,2-dihydro-3H-pyrazol-3-one Hydrochloride (4-<br />
N<br />
x HCl<br />
N<br />
Methylaminophenazone Hydrochloride)<br />
MM 0052.05<br />
Imp. D (EP): 4-Dimethylamino-1,5-dimethyl-2-phenyl-1,2-dihydro-3Hpyrazol-3-one<br />
(4,4-Dimethylaminophenazone)<br />
O<br />
N<br />
N<br />
N<br />
(A)<br />
100 mg<br />
MM 0052.01<br />
4-Acetylaminophenazone<br />
O H N O<br />
(A) 100 mg<br />
N<br />
N<br />
MM 0052.50<br />
4-Benzylideneaminoantipyrine<br />
O<br />
N<br />
N<br />
N<br />
(A)<br />
100 mg<br />
Metformin Hydrochloride<br />
MM 0056.00 Metformin Hydrochloride<br />
NH<br />
NH<br />
H 2 N N<br />
H<br />
N<br />
x HCl<br />
(A)<br />
500 mg<br />
NH<br />
MM 0056.01 Imp. A (EP): Cyanoguanidine N (B) 100 mg<br />
H 2 N N<br />
H<br />
MM 0056.02<br />
MM 0056.03<br />
Imp. B (EP): (4,6-Diamino-1,3,5-triazin-2-yl)guanidine<br />
Imp. C (EP): N,N-Dimethyl-1,3,5-triazine-2,4,6-triamine<br />
N<br />
NH 2<br />
N NH<br />
H 2N N N H<br />
H 2 N N N<br />
N N<br />
NH 2<br />
(A) 100 mg<br />
NH 2<br />
(A) 100 mg<br />
MM 0056.04<br />
Imp. D (EP): 1,3,5-Triazine-2,4,6-triamine (Melamine)<br />
H 2N N NH 2<br />
N<br />
N<br />
(B)<br />
100 mg<br />
NH 2<br />
MM 0056.05 Imp. E (EP) as Hydrochloride:1-Methylbiguanide Hydrochloride<br />
NH<br />
NH<br />
H 2N N H<br />
N H<br />
x HCl<br />
(A)<br />
100 mg<br />
MM 0056.06 Imp. F (EP) as Hydrochloride: N-Methylmethanamine Hydrochloride<br />
H<br />
N x HCl (C) 100 mg<br />
Methamphetamine Hydrochloride<br />
MM 0964.00<br />
Methamphetamine Hydrochloride<br />
[Controlled Substance]<br />
H<br />
N<br />
x HCl<br />
(A)<br />
100 mg<br />
Methotrexate<br />
MM 0040.00<br />
Methotrexate<br />
O O<br />
(A)<br />
500 mg<br />
OH<br />
O<br />
N<br />
NH 2<br />
N<br />
N<br />
N<br />
H<br />
OH<br />
H 2 N<br />
N<br />
N<br />
MM 0040.08<br />
Imp. A (EP) as Hydrochloride: (2,4-Diaminopteridin-6-<br />
yl)methanol Hydrochloride<br />
N<br />
NH 2<br />
N<br />
OH<br />
x HCl<br />
(A)<br />
100 mg<br />
H 2 N<br />
N<br />
N<br />
Methoxsalen<br />
MM 0555.00<br />
Methoxsalen<br />
O<br />
O<br />
O (A) 500 mg<br />
O<br />
O O<br />
MM 0555.01 5-Methoxypsoralen (Bergapten) O<br />
(A)<br />
100 mg<br />
Methoxyphenamine Hydrochloride<br />
O<br />
MM 0655.00<br />
Methoxyphenamine Hydrochloride<br />
O<br />
H<br />
N<br />
x HCl<br />
(A)<br />
500 mg<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 257
<strong>Pharmac<strong>eu</strong>tical</strong> Impurities<br />
Code Product Category Unit<br />
Methyl Nicotinate<br />
MM 0549.00<br />
Methyl Nicotinate<br />
O<br />
(A) 500 mg<br />
N<br />
O<br />
MM 0549.01<br />
Imp. A (EP): Nicotinic Acid<br />
O<br />
(A) 500 mg<br />
N<br />
OH<br />
Methyl Parahydroxybenzoate<br />
MM 0431.00<br />
Methyl Parahydroxybenzoate<br />
O<br />
(A) 500 mg<br />
O<br />
HO<br />
MM 0431.02<br />
Imp. A (EP): 4-Hydroxybenzoic Acid<br />
O<br />
(B) 100 mg<br />
OH<br />
HO<br />
MM 0431.03<br />
Imp. B (EP): Ethyl 4-Hydroxybenzoate<br />
O<br />
(A) 500 mg<br />
O<br />
HO<br />
MM 0431.04<br />
Imp. C (EP): Propyl 4-Hydroxybenzoate<br />
O<br />
(A) 500 mg<br />
O<br />
HO<br />
MM 0431.05<br />
Imp. D (EP): Butyl 4-Hydroxybenzoate<br />
O<br />
(A) 500 mg<br />
O<br />
HO<br />
MM 0431.01<br />
Sodium Methyl Parahydroxybenzoate<br />
O<br />
(A) 500 mg<br />
O<br />
NaO<br />
Methylprednisolone<br />
MM 0190.00<br />
Methylprednisolone<br />
HO<br />
O<br />
OH<br />
OH<br />
(A)<br />
100 mg<br />
O<br />
MM0190.01<br />
Imp. A (EP): 17,21-Dihydroxy-6α-methylpregna-1,4-diene-<br />
3,11,20-trione<br />
O<br />
O<br />
OH<br />
OH<br />
(D)<br />
50 mg<br />
O<br />
Methylprednisolone Acetate<br />
MM 0191.00<br />
Methylprednisolone Acetate<br />
HO<br />
O<br />
O<br />
OH<br />
O<br />
(D) 100 mg<br />
O<br />
MM 0191.02<br />
Imp. B (EP): Methylprednisolone<br />
HO<br />
O<br />
OH<br />
OH<br />
(A)<br />
100 mg<br />
O<br />
MM 0191.05<br />
Imp. E (EP): Prednisolone Acetate<br />
HO<br />
O<br />
O<br />
OH<br />
O<br />
(A) 500 mg<br />
O<br />
Methylprednisolone Hydrogen Succinate<br />
MM 0192.00<br />
Methylprednisolone Hydrogen Succinate Sodium Salt<br />
HO<br />
O<br />
O<br />
OH<br />
O<br />
ONa<br />
O<br />
on request<br />
O<br />
258 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
<strong>Pharmac<strong>eu</strong>tical</strong> Impurities<br />
Code Product Category Unit<br />
MM 0192.04 Imp. A (EP): Methylprednisolone<br />
O<br />
OH (A) 100 mg<br />
HO<br />
OH<br />
O<br />
MM 0192.05<br />
Imp. C (EP): Methylprednisolone Acetate<br />
HO<br />
O<br />
O<br />
OH<br />
O<br />
(D) 100 mg<br />
O<br />
Methyltestosterone<br />
MM 0558.00<br />
Methyltestosterone<br />
OH<br />
(A) 250 mg<br />
O<br />
MM 0558.01<br />
Testosterone<br />
OH<br />
(A) 500 mg<br />
O<br />
Metixene Hydrochloride<br />
MM 0125.01<br />
Imp. A (EP): 9H-Thioxanthene<br />
(A)<br />
100 mg<br />
S<br />
MM 0125.02<br />
Imp. B (EP): 9H-Thioxanthen-9-one<br />
(Thioxanthone)<br />
O<br />
(B)<br />
100 mg<br />
S<br />
MM 0125.03 3-Chloromethyl-1-methylpiperidine Cl<br />
on request<br />
N<br />
MM 0125.04<br />
Metixene<br />
on request<br />
S<br />
N<br />
Metoclopramide<br />
MM 0073.00<br />
Metoclopramide Hydrochloride Monohydrate<br />
Cl<br />
H 2N<br />
O<br />
O<br />
N<br />
H<br />
N<br />
x HCl<br />
x H 2O<br />
(A)<br />
500 mg<br />
MM 0073.03<br />
Imp. A (EP): 4-(Acetylamino)-5-chloro-N-[2-<br />
(diethylamino)ethyl]-2-methoxybenzamide<br />
Cl<br />
O<br />
N<br />
H<br />
O<br />
O<br />
N<br />
H<br />
N<br />
(A)<br />
100 mg<br />
MM 0073.04<br />
Imp. B (EP): Methyl 4-(Acetylamino)-5-chloro-2-methoxybenzoate<br />
Cl<br />
O<br />
O<br />
O<br />
(A)<br />
100 mg<br />
N<br />
H<br />
O<br />
MM 0073.02<br />
Imp. C (EP): 4-Amino-5-chloro-2-methoxybenzoic Acid<br />
Cl<br />
O<br />
OH<br />
(B)<br />
100 mg<br />
H 2N<br />
O<br />
MM 0073.05<br />
Imp. D (EP): Methyl 4-(Acetylamino)-2-methoxybenzoate<br />
O<br />
O<br />
O<br />
(A)<br />
100 mg<br />
N<br />
H<br />
O<br />
MM 0073.01<br />
Imp. E (EP): N,N-Diethylethane-1,2-diamine<br />
H 2N<br />
N<br />
(B)<br />
100 mg<br />
MM 0073.06<br />
Imp. F (EP): 4-Amino-5-chloro-N-[2-(diethylamino)ethyl]-2-<br />
hydroxybenzamide<br />
Cl<br />
H 2N<br />
O<br />
N<br />
H<br />
OH<br />
N<br />
(A)<br />
100 mg<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 259
<strong>Pharmac<strong>eu</strong>tical</strong> Impurities<br />
Code Product Category Unit<br />
MM 0073.07 Imp. G (EP): N'-(4-Amino-5-chloro-2-methoxybenzoyl)-N,Ndiethylethane-1,2-diamine<br />
O<br />
(A) 100 mg<br />
N-Oxide (Metoclopramide N-Oxide)<br />
N<br />
Cl<br />
N<br />
H O<br />
H 2N O<br />
MM 0073.08<br />
Imp. H (EP): 4-(Acetylamino)-2-hydroxybenzoic Acid<br />
O<br />
O<br />
OH<br />
(A)<br />
100 mg<br />
N<br />
H<br />
OH<br />
MM 0073.09<br />
Methyl 4-Amino-2-hydroxybenzoate<br />
O<br />
(A) 100 mg<br />
O<br />
H 2N<br />
OH<br />
MM 0073.10<br />
Methyl 4-(Acetylamino)-2-hydroxybenzoate<br />
O<br />
O<br />
O<br />
(A)<br />
100 mg<br />
N<br />
H<br />
OH<br />
Metoprolol Succinate<br />
MM 0279.00<br />
Metoprolol Succinate<br />
O<br />
(A)<br />
100 mg<br />
OH<br />
HN<br />
2<br />
O<br />
O<br />
x HO<br />
OH<br />
O<br />
MM 0279.04<br />
Imp. A (EP): (2RS)-1-(Ethylamino)-3-[4-(2-methoxyethyl)-<br />
phenoxy]propan-2-ol<br />
O<br />
OH HN (A) 100 mg<br />
O<br />
MM 0279.01<br />
Imp. B (EP): 4-(2-Methoxyethyl)phenol<br />
OH<br />
(A) 100 mg<br />
O<br />
MM 0279.24<br />
Imp. C (EP) as Hydrochloride: 4-[(2RS)-2-<br />
Hydroxy-3-[(1-methylethyl)amino]propoxy]-<br />
benzaldehyde Hydrochloride<br />
O<br />
O<br />
OH<br />
H<br />
N<br />
x HCl<br />
(A)<br />
100 mg<br />
MM 0279.06<br />
Imp. D (EP): (2RS)-3-[4-(2-Methoxyethyl)phenoxy]propane-<br />
1,2-diol<br />
O<br />
OH<br />
OH<br />
(A)<br />
100 mg<br />
O<br />
MM 0279.07<br />
Imp. E (EP): (2RS)-1-[2-(2-Methoxyethyl)phenoxy]-3-[(1-<br />
methylethyl)amino]propan-2-ol<br />
O<br />
OH<br />
HN<br />
(A)<br />
100 mg<br />
O<br />
MM 0279.08<br />
Imp. F (EP): (2RS)-1-[(1-Methylethyl)amino]-3-phenoxypropan-2-ol<br />
O<br />
OH HN (A) 100 mg<br />
MM 0279.09<br />
Imp. G (EP): 2-(4-Hydroxyphenyl)ethanol<br />
OH<br />
(A) 100 mg<br />
HO<br />
MM 0279.10<br />
Imp. H (EP): (2RS)-1-[4-(2-Hydroxyethyl)phenoxy]-3-[(1-<br />
methylethyl)amino]propan-2-ol<br />
O<br />
OH HN (A) 100 mg<br />
HO<br />
MM 0279.11<br />
(2RS)-1-(4-Ethenylphenoxy)-3-[(1-methylethyl)amino]-<br />
propan-2-ol<br />
O<br />
OH HN (A) 100 mg<br />
MM 0279.12<br />
Imp. J (EP): 1-[2-Hydroxy-3-[(1-<br />
methylethyl)amino]propoxy]-3-[4-(2-<br />
methoxyethyl)phenoxy]propan-2-ol<br />
O<br />
O<br />
OH<br />
O<br />
OH<br />
HN (A) 50 mg<br />
MM 0279.13<br />
(2RS)-1-[4-[(EZ)-2-Methoxyethenyl]phenoxy]-3-<br />
[(1methylethyl)amino]propan-2-ol<br />
O<br />
O<br />
OH<br />
HN<br />
(A)<br />
100 mg<br />
MM 0279.28<br />
Imp. M (EP) as Dihydrochloride: 1,3-Bis[(1-<br />
methylethyl)amino]propan-2-ol Dihydrochloride<br />
H<br />
N<br />
OH<br />
HN<br />
x 2 HCl<br />
(A) 100 mg<br />
MM 0279.16<br />
Imp. N (EP): (2RS)-3-[(1-Methylethyl)amino]propane-1,2-diol<br />
HO<br />
OH HN (A) 100 mg<br />
MM 0279.03<br />
Imp. O (EP): 1,1'-[(1-Methylethyl)imino]bis-<br />
[3-[4-(2-methoxyethyl)phenoxy]propan-<br />
2-ol]<br />
O<br />
O<br />
OH<br />
N<br />
OH (A) 100 mg<br />
O<br />
O<br />
260 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
<strong>Pharmac<strong>eu</strong>tical</strong> Impurities<br />
Code Product Category Unit<br />
Metoprolol Tartrate<br />
MM 0027.00 Metoprolol Tartrate<br />
O<br />
(A) 500 mg<br />
OH<br />
HN<br />
2<br />
O<br />
MM 0027.04<br />
MM 0027.01<br />
Imp. A (EP): (2RS)-1-(Ethylamino)-3-[4-(2-<br />
methoxyethyl)phenoxy]propan-2-ol<br />
Imp. B (EP): 4-(2-Methoxyethyl)phenol<br />
OH O<br />
x HO<br />
OH<br />
O OH<br />
O<br />
O<br />
OH HN (A) 100 mg<br />
OH<br />
(A) 100 mg<br />
O<br />
MM 0027.24<br />
Imp. C (EP) as Hydrochloride: 4-[(2RS)-2-<br />
Hydroxy-3-[(1-methylethyl)amino]propoxy]-<br />
benzaldehyde Hydrochloride<br />
O<br />
O<br />
OH<br />
H<br />
N<br />
x HCl<br />
(A)<br />
100 mg<br />
MM 0027.06<br />
Imp. D (EP): (2RS)-3-[4-(2-Methoxyethyl)phenoxy]propane-<br />
1,2-diol<br />
O<br />
O<br />
OH<br />
OH<br />
(A)<br />
100 mg<br />
MM 0027.07<br />
Imp. E (EP): (2RS)-1-[2-(2-Methoxyethyl)-<br />
phenoxy]-3-[(1-methylethyl)amino]propan-<br />
2-ol<br />
O<br />
OH<br />
O<br />
HN<br />
(A)<br />
100 mg<br />
MM 0027.08<br />
Imp. F (EP): (2RS)-1-[(1-Methylethyl)amino]-3-phenoxypropan-2-ol<br />
O<br />
OH HN (A) 100 mg<br />
MM 0027.09<br />
Imp. G (EP): 2-(4-Hydroxyphenyl)ethanol<br />
OH<br />
(A) 100 mg<br />
HO<br />
MM 0027.10<br />
Imp. H (EP): (2RS)-1-[4-(2-Hydroxyethyl)-<br />
phenoxy]-3-[(1-methylethyl)amino]propan-<br />
2-ol<br />
HO<br />
O<br />
OH HN (A) 100 mg<br />
MM 0027.11<br />
(2RS)-1-(4-Ethenylphenoxy)-3-[(1-methylethyl)amino]propan-2-<br />
ol<br />
O<br />
OH HN (A) 100 mg<br />
MM 0027.12<br />
MM 0027.13<br />
Imp. J (EP): 1-[2-Hydroxy-3-[(1-<br />
methylethyl)amino]propoxy]-3-[4-(2-<br />
methoxyethyl)phenoxy]propan-2-ol<br />
(2RS)-1-[4-[(EZ)-2-Methoxyethenyl]phenoxy]-3-<br />
[(1methylethyl)amino]propan-2-ol<br />
O<br />
O<br />
O<br />
OH<br />
O<br />
O<br />
OH<br />
HN (A) 50 mg<br />
OH HN<br />
(A) 100 mg<br />
MM 0027.28<br />
Imp. M (EP) as Dihydrochloride: 1,3-Bis[(1-<br />
methylethyl)amino]propan-2-ol Dihydrochloride<br />
H<br />
N<br />
OH<br />
HN<br />
x 2 HCl<br />
(A) 100 mg<br />
MM 0027.16<br />
Imp. N (EP): (2RS)-3-[(1-Methylethyl)amino]propane-1,2-diol<br />
HO<br />
OH HN (A) 100 mg<br />
MM 0027.03<br />
Imp. O (EP): 1,1'-[(1-Methylethyl)imino]bis-[3-<br />
[4-(2-methoxyethyl)phenoxy]propan-2-ol]<br />
O<br />
OH<br />
N<br />
OH (A) 100 mg<br />
O<br />
O<br />
O<br />
MM 0027.02<br />
1-[4-(2-Methoxyethyl)phenoxy]-2,3-epoxypropane<br />
O<br />
O<br />
(A) 100 mg<br />
O<br />
MM 0027.17<br />
1-Chloro-3-[4-(2-methoxyethyl)phenoxy]propan-2-ol<br />
O<br />
OH<br />
(A) 100 mg<br />
Cl<br />
O<br />
MM 0027.18<br />
4,4'-(2-Hydroxy-1,3-prop<strong>and</strong>iyldioxy)-<br />
bis[(2-methoxyethyl)benzene)]<br />
O<br />
O<br />
OH<br />
O<br />
O<br />
(A)<br />
100 mg<br />
MM 0027.22<br />
3-Chloropropane-1,2-diol<br />
Cl<br />
OH<br />
OH<br />
(B)<br />
100 mg<br />
MM 0027.26<br />
1-[2-(2-Methoxyethyl)phenyoxy]-2,3-epoxypropane<br />
O O (A) 100 mg<br />
O<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 261
<strong>Pharmac<strong>eu</strong>tical</strong> Impurities<br />
Code Product Category Unit<br />
Metronidazole<br />
MM 0012.00<br />
Metronidazole<br />
O 2 N<br />
N<br />
N<br />
OH<br />
(A) 500 mg<br />
MM 0012.02 Imp. A (EP): 2-Methyl-4-nitroimidazole<br />
NH<br />
O 2 N<br />
(B) 100 mg<br />
MM 0012.05 Imp. B (EP): 4-Nitroimidazole NH<br />
O 2 N<br />
(C) 100 mg<br />
MM 0012.01 Imp. E (EP): 2-(2-Methyl-4-nitro-1H-imidazol-1-yl)ethanol N<br />
MM 0012.04<br />
Metronidazole Benzoate<br />
MM 0278.00<br />
MM 0278.02<br />
1-(2-Hydroxyethyl)-2-hydroxymethyl-5-nitroimidazole<br />
(Hydroxymetronidazole)<br />
Metronidazole Benzoate<br />
Imp. A (EP): Metronidazole<br />
O 2 N<br />
N<br />
N<br />
O 2N<br />
N<br />
O 2N<br />
N<br />
N<br />
O 2 N<br />
O<br />
N<br />
O<br />
N<br />
N<br />
OH<br />
OH<br />
OH<br />
OH<br />
(A)<br />
(A)<br />
(A)<br />
(A)<br />
100 mg<br />
100 mg<br />
100 mg<br />
500 mg<br />
N<br />
MM 0278.03<br />
Imp. B (EP): 2-Methyl-5-nitroimidazole<br />
O 2 N<br />
(B) 100 mg<br />
NH<br />
N<br />
MM 0278.01<br />
Imp. C (EP): Benzoic Acid<br />
O<br />
(B) 100 mg<br />
OH<br />
MM 0278.04<br />
2-(2-Methyl-4-nitro-1H-imidazol-1-yl)ethyl Benzoate<br />
O 2 N<br />
N<br />
N<br />
O<br />
O<br />
(A)<br />
100 mg<br />
Mevastatin<br />
MM 0377.00<br />
Mevastatin<br />
O<br />
O<br />
(A)<br />
100 mg<br />
O<br />
O<br />
OH<br />
Mexiletine Hydrochloride<br />
MM 0146.00<br />
Mexiletine Hydrochloride<br />
O<br />
NH 2<br />
x HCl<br />
(A)<br />
500 mg<br />
MM 0146.01<br />
Imp. A (EP): 2,6-Dimethylphenol<br />
OH<br />
(A)<br />
100 mg<br />
MM 0146.02<br />
Imp. B (EP): 1-(2,6-Dimethylphenoxy)propan-2-one<br />
O<br />
O<br />
(A) 100 mg<br />
Mianserin Hydrochloride<br />
MM 0147.00<br />
Mianserin Hydrochloride<br />
N<br />
(A)<br />
100 mg<br />
N<br />
x HCl<br />
MM 0147.01<br />
Imp. A (EP): [2-[(2RS)-4-Methyl-2-phenylpiperazin-1-yl]<br />
phenyl]methanol<br />
N<br />
N<br />
(A)<br />
100 mg<br />
MM 0147.04 Imp. C (Pharm<strong>eu</strong>ropa): (2-Aminophenyl)methanol H 2 N<br />
OH<br />
(B)<br />
100 mg<br />
OH<br />
262 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
<strong>Pharmac<strong>eu</strong>tical</strong> Impurities<br />
Code Product Category Unit<br />
MM 0147.06 Mianserin N-Oxide<br />
O<br />
(D) 100 mg<br />
N<br />
N<br />
Miconazole Nitrate<br />
MM 0281.00<br />
Miconazole Nitrate<br />
Cl<br />
(A)<br />
500 mg<br />
Cl<br />
x HNO 3<br />
O<br />
Cl<br />
Cl<br />
N<br />
N<br />
MM 0074.00<br />
Miconazole<br />
Cl<br />
(A)<br />
250 mg<br />
Cl<br />
MM 0281.01<br />
Imp. A (EP): (1RS)-1-(2,4-Dichlorophenyl)-2-(1H-imidazol-1-yl)ethanol<br />
Cl<br />
O<br />
N<br />
Cl<br />
N<br />
Cl<br />
(A) 100 mg<br />
Cl<br />
HO<br />
N<br />
N<br />
MM 0281.02<br />
Imp. B (EP) as Nitrate: 1-[(2RS)-2-[(4-Chlorobenzyl)oxy]-<br />
2-(2,4-dichlorophenyl)ethyl]-1H-imidazole Nitrate<br />
(Econazole Nitrate)<br />
Cl<br />
Cl<br />
x HNO 3<br />
(A)<br />
500 mg<br />
O<br />
Cl<br />
N<br />
N<br />
MM 0281.03<br />
Imp. C (EP) as Nitrate: (2RS)-2-[(2,4-Dichlorobenzyl)oxy]-<br />
2-(2,4-dichlorophenyl)ethanamine Nitrate<br />
Cl<br />
(D)<br />
100 mg<br />
Cl<br />
x HNO 3<br />
O<br />
MM 0281.04<br />
Imp. D (EP) as Nitrate: 1-[(2RS)-2-[(2,6-Dichlorobenzyl)oxy]-<br />
2-(2,4-dichlorophenyl)-<br />
ethyl]-1H-imidazole Nitrate (Isoconazole Nitrate)<br />
Cl<br />
Cl<br />
Cl<br />
Cl<br />
NH 2<br />
Cl<br />
x HNO 3<br />
(A)<br />
100 mg<br />
O<br />
Cl<br />
N<br />
N<br />
MM 0281.06<br />
Imp. F (EP) as Nitrate: 1-[(2RS)-2-[(3,4-<br />
Dichlorobenzyl)oxy]-2-(2,4-dichlorophenyl)ethyl]-1Himidazole<br />
Nitrate<br />
Cl<br />
Cl<br />
x HNO 3<br />
(A)<br />
100 mg<br />
O<br />
MM 0281.07<br />
Imp. G (EP) as Nitrate: 1-[(2RS)-2-[(2,5-<br />
Dichlorobenzyl)oxy]-2-(2,4-dichlorophenyl)ethyl]-1Himidazole<br />
Nitrate<br />
Cl<br />
Cl<br />
Cl<br />
N<br />
N<br />
Cl<br />
Cl<br />
O<br />
N<br />
Cl<br />
x HNO 3<br />
(A)<br />
100 mg<br />
N<br />
MM 0281.08<br />
Imp. H (EP) as Nitrate: 1-[(2RS)-2-Benzyloxy-2-(2,4-<br />
dichlorophenyl)ethyl]-1H-imidazole Nitrate<br />
Cl<br />
(A) 100 mg<br />
Cl<br />
x HNO 3<br />
O<br />
N<br />
N<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 263
<strong>Pharmac<strong>eu</strong>tical</strong> Impurities<br />
Code Product Category Unit<br />
MM 0281.09 Imp. I (EP) as Nitrate: 1-[(2RS)-2-[(2-Chlorobenzyl)-<br />
Cl<br />
(A) 100 mg<br />
oxy]-2-(2,4-dichlorophenyl)ethyl]-1H-imidazole Nitrate<br />
Cl<br />
x HNO 3<br />
O<br />
Cl<br />
N<br />
N<br />
MM 0281.10<br />
1-(2,4-Dichlorobenzoylmethyl)imidazole<br />
Cl<br />
(A) 100 mg<br />
Cl<br />
O<br />
N<br />
N<br />
Midazolam<br />
New MM 1106.02<br />
Imp. F (EP): 7-Chloro-5-(2-fluorophenyl)-1,3-<br />
dihydro-2H-1,4-benzodiazepin-2-one<br />
(1-Des[(diethylamino)ethyl]flurazepam)<br />
Cl<br />
H<br />
N<br />
N<br />
O<br />
(A)<br />
100 mg<br />
F<br />
Minoxidil<br />
MM 0521.00<br />
Minoxidil<br />
N N NH 2<br />
(A)<br />
500 mg<br />
N<br />
O<br />
NH 2<br />
MM 0521.01<br />
Imp. A (EP): 6-Chloropyrimidine-2,4-diamine 3-Oxide<br />
Cl N NH 2<br />
N<br />
O<br />
(A)<br />
100 mg<br />
NH 2<br />
MM 0521.02<br />
Imp. B (EP): 6-Chloropyrimidine-2,4-diamine<br />
Cl N NH 2<br />
N<br />
(C)<br />
100 mg<br />
NH 2<br />
MM 0521.05<br />
Mirtazapine<br />
New MM 1005.02<br />
Imp. E (EP): 6-(Piperidin-1-yl)pyrimidine-2,4-diamine<br />
(Desoxyminoxidil)<br />
Imp. A (EP): (14bRS)-2-Methyl-1,2,3,4,10-<br />
14b-hexahydropyrazino[2,1-a]pyrido[2,3-<br />
c][2]benzazepine 2-Oxide<br />
(A) 100 mg<br />
N N NH 2<br />
N<br />
NH 2<br />
N<br />
N<br />
O<br />
N<br />
(A)<br />
100 mg<br />
MM 1005.07<br />
1-Methyl-3-phenylpiperazine<br />
(A)<br />
100 mg<br />
HN<br />
N<br />
Moclobemide<br />
MM 0250.00 Moclobemide O<br />
Molsidomine<br />
MM 0267.00<br />
MM 0267.02<br />
Molsidomine<br />
Imp. A (Pharm<strong>eu</strong>ropa) as Hydrochloride: 3-(Morpholin-4-<br />
yl)sydnonimine Hydrochloride (Linsidomine Hydrochloride)<br />
Cl<br />
HN<br />
O<br />
O<br />
N<br />
N<br />
H<br />
O N<br />
-<br />
N+<br />
N<br />
N<br />
O N<br />
-<br />
N+<br />
N<br />
O<br />
O (A) 100 mg<br />
O<br />
x HCl<br />
(A)<br />
(A)<br />
250 mg<br />
100 mg<br />
MM 0267.03<br />
Imp. B (Pharm<strong>eu</strong>ropa): 4-Nitrosomorpholine<br />
O<br />
(A) 100 mg<br />
N<br />
N<br />
O<br />
264 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
<strong>Pharmac<strong>eu</strong>tical</strong> Impurities<br />
Code Product Category Unit<br />
New MM 0267.01 Imp. C (Pharm<strong>eu</strong>ropa): (2E)-(Morpholin-4-ylimino)acetonitrile<br />
New MM 0267.06 Imp. E (Pharm<strong>eu</strong>ropa): Morpholine<br />
N<br />
(A) 100 mg<br />
N<br />
N<br />
O<br />
HN (A) 100 mg<br />
O<br />
Montelukast Sodium<br />
MM 0698.00<br />
Montelukast Sodium<br />
NaO<br />
O on request<br />
S<br />
Cl<br />
N<br />
OH<br />
Morphine Hydrochloride<br />
MM 0037.00<br />
Morphine Hydrochloride Trihydrate [Controlled Substance]<br />
N<br />
(A)<br />
250 mg<br />
x HCl<br />
x 3 H 2 O<br />
HO<br />
O<br />
OH<br />
MM 0037.10<br />
Imp. A (EP) as Phosphate Hemihydrate:<br />
Codeine Phosphate Hemihydrate<br />
[Controlled Substance]<br />
N<br />
(A) 100 mg<br />
x ½ H 2 O<br />
O<br />
O<br />
OH<br />
MM 0037.01<br />
Imp. B (EP): 7,7',8,8'-Tetradehydro-4,5α:4',5'α-diepoxy-<br />
17,17'-dimethyl-2,2'-bimorphinanyl-3,3',6α,6'α-tetrol<br />
(Ps<strong>eu</strong>domorphine; 2,2'-Bimorphine)<br />
HO<br />
O<br />
OH<br />
N<br />
(A)<br />
100 mg<br />
N<br />
HO<br />
O<br />
OH<br />
MM 0037.03<br />
Imp. F (Pharm<strong>eu</strong>ropa): Morphine N-Oxide [Controlled Substance]<br />
O<br />
(A) 100 mg<br />
N<br />
HO<br />
O<br />
OH<br />
MM 0037.02<br />
Dimethyl Ps<strong>eu</strong>domorphine<br />
HO<br />
O<br />
O<br />
N<br />
(A)<br />
100 mg<br />
N<br />
O<br />
O<br />
OH<br />
Morphine Sulphate<br />
MM 0280.00<br />
Morphine Hemisulphate Pentahemihydrate<br />
[Controlled Substance]<br />
N<br />
x H 2 SO 4<br />
x 5 H 2 O<br />
(A)<br />
250 mg<br />
HO<br />
O<br />
OH<br />
2<br />
MM 0280.01<br />
Imp. A (EP) as Phosphate Hemihydrate:<br />
Codeine Phosphate Hemihydrate<br />
[Controlled Substance]<br />
N<br />
(A) 100 mg<br />
x ½ H 2 O<br />
O<br />
O<br />
OH<br />
MM 0280.02<br />
Imp. B (EP): 7,7',8,8'-Tetradehydro-4,5α:4',5'α-diepoxy-<br />
17,17'-dimethyl-2,2'-bimorphinanyl-3,3',6α,6'α-tetrol<br />
(Ps<strong>eu</strong>domorphine;2,2'-Bimorphine)<br />
HO<br />
O<br />
OH<br />
N<br />
(A)<br />
100 mg<br />
N<br />
HO<br />
O<br />
OH<br />
MM 0280.03<br />
Imp. F (Pharm<strong>eu</strong>ropa): Morphine N-Oxide [Controlled Substance]<br />
O<br />
(A) 100 mg<br />
N<br />
HO<br />
O<br />
OH<br />
Moxifloxacin Hydrochloride<br />
New MM 0885.00<br />
Moxifloxacine Hydrochloride<br />
HN<br />
H<br />
H<br />
N<br />
O<br />
N<br />
x HCl<br />
on request<br />
F<br />
O<br />
OH<br />
O<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 265
<strong>Pharmac<strong>eu</strong>tical</strong> Impurities<br />
Code Product Category Unit<br />
Mycophenolate Mofetil<br />
New MM 1001.00 Mycophenolate Mofetil<br />
O OH<br />
O<br />
N<br />
O<br />
O<br />
O<br />
O<br />
on request<br />
Nabumetone<br />
MM 0153.00<br />
Nabumetone<br />
O<br />
(A) 500 mg<br />
O<br />
MM 0153.02<br />
Imp. A (EP): 3-(6-Methoxynaphthalen-2-yl)-5-<br />
methylcyclohexanone<br />
O<br />
(A) 100 mg<br />
O<br />
MM 0153.03<br />
Imp. B (EP): (5RS)-5-(6-Methoxynaphthalen-2-yl)-3-<br />
methylcyclohex-2-enone<br />
O<br />
(A) 100 mg<br />
O<br />
MM 0153.04<br />
Imp. C (EP): (2RS)-4-(6-Methoxynaphthalen-2-yl)-butan-2-ol<br />
OH<br />
(A) 100 mg<br />
O<br />
MM 0153.05<br />
Imp. D (EP): (E)-4-(6-Methoxynaphthalen-2-yl)-but-3-en-2-one<br />
O<br />
(A) 100 mg<br />
O<br />
MM 0153.07<br />
Imp. F (EP): 6,6'-Dimethoxy-2,2'-binaphthalenyl<br />
O<br />
(A) 100 mg<br />
O<br />
MM 0153.09<br />
(6-Methoxy-2-naphthyl)acetic Acid<br />
O<br />
OH<br />
O<br />
(A)<br />
100 mg<br />
Nadolol<br />
MM 0439.00<br />
Nadolol<br />
HO<br />
OH<br />
O<br />
OH<br />
HN<br />
on request<br />
<strong>and</strong> enantiomers<br />
Nafcillin Sodium<br />
MM 0392.00<br />
Nafcillin Sodium<br />
O<br />
O<br />
NH<br />
O<br />
N<br />
S<br />
H<br />
ONa<br />
on request<br />
O<br />
MM 0392.01<br />
MM 0392.02<br />
MM 0392.03<br />
Penicilloic Acids of Nafcillin<br />
Penilloic Acids of Nafcillin<br />
6-Aminopenicillanic Acid<br />
O OH<br />
MM 0392.04 2-Ethoxynaphthoic Acid<br />
O<br />
H<br />
N<br />
O<br />
HO<br />
O<br />
O<br />
H<br />
N<br />
O<br />
H 2 N<br />
HN<br />
O<br />
O<br />
HN<br />
S<br />
HO<br />
O<br />
S<br />
N<br />
S<br />
H<br />
O<br />
OH<br />
O<br />
(D)<br />
(D)<br />
100 mg<br />
100 mg<br />
OH (B) 100 mg<br />
(B)<br />
100 mg<br />
266 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
<strong>Pharmac<strong>eu</strong>tical</strong> Impurities<br />
Code Product Category Unit<br />
Naftidrofuryl Hydrogen Oxalate<br />
MM 0373.00<br />
Naftidrofuryl Hydrogen Oxalate<br />
Naloxone Hydrochloride Dihydrate<br />
MM 0272.00<br />
Naloxone Hydrochloride Dihydrate<br />
O<br />
O<br />
O<br />
N O OH<br />
x<br />
O OH<br />
N<br />
OH<br />
x HCl<br />
x 2 H 2O<br />
(A)<br />
(A)<br />
500 mg<br />
250 mg<br />
HO<br />
O<br />
O<br />
Naltrexone<br />
MM 0233.00<br />
Naltrexone Hydrochloride<br />
N<br />
(A)<br />
100 mg<br />
HO<br />
x HCl<br />
HO<br />
O<br />
O<br />
N<strong>and</strong>rolone<br />
MM 0660.00<br />
N<strong>and</strong>rolone<br />
OH<br />
(A) 250 mg<br />
H<br />
O<br />
MM 0660.01<br />
19-Nor<strong>and</strong>rost-4-ene-3,17-dione (Estr-4-ene-3,17-dione)<br />
O<br />
(A) 100 mg<br />
H<br />
N<strong>and</strong>rolone Decanoate<br />
MM 0982.00<br />
N<strong>and</strong>rolone Decanoate<br />
O<br />
O<br />
O<br />
(A) 100 mg<br />
H<br />
MM 0982.04<br />
Imp. D (EP): 17β-Hydroxyestr-4-en-3-one (N<strong>and</strong>rolone)<br />
O<br />
OH<br />
(A) 250 mg<br />
H<br />
O<br />
Naphazoline Hydrochloride<br />
MM 0075.00<br />
Naphazoline Hydrochloride<br />
HN<br />
N<br />
x HCl<br />
(A)<br />
500 mg<br />
MM 0075.06<br />
Imp. A (EP) as Hydrochloride: N-(2-Aminoethyl)-2-<br />
(naphthalen-1-yl)acetamide Hydrochloride<br />
(Naphthylacetylethylenediamine Hydrochloride)<br />
O<br />
N<br />
H<br />
NH 2<br />
x HCl<br />
(A)<br />
100 mg<br />
MM 0075.02<br />
Imp. B (EP): (Naphthalen-1-yl)acetic Acid<br />
(1-Naphthylacetic Acid)<br />
O<br />
OH<br />
(B)<br />
100 mg<br />
MM 0075.04<br />
Imp. C (EP): (Naphthalen-1-yl)acetonitrile<br />
(1-Naphthylacetonitrile)<br />
N<br />
(B) 100 mg<br />
MM 0075.05 Ethyl (1-Naphthyl)acetate<br />
O<br />
O<br />
(A)<br />
100 mg<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 267
<strong>Pharmac<strong>eu</strong>tical</strong> Impurities<br />
Code Product Category Unit<br />
O<br />
MM 0075.07 (Naphthalen-1-y)lacetamide (1-Naphthylacetamide) (A) 100 mg<br />
NH 2<br />
Naphazoline Nitrate<br />
MM 0286.00<br />
Naphazoline Nitrate<br />
HN<br />
N<br />
x HNO 3<br />
(A) 500 mg<br />
MM 0286.06<br />
Imp. A (EP) as Hydrochloride:<br />
N-(2-Aminoethyl)-2-(naphthalen-1-yl)acetamide<br />
Hydrochloride (Naphthylacetylethylenediamine<br />
Hydrochloride)<br />
O<br />
N<br />
H<br />
NH 2<br />
x HCl<br />
(A)<br />
100 mg<br />
MM 0286.02<br />
Imp. B (EP): (Naphthalen-1-yl)acetic Acid<br />
(1-Naphthylacetic Acid)<br />
O<br />
OH<br />
(B)<br />
100 mg<br />
MM 0286.03 Imp. C (EP): (Naphthalen-1-yl)acetonitrile (1-Naphthylacetonitrile)<br />
N<br />
(B) 100 mg<br />
MM 0286.05 Ethyl (1-Naphthyl)acetate<br />
O<br />
O<br />
(A)<br />
100 mg<br />
MM 0286.07<br />
(Naphthalen-1-yl)acetamide<br />
(1-Naphthylacetamide)<br />
O<br />
NH 2<br />
(A) 100 mg<br />
Naproxen<br />
MM 0152.00<br />
Naproxen<br />
OH<br />
(A)<br />
500 mg<br />
O<br />
O<br />
MM 0152.06<br />
Imp. A (EP): (2S)-2-(6-Hydroxynaphthalen-2-yl)-<br />
propanoic Acid (O-Demethylnaproxen)<br />
HO<br />
OH<br />
O<br />
(A)<br />
100 mg<br />
MM 0152.09<br />
Imp. B (EP): (2S)-2-(5-Chloro-6-methoxynaphthalen-2-<br />
yl)propanoic Acid<br />
(5-Chloronaproxene)<br />
O<br />
Cl<br />
OH<br />
O<br />
(A)<br />
100 mg<br />
MM 0152.10<br />
MM 0152.11<br />
MM 0152.02<br />
MM 0152.12<br />
MM 0152.14<br />
Imp. C (EP): (2S)-2-(5-Bromo-6-methoxynaphthalen-2-<br />
yl)propanoic Acid<br />
(5-Bromonaproxene)<br />
Imp. D (EP): (2S)-2-(5-Iodo-6-methoxynaphthalen-2-yl)propanoic<br />
Acid<br />
(5-Iodonaproxene)<br />
Imp. E (EP): Methyl (2S)-2-(6-Methoxynaphthalen-2-yl)propanoate<br />
(Naproxen Methyl Ester)<br />
Imp. F (EP): Ethyl (2S)-2-(6-Methoxynaphthalen-2-yl)propanoate<br />
(Naproxen Ethyl Ester)<br />
Imp. H (EP): 6-Methoxynaphthalen-2-ol (Hydroxynerolin)<br />
O<br />
O<br />
O<br />
O<br />
Br<br />
I<br />
OH<br />
O<br />
OH<br />
O<br />
O<br />
O<br />
O<br />
O<br />
(A) 100 mg<br />
(A) 100 mg<br />
(A) 100 mg<br />
(A) 100 mg<br />
OH<br />
(A) 100 mg<br />
O<br />
MM 0152.01<br />
Imp. I (EP): (6-Methoxynaphthalen-2-yl)acetic Acid<br />
(α-Demethylnaproxen)<br />
O<br />
OH<br />
O<br />
(A)<br />
100 mg<br />
MM 0152.18<br />
Imp. J (EP): 2-Ethyl-6-methoxynaphthalene (Ethylnerolin)<br />
(A)<br />
100 mg<br />
O<br />
268 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
<strong>Pharmac<strong>eu</strong>tical</strong> Impurities<br />
Code Product Category Unit<br />
MM 0152.16 Imp. K (EP): (1RS)-1-(6-Methoxynaphthalen-2-yl)ethanol<br />
OH<br />
(A) 100 mg<br />
O<br />
MM 0152.07<br />
Imp. L (EP): 1-(6-Methoxynaphthalen-2-yl)ethanone (Acetylnerolin)<br />
O<br />
(B) 100 mg<br />
O<br />
MM 0152.08<br />
Imp. M (EP): 2-Methoxynaphthalene (Nerolin)<br />
(B)<br />
100 mg<br />
O<br />
MM 0152.17<br />
Imp. N (EP): 2-Bromo-6-methoxynaphthalene<br />
Br<br />
(C) 100 mg<br />
O<br />
MM 0152.04<br />
Naproxen Sodium<br />
ONa<br />
(A)<br />
500 mg<br />
MM 0152.15<br />
2-Carboxy-6-methoxynaphthalene<br />
O<br />
O<br />
O<br />
(A) 100 mg<br />
OH<br />
O<br />
Nateglinide<br />
MM 0847.00<br />
Nateglinide<br />
O OH<br />
O on request<br />
N<br />
H<br />
Nevirapine<br />
Cl N<br />
MM 1146.04 3-Amino-2-chloro-4-methylpyridine<br />
H 2 N<br />
(A)<br />
100 mg<br />
Nicardipine Hydrochloride<br />
MM 0465.00 Nicardipine Hydrochloride<br />
H<br />
N<br />
(A)<br />
250 mg<br />
O<br />
O<br />
O<br />
O<br />
N<br />
x HCl<br />
NO 2<br />
MM 0465.01<br />
3-Methyl 5-[Methyl(phenylmethyl)amino]-<br />
ethyl 2,6-Dimethyl-4-(3-nitrophenyl)pyridine-<br />
3,5-dicarboxylate Dihydrochloride<br />
O<br />
O<br />
N<br />
O<br />
O<br />
N<br />
x 2 HCl<br />
(A)<br />
100 mg<br />
NO 2<br />
Nicergoline<br />
MM 0115.00<br />
Nicergoline<br />
H<br />
N<br />
Br<br />
(A) 100 mg<br />
N<br />
O<br />
O<br />
O<br />
N<br />
New MM 0115.02<br />
Imp. A (EP): [(6aR,9R,10aS)-10a-Methoxy-<br />
4,7-dimethyl-4,6,6a,7,8,9,10,10a-octahydroindolo[4,3-fg]quinolin-9-yl]methyl<br />
5-Chloropyridine-3-carboxylate<br />
N<br />
H<br />
N<br />
O<br />
O<br />
O<br />
Cl<br />
(D) 50 mg<br />
N<br />
MM 0115.04<br />
Imp. C (EP): [(6aR,9R,10aS)-10a-Methoxy-4,7-dimethyl-<br />
4,6,6a,7,8,9,10,10a-octahydroindolo[4,3-fg]quinolin-9-<br />
yl]methanol (Methylmethoxylumilysergol)<br />
N<br />
H (D) 100 mg<br />
N<br />
OH<br />
O<br />
MM 0115.06<br />
Imp. D (EP): 5-Bromopyridine-3-carboxylic Acid<br />
Br<br />
(B) 100 mg<br />
HO<br />
N<br />
O<br />
MM 0115.03<br />
5-Debromonicergoline<br />
H (D) 50 mg<br />
N<br />
N<br />
O<br />
O<br />
O<br />
N<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 269
<strong>Pharmac<strong>eu</strong>tical</strong> Impurities<br />
Code Product Category Unit<br />
Nicor<strong>and</strong>il<br />
MM 0924.00<br />
Nicotinamide<br />
MM 0552.00<br />
Nicor<strong>and</strong>il<br />
Nicotinamide<br />
N<br />
O<br />
N<br />
H<br />
N NH 2<br />
O<br />
NO2<br />
(A) 100 mg<br />
O<br />
(A) 500 mg<br />
MM 0552.01<br />
Isonicotinamide<br />
O<br />
(A) 100 mg<br />
N<br />
NH 2<br />
Nicotine<br />
MM 0517.00<br />
Nicotine<br />
N<br />
N<br />
(A)<br />
500 mg<br />
MM 0517.03<br />
Imp. C (EP): (5S)-1-Methyl-5-(pyridin-3-yl)pyrrolidin-2-one (Cotinine)<br />
N N O<br />
(A)<br />
100 mg<br />
MM 0517.02<br />
Imp. D (EP): 3-(4,5-Dihydro-3H-pyrrol-2-yl)-<br />
pyridine (Myosmine)<br />
N N<br />
on request<br />
MM 0517.01<br />
Imp. G (Pharm<strong>eu</strong>ropa): 3-[(2S)-Piperidin-2-yl]pyridine ((-)-Anabasine)<br />
(A)<br />
100 mg<br />
N<br />
N<br />
H<br />
Nicotinic Acid<br />
MM 0553.00<br />
Nicotinic Acid<br />
N<br />
O<br />
(A) 500 mg<br />
OH<br />
MM 0553.01<br />
Methyl Nicotinate<br />
N<br />
O<br />
(A) 500 mg<br />
O<br />
MM 0553.02<br />
Benzyl Nicotinate<br />
N<br />
O<br />
(A) 500 mg<br />
O<br />
MM 0553.03<br />
Isonicotinic Acid<br />
O<br />
(A) 100 mg<br />
OH<br />
N<br />
Nifedipine<br />
MM 0003.00<br />
Nifedipine<br />
O<br />
O<br />
H<br />
N<br />
(A) 500 mg<br />
O<br />
O<br />
NO 2<br />
MM 0003.02<br />
Imp. A (EP): Dimethyl 2,6-Dimethyl-4-(2-nitrophenylpyridine-3,5-<br />
dicarboxylate (Nitrophenylpyridine Analogue of Nifedipine)<br />
O<br />
O<br />
N<br />
(A) 100 mg<br />
O<br />
O<br />
NO<br />
MM 0003.01<br />
Imp. B (EP): Dimethyl 2,6-Dimethyl-4-(2-nitrosophenylpyridine-<br />
3,5-dicarboxylate (Nitrosophenylpyridine Analogue of Nifedipine)<br />
O<br />
N<br />
O<br />
(A)<br />
100 mg<br />
O<br />
O<br />
NO<br />
MM 0003.07<br />
Imp. C (EP) as E/Z-Mixture: Methyl (E/Z)-2-(2-Nitrobenzylidene)-3-<br />
oxobutanoate<br />
O<br />
O<br />
(A)<br />
100 mg<br />
O<br />
NO 2<br />
270 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
<strong>Pharmac<strong>eu</strong>tical</strong> Impurities<br />
Code Product Category Unit<br />
MM 0003.08 Imp. D (EP): Methyl 3-Aminobut-2-enoate<br />
H 2 N<br />
(C) 100 mg<br />
O<br />
MM 0003.03 2-Nitrobenzaldehyde<br />
O<br />
O<br />
NO 2<br />
(B) 100 mg<br />
Niflumic Acid<br />
MM 0850.00<br />
Niflumic Acid<br />
O<br />
(A)<br />
250 mg<br />
OH<br />
N<br />
NH<br />
F<br />
F F<br />
MM 0850.04<br />
Imp. A (Pharm<strong>eu</strong>ropa): 2-Chloropyridine-3-<br />
carboxylic Acid (2-Chloronicotinic Acid)<br />
N<br />
Cl<br />
(A) 100 mg<br />
OH<br />
MM 0850.06<br />
Imp. C (Pharm<strong>eu</strong>ropa): 3-(Trifluoromethyl)aniline<br />
F<br />
O<br />
F F<br />
(B) 100 mg<br />
NH 2<br />
Nifuroxazide<br />
MM 0574.00<br />
Nifuroxazide<br />
O 2N<br />
O<br />
N<br />
H<br />
N<br />
O<br />
OH<br />
(A)<br />
500 mg<br />
MM 0574.01<br />
Imp. A (EP): (4-Hydroxybenzoyl)diazane (p-Hydroxybenzohydrazide)<br />
H 2 N<br />
H<br />
N<br />
O<br />
OH<br />
(C)<br />
100 mg<br />
MM 0574.02<br />
Imp. B (EP): Methyl 4-Hydroxybenzoate<br />
OH<br />
(A)<br />
500 mg<br />
O<br />
O<br />
MM 0574.03<br />
Imp. C (EP): (5-Nitrofuran-2-yl)methylene Diacetate<br />
O<br />
(A)<br />
100 mg<br />
O 2 N<br />
O<br />
O<br />
O<br />
Nifursol<br />
MM 0444.00 Nifursol OH<br />
O 2 N<br />
O<br />
N<br />
H<br />
N<br />
O<br />
O<br />
NO 2<br />
(A) 100 mg<br />
NO 2<br />
MM 0444.01<br />
MM 0444.02<br />
5-Nitro-2-furfural<br />
5-Nitro-furfural Hydrazone<br />
MM 0444.03 3,5-Dinitrosalicylic Acid Hydrazide<br />
OH<br />
O 2 N<br />
O (C) 100 mg<br />
O<br />
NO 2<br />
H N 2 N (A) 100 mg<br />
O<br />
NO 2<br />
O<br />
N<br />
H<br />
NH 2<br />
(A) 100 mg<br />
NO 2<br />
Nikethamide<br />
MM 0627.00<br />
Nikethamide<br />
N<br />
O<br />
on request<br />
N<br />
Nimesulide<br />
MM 0378.00<br />
Nimesulide<br />
H<br />
N<br />
S<br />
(A)<br />
250 mg<br />
O 2 N<br />
O<br />
O<br />
O<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 271
<strong>Pharmac<strong>eu</strong>tical</strong> Impurities<br />
Code Product Category Unit<br />
MM 0378.01<br />
Imp. A (EP): N-(2,4-Dinitro-6-phenoxyphenyl)methanesulphonamide<br />
O 2 N<br />
NO 2<br />
(A) 100 mg<br />
H<br />
N S<br />
O O<br />
O<br />
MM 0378.02<br />
Imp. B (EP): N-(2-Phenoxyphenyl)methanesulphonamide<br />
H<br />
N S<br />
O O<br />
O<br />
(A)<br />
100 mg<br />
MM 0378.03<br />
Imp. C (EP): 2-Phenoxyaniline<br />
NH 2<br />
(A) 100 mg<br />
O<br />
New MM 0378.04<br />
Imp. D (EP): 4-Nitro-2-phenoxyaniline<br />
NH 2<br />
(A)<br />
100 mg<br />
O 2 N<br />
O<br />
New MM 0378.05<br />
Imp. E (EP): N,N-Bis(methylsulphonyl)-2-<br />
phenoxyaniline<br />
O<br />
O S<br />
N<br />
S<br />
O O<br />
O<br />
(A)<br />
100 mg<br />
Nimodipine<br />
MM 0416.00 Nimodipine<br />
H<br />
N<br />
(A)<br />
100 mg<br />
O<br />
O<br />
O<br />
O<br />
O<br />
NO 2<br />
MM 0416.01<br />
Imp. A (EP): 2-Methoxyethyl 1-Methylethyl 2,6-Dimethyl-4-(3-<br />
nitrophenyl)pyridine-3,5-dicarboxylate<br />
O<br />
O<br />
N<br />
O<br />
O<br />
O<br />
(A)<br />
100 mg<br />
NO 2<br />
MM 0416.02<br />
Imp. B (EP): Bis(1-methylethyl) 2,6-Dimethyl-4-(3-nitrophenyl)-<br />
1,4-dihydropyridine-3,5-dicarboxylate<br />
O<br />
O<br />
H<br />
N<br />
O<br />
O<br />
NO 2<br />
(A) 100 mg<br />
MM 0416.03<br />
Imp. C (EP): Bis(2-methoxyethyl) 2,6-Dimethyl-4-(3-<br />
nitrophenyl)-1,4-dihydropyridine-3,5-dicarboxylate<br />
O<br />
O<br />
O<br />
H<br />
N<br />
O<br />
O<br />
O<br />
(A)<br />
100 mg<br />
NO 2<br />
Nitrazepam<br />
MM 0078.00<br />
Nitrazepam [Controlled Substance]<br />
H<br />
N<br />
O<br />
(A)<br />
100 mg<br />
O 2N<br />
N<br />
MM 0078.02<br />
Imp. A (EP): 3-Amino-6-nitro-4-phenylquinolin-2(1H)-one<br />
H<br />
N<br />
O (A) 100 mg<br />
O 2N<br />
NH 2<br />
MM 0078.01<br />
Imp. B (EP): (2-Amino-5-nitrophenyl)phenylmethanone<br />
(2-Amino-5-nitrobenzophenone)<br />
O 2N<br />
NH 2<br />
O<br />
(B)<br />
100 mg<br />
272 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
<strong>Pharmac<strong>eu</strong>tical</strong> Impurities<br />
Code Product Category Unit<br />
MM 0078.07<br />
7-Aminonitrazepam<br />
H<br />
N<br />
O<br />
(A)<br />
100 mg<br />
H 2 N<br />
N<br />
Nitrendipine<br />
MM 0092.00 Nitrendipine<br />
H N<br />
NO 2<br />
O<br />
(A)<br />
500 mg<br />
O<br />
O<br />
O<br />
MM 0092.03<br />
Imp. A (EP): Ethyl Methyl 2,6-Dimethyl-4-(3-nitrophenyl)pyridine-<br />
3,5-dicarboxylate (Photolysis Product)<br />
O<br />
O<br />
N<br />
O<br />
O<br />
NO 2<br />
(A)<br />
100 mg<br />
MM 0092.01<br />
Imp. B (EP): Dimethyl 2,6-Dimethyl-4-(3-nitrophenyl)-1,4-<br />
dihydropyridine-3,5-dicarboxylate<br />
O<br />
O<br />
H<br />
N<br />
O<br />
O<br />
NO 2<br />
(A)<br />
100 mg<br />
MM 0092.02<br />
Imp. C (EP): Diethyl 2,6-Dimethyl-4-(3-nitrophenyl)-1,4-<br />
dihydropyridine-3,5-dicarboxylate<br />
O<br />
O<br />
H<br />
N<br />
O<br />
O<br />
NO 2<br />
(A)<br />
100 mg<br />
MM 0092.04<br />
1,4-Dihydro-2,6-dimethyl-4-(3-nitrophenyl)pyridine-3,5-dicarboxylic<br />
Acid Methyl Ester<br />
O<br />
O<br />
H<br />
N<br />
OH<br />
O<br />
NO 2<br />
(A)<br />
50 mg<br />
MM 0092.05<br />
1,4-Dihydro-2,6-dimethyl-4-(3-nitrophenyl)pyridine-3,5-dicarboxylic<br />
Acid Ethyl Ester<br />
O<br />
O<br />
H<br />
N<br />
OH<br />
O<br />
NO 2<br />
(A)<br />
50 mg<br />
Nitrofural<br />
MM 0943.00 Nitrofural O O 2 N<br />
MM 0943.02<br />
Imp. B (EP): (5-Nitrofuran-2-yl)methylene Diacetate<br />
N<br />
H<br />
N NH 2<br />
O<br />
O<br />
(A)<br />
(A)<br />
500 mg<br />
100 mg<br />
O 2 N<br />
O<br />
O<br />
O<br />
O<br />
Nitrofurantoin<br />
MM 0506.00<br />
Nitrofurantoin<br />
O 2 N<br />
O<br />
O<br />
N N H<br />
N<br />
O<br />
(A)<br />
500 mg<br />
Nizatidine<br />
MM 0220.00<br />
Nizatidine<br />
MM 0220.01 Imp. A (EP): N,N‘-Dimethyl-2-nitroethene-1,1-diamine<br />
NO 2<br />
N<br />
(A) 500 mg<br />
S<br />
N<br />
S<br />
N<br />
H<br />
NO 2<br />
N<br />
H<br />
(A)<br />
100 mg<br />
MM 0220.09 Imp. B (EP): (EZ)-N-Methyl-1-methylsulphanyl)-2-nitroethen-1-amine<br />
NO 2<br />
N<br />
H<br />
N<br />
H<br />
S N<br />
H<br />
(A) 100 mg<br />
MM 0220.02<br />
Imp. C (EP): (EZ)-N-[2-[[[2-[(Dimethylamino)methyl]thiazol-<br />
4-yl]methyl]sulphinyl]ethyl]-N‘-methyl-2-nitroethene-1,1-<br />
diamine<br />
N<br />
S<br />
N<br />
O<br />
S<br />
N<br />
H<br />
NO 2<br />
N<br />
H<br />
(A)<br />
100 mg<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 273
<strong>Pharmac<strong>eu</strong>tical</strong> Impurities<br />
Code Product Category Unit<br />
S<br />
MM 0220.11 Imp. H (EP) as Hydrochloride: 2-(Dimethylamino)thioacetamide<br />
(A) 100 mg<br />
x HCl<br />
N<br />
Hydrochloride<br />
NH 2<br />
MM 0220.12<br />
Imp. K (EP): 3-(Methylamino)-5,6-dihydro-2H-1,4-thiazin-2-one Oxime<br />
S<br />
N OH (A) 100 mg<br />
N<br />
N<br />
H<br />
Nonivamide<br />
MM 1033.00<br />
MM 1033.01<br />
Nonivamide<br />
4-(Aminomethyl)-2-methoxyphenol Hydrochloride<br />
(Vanillylamine Hydrochloride)<br />
O<br />
HO<br />
N<br />
H<br />
O<br />
HO<br />
O<br />
(A) 500 mg<br />
NH 2<br />
x HCl<br />
(A)<br />
100 mg<br />
MM 1033.02<br />
MM 1033.03<br />
MM 1033.04<br />
N-[(4-Hydroxy-3-methoxyphenyl)methyl]octanamide<br />
(N-Vanillyloctanamide)<br />
N-[(4-Hydroxy-3-methoxyphenyl)methyl]-<br />
decanamide (N-Vanillyldecanamide)<br />
N,O-Dinonanoylvanillylamine<br />
O<br />
HO<br />
O<br />
HO<br />
O<br />
O<br />
N<br />
H<br />
N<br />
H<br />
O<br />
(A) 100 mg<br />
O<br />
(A) 100 mg<br />
N<br />
H<br />
O<br />
(A)<br />
100 mg<br />
O<br />
Noradrenaline Tartrate<br />
MM 0785.01<br />
Imp. A (EP): Adrenaline<br />
HO<br />
OH<br />
H (A) 500 mg<br />
N<br />
HO<br />
MM 0785.03 Imp. C (EP) as Hydrochloride: Dopamine Hydrochloride<br />
HO<br />
NH 2<br />
x HCl<br />
(A)<br />
500 mg<br />
HO<br />
Norethisterone<br />
MM 0218.00<br />
Norethisterone<br />
OH<br />
(A) 250 mg<br />
O<br />
MM 0218.04<br />
Imp. A (EP): 17-Hydroxy-19-nor-17α-pregna-4,6-dien-20-yn-3-one<br />
(6,7-Didehydronorethisterone)<br />
OH<br />
(D) 100 mg<br />
O<br />
MM 0218.05<br />
Imp. B (EP): Estr-4-ene-3,17-dione (Nor<strong>and</strong>rostenedione)<br />
O<br />
(A) 100 mg<br />
O<br />
MM 0218.01<br />
Imp. H (EP): 6β,17-Dihydroxy-19-nor-17α-pregn-4-en-20-yn-3-one<br />
(6β-Hydroxynorethisterone)<br />
OH<br />
(D)<br />
100 mg<br />
O<br />
OH<br />
MM 0218.02<br />
6α-Hydroxynorethisterone<br />
OH<br />
(D)<br />
50 mg<br />
O<br />
OH<br />
MM 0218.03<br />
6-Ketonorethisterone<br />
OH<br />
(D)<br />
100 mg<br />
O<br />
O<br />
Norethisterone Acetate<br />
MM 0219.00<br />
Norethisterone Acetate<br />
O<br />
O<br />
(A) 100 mg<br />
O<br />
274 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
<strong>Pharmac<strong>eu</strong>tical</strong> Impurities<br />
Code Product Category Unit<br />
MM 0219.11 Imp. A (EP): Norethisterone<br />
OH<br />
(A) 250 mg<br />
O<br />
MM 0219.10<br />
Imp. B (EP): 3-Oxo-19-nor-17α-pregn-5(10)-en-20-yn-17-yl<br />
Acetate<br />
O<br />
O<br />
(D) 100 mg<br />
O<br />
MM 0219.01<br />
Imp. F (EP): 6β-Hydroxy-3-oxo-19-nor-17α-pregn-4-en-20-yn-17-<br />
yl Acetate<br />
(6β-Hydroxynorethisterone Acetate)<br />
O<br />
O<br />
(D)<br />
100 mg<br />
O<br />
OH<br />
MM 0219.03<br />
Imp. G (EP): 3,6-Dioxo-19-nor-17α-pregn-4-en-20-yn-17-yl<br />
Acetate<br />
(6-Ketonorethisterone Acetate)<br />
O<br />
O<br />
(D)<br />
100 mg<br />
O<br />
O<br />
MM 0219.02<br />
6α-Hydroxynorethisterone Acetate<br />
O<br />
O<br />
(D)<br />
50 mg<br />
O<br />
OH<br />
MM 0219.04<br />
6,7-Didehydronorethisterone Acetate<br />
O<br />
O<br />
(D) 100 mg<br />
O<br />
Norfenefrine Hydrochloride<br />
MM 0973.00<br />
Norfenefrine Hydrochloride<br />
HO<br />
OH<br />
NH 2 x HCl<br />
(A) 500 mg<br />
Norfloxacin<br />
MM 0350.00<br />
Norfloxacin<br />
HN (A) 250 mg<br />
N<br />
N<br />
MM 0350.01<br />
MM 0350.03<br />
MM 0350.04<br />
Nortriptyline Hydrochloride<br />
MM 0079.00<br />
MM 0079.08<br />
Imp. A (EP): 7-Chloro-1-ethyl-6-fluoro-4-oxo-1,4-dihydroquinoline-<br />
3-carboxylic Acid<br />
Imp. D (Pharm<strong>eu</strong>ropa): 1-Ethyl-6-fluoro-7-piperazin-1-yl-quinolin-<br />
4(1H)-one<br />
Imp. G (Pharm<strong>eu</strong>ropa): 1-Ethyl-6-fluoro-7-(4-formylpiperazin-<br />
1-yl)-4-oxo-1,4-dihydroquinoline-3-carboxylic Acid<br />
Nortriptyline Hydrochloride<br />
Imp. A (EP): 10,11-Dihydro-5H-dibenzo[a,d][7]annulen-5-one<br />
(Dibenzosuberone)<br />
Cl<br />
F<br />
F<br />
HN<br />
N<br />
F<br />
N<br />
O<br />
O<br />
O<br />
OH<br />
O<br />
O<br />
O<br />
OH<br />
N<br />
O<br />
OH<br />
(A)<br />
(D)<br />
100 mg<br />
100 mg<br />
O N<br />
(D) 100 mg<br />
N N<br />
F<br />
N<br />
H<br />
O<br />
x HCl<br />
(A)<br />
(B)<br />
500 mg<br />
100 mg<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 275
<strong>Pharmac<strong>eu</strong>tical</strong> Impurities<br />
Code Product Category Unit<br />
Ofloxacin<br />
MM 0228.00 Ofloxacin<br />
N O<br />
N N<br />
(A) 500 mg<br />
MM 0228.04<br />
MM 0228.05<br />
MM 0228.08<br />
MM 0228.10<br />
Omeprazole<br />
MM 0095.00<br />
MM 0095.03<br />
MM 0095.04<br />
MM 0095.06<br />
MM 0095.05<br />
MM 0095.07<br />
MM 0095.01<br />
Imp. A (EP): (RS)-9,10-Difluoro-3-methyl-7-oxo-2,3-dihydro-7Hpyrido[1,2,3-de]-1,4-benzoxazine-6-carboxylic<br />
Acid (FPA)<br />
Imp. B (EP): (RS)-9-Fluoro-3-methyl-10-(4-<br />
methylpiperazin-1-yl)-2,3-dihydro-7H-pyrido-<br />
[1,2,3-de]-1,4-benzoxazin-7-one<br />
Imp. E (EP): (RS)-9-Fluoro-3-methyl-7-oxo-10-(piperazin-1-<br />
yl)-2,3-dihydro-7H-pyrido[1,2,3-de]-1,4-benzoxazine-6-<br />
carboxylic Acid<br />
Imp. F (EP) as Hydrochloride: 4-[(RS)-6-Carboxy-9-<br />
fluoro-3-methyl-7-oxo-2,3-dihydro-7H-pyrido[1,2,3-de]-<br />
1,4-benzoxazine-10-yl]-1-methylpiperazine 1-Oxide<br />
Hydrochloride (Ofloxacin N-Oxide Hydrochloride)<br />
Omeprazole<br />
Imp. A (EP): 5-Methoxy-1H-benzimidazole-2-thiol<br />
Imp. B (EP): 2-[(RS)-[(3,5-Dimethylpyridin-2-yl)<br />
methyl]sulphinyl]-5-methoxy-1H-benzimidazole<br />
N<br />
O<br />
Imp. C (EP): 5-Methoxy-2-[[(4-methoxy-3,5-dimethylpyridin-2-<br />
yl)methyl]sulphanyl]-1H-benzimidazole (Ufiprazole)<br />
Imp. D (EP): 5-Methoxy-2-[[(4-methoxy-3,5-dimethylpyridin-2-<br />
yl) methyl]sulphonyl]-1H-benzimidazole (Omeprazole<br />
Sulphone)<br />
Imp. E (EP): 4-Methoxy-2-[[(RS)-(5-methoxy-1Hbenzimidazol-2-yl)sulphinyl]methyl]-3,5-dimethylpyridine<br />
1-Oxide (Omeprazole N-Oxide)<br />
Imp. F (EP): 8-Methoxy-1,3-dimethyl-12-<br />
thioxopyrido[1',2':3,4]imidazo[1,2-a]-benzimidazol-2(12H)-one<br />
O<br />
N<br />
F<br />
HN<br />
O<br />
O<br />
O<br />
O<br />
O<br />
O<br />
F<br />
F<br />
N<br />
F<br />
F<br />
O<br />
N<br />
O<br />
O<br />
OH<br />
O<br />
O<br />
OH<br />
(A)<br />
100 mg<br />
N O<br />
(A) 100 mg<br />
N<br />
N<br />
N<br />
O<br />
O<br />
H<br />
N<br />
N<br />
O<br />
H<br />
N<br />
N<br />
H<br />
N<br />
N<br />
F<br />
O<br />
N<br />
O<br />
S<br />
O<br />
S<br />
O<br />
S<br />
OH<br />
N<br />
O<br />
H<br />
N<br />
N<br />
N<br />
N<br />
H<br />
N<br />
S N<br />
N<br />
O<br />
O<br />
NH<br />
N S<br />
O N<br />
O<br />
N<br />
N<br />
S<br />
N<br />
O<br />
OH<br />
x HCl<br />
O<br />
O<br />
O<br />
SH<br />
O<br />
O<br />
(A)<br />
(A)<br />
(A)<br />
(A)<br />
(A)<br />
(A)<br />
(A)<br />
(A)<br />
(D)<br />
100 mg<br />
100 mg<br />
500 mg<br />
100 mg<br />
100 mg<br />
100 mg<br />
100 mg<br />
100 mg<br />
50 mg<br />
MM 0095.02<br />
Imp. G (EP): 9-Methoxy-1,3-dimethyl-12-<br />
thioxopyrido[1',2':3,4]imidazo[1,2-a]-benzimidazol-2(12H)-one<br />
O<br />
S<br />
(D) 50 mg<br />
N<br />
O<br />
N<br />
N<br />
MM 0095.15<br />
MM 0095.16<br />
MM 0095.08<br />
Imp. H (EP): 2-[(RS)-[(4-Chloro-3,5-dimethylpyridin-2-<br />
yl)methyl]sulfinyl]-5-methoxy-1H-benzimidazole<br />
Imp. I (EP): 4-Methoxy-2-[[(5-methoxy-1H-benzimidazol-<br />
2-yl)sulphonyl]methyl]-3,5-dimethylpyridine 1-Oxide<br />
(Omeprazole Sulphone N-Oxide)<br />
5-Methoxy-2-[[(3,5-dimethylpyridin-2-yl)methyl]sulphanyl]-<br />
1H-benzimidazole<br />
O<br />
NH<br />
N S<br />
Cl<br />
O N<br />
O<br />
NH<br />
N S<br />
O<br />
O O N<br />
O<br />
NH<br />
N S<br />
N<br />
(D) 100 mg<br />
(A) 100 mg<br />
O<br />
(A) 100 mg<br />
276 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
<strong>Pharmac<strong>eu</strong>tical</strong> Impurities<br />
Code Product Category Unit<br />
MM 0095.19<br />
MM 0095.20<br />
5-Methoxy-2-[[(4-chloro-3,5-dimethylpyridin-2-yl)<br />
methyl]sulphanyl]-1H-benzimidazole<br />
5-Methoxy-1,3-dihydrobenzimidazol-2-one<br />
O<br />
(D) 100 mg<br />
NH<br />
Cl<br />
N S<br />
N<br />
O<br />
(A) 100 mg<br />
NH<br />
N<br />
H<br />
O<br />
MM 0095.23<br />
2-[[(4-Methoxy-3,5-dimethylpyridin-2-yl)methyl]sulphinyl]-1Hbenzimidazole<br />
NH<br />
N S<br />
O<br />
(A)<br />
100 mg<br />
O<br />
N<br />
MM 0095.24<br />
5-Methoxy-2-(4-methoxy-3,5-dimethylpyridin-2-yl)-1Hbenzimidazole<br />
O<br />
NH<br />
N<br />
O<br />
(A)<br />
100 mg<br />
N<br />
Ondansetron Hydrochloride Dihydrate<br />
MM 0252.00 Ondansetron Hydrochloride Dihydrate<br />
N<br />
N<br />
N<br />
x HCl<br />
x 2 H 2 O<br />
on request<br />
MM 0252.09 Ondansetron<br />
N<br />
O<br />
N<br />
on request<br />
N<br />
O<br />
MM 0252.03<br />
Imp. A (EP): (3RS)-3-(Dimethylamino)methyl-9-methyl-1,2,3,9-<br />
tetrahydro-4H-carbazol-4-one<br />
N<br />
N<br />
(A)<br />
100 mg<br />
O<br />
MM 0252.02<br />
Imp. B (EP): 6,6'-Methylene bis[(3RS)-9-<br />
methyl-3-[(2-methyl-1H-imidazol-1-<br />
yl)methyl]-1,2,3,9-tetrahydro-4H-carbazol-4-<br />
one]<br />
N<br />
N<br />
N<br />
O<br />
N<br />
O<br />
N<br />
N<br />
(D)<br />
50 mg<br />
MM 0252.01 Imp. C (EP): 9-Methyl-1,2,3,9-tetrahydro-4H-carbazol-4-one<br />
N<br />
(A)<br />
100 mg<br />
O<br />
MM 0252.04<br />
Imp. D (EP): 9-Methyl-3-methylene-1,2,3,9-tetrahydro-4H-carbazol-4-<br />
one<br />
N<br />
(A)<br />
100 mg<br />
MM 0252.05 Imp. E (EP): 1H-Imidazole<br />
N<br />
O<br />
N<br />
H<br />
(B)<br />
100 mg<br />
N<br />
MM 0252.06 Imp. F (EP): 2-Methyl-1H-imidazole (B) 100 mg<br />
N<br />
H<br />
MM 0252.07<br />
Imp. G (EP): (3RS)-3-[(1H-Imidazol-1-yl)methyl]-9-methyl-1,2,3,9-<br />
tetrahydro-4H-carbazol-4-one (C-Demethylondansetron)<br />
N<br />
N<br />
N<br />
(A)<br />
100 mg<br />
O<br />
MM 0252.08<br />
Imp. H (EP): (3RS)-3-[(2-Methyl-1H-imidazol-1-yl)methyl]-1,2,3,9-<br />
tetrahydro-4H-carbazol-4-one (N-Demethylondansetron)<br />
H<br />
N<br />
N<br />
N<br />
(A)<br />
100 mg<br />
O<br />
Opipramol Dihydrochloride<br />
MM 0422.01<br />
5-(3-Piperazin-1-yl-propyl)-5H-dibenzo[b,f]azepine<br />
Dihydrochloride<br />
N<br />
x 2 HCl<br />
(A)<br />
100 mg<br />
N<br />
NH<br />
Ornidazole<br />
MM 0948.00<br />
Ornidazole<br />
O 2 N<br />
(A)<br />
500 mg<br />
N<br />
Cl<br />
N<br />
OH<br />
New MM 0948.01<br />
2-Methyl-5-nitroimidazole<br />
O 2 N<br />
(B) 100 mg<br />
N<br />
NH<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 277
<strong>Pharmac<strong>eu</strong>tical</strong> Impurities<br />
Code Product Category Unit<br />
New MM 0948.02 3-(2-Methyl-5-nitro-1H-imidazol-1-yl)propane-1,2-diol<br />
New MM 0948.03 3-(2-Methyl-5-nitro-1H-imidazol-1-yl)-1,2-epoxypropane<br />
Orphenadrine Hydrochloride<br />
O 2 N<br />
N<br />
OH<br />
OH<br />
N<br />
O 2 N<br />
N<br />
O<br />
N<br />
(A) 100 mg<br />
(A) 200 mg<br />
MM 0801.00 Orphenadrine Hydrochloride<br />
(A) 500 mg<br />
O<br />
N<br />
x HCl<br />
MM 0801.01<br />
Imp. A (EP): (RS)-(2-Methylphenyl)phenylmethanol<br />
(2-Methylbenzhydrol)<br />
(A)<br />
100 mg<br />
OH<br />
MM 0801.02<br />
Imp. B (EP): (2-Methylphenyl)phenylmethanone (2-Methylbenzophenone)<br />
(A)<br />
100 mg<br />
O<br />
MM 0801.04<br />
Imp. D (EP) as Hydrochloride: Diphenhydramine<br />
Hydrochloride<br />
O<br />
N<br />
x HCl<br />
(A)<br />
500 mg<br />
MM 0801.05<br />
Imp. E (EP) as Hydrochloride: (RS)-N,N-Dimethyl-2-[(3-<br />
methylphenyl)phenylmethoxy]ethanamine Hydrochloride<br />
(meta-Methylbenzyl Isomer Hydrochloride)<br />
O<br />
N<br />
x HCl<br />
(A)<br />
100 mg<br />
MM 0801.06<br />
Imp. F (EP) as Hydrochloride: (RS)-N,N-Dimethyl-<br />
2-[(4-methylphenyl)phenylmethoxy]ethanamine<br />
Hydrochloride (para-Methylbenzyl Isomer<br />
Hydrochloride)<br />
O<br />
N<br />
x HCl<br />
(A)<br />
100 mg<br />
MM 0801.07<br />
N-Desmethylorphenadrine Hydrochloride<br />
(A)<br />
100 mg<br />
O<br />
H<br />
N<br />
x HCl<br />
Oxacillin Sodium<br />
MM 0686.00<br />
Oxacillin Sodium Monohydrate<br />
N<br />
O<br />
O<br />
O<br />
N<br />
H<br />
O<br />
N<br />
S<br />
H<br />
ONa<br />
x H 2 O<br />
(A)<br />
250 mg<br />
New MM 0686.03<br />
New MM 0686.04<br />
Oxalic Acid Dihydrate<br />
MM 0928.00<br />
Imp. A (EP): (2S,5R,6R)-6-Amino-3,3-dimethyl-<br />
7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-<br />
carboxylic Acid (6-Aminopenicillanic Acid)<br />
Imp. E (EP) as Sodium Salt Monohydrate:<br />
Cloxacillin Sodium Monohydrate<br />
Oxalic Acid Dihydrate<br />
O<br />
H 2 N<br />
N<br />
H<br />
O<br />
S<br />
OH<br />
(B)<br />
100 mg<br />
Cl O<br />
(A) 500 mg<br />
ONa<br />
O<br />
N<br />
N<br />
H<br />
x H 2 O<br />
O N<br />
S<br />
H<br />
O<br />
O<br />
O<br />
OH<br />
OH<br />
x 2 H 2 O<br />
(A)<br />
500 mg<br />
278 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
<strong>Pharmac<strong>eu</strong>tical</strong> Impurities<br />
Code Product Category Unit<br />
Oxazepam<br />
MM 0080.00<br />
Oxazepam [Controlled Substance]<br />
Cl<br />
H<br />
N<br />
N<br />
O<br />
OH<br />
(D)<br />
100 mg<br />
MM 0080.07<br />
Imp. D (EP): (2-Amino-5-chlorophenyl)phenylmethanone<br />
(2-Amino-5-chlorobenzophenone)<br />
Cl<br />
NH 2<br />
O<br />
(B)<br />
100 mg<br />
MM 0080.03<br />
6-Chloro-4-phenyl-3,4-dihydroquinazoline-2-carboxylic Acid<br />
Cl<br />
O<br />
N<br />
OH<br />
NH<br />
(A)<br />
100 mg<br />
Oxcarbazepine<br />
MM 0637.00<br />
Oxcarbazepine<br />
O<br />
(A) 100 mg<br />
N<br />
MM 0637.01<br />
10-Hydroxy-10,11-dihydrocarbamazepine<br />
O NH 2<br />
HO<br />
(A) 100 mg<br />
N<br />
O NH 2<br />
Oxeladin Hydrogen Citrate<br />
MM 0547.00 Oxeladin Hydrogen Citrate<br />
O<br />
O<br />
O<br />
N<br />
MM 0547.02 Imp. A (EP): 2-[2-(Diethylamino)ethoxy]ethanol HO<br />
O<br />
x<br />
O<br />
O<br />
OH<br />
O<br />
OH<br />
OH<br />
OH<br />
(A)<br />
500 mg<br />
N (A) 100 mg<br />
MM 0547.01<br />
Oxeladin N-Oxide<br />
O<br />
O<br />
O<br />
N<br />
O<br />
(A)<br />
100 mg<br />
Oxfendazole<br />
MM 1012.02<br />
Imp. B (EP): Methyl [5-(Phenylsulphonyl)-1H-benzimidazol-<br />
2-yl]carbamate<br />
S<br />
O O<br />
H<br />
N<br />
N<br />
O<br />
NH<br />
O<br />
(A)<br />
100 mg<br />
Oxolinic Acid<br />
MM 0898.00<br />
Oxolinic Acid<br />
O<br />
N<br />
(A)<br />
250 mg<br />
O<br />
OH<br />
O<br />
O<br />
Oxomemazine<br />
MM 0957.00<br />
Oxomemazine<br />
N<br />
(A)<br />
100 mg<br />
N<br />
S<br />
O O<br />
MM 0957.01<br />
Trimeprazine Tartrate<br />
N<br />
S<br />
N<br />
OH O<br />
x HO<br />
OH<br />
O OH<br />
2<br />
(A)<br />
500 mg<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 279
<strong>Pharmac<strong>eu</strong>tical</strong> Impurities<br />
Code Product Category Unit<br />
MM 0957.02 Trimeprazine Sulphoxide Hydrochloride<br />
N<br />
(A) 100 mg<br />
N<br />
x HCl<br />
S<br />
O<br />
MM 0957.04<br />
Oxomemazine N-Oxide Hydrochloride(Trimeprazine Sulphone<br />
N-Oxide Hydrochloride)<br />
N<br />
N O<br />
x HCl<br />
(A)<br />
100 mg<br />
S<br />
O O<br />
Oxprenolol Hydrochloride<br />
MM 0129.00<br />
Oxprenolol Hydrochloride<br />
O<br />
OH<br />
H<br />
N<br />
x HCl<br />
(A)<br />
500 mg<br />
O<br />
Oxybuprocaine Hydrochloride<br />
MM 0543.00<br />
Oxybuprocaine Hydrochloride<br />
H 2 N<br />
O<br />
O<br />
O<br />
N<br />
x HCl<br />
(A)<br />
500 mg<br />
MM 0543.01<br />
Imp. A (EP): 4-Aminobenzoic Acid<br />
O<br />
OH<br />
(B)<br />
100 mg<br />
H 2N<br />
MM 0543.02<br />
Imp. B (EP): 4-Amino-3-butoxybenzoic Acid<br />
O<br />
(A)<br />
100 mg<br />
OH<br />
H 2 N<br />
O<br />
MM 0543.03<br />
Imp. C (EP): 4-Amino-3-hydroxybenzoic Acid<br />
O<br />
OH<br />
(A)<br />
100 mg<br />
H 2 N<br />
OH<br />
MM 0543.05<br />
Oxybuprocaine N-Oxide Dihydrochloride<br />
H 2 N<br />
O<br />
O<br />
O<br />
N<br />
O<br />
x 2 HCl<br />
(A)<br />
100 mg<br />
Oxybutynin Hydrochloride<br />
MM 0047.00<br />
Oxybutynin Hydrochloride<br />
HO<br />
O<br />
N<br />
x HCl<br />
(A)<br />
250 mg<br />
O<br />
MM 0047.06<br />
Imp. B (EP): 4-(Diethylamino)but-2-ynyl<br />
2-Hydroxy-2,2-diphenylacetate<br />
(Diphenyl analogue of Oxybutynin)<br />
HO<br />
O<br />
O<br />
N<br />
(A)<br />
100 mg<br />
MM 0047.04<br />
Imp. C (EP) as Hydrochloride: 4-(Ethylmethylamino)but-2-<br />
ynyl (RS)-2-Cyclohexyl-2-hydroxy-2-phenylacetate Hydrochloride<br />
(Methylethyl analogue of Oxybutynin<br />
Hydrochloride)<br />
HO<br />
O<br />
O<br />
N<br />
x HCl<br />
(D)<br />
100 mg<br />
MM 0047.01<br />
Imp. D (EP): (RS)-2-Cyclohexyl-2-hydroxy-2-phenylacetic Acid<br />
(Phenylcyclohexylglycolic Acid)<br />
HO<br />
OH<br />
(A)<br />
100 mg<br />
O<br />
MM 0047.07<br />
Imp. E (EP): 4-(Ethylpropylamino)but-2-ynyl (RS)-<br />
2-Cyclohexyl-2-hydroxy-2-phenylacetate (Ethylpropyl<br />
analogue of Oxybutynin)<br />
HO<br />
O<br />
O<br />
N<br />
(A)<br />
100 mg<br />
MM 0047.02<br />
Methyl (RS)-2-Cyclohexyl-2-hydroxy-2-phenylacetate<br />
(Phenylcycloheyxlglycolic Acid Methyl Ester)<br />
HO<br />
O<br />
(A)<br />
100 mg<br />
MM 0047.03 4-Diethylaminobut-2-yn-1-ol N<br />
HO<br />
O<br />
(A)<br />
100 mg<br />
280 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
<strong>Pharmac<strong>eu</strong>tical</strong> Impurities<br />
Code Product Category Unit<br />
MM 0047.11<br />
Desethyloxybutynin Hydrochloride<br />
HO<br />
O<br />
O<br />
N<br />
H<br />
x HCl<br />
(D)<br />
100 mg<br />
MM 0047.50<br />
Propargyl (RS)-2-Cyclohexyl-2-hydroxy-2-phenylacetate<br />
(Phenylcyclohexylglycolic Acid Propargyl Ester)<br />
HO<br />
O<br />
(A)<br />
100 mg<br />
O<br />
Oxycodone Hydrochloride<br />
MM 0672.00<br />
Oxycodone Hydrochloride<br />
[Controlled Substance]<br />
HO<br />
N<br />
x HCl<br />
(A)<br />
100 mg<br />
MM 0672.03<br />
Imp. C (EP) as Hydrochloride: 4,5α-Epoxy-14-hydroxy-3-<br />
methoxymorphinan-6-one Hydrochloride (Noroxycodone<br />
Hydrochloride)<br />
O<br />
O<br />
HO<br />
H<br />
N<br />
O<br />
x HCl<br />
(D)<br />
50 mg<br />
MM 0672.05<br />
MM 0672.06<br />
4,5α-Epoxy-3-methoxy-17-methylmorphinan-6β,14-diol<br />
Hydrochloride<br />
(6β-Oxycodol Hydrochloride)<br />
[Controlled Substance]<br />
Oxycodone N-Oxide<br />
O<br />
O<br />
O<br />
HO<br />
O<br />
N<br />
O<br />
x HCl<br />
OH<br />
N<br />
(D) 50 mg<br />
O<br />
(D) 50 mg<br />
HO<br />
O<br />
O<br />
O<br />
Oxymetazoline Hydrochloride<br />
MM 0177.00<br />
Oxymetazoline Hydrochloride<br />
HO<br />
HN<br />
N<br />
x HCl<br />
(A)<br />
250 mg<br />
MM 0177.01<br />
Imp. A (EP) as Hydrochloride: N-(2-Aminoethyl)-2-[4-(1,1-<br />
dimethylethyl)-3-hydroxy-2,6-dimethylphenyl)]acetamide<br />
Hydrochloride<br />
HO<br />
O<br />
H<br />
N<br />
NH 2 x HCl<br />
(A) 100 mg<br />
New MM 0177.08 Imp. B (Pharm<strong>eu</strong>ropa) as Hydrochloride: 2-(4-<br />
tert-Butyl-2,6-dimethylbenzyl)-4,5-dihydro-1Himidazole<br />
Hydrochloride (Xylometazoline<br />
Hydrochloride)<br />
N<br />
N<br />
H<br />
x HCl<br />
(A)<br />
500 mg<br />
Oxyphenbutazone<br />
MM 0933.00<br />
Oxyphenbutazone Monohydrate<br />
O<br />
OH<br />
(A)<br />
250 mg<br />
N<br />
N<br />
x H 2 O<br />
O<br />
Oxytetracycline Hydrochloride<br />
MM 0554.00 Oxytetracycline Hydrochloride<br />
OH O OH O<br />
OH<br />
O<br />
(A)<br />
500 mg<br />
HO<br />
H<br />
H<br />
OH<br />
N<br />
OH<br />
NH 2<br />
x HCl<br />
MM 0554.02<br />
Imp. B (EP) as Hydrochloride: Tetracycline<br />
Hydrochloride<br />
OH O OH O<br />
OH<br />
H H<br />
HO<br />
N<br />
O<br />
NH 2<br />
OH<br />
x HCl<br />
(A)<br />
500 mg<br />
Pantoprazole Sodium Sesquihydrate<br />
MM 0099.00<br />
Pantoprazole Sodium<br />
F<br />
O<br />
F<br />
NNa<br />
N S<br />
O<br />
N<br />
O<br />
O<br />
on request<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 281
<strong>Pharmac<strong>eu</strong>tical</strong> Impurities<br />
Code Product Category Unit<br />
MM 0099.01 Pantoprazole<br />
on request<br />
O<br />
NH O<br />
F<br />
O<br />
F N S<br />
MM 0099.02<br />
Imp. A (Pharm<strong>eu</strong>ropa): 5-(Difluoromethoxy)-2-[[(3,4-<br />
dimethoxypyridin-2-yl)methyl]sulfonyl]-1H-benzimidazole<br />
(Pantoprazole Sulphone)<br />
F<br />
O<br />
F<br />
O<br />
N<br />
NH<br />
O<br />
N S O O<br />
N<br />
O<br />
(A)<br />
100 mg<br />
MM 0099.03<br />
Imp. B (Pharm<strong>eu</strong>ropa): 5-(Difluoromethoxy)-<br />
2-[[(3,4-dimethoxypyridin-2-yl)methyl]thio]-1Hbenzimidazole<br />
F<br />
O<br />
F<br />
NH<br />
N S<br />
O<br />
N<br />
O<br />
(A)<br />
100 mg<br />
MM 0099.04<br />
Imp. C (Pharm<strong>eu</strong>ropa): 5-(Difluoromethoxy)-<br />
1H-benzimidazole-2-thiol<br />
New MM 0099.11 Mixture of Imp. D <strong>and</strong> F (Pharm<strong>eu</strong>ropa): 5- <strong>and</strong> 6-<br />
(Difluoromethoxy)-2-[(2RS)-[(3,4-dimethoxypyridin-<br />
2-yl)methyl]sulfinyl]-1-methyl-1H-benzimidazole<br />
F<br />
O<br />
F<br />
O<br />
F<br />
F<br />
N<br />
N S<br />
O<br />
NH<br />
N SH<br />
O<br />
O<br />
N<br />
(A)<br />
100 mg<br />
on request<br />
F +<br />
O<br />
F<br />
N<br />
N<br />
S<br />
O<br />
O<br />
N<br />
O<br />
MM 0099.05<br />
2-Chloromethyl-3,4-dimethoxypyridine Hydrochloride<br />
Cl<br />
O<br />
O<br />
x HCl<br />
(A)<br />
100 mg<br />
N<br />
MM 0099.06<br />
Pantoprazole N-Oxide<br />
F<br />
O<br />
F<br />
NH O<br />
N S<br />
O N<br />
O<br />
O<br />
(D)<br />
100 mg<br />
MM 0099.07<br />
Pantoprazole Sulphone N-Oxide<br />
F<br />
O<br />
F<br />
NH O<br />
N S<br />
O O N<br />
O<br />
O<br />
(A)<br />
100 mg<br />
Paracetamol<br />
MM 0042.00 Paracetamol<br />
H<br />
N<br />
O<br />
HO<br />
(A)<br />
500 mg<br />
MM 0042.08<br />
Imp. A (EP): N-(2-Hydroxyphenyl)acetamide<br />
(2-Acetamidophenol)<br />
OH<br />
H<br />
N<br />
O<br />
(B)<br />
100 mg<br />
MM 0042.05<br />
MM0042.09<br />
Imp. B (EP): N-(4-Hydroxyphenyl)propanamide<br />
(N-Propionyl-4-aminophenol)<br />
Imp. C (EP): N-(3-Chloro-4-hydroxyphenyl)acetamide<br />
(3-Chloro-4-hydroxyacetanilide)<br />
MM 0042.10 Imp. D (EP): N-Phenylacetamide (Acetanilide)<br />
H<br />
N<br />
MM 0042.11<br />
Imp. E (EP): 1-(4-Hydroxyphenyl)ethanone<br />
(4-Hydroxyacetophenone)<br />
MM 0042.03 Imp. F (EP): 4-Nitrophenol<br />
NO 2<br />
HO<br />
HO<br />
H<br />
N<br />
O<br />
H<br />
N<br />
O<br />
(A)<br />
100 mg<br />
Cl<br />
(A) 100 mg<br />
HO<br />
O<br />
(B)<br />
100 mg<br />
O<br />
(B) 100 mg<br />
(B)<br />
100 mg<br />
HO<br />
MM 0042.12<br />
Imp. G (EP): 1-(4-Hydroxyphenyl)ethanone Oxime<br />
(4-Hydroxyacetophenone Oxime)<br />
HO<br />
N<br />
(A)<br />
100 mg<br />
HO<br />
MM 0042.04<br />
Imp. H (EP): 4-(Acetylamino)phenyl Acetate<br />
(N,O-Diacetyl-4-aminophenol)<br />
O<br />
O<br />
H<br />
N<br />
O<br />
(A)<br />
100 mg<br />
MM 0042.13<br />
Imp. I (EP): 1-(2-Hydroxyphenyl)ethanone<br />
(2-Hydroxyacetophenone)<br />
O<br />
OH<br />
(B)<br />
100 mg<br />
282 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
<strong>Pharmac<strong>eu</strong>tical</strong> Impurities<br />
Code Product Category Unit<br />
MM 0042.02<br />
Imp. J (EP): N-(4-Chlorophenyl)acetamide<br />
(4-Chloroacetanilide)<br />
MM 0042.01 Imp. K (EP): 4-Aminophenol<br />
NH 2<br />
Cl<br />
HO<br />
H<br />
N<br />
O<br />
(B)<br />
(B)<br />
100 mg<br />
100 mg<br />
HO NH<br />
MM 0042.07 3-Aminophenol 2 (B) 100 mg<br />
Paroxetine Hydrochloride Anhydrous<br />
MM 1032.02 Imp. B (EP): 1,3-Benzodioxol-5-ol (Sesamol) O<br />
OH<br />
(A) 100 mg<br />
MM 1032.12<br />
[(3S,4R)-4-(4-Fluorophenyl)-1-methylpiperidin-3-yl]methanol<br />
O<br />
F<br />
(A) 100 mg<br />
HO<br />
N<br />
Pentetrazol<br />
MM 0692.00 Pentetrazol N<br />
N<br />
N N<br />
(A)<br />
500 mg<br />
Pentoxifylline<br />
MM 0761.00<br />
Pentoxifylline<br />
O O<br />
(A) 500 mg<br />
N<br />
N<br />
O<br />
N<br />
N<br />
MM 0761.03<br />
Imp. A (EP): Theobromine<br />
HN<br />
O<br />
(A) 500 mg<br />
N<br />
O<br />
N<br />
N<br />
MM 0761.04<br />
Imp. B (EP): 3-Methyl-3,7-dihydro-1H-purine-2,6-dione<br />
HN<br />
O<br />
(A) 100 mg<br />
H<br />
N<br />
O<br />
N<br />
N<br />
MM 0761.05<br />
Imp. C (EP): Theophylline<br />
N<br />
O<br />
(A) 500 mg<br />
H<br />
N<br />
O<br />
N<br />
N<br />
MM 0761.08<br />
Imp. F (EP): Caffeine<br />
N<br />
O<br />
(A) 500 mg<br />
N<br />
O<br />
N<br />
N<br />
Peppermint Oil<br />
MM 0163.03<br />
(-)-Menthol<br />
(A)<br />
500 mg<br />
OH<br />
MM 0163.12<br />
(+)-(R)-Pulegone<br />
(A)<br />
100 mg<br />
O<br />
Perazine Dimaleate<br />
MM 0815.00<br />
Perazine Dimaleate<br />
N<br />
N<br />
N<br />
x 2<br />
HO<br />
HO<br />
O<br />
(A)<br />
100 mg<br />
S<br />
O<br />
Perazine Dimalonate<br />
MM 0157.00<br />
Perazine Dimalonate<br />
N<br />
S<br />
N<br />
N<br />
O<br />
x 2<br />
HO<br />
OH<br />
O<br />
(A)<br />
100 mg<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 283
<strong>Pharmac<strong>eu</strong>tical</strong> Impurities<br />
Code Product Category Unit<br />
MM 0157.01<br />
Perazine Sulphoxide<br />
N<br />
N<br />
(A)<br />
100 mg<br />
N<br />
S<br />
O<br />
MM 0157.02<br />
Phenothiazine<br />
H<br />
N (B) 100 mg<br />
S<br />
MM 0157.03<br />
1-(3-Chloropropyl)-4-methylpiperazine<br />
Cl<br />
N<br />
N<br />
on request<br />
Perphenazine<br />
MM 0826.00<br />
Perphenazine<br />
(A)<br />
250 mg<br />
N<br />
N<br />
S<br />
N<br />
OH<br />
Cl<br />
MM 0826.01<br />
Imp. A (Pharm<strong>eu</strong>ropa): 2-[4-[3-(2-Chloro-<br />
5-oxido-10H-phenothiazin-10-yl)propyl]-<br />
piperazin-1-yl]ethanol (Perphenazine<br />
Sulphoxide)<br />
S<br />
O<br />
N<br />
N<br />
N<br />
OH<br />
(A)<br />
100 mg<br />
Cl<br />
Phenacetin<br />
MM 0551.00<br />
Phenacetin<br />
H<br />
N<br />
(A)<br />
100 mg<br />
O<br />
O<br />
MM 0551.01 Paracetamol<br />
H<br />
N<br />
O<br />
HO<br />
(A)<br />
500 mg<br />
MM 0551.02 4-Aminophenol<br />
NH 2<br />
Phenethyl Alcohol<br />
HO<br />
(B)<br />
100 mg<br />
MM 0953.00 Phenylethyl Alcohol<br />
OH<br />
(A) 500 mg<br />
Pheniramine Maleate<br />
MM 0059.00 Pheniramine Maleate N<br />
O<br />
N<br />
OH<br />
x<br />
OH<br />
O<br />
(A)<br />
100 mg<br />
MM 0059.02 Imp. A (EP): 2-Benzylpyridine N (C) 100 mg<br />
MM 0059.03 Imp. B (EP): 4-Benzylpyridine N (C) 100 mg<br />
New MM 0059.07<br />
Imp. C (EP) as Fumarate: (3RS)-N,N-Dimethyl-<br />
3-phenyl-3-(pyridin-4-yl)propan-1-amine<br />
Fumarate<br />
N<br />
N<br />
x<br />
HO<br />
O<br />
OH<br />
(A)<br />
100 mg<br />
O<br />
MM 0059.08<br />
Imp. D (EP) as Dihydrochloride: N,N,N',N'-Tetramethyl-3-<br />
phenyl-3-(pyridin-2-yl)pentane-1,5-diamine Dihydrochloride<br />
N<br />
N<br />
(A)<br />
100 mg<br />
N<br />
x 2 HCl<br />
MM 0059.01<br />
Pheniramine<br />
N (A) 100 mg<br />
N<br />
284 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
<strong>Pharmac<strong>eu</strong>tical</strong> Impurities<br />
Code Product Category Unit<br />
MM 0059.05 Pheniramine N-Oxide Dihydrochloride<br />
N<br />
O<br />
N<br />
x 2 HCl<br />
(A) 100 mg<br />
MM 0059.06<br />
Norpheniramine Maleate<br />
N<br />
H<br />
N<br />
x<br />
O<br />
OH<br />
OH<br />
(A)<br />
100 mg<br />
O<br />
Phenobarbital<br />
MM 0265.01<br />
Phenylethylacetylurea<br />
(2-Phenylbutyrylurea)<br />
O<br />
N<br />
H<br />
O<br />
(A) 100 mg<br />
NH 2<br />
MM 0265.02<br />
N-Benzoyl-N'-(2-phenyl)butanoylurea<br />
O<br />
N<br />
H<br />
O O<br />
(A) 100 mg<br />
N<br />
H<br />
MM 0265.03<br />
Barbituric Acid<br />
O<br />
H<br />
N O (C) 100 mg<br />
NH<br />
Phenoxyethanol<br />
MM 0952.00 Phenoxyethanol<br />
O<br />
O<br />
OH (A) 500 mg<br />
Phenoxymethylpenicillin Potassium<br />
MM 0026.00<br />
MM 0026.06<br />
MM 0026.03<br />
MM 0026.04<br />
MM 0026.02<br />
MM 0026.01<br />
MM 0026.05<br />
Phenylbutazone<br />
MM 0548.00<br />
Phenoxymethylpenicillin Potassium<br />
Imp. A (EP) as Potassium Salt: Benzylpenicillin<br />
Potassium<br />
Imp. B (EP): Phenoxyacetic Acid<br />
Imp. C (EP): (2S,5R,6R)-6-Amino-3,3-dimethyl-7-oxo-4-thia-1-<br />
azabicyclo[3.2.0]-heptane-2-carboxylic Acid<br />
(6-Aminopenicillanic Acid)<br />
Imp. D (EP): (2S,5R,6R)-3,3-Dimethyl-7-oxo-6-[[2-(4-<br />
hydroxyphenoxy)acetyl]amino]-4-thia-1-<br />
azabicyclo[3.2.0]heptane-2-carboxylic Acid<br />
(4-Hydroxyphenoxymethylpenicillin)<br />
Imp. E (EP): (4S)-2-<br />
[Carboxy[(phenoxyacetyl)amino]methyl]-5,5-<br />
dimethylthiazolidine-4-carboxylic Acid (Penicilloic Acids of<br />
Phenoxymethylpenicillin)<br />
Imp. F (EP): (2RS,4S)-5,5-Dimethyl-2-<br />
[[(phenoxyacetyl)amino]methyl]thiazolidine-<br />
4-carboxylic Acid<br />
(Penilloic Acids of Phenoxymethylpenicillin)<br />
Phenylbutazone<br />
HO<br />
O<br />
O<br />
O<br />
O<br />
O<br />
O<br />
O<br />
H<br />
N<br />
O<br />
H<br />
N<br />
O<br />
H 2 N<br />
O<br />
H<br />
N<br />
H<br />
N<br />
O<br />
O<br />
O<br />
O<br />
N<br />
H<br />
N<br />
H<br />
N<br />
H<br />
N<br />
H<br />
HN<br />
O<br />
O<br />
O<br />
O<br />
O<br />
OH<br />
NH<br />
O<br />
N<br />
N<br />
O<br />
S<br />
S<br />
S<br />
S<br />
S<br />
O<br />
O<br />
HN<br />
S<br />
OK<br />
OK<br />
OH<br />
(A)<br />
(A)<br />
(B)<br />
250 mg<br />
250 mg<br />
100 mg<br />
OH (B) 100 mg<br />
OH<br />
OH<br />
OH<br />
(A)<br />
(A)<br />
(A)<br />
100 mg<br />
100 mg<br />
100 mg<br />
O<br />
(A) 500 mg<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 285
<strong>Pharmac<strong>eu</strong>tical</strong> Impurities<br />
Code Product Category Unit<br />
New MM 0548.01<br />
Imp. A (EP): (2RS)-2-[(1,2-Diphenyldiazanyl)-<br />
carbonyl]hexanoic Acid<br />
O<br />
N<br />
NH<br />
O<br />
OH<br />
(D)<br />
100 mg<br />
MM 0548.02<br />
Imp. B (EP): 4-Butyl-4-hydroxy-1,2-diphenylpyrazolidine-3,5-dione<br />
O<br />
(A)<br />
50 mg<br />
N<br />
N<br />
OH<br />
O<br />
MM 0548.03<br />
Imp. C (EP): 1,2-Diphenyldiazane<br />
(1,2-Diphenylhydrazine)<br />
H<br />
N N<br />
H<br />
(A)<br />
100 mg<br />
MM 0548.04<br />
Imp. D (EP): 1,2-Diphenyldiazene<br />
N N<br />
(C) 100 mg<br />
MM 0548.05<br />
Phenylephrine Hydrochloride<br />
MM 0081.00<br />
Imp. E (EP) as Dihydrochloride: Biphenyl-4,4'-diamine<br />
Dihydrochloride<br />
(Benzidine Dihydrochloride)<br />
Phenylephrine Hydrochloride<br />
H 2 N NH 2<br />
x 2 HCl (A) 100 mg<br />
HO<br />
OH<br />
H<br />
N<br />
x HCl<br />
(A)<br />
500 mg<br />
MM 0081.05<br />
1,2,3,4-Tetrahydro-4,6-dihydroxy-2-methylisoquinoline<br />
Hydrochloride<br />
HO<br />
OH<br />
N<br />
x HCl<br />
(A)<br />
100 mg<br />
MM 0081.06<br />
1,2,3,4-Tetrahydro-4,8-dihydroxy-2-methylisoquinoline<br />
Hydrochloride<br />
OH<br />
N<br />
x HCl<br />
(A)<br />
50 mg<br />
OH<br />
Phenylpropanolamine Hydrochloride<br />
MM 0656.00<br />
Phenylpropanolamine Hydrochloride [Controlled Substance]<br />
OH<br />
NH 2<br />
x HCl<br />
(A)<br />
500 mg<br />
<strong>and</strong> enatiomere<br />
Phenyltoloxamine Citrate<br />
MM 0770.00<br />
Phenyltoloxamine Citrate<br />
O<br />
N<br />
x<br />
O<br />
OH<br />
OH<br />
O<br />
(A)<br />
500 mg<br />
O<br />
OH<br />
OH<br />
Phenytoin<br />
MM 0630.00<br />
Phenytoin<br />
H<br />
N<br />
O<br />
(A)<br />
500 mg<br />
NH<br />
O<br />
MM 0630.01<br />
Imp. A (EP): Diphenylmethanone (Benzophenone)<br />
(B)<br />
100 mg<br />
MM 0630.02<br />
Imp. B (EP): Diphenylethanedione (Benzil)<br />
O<br />
O (B) 100 mg<br />
O<br />
MM 0630.03<br />
5-(4-Methylphenyl)hydantoin<br />
H<br />
N<br />
O<br />
(A)<br />
100 mg<br />
NH<br />
O<br />
Phenytoin Sodium<br />
MM 0622.00<br />
Phenytoin Sodium<br />
H<br />
N<br />
ONa<br />
(A)<br />
500 mg<br />
N<br />
O<br />
286 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
<strong>Pharmac<strong>eu</strong>tical</strong> Impurities<br />
Code Product Category Unit<br />
New MM 0622.01 Imp. A (Pharm<strong>eu</strong>ropa): Diphenylmethanone (Benzophenone)<br />
(B) 100 mg<br />
New MM 0622.02 Imp. B (Pharm<strong>eu</strong>ropa): Diphenylethanedione (Benzil) O<br />
O<br />
(B)<br />
100 mg<br />
O<br />
Pholcodine<br />
MM 0733.01<br />
Imp. A (EP) as Hydrochloride Trihydrate:<br />
Morphine Hydrochloride Trihydrate<br />
[Controlled Substance]<br />
N<br />
x HCl<br />
x 3 H 2 O<br />
(A)<br />
250 mg<br />
HO<br />
O<br />
OH<br />
MM 0733.02<br />
Imp. A (EP) as Hemisulphate Pentahemihydrate: Morphine<br />
Hemisulphate Pentahemihydrate [Controlled Substance]<br />
N<br />
x H 2 SO 4<br />
x 5 H 2 O<br />
(A)<br />
250 mg<br />
HO<br />
O<br />
OH<br />
2<br />
MM 0733.03<br />
Imp. B (EP) as Phosphate Hemihydrate:<br />
Codeine Phosphate Hemihydrate<br />
[Controlled Substance]<br />
N<br />
x H 3 PO 4<br />
x 1/2 H 2 O<br />
(A)<br />
100 mg<br />
O<br />
O<br />
OH<br />
MM 0733.04<br />
Imp. B (EP) as Monohydrate: Codeine Monohydrate<br />
[Controlled Substance]<br />
N<br />
x H 2 O<br />
(A)<br />
100 mg<br />
O<br />
O<br />
OH<br />
Pilocarpine Hydrochloride<br />
MM 0338.00<br />
Pilocarpine Hydrochloride<br />
N<br />
N<br />
O<br />
O<br />
x HCl<br />
(A)<br />
500 mg<br />
MM 0338.01<br />
Imp. A (EP) as Hydrochloride: (3R,4R)-3-Ethyl-4-<br />
[(1-methyl-1H-imidazol-5-yl)methyl]dihydrofuran-<br />
2(3H)-one Hydrochloride (Isopilocarpine<br />
Hydrochloride)<br />
N<br />
N<br />
O<br />
O<br />
x HCl<br />
(A)<br />
100 mg<br />
MM 0338.02<br />
Imp. B (EP) as Sodium Salt: (2S,3R)-2-Ethyl-3-<br />
(hydroxymethyl)-4-(1-methyl-1H-imidazol-5-<br />
yl)butanoic Acid Sodium Salt (Pilocarpic Acid<br />
Sodium Salt)<br />
N<br />
N<br />
OH<br />
O (A) 100 mg<br />
ONa<br />
MM 0338.03<br />
Imp. C (EP) as Sodium Salt: (2R,3R)-2-Ethyl-3-<br />
(hydroxymethyl)-4-(1-methyl-1H-imidazol-5-<br />
yl)butanoic Acid Sodium Salt (Isopilocarpic<br />
Acid Sodium Salt)<br />
N<br />
N<br />
OH<br />
O (A) 100 mg<br />
ONa<br />
Pindolol<br />
MM 0082.00<br />
Pindolol<br />
O<br />
OH<br />
N<br />
H<br />
(A)<br />
250 mg<br />
N<br />
H<br />
MM 0082.01<br />
Imp. E (EP): 1H-Indol-4-ol<br />
OH<br />
(A) 100 mg<br />
N<br />
H<br />
Pipazetate Hydrochloride<br />
MM 0486.06<br />
MM 0486.02<br />
Bis-(2-piperidinoethyl)ether Dihydrochloride (BPEE<br />
Dihydrochloride)<br />
1,2-Dipiperidinoethane (DPE)<br />
N<br />
O<br />
N<br />
N<br />
x 2 HCl<br />
N<br />
(A)<br />
(A)<br />
100 mg<br />
100 mg<br />
MM 0486.05<br />
2-(2-Piperidinoethoxy)ethanol Hydrochloride<br />
HO<br />
O<br />
N<br />
x HCl (A) 100 mg<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 287
<strong>Pharmac<strong>eu</strong>tical</strong> Impurities<br />
Code Product Category Unit<br />
Pipemidic Acid Trihydrate<br />
MM 0401.00 Pipemidic Acid Trihydrate<br />
HN<br />
N N N<br />
x 3 H 2 O<br />
N<br />
OH<br />
(A) 250 mg<br />
Pipenzolate Bromide<br />
MM 0783.00<br />
Pipenzolate Bromide<br />
O O<br />
N + Br - (A) 500 mg<br />
O<br />
O<br />
OH<br />
MM 0783.02<br />
1-Ethyl-3-hydroxy-1-methylpiperidinium Bromide<br />
N + Br - on request<br />
OH<br />
MM 0783.08<br />
Diphenylmethanone (Benzophenone)<br />
O<br />
(B)<br />
100 mg<br />
MM 0783.09 Benzilic Acid O<br />
(B)<br />
100 mg<br />
HO<br />
OH<br />
Piperacillin<br />
MM 0295.00<br />
Piperacillin<br />
O<br />
N<br />
N O<br />
O NH<br />
O<br />
H<br />
N<br />
O<br />
O<br />
N<br />
S<br />
H<br />
OH<br />
(A)<br />
100 mg<br />
Piperacillin Sodium<br />
MM 0296.00<br />
Piperacillin Sodium<br />
O<br />
N<br />
N O<br />
O<br />
O NH<br />
H<br />
N<br />
O<br />
NaO<br />
N<br />
S<br />
H<br />
O<br />
(A)<br />
100 mg<br />
MM 0296.01<br />
Imp. A (EP) as Sodium Salt: Ampicillin Sodium<br />
O<br />
NH 2<br />
H<br />
N<br />
O<br />
NaO<br />
N<br />
S<br />
H<br />
O<br />
(A)<br />
500 mg<br />
MM 0296.05<br />
MM 0296.07<br />
Imp. E (EP): 1-Ethylpiperazine-2,3-dione<br />
Imp. G (EP): (2R)-2-[[(4-Ethyl-2,3-dioxopiperazin-1-yl)-<br />
carbonyl]amino]-2-phenylacetic Acid<br />
NH<br />
O<br />
O<br />
N<br />
N O<br />
O<br />
O NH<br />
OH<br />
O<br />
N (A) 100 mg<br />
(A) 100 mg<br />
MM 0296.08<br />
Imp. H (EP): (2S,5R,6R)-6-Amino-3,3-dimethyl-7-oxo-4-thia-1-<br />
azabicyclo[3.2.0]-heptane-2-carboxylic Acid (6-Aminopenicillanic Acid)<br />
O<br />
N<br />
O<br />
OH (B) 100 mg<br />
H 2 N<br />
S<br />
H<br />
Piprinhydrinate<br />
MM 0155.00<br />
Piprinhydrinate<br />
O<br />
N<br />
O<br />
N<br />
O N<br />
H<br />
N<br />
N<br />
Cl<br />
on request<br />
288 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
<strong>Pharmac<strong>eu</strong>tical</strong> Impurities<br />
Code Product Category Unit<br />
MM 0155.01 Diphenylpyraline<br />
(A) 100 mg<br />
O<br />
N<br />
MM 0155.02<br />
8-Chlorotheophylline<br />
O<br />
N<br />
O N<br />
H<br />
N<br />
N<br />
Cl<br />
(B)<br />
100 mg<br />
MM 0155.03<br />
Diphenylmethanol (Benzhydrol)<br />
OH<br />
(B)<br />
100 mg<br />
Piracetam<br />
MM 0083.00 Piracetam<br />
MM 0083.05 Imp. A (EP): Pyrrolidin-2-one (2-Pyrrolidone)<br />
MM 0083.04 Imp. B (EP): Methyl (2-Oxopyrrolidin-1-yl)acetate<br />
MM 0083.02 Imp. C (EP): Ethyl (2-Oxopyrrolidin-1-yl)acetate<br />
MM 0083.01 Imp. D (EP): (2-Oxopyrrolidin-1-yl)acetic Acid<br />
MM 0083.03 N-Vinyl-2-pyrrolidone<br />
O<br />
N<br />
NH 2<br />
O<br />
NH<br />
O<br />
O<br />
N<br />
O<br />
O<br />
O<br />
N<br />
O<br />
O<br />
O<br />
N<br />
OH<br />
O<br />
N<br />
O<br />
MM 0083.06 2-Chloroacetamide<br />
O<br />
Cl<br />
NH 2<br />
(A)<br />
(B)<br />
(A)<br />
(A)<br />
(A)<br />
(A)<br />
(C)<br />
500 mg<br />
100 mg<br />
100 mg<br />
100 mg<br />
100 mg<br />
100 mg<br />
100 mg<br />
Piroxicam<br />
MM 0084.00<br />
Piroxicam<br />
O O<br />
S<br />
N<br />
H<br />
N<br />
N<br />
(A)<br />
500 mg<br />
OH<br />
O<br />
MM 0084.01 Imp. A (EP): Pyridin-2-amine (2-Pyridylamine)<br />
N NH 2 (B) 100 mg<br />
MM 0084.08<br />
Imp. B (EP): 4-Hydroxy-N-(pyridin-2-yl)-2H-1,2-benzothiazine-3-<br />
carboxamide 1,1-Dioxide<br />
O O<br />
S<br />
NH<br />
H<br />
N<br />
N<br />
(A)<br />
100 mg<br />
MM 0084.09<br />
MM 0084.07<br />
MM 0084.05<br />
MM 0084.10<br />
Imp. C (EP): 4-Hydroxy-2-methyl-2H-1,2-benzothiazine-3-<br />
carboxamide<br />
1,1-Dioxide<br />
Imp. D (EP): Methyl (1,1-Dioxido-3-oxo-1,2-benzisothiazol-2(3H)-<br />
yl)acetate<br />
Imp. E (EP): Ethyl (1,1-Dioxido-3-oxo-1,2-benzisothiazol-2(3H)-<br />
yl)acetate<br />
Imp. F (EP): 1-Methylethyl (1,1-Dioxido-3-oxo-1,2-benzisothiazol-<br />
2(3H)-yl)acetate<br />
OH<br />
O<br />
O O<br />
S<br />
N<br />
OH<br />
O<br />
S O<br />
N<br />
O<br />
O<br />
S O<br />
N<br />
O<br />
O<br />
O O<br />
S<br />
N<br />
O O<br />
O<br />
O<br />
O<br />
O<br />
NH 2<br />
(A) 100 mg<br />
O<br />
(A)<br />
(A)<br />
(A)<br />
100 mg<br />
100 mg<br />
100 mg<br />
MM 0084.04<br />
Imp. G (EP): Methyl 4-Hydroxy- 2H-1,2-benzothiazine-3-carboxylate<br />
1,1-Dioxide<br />
O O<br />
S<br />
NH<br />
O<br />
(A)<br />
100 mg<br />
OH<br />
O<br />
MM 0084.06<br />
Imp. H (EP): Ethyl 4-Hydroxy- 2H-1,2-benzothiazine-3-carboxylate<br />
1,1-Dioxide<br />
O O<br />
S<br />
NH<br />
O<br />
(A)<br />
100 mg<br />
OH<br />
O<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 289
<strong>Pharmac<strong>eu</strong>tical</strong> Impurities<br />
Code Product Category Unit<br />
MM 0084.11<br />
Imp. I (EP): 1-Methylethyl 4-Hydroxy-2H-1,2-benzothiazine-3-<br />
carboxylate 1,1-Dioxide<br />
O O<br />
S<br />
NH<br />
O<br />
(A)<br />
100 mg<br />
OH<br />
O<br />
MM 0084.02<br />
Imp. J (EP): Methyl 4-Hydroxy-2-methyl-2H-1,2-benzothiazine-3-<br />
carboxylate 1,1-Dioxide<br />
O O<br />
S<br />
N<br />
O<br />
(A)<br />
100 mg<br />
OH<br />
O<br />
MM 0084.03<br />
Imp. K (EP): Ethyl 4-Hydroxy-2-methyl-2H-1,2-benzothiazine-3-<br />
carboxylate 1,1-Dioxide<br />
O O<br />
S<br />
N<br />
O<br />
(A)<br />
100 mg<br />
OH<br />
O<br />
MM 0084.12<br />
Imp. L (EP): 1-Methylethyl 4-Hydroxy-2-methyl-2H-1,2-<br />
benzothiazine-3-carboxylate 1,1-Dioxide<br />
O O<br />
S<br />
N<br />
O<br />
(A)<br />
100 mg<br />
OH<br />
O<br />
MM 0084.13<br />
N-Methylsaccharin<br />
O<br />
S O<br />
N<br />
(A)<br />
100 mg<br />
O<br />
MM 0084.15<br />
4-Isopropoxy-2-methyl-N-(2-pyridinyl)-2H-<br />
1,2-benzothiazine-3-carboxamide 1,1-Dioxide<br />
O O<br />
S<br />
N<br />
H<br />
N<br />
N<br />
(A)<br />
100 mg<br />
O<br />
O<br />
MM 0084.16 N,N'-Di-(2-pyridinyl)oxamide<br />
H N N<br />
O<br />
O<br />
N<br />
H<br />
N<br />
(A)<br />
100 mg<br />
MM 0084.17 N-(2-Pyridinyl)oxamic Acid Hydrochloride H<br />
N N<br />
O<br />
O<br />
OH<br />
x HCl<br />
(A)<br />
100 mg<br />
MM 0084.20<br />
2-(1,1-Dioxido-3-oxo-1,2-benzisothiazol-2(3H)-yl)acetamide<br />
O<br />
S O<br />
N<br />
(A)<br />
100 mg<br />
O<br />
O<br />
NH 2<br />
MM 0084.21<br />
N-(6-Methyl-2-pyridyl)-4-hydroxy-2-methyl-2H-1,2-benzothiazine-<br />
3-carboxamide-1,1-Dioxide<br />
O O<br />
S<br />
N<br />
H<br />
N<br />
N<br />
(A)<br />
100 mg<br />
OH<br />
O<br />
MM 0084.22<br />
4-Methoxy-2-methyl-N-(2-pyridyl)-2H-1,2-benzothiazine-3-<br />
carboxamide-1,1-Dioxide<br />
O O<br />
S<br />
N<br />
H<br />
N<br />
N<br />
(A)<br />
50 mg<br />
O<br />
O<br />
MM 0084.23<br />
2-Methyl-N-2-(1-methylpyridinium)-2H-1,2-benzothiazine-3-<br />
carboxamide-4-olate 1,1-Dioxide<br />
O O<br />
S<br />
N<br />
H<br />
N<br />
N<br />
(A)<br />
100 mg<br />
O<br />
O<br />
MM 0084.24<br />
Potassium Sorbate<br />
4-Hydroxy-2H-1,2-benzothiazine-3-carboxamide 1,1-Dioxide<br />
O O<br />
S<br />
NH<br />
MM 0955.00 Potassium Sorbate<br />
O<br />
Povidone<br />
MM 0537.02<br />
Imp. A (EP): 1-Ethenylpyrrolidin-2-one (1-Vinylpyrrolidin-2-one)<br />
OH<br />
O<br />
N<br />
NH 2<br />
(A) 100 mg<br />
OK<br />
O<br />
(A)<br />
(A)<br />
500 mg<br />
100 mg<br />
MM 0537.03 Imp. B (EP): Pyrrolidin-2-one (2-Pyrrolidone)<br />
H<br />
N<br />
O<br />
(B)<br />
100 mg<br />
MM 0537.01 Vinyl Acetate<br />
O<br />
O<br />
(B)<br />
100 mg<br />
Pralidoxime Methyl Sulphate<br />
MM 0689.00<br />
Pralidoxime Methyl Sulphate<br />
N<br />
N OH<br />
O O<br />
O S O<br />
(A)<br />
100 mg<br />
New MM 0689.01<br />
2-Carboxy-N-methylpyridinium Iodide<br />
N<br />
O<br />
OH<br />
I - (A) 100 mg<br />
290 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
<strong>Pharmac<strong>eu</strong>tical</strong> Impurities<br />
Code Product Category Unit<br />
New MM 0689.02<br />
2-Carbamoyl-N-methylpyridinium Methanesulfonate<br />
N<br />
O<br />
(A) 100 mg<br />
NH 2<br />
O O<br />
O S<br />
Prasterone<br />
MM 0651.00 Prasterone<br />
O<br />
(A)<br />
500 mg<br />
HO<br />
New MM 0651.02<br />
16-Dehydropregnenolone Acetate Oxime<br />
N<br />
OH<br />
(A)<br />
100 mg<br />
O<br />
O<br />
Pravastatin Sodium<br />
MM 0503.00<br />
Pravastatin Sodium<br />
O<br />
(A)<br />
100 mg<br />
OH<br />
ONa<br />
H<br />
O<br />
O<br />
OH<br />
OH<br />
MM 0503.04<br />
Imp. D (EP): (1S,3S,7S,8S,8aR)-3-Hydroxy-8-[2-[(2R,4R)-4-<br />
hydroxy-6-oxotetrahydro-2H-pyran-2-yl]ethyl]-7-methyl-<br />
1,2,3,7,8,8a-hexahydronaphthalen-1-yl (2S)-2-Methylbutanoate<br />
(Pravastatin Lactone)<br />
O<br />
(D) 100 mg<br />
O<br />
OH<br />
H<br />
O O<br />
OH<br />
Praziquantel<br />
MM 0615.00 Praziquantel<br />
O<br />
N<br />
H<br />
N<br />
O<br />
(A)<br />
250 mg<br />
MM 0615.02<br />
Imp. B (EP): 2-(Cyclohexylcarbonyl)-<br />
2,3,6,7-tetrahydro-4H-pyrazino[2,1-a]-<br />
isoquinolin-4-one<br />
O<br />
N<br />
N<br />
O<br />
(A)<br />
50 mg<br />
Prazosin Hydrochloride<br />
MM 0085.00<br />
Prazosin Hydrochloride<br />
O<br />
(A)<br />
100 mg<br />
N<br />
O<br />
N<br />
N<br />
O<br />
O<br />
N<br />
x HCl<br />
MM 0085.04 Imp. A (EP): 2-Chloro-6,7-dimethoxyquinazoline-4-amine<br />
O N<br />
MM 0085.05 Imp. B (EP): 1,4-Bis(furan-2-ylcarbonyl)piperazine<br />
NH 2<br />
Cl<br />
(A) 100 mg<br />
N<br />
O<br />
O<br />
O<br />
N<br />
N O<br />
(A) 100 mg<br />
O<br />
MM 0085.01<br />
Imp. C (EP): 6,7-Dimethoxy-2-(piperazin-1-yl)-quinazolin-4-amine<br />
O<br />
O<br />
NH (A) 100 mg<br />
N N<br />
N<br />
NH 2<br />
MM 0085.02<br />
Imp. D (EP): 1-(Furan-2-ylcarbonyl)piperazine<br />
O<br />
(A)<br />
100 mg<br />
N<br />
HN<br />
O<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 291
<strong>Pharmac<strong>eu</strong>tical</strong> Impurities<br />
Code Product Category Unit<br />
MM 0085.03<br />
Imp. E (EP): 2,2'-(Piperazin-1,4-diyl)bis-<br />
(6,7-dimethoxyquinazolin-4-amine<br />
N<br />
NH 2<br />
O<br />
(D)<br />
100 mg<br />
O<br />
N<br />
N<br />
N<br />
N<br />
O<br />
O<br />
N<br />
O<br />
N<br />
MM 0085.06 2,4-Dichloro-6,7-dimethoxyquinazoline<br />
MM 0085.07<br />
6,7-Dimethoxyquinazolin-2,4-dione<br />
NH 2<br />
O<br />
O<br />
Cl<br />
H<br />
N<br />
N<br />
Cl<br />
(A) 100 mg<br />
O<br />
(C)<br />
100 mg<br />
O<br />
NH<br />
O<br />
Prednisolone<br />
MM 0193.00<br />
Prednisolone<br />
HO<br />
O<br />
OH<br />
OH<br />
(A)<br />
500 mg<br />
O<br />
MM 0193.03<br />
Imp. A (EP): Hydrocortisone<br />
HO<br />
O<br />
OH<br />
OH<br />
(A)<br />
500 mg<br />
O<br />
MM 0193.01<br />
(20R)-Hydroxyprednisolone<br />
HO<br />
HO<br />
OH<br />
OH<br />
(D)<br />
50 mg<br />
O<br />
MM 0193.02<br />
(20S)-Hydroxyprednisolone<br />
HO<br />
HO<br />
OH<br />
OH<br />
(D)<br />
50 mg<br />
O<br />
Prednisolone Acetate<br />
MM 0194.00<br />
Prednisolone Acetate<br />
HO<br />
O<br />
O<br />
OH<br />
O<br />
(A) 500 mg<br />
O<br />
MM 0194.01<br />
Imp. A (EP): Hydrocortisone Acetate<br />
HO<br />
O<br />
O<br />
OH<br />
O<br />
(A) 500 mg<br />
O<br />
MM 0194.02<br />
Imp. B (EP): Prednisolone<br />
HO<br />
O<br />
OH<br />
OH<br />
(A)<br />
500 mg<br />
O<br />
New MM 0194.07<br />
Prednienic Acid<br />
HO<br />
O<br />
OH (A) 100 mg<br />
OH<br />
O<br />
MM 0194.04<br />
Prednisolone 17-Acetate<br />
HO<br />
O<br />
O<br />
OH<br />
(A)<br />
100 mg<br />
O<br />
O<br />
Prednisolone Pivalate<br />
MM 0304.00<br />
Prednisolone Pivalate<br />
HO<br />
O<br />
O<br />
OH<br />
O<br />
(D) 250 mg<br />
O<br />
292 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
<strong>Pharmac<strong>eu</strong>tical</strong> Impurities<br />
Code Product Category Unit<br />
Prednisolone Sodium Phosphate<br />
MM 0305.00 Prednisolone Sodium Phosphate<br />
O<br />
HO<br />
O ONa<br />
(A) 100 mg<br />
O P ONa<br />
OH<br />
O<br />
Prednisolone Sodium Sulfobenzoate<br />
MM 0484.01<br />
Sodium 3-Sulfobenzoate<br />
HO<br />
O<br />
O O (C) 100 mg<br />
S ONa<br />
Prednisone<br />
MM 0482.00<br />
Prednisone<br />
O<br />
O<br />
OH<br />
OH<br />
(A)<br />
250 mg<br />
O<br />
Prednisone Acetate<br />
MM 0196.00<br />
Prednisone Acetate<br />
O<br />
O<br />
O<br />
OH<br />
O<br />
(A)<br />
250 mg<br />
O<br />
Prilocaine Hydrochloride<br />
MM 0563.00 Prilocaine Hydrochloride H<br />
N<br />
O<br />
N<br />
H<br />
x HCl<br />
(A)<br />
500 mg<br />
MM 0563.02<br />
Primidone<br />
MM 1030.03<br />
Imp. B (EP): 2-Methylbenzenamine<br />
(o-Toluidine)<br />
Imp. C (EP): (2RS)-2-Phenylbutanamide<br />
NH 2<br />
(A) 100 mg<br />
(A) 100 mg<br />
NH 2<br />
O<br />
MM 1030.05<br />
Imp. E (EP): (2RS)-2-Phenylbutanoic Acid<br />
OH<br />
(A)<br />
100 mg<br />
O<br />
Probenecid<br />
MM 0657.00<br />
Probenecid<br />
N<br />
S<br />
O O<br />
O<br />
OH<br />
(A)<br />
500 mg<br />
Procainamide Hydrochloride<br />
MM 0550.00<br />
Procainamide Hydrochloride<br />
H 2N<br />
O<br />
N<br />
H<br />
N<br />
x HCl<br />
(A)<br />
500 mg<br />
MM 0550.02<br />
Procainamide N-Oxide Dihydrochloride<br />
H 2 N<br />
O<br />
N<br />
H<br />
O<br />
N<br />
x 2 HCl<br />
(A)<br />
100 mg<br />
Procaine Hydrochloride<br />
MM 0596.00<br />
Procaine Hydrochloride<br />
O<br />
O<br />
N<br />
x HCl<br />
(A)<br />
500 mg<br />
H 2N<br />
MM 0596.01<br />
4-Aminobenzoic Acid<br />
O<br />
(B)<br />
100 mg<br />
OH<br />
H 2 N<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 293
<strong>Pharmac<strong>eu</strong>tical</strong> Impurities<br />
Code Product Category Unit<br />
Progesterone<br />
MM 0222.00<br />
Progesterone<br />
O<br />
(A) 500 mg<br />
O<br />
MM 0222.02<br />
Imp. A (EP): Pregna-4,14-diene-3,20-dione<br />
O<br />
(D) 50 mg<br />
O<br />
MM 0222.03<br />
Imp. C (EP): (20R)-20-Hydroxypregn-4-en-3-one<br />
HO<br />
(A) 100 mg<br />
O<br />
MM 0222.01<br />
Imp. E (EP): (20R)-3-Oxopregn-4-en-20-yl Acetate<br />
O<br />
(D) 100 mg<br />
O<br />
O<br />
MM 0222.08<br />
11α-Hydroxyprogesterone<br />
O<br />
(A)<br />
100 mg<br />
HO<br />
O<br />
MM 0222.12<br />
11-Ketoprogesterone<br />
O<br />
(A)<br />
100 mg<br />
O<br />
O<br />
MM 0222.14<br />
Pregnanediol (5β-Pregnane-3α,20(S)-diol)<br />
HO<br />
(A)<br />
100 mg<br />
HO<br />
H<br />
MM 0222.15<br />
Pregnanetriol (5β-Pregnane-3α,17,20(S)-triol)<br />
HO<br />
(A)<br />
50 mg<br />
OH<br />
Proguanil Hydrochloride<br />
HO<br />
H<br />
MM 0840.02 Imp. B (EP): 4-Chloroaniline<br />
Cl<br />
NH 2<br />
(B) 100 mg<br />
Prolintane Hydrochloride<br />
MM 0663.00<br />
Prolintane Hydrochloride<br />
(A)<br />
100 mg<br />
N<br />
x HCl<br />
Promazine Hydrochloride<br />
MM 0290.00<br />
Promazine Hydrochloride<br />
N<br />
(A)<br />
500 mg<br />
N<br />
x HCl<br />
S<br />
MM 0290.01<br />
Imp. A (EP): 3-(10H-Phenothiazin-10-yl)-N,N-dimethylpropan-1-amine<br />
S-Oxide (Promazine Sulphoxide)<br />
N<br />
N<br />
(A)<br />
100 mg<br />
S<br />
O<br />
MM 0290.02<br />
MM 0290.03<br />
N,N-Dimethyl-3-chloropropylamine Hydrochloride<br />
Phenothiazine<br />
Cl N x HCl<br />
(B) 100 mg<br />
H<br />
N (B) 100 mg<br />
S<br />
294 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
<strong>Pharmac<strong>eu</strong>tical</strong> Impurities<br />
Code Product Category Unit<br />
Promethazine Hydrochloride<br />
MM 0412.00 Promethazine Hydrochloride<br />
(A) 500 mg<br />
N<br />
N<br />
x HCl<br />
S<br />
MM 0412.01<br />
Imp. A (EP): Phenothiazine<br />
(B)<br />
100 mg<br />
S<br />
NH<br />
New MM 0412.02<br />
Imp. B (EP) as Hydrochloride: (2RS)-N,N-<br />
Dimethyl-2-(10H-phenothiazin-10-yl)propan-<br />
1-amine Hydrochloride (Isopromethazine<br />
Hydrochloride)<br />
S<br />
N<br />
N<br />
x HCl<br />
(A)<br />
100 mg<br />
MM 0412.04<br />
Imp. D (EP): (2RS)-N,N-Dimethyl-1-(10H-phenothiazin-10-yl)propan-<br />
2-amine S-Oxide (Promethazine Sulphoxide)<br />
S<br />
O<br />
N<br />
N<br />
(A)<br />
100 mg<br />
MM 0412.05<br />
Promethazine Sulphoxide N-Oxide Hydrochloride<br />
S<br />
O<br />
N<br />
O<br />
N<br />
x HCl<br />
(A)<br />
100 mg<br />
New MM0412.06<br />
(2RS)-N-Methyl-2-(10H-phenothiazin-10-yl)propan-1-amine<br />
Hydrochloride (Norisopromethazine Hydrochloride)<br />
S<br />
N<br />
H<br />
N<br />
x HCl<br />
(A)<br />
100 mg<br />
Propafenone Hydrochloride<br />
MM 0405.00 Propafenone Hydrochloride O O<br />
OH<br />
N<br />
H<br />
x HCl<br />
(A)<br />
500 mg<br />
MM 0405.01<br />
5-Hydroxypropafenone Hydrochloride<br />
O<br />
O<br />
OH<br />
N<br />
H<br />
x HCl<br />
(A)<br />
100 mg<br />
OH<br />
Propentofylline<br />
MM 0875.01<br />
3-Methyl-7-propylxanthine<br />
O<br />
(A)<br />
100 mg<br />
HN<br />
N<br />
O<br />
N<br />
N<br />
MM 0875.02<br />
1-(3-Hydroxypropyl)-3-methyl-7-propylxanthine<br />
O<br />
(A)<br />
100 mg<br />
HO<br />
N<br />
N<br />
O<br />
N<br />
N<br />
MM 0875.03<br />
1,7-Bis-(5-oxohexyl)-3-methylxanthine<br />
O<br />
(A) 100 mg<br />
O<br />
N<br />
O<br />
N<br />
O<br />
N<br />
N<br />
Propofol<br />
MM 0461.00 Propofol<br />
OH<br />
(A) 250 mg<br />
MM 0461.03 Imp. A (EP): 2,4-Bis(1-methylethyl)phenol<br />
OH<br />
(A) 100 mg<br />
MM 0461.04 Imp. C (EP): 2-(1-Methylethyl)phenol<br />
OH<br />
(C) 100 mg<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 295
<strong>Pharmac<strong>eu</strong>tical</strong> Impurities<br />
Code Product Category Unit<br />
MM 0461.02 Imp. E (EP): 3,3',5,5'-Tetrakis(1-Methylethyl)bisphenyl-4,4'-diol<br />
(A) 100 mg<br />
HO<br />
OH<br />
MM 0461.05 Imp. F (EP): 3-(1-Methylethyl)phenol<br />
HO<br />
(C)<br />
100 mg<br />
MM 0461.08<br />
Imp. G (EP): 2-(1-Methylethoxy)-1,3-bis(1-methylethyl)benzene<br />
(A)<br />
100 mg<br />
O<br />
MM 0461.06 Imp. H (EP): 4-(1-Methylethyl)phenol<br />
HO<br />
(C) 100 mg<br />
MM 0461.07 Imp. I (EP): Oxydibenzene<br />
O<br />
(B) 100 mg<br />
MM 0461.11<br />
Imp. K (EP): 1-(1-Methylethoxy)-2-(1-methylethyl)benzene<br />
O<br />
(A)<br />
100 mg<br />
Propranolol Hydrochloride<br />
MM 0043.00<br />
Propranolol Hydrochloride<br />
O<br />
OH H<br />
N x HCl<br />
(A)<br />
500 mg<br />
MM 0043.01<br />
Imp. A (EP): (2RS)-3-(Naphthalen-1-<br />
yloxy)propane-1,2-diol (Diol Derivative)<br />
O<br />
OH<br />
OH<br />
(A)<br />
100 mg<br />
MM 0043.03<br />
Imp. B (EP) as Hydrochloride: 1,1'-[(1-<br />
Methylethyl)imino]bis[3-(naphthalen-1-<br />
yloxy)propan-2-ol] Hydrochloride<br />
(Tertiary Amine Derivative Hydrochloride)<br />
O<br />
OH<br />
N<br />
x HCl<br />
OH<br />
O<br />
(A)<br />
100 mg<br />
MM 0043.04 1-Naphthol<br />
OH<br />
(B) 100 mg<br />
MM 0043.05 1-(1-Naphtyloxy)-2,3-epoxypropane O<br />
O<br />
(A)<br />
100 mg<br />
Propyl Gallate<br />
MM 1037.00<br />
Propyl Gallate<br />
HO<br />
O<br />
(A) 500 mg<br />
O<br />
Propyl Parahydroxybenzoate<br />
HO<br />
OH<br />
MM 0432.00<br />
Propyl Parahydroxybenzoate<br />
O<br />
(A) 500 mg<br />
O<br />
HO<br />
MM 0432.02<br />
Imp. A (EP): 4-Hydroxybenzoic Acid<br />
O<br />
(B) 100 mg<br />
OH<br />
HO<br />
MM 0432.03<br />
Imp. B (EP): Methyl 4-Hydroxybenzoate<br />
O<br />
(A) 500 mg<br />
O<br />
HO<br />
MM 0432.04<br />
Imp. C (EP): Ethyl 4-Hydroxybenzoate<br />
O<br />
(A) 500 mg<br />
O<br />
HO<br />
MM 0432.05<br />
Imp. D (EP): Butyl 4-Hydroxybenzoate<br />
O<br />
(A) 500 mg<br />
O<br />
HO<br />
MM 0432.01<br />
Sodium Propyl Parahydroxybenzoate<br />
O<br />
(B) 100 mg<br />
O<br />
NaO<br />
296 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
<strong>Pharmac<strong>eu</strong>tical</strong> Impurities<br />
Code Product Category Unit<br />
Propylhexidrine Hydrochloride<br />
MM 0664.00<br />
Propylhexidrine Hydrochloride<br />
NH<br />
x HCl (A) 100 mg<br />
Propyphenazone<br />
MM 0036.00<br />
Propyphenazone<br />
O (A) 500 mg<br />
N<br />
N<br />
MM 0036.05<br />
Imp. A (EP): Phenazone<br />
O (A) 100 mg<br />
N<br />
N<br />
Proxymetacaine Hydrochloride<br />
MM 0404.00<br />
Proxymetacaine Hydrochloride<br />
H 2 N<br />
O<br />
O<br />
N<br />
x HCl<br />
(A)<br />
500 mg<br />
O<br />
MM 0404.01<br />
3-Amino-4-propoxybenzoic Acid Hydrochloride<br />
H 2 N<br />
O<br />
OH<br />
x HCl<br />
(A)<br />
100 mg<br />
O<br />
MM 0404.02<br />
Proxymetacaine N-Oxide Dihydrochloride<br />
H 2 N<br />
O<br />
O<br />
N<br />
O<br />
x 2 HCl<br />
(A)<br />
100 mg<br />
O<br />
Ps<strong>eu</strong>doephedrine Hydrochloride<br />
MM 2115.01<br />
Methcathinone Hydrochloride<br />
(2-Methylamino-1-phenylpropan-1-one Hydrochloride)<br />
[Controlled Substance]<br />
O<br />
NH<br />
x HCl<br />
(A)<br />
100 mg<br />
Pyrazinamide<br />
MM 0385.00<br />
Pyrazinamide<br />
N<br />
O<br />
on request<br />
NH 2<br />
N<br />
MM 0385.01<br />
Imp. A (EP): Pyrazine-2-carboxylic Acid<br />
N<br />
O<br />
(A) 100 mg<br />
OH<br />
N<br />
Pyridostigmine Bromide<br />
MM 0429.02<br />
Imp. B (EP) as Iodide: 3-Hydroxy-1-methylpyridinium<br />
Iodide<br />
HO<br />
N +<br />
I -<br />
(A)<br />
100 mg<br />
Pyridoxine Hydrochloride<br />
MM 0021.00<br />
Pyridoxine Hydrochloride<br />
N<br />
(A)<br />
500 mg<br />
HO<br />
OH<br />
x HCl<br />
OH<br />
MM 0021.02<br />
Imp. B (EP) as Hydrochloride: 5-(Hydroxymethyl)-2,4-<br />
dimethylpyridin-3-ol Hydrochloride<br />
HO<br />
N<br />
OH x HCl (A) 100 mg<br />
MM 0021.03 Pyridoxine Diacetate<br />
N<br />
HO<br />
O<br />
O<br />
O<br />
(A)<br />
100 mg<br />
O<br />
MM 0021.05 Pyridoxal Hydrochloride<br />
N<br />
(A)<br />
100 mg<br />
HO<br />
OH<br />
x HCl<br />
O<br />
MM 0021.06 Pyridoxamine Dihydrochloride<br />
N<br />
(A)<br />
100 mg<br />
HO<br />
OH<br />
x 2 HCl<br />
NH 2<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 297
<strong>Pharmac<strong>eu</strong>tical</strong> Impurities<br />
Code Product Category Unit<br />
MM 0021.07 4-Pyridoxic Acid<br />
N<br />
Quinapril Hydrochloride<br />
MM 0628.00<br />
Quinapril Hydrochloride<br />
O<br />
O<br />
N<br />
H<br />
HO<br />
N<br />
O<br />
O<br />
O<br />
OH<br />
OH<br />
OH<br />
x HCl<br />
(D)<br />
50 mg<br />
on request<br />
MM 0628.01 4-Amino-6-chlorobenzene-1,3-disulphonamide<br />
O O O O<br />
(B) 100 mg<br />
S<br />
H 2 N<br />
S NH2<br />
Cl NH 2<br />
Quinine Dihydrochloride<br />
MM 0458.00<br />
Quinine Dihydrochloride<br />
H<br />
(A)<br />
500 mg<br />
O<br />
HO<br />
N<br />
H<br />
x 2 HCl<br />
N<br />
Quinuclidinyl Benzilate<br />
MM 0825.01<br />
Benzilic Acid<br />
HO<br />
O<br />
OH<br />
(B)<br />
100 mg<br />
MM 0825.02 3-Quinuclidinol<br />
N<br />
(A)<br />
100 mg<br />
Rabeprazole Sodium<br />
MM 0618.01<br />
Rabeprazole Sodium<br />
OH<br />
O<br />
on request<br />
O<br />
MM0618.00<br />
Rabeprazole<br />
Na<br />
N<br />
N<br />
S<br />
O<br />
N<br />
O<br />
on request<br />
O<br />
MM 0618.02<br />
MM 0618.03<br />
MM 0618.04<br />
MM 0618.05<br />
2-[[[4-(3-Methoxypropoxy)-3-methyl-2-<br />
pyridinyl]methyl]thio]-1H-benzimidazole<br />
Rabeprazole Sulphone<br />
Rabeprazole N-Oxide<br />
Rabeprazole Sulphone N-Oxide<br />
H<br />
N<br />
N<br />
H<br />
N<br />
N<br />
H<br />
N<br />
N<br />
H<br />
N<br />
N<br />
H<br />
N<br />
N<br />
S<br />
O<br />
S<br />
N<br />
N<br />
O<br />
O<br />
(A) 100 mg<br />
(A) 100 mg<br />
N<br />
O<br />
O<br />
O<br />
O<br />
S<br />
O<br />
S<br />
N<br />
O<br />
O<br />
O<br />
S<br />
N<br />
O<br />
O<br />
O<br />
O<br />
O<br />
(D)<br />
(A)<br />
100 mg<br />
100 mg<br />
MM 0618.07<br />
2-Chloromethyl-3-methyl-4-(3-methoxy-propoxy)pyridine<br />
Hydrochloride<br />
Cl<br />
O<br />
O<br />
x HCl<br />
(A)<br />
100 mg<br />
N<br />
298 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
<strong>Pharmac<strong>eu</strong>tical</strong> Impurities<br />
Code Product Category Unit<br />
Raloxifene Hydrochloride<br />
HO<br />
MM 0738.00 Raloxifene Hydrochloride S<br />
OH<br />
x HCl<br />
(A)<br />
100 mg<br />
O<br />
O<br />
N<br />
Ramipril<br />
MM 0448.02<br />
Imp. F (EP): (2S)-2-[[(S)-1-(Ethoxycarbonyl)-3-<br />
phenylpropyl]amino]propanoic Acid<br />
H<br />
N<br />
O<br />
OH<br />
(A)<br />
100 mg<br />
O<br />
O<br />
MM 0448.03 Imp. G (EP): Toluene (C) 100 mg<br />
MM 0448.04<br />
Ranitidine Hydrochloride<br />
Imp. M (EP): (2R,3R)-2,3-Di(benzoyloxy)butanedioic Acid<br />
(Dibenzoyltartric Acid)<br />
MM 0086.00 Ranitidine Hydrochloride O<br />
MM 0086.02<br />
MM 0086.01<br />
MM 0086.03<br />
MM 0086.06<br />
MM 0086.05<br />
MM 0086.04<br />
MM 0086.07<br />
Imp. A (EP): N,N'-Bis[2-[[[5-<br />
[(dimethylamino)methyl]furan-2-yl]-<br />
methyl]sulphanyl]ethyl]-2-nitroethene-1,1-<br />
diamine<br />
Imp. B (EP): 2-[[[5-[(Dimethylamino)methyl]-<br />
furan-2-yl]methyl]sulphanyl]ethanamine<br />
Imp. C (EP): N-[2-[[[5-[(Dimethylamino)-<br />
methyl]furan-2-yl]methyl]sulphinyl]ethyl]-N'-<br />
methyl-2-nitroethene-1,1-diamine<br />
(Ranitidine Sulphoxide)<br />
Imp. D (EP) as Sodium Salt: N-[2-[[[5-<br />
[(Dimethylamino)methyl]furan-2-yl]-<br />
methyl]sulphanyl]ethyl]-2-nitroacetamide<br />
Sodium Salt<br />
Imp. E (EP): N-[2-[[[5-[(Dimethyloxidoamino)<br />
methyl]furan-2-yl]methyl]sulphanyl]<br />
ethyl]-N'-methyl-2-nitroethene-1,1-diamine<br />
(Ranitidine N-Oxide)<br />
Imp. F (EP): [5-[(Dimethylamino)methyl]-<br />
furan-2-yl]methanol<br />
Imp. G (EP): 3-(Methylamino)-5,6-dihydro-2H-1,4-thiazin-2-one Oxime<br />
N<br />
N<br />
O<br />
S<br />
N<br />
N<br />
O<br />
N<br />
H<br />
N<br />
S<br />
O<br />
O<br />
O<br />
O<br />
O<br />
HO<br />
H<br />
N<br />
NO 2<br />
N<br />
O<br />
H<br />
N<br />
S<br />
O<br />
S<br />
O<br />
S<br />
S<br />
O<br />
OH<br />
O<br />
O<br />
(A)<br />
100 mg<br />
H<br />
N<br />
NO 2<br />
(A) 500 mg<br />
x HCl<br />
O<br />
S<br />
H<br />
N<br />
H<br />
N<br />
H<br />
N<br />
N<br />
(A)<br />
100 mg<br />
NH 2 (A) 100 mg<br />
H<br />
N (A) 100 mg<br />
NO 2<br />
ONa (A) 100 mg<br />
NO 2<br />
H<br />
N (D) 100 mg<br />
NO 2<br />
O<br />
N OH (A) 100 mg<br />
S<br />
N OH (A) 100 mg<br />
N<br />
N<br />
H<br />
MM 0086.08<br />
Imp. H (EP): N-Methyl-2-nitroacetamide<br />
NO 2<br />
(A) 100 mg<br />
MM 0086.12<br />
Imp. K (EP): N-Methyl-1-methylthio-2-nitroethenamine<br />
O<br />
N<br />
H<br />
NO 2<br />
(A) 100 mg<br />
S<br />
N<br />
H<br />
Reagents<br />
MM 0334.01<br />
Diethylhexylphthalate (Bis-(2-ethylhexyl) Phthalate)<br />
O<br />
O<br />
O<br />
(C)<br />
500 mg<br />
O<br />
MM 0334.02<br />
3-(N-Morpholino)propane Sulfonic Acid (MOPS)<br />
O<br />
N<br />
S OH<br />
O O<br />
(C)<br />
500 mg<br />
MM 0334.03<br />
3-(N-Morpholino)ethane Sulfonic Acid (MES)<br />
O<br />
N<br />
O O<br />
(C) 500 mg<br />
S<br />
OH<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 299
N<br />
N<br />
H<br />
N N<br />
H<br />
<strong>Pharmac<strong>eu</strong>tical</strong> Impurities<br />
Code Product Category Unit<br />
New MM 0334.08<br />
Salicylaldehyde Azine<br />
HO<br />
(A)<br />
100 mg<br />
N<br />
N<br />
OH<br />
Ribavirin<br />
MM 0542.00<br />
MM 0542.01<br />
MM 0542.03<br />
Ribavirin<br />
Imp. A (EP): 1-β-D-Ribofuranosyl-1H-1,2,4-triazole-3-carboxylic Acid<br />
Imp. C (EP): 1H-1,2,4-Triazole-3-carboxylic Acid<br />
O<br />
(A) 250 mg<br />
H 2 N N<br />
HO N<br />
N<br />
O<br />
OH OH<br />
O<br />
(D) 100 mg<br />
HO N<br />
HO N<br />
N<br />
O<br />
OH OH<br />
O<br />
(D) 100 mg<br />
HO N<br />
MM 0542.04<br />
Imp. D (EP): 1H-1,2,4-Triazole-3-carboxamide<br />
H 2N<br />
O<br />
(D) 100 mg<br />
N<br />
MM 0542.05<br />
MM 0542.06<br />
Riboflavin<br />
Imp. E (EP): 1-(5-O-Benzoyl-β-D-ribofuranosyl)-1H-1,2,4-triazole-3-<br />
carboxamide (5'-O-Benzoylribavirin)<br />
Imp. F (EP): 1-(5-O-Acetyl-β-D-ribofuranosyl)-1H-1,2,4-triazole-3-<br />
carboxamide (5'-O-Acetylribavirin)<br />
O<br />
(D) 100 mg<br />
H 2 N N<br />
O N<br />
N<br />
O O<br />
OH OH<br />
O<br />
(D) 100 mg<br />
H 2 N N<br />
O N<br />
N<br />
O O<br />
OH OH<br />
MM 0030.00<br />
Riboflavin<br />
HO<br />
OH<br />
OH<br />
(A)<br />
500 mg<br />
OH<br />
N<br />
N<br />
O<br />
N<br />
O<br />
NH<br />
Rifampicin<br />
New MM 0514.02<br />
3-Formylrifamycin Isonicotinylhydrazone<br />
N<br />
H<br />
N<br />
N<br />
O<br />
OH<br />
O<br />
O<br />
(D)<br />
100 mg<br />
O<br />
HN<br />
O<br />
OH<br />
OH<br />
O<br />
O<br />
OH<br />
O<br />
OH<br />
Risperidone<br />
MM 0491.00<br />
Risperidone<br />
N<br />
on request<br />
N<br />
N<br />
F<br />
O<br />
N<br />
O<br />
MM 0491.10<br />
Imp. H (EP): 3-[2-[4-(2,4-Difluorobenzoyl)piperidin-1-<br />
yl]ethyl]-2-methyl-6,7,8,9-tetrahydro-4H-pyrido-[1,2-<br />
a]pyrimidin-4-one<br />
N<br />
N<br />
O<br />
N<br />
F<br />
(A)<br />
100 mg<br />
O<br />
F<br />
MM 0491.13<br />
3-(2-Chloroethyl)-2-methyl-6,7,8,9-tetrahydro-4H-pyrido[1,2-<br />
a]pyrimidin-4-one Hydrochloride<br />
N<br />
N<br />
Cl<br />
x HCl<br />
(A)<br />
100 mg<br />
O<br />
300 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
<strong>Pharmac<strong>eu</strong>tical</strong> Impurities<br />
Code Product Category Unit<br />
Ritodrine Hydrochloride<br />
MM 0800.01<br />
Imp. A (BP): Tyramine<br />
NH 2<br />
(B) 100 mg<br />
HO<br />
Ronidazole<br />
MM 1026.01<br />
(1-Methyl-5-nitroimidazol-2-yl)methanol<br />
O 2 N<br />
N<br />
N<br />
OH<br />
(A)<br />
100 mg<br />
Rosiglitazone Maleate<br />
MM 0522.01<br />
Rosiglitazone Maleate<br />
N<br />
N<br />
O<br />
O<br />
N<br />
H<br />
S<br />
O<br />
x<br />
O<br />
OH<br />
OH<br />
O<br />
on request<br />
Rutoside Trihydrate<br />
MM 0109.03<br />
Imp. C (EP) as Dihydrate: 2-(3,4-Dihydroxyphenyl)-<br />
3,5,7-trihydroxy-4H-1-benzopyran-4-one Dihydrate<br />
(Quercetin Dihydrate)<br />
HO<br />
O<br />
HO<br />
O<br />
OH<br />
x 2 H 2 O<br />
(A)<br />
100 mg<br />
OH<br />
OH<br />
Saccharin Sodium<br />
MM 0818.00<br />
Saccharin Sodium<br />
O<br />
O<br />
S<br />
NNa<br />
(A)<br />
500 mg<br />
O<br />
Salbutamol Sulphate<br />
MM 0381.00<br />
Salbutamol Sulphate<br />
(A)<br />
500 mg<br />
HO<br />
x H 2 SO 4<br />
OHOH<br />
HN<br />
2<br />
MM 0381.03<br />
Imp. C (EP): (1RS)-2-[(1,1-Dimethylethyl)amino]-1-(4-hydroxy-3-<br />
methylphenyl)ethanol<br />
OH<br />
H<br />
N<br />
(A)<br />
50 mg<br />
HO<br />
MM 0381.08<br />
Imp. H (EP): 4-[2-[1,1-Dimethylethyl)amino]ethyl]-2-methylphenol<br />
H<br />
N (A) 100 mg<br />
HO<br />
Salicylic Acid<br />
MM 0045.00<br />
Salicylic Acid<br />
O<br />
(A) 500 mg<br />
OH<br />
OH<br />
MM 0045.01<br />
Imp. A (EP): 4-Hydroxybenzoic Acid<br />
O<br />
(B)<br />
100 mg<br />
HO<br />
OH<br />
MM 0045.02<br />
Imp. B (EP): 4-Hydroxyisophthalic Acid<br />
HO<br />
O<br />
O<br />
(A) 100 mg<br />
OH<br />
OH<br />
MM 0045.11<br />
Imp. C (EP): Phenol<br />
(B)<br />
100 mg<br />
OH<br />
MM 0045.12<br />
Imidazole Salicylate<br />
O<br />
O<br />
H<br />
N<br />
(A)<br />
100 mg<br />
OH<br />
N<br />
H<br />
MM 0045.13<br />
Choline Salicylate<br />
O<br />
O<br />
N<br />
OH<br />
on request<br />
OH<br />
MM 0045.14<br />
N,N-Diethylsalicylamide<br />
O<br />
(A) 100 mg<br />
N<br />
OH<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 301
<strong>Pharmac<strong>eu</strong>tical</strong> Impurities<br />
Code Product Category Unit<br />
Secnidazole<br />
MM 0119.00<br />
Secnidazole<br />
O 2N<br />
N<br />
N<br />
OH<br />
(A) 100 mg<br />
MM 0119.02 2-Methyl-5-nitroimidazole NH<br />
O 2 N<br />
(B) 100 mg<br />
Selegiline Hydrochloride<br />
MM 0216.03<br />
Sertraline Hydrochloride<br />
Imp. C (EP) as Hydrochloride: (1RS, 2SR)-2-<br />
Amino-1-phenylpropan-1-ol Hydrochloride<br />
(Phenylpropanolamine Hydrochloride)<br />
OH<br />
<strong>and</strong> enatiomer<br />
MM 0317.01 Sertraline Hydrochloride HN<br />
NH 2<br />
N<br />
x HCl<br />
(A)<br />
(A)<br />
500 mg<br />
100 mg<br />
x HCl<br />
MM 0317.00 Sertraline HN<br />
Cl<br />
Cl<br />
(A)<br />
100 mg<br />
MM 0317.08<br />
MM 0317.09<br />
Imp. E (Pharm<strong>eu</strong>ropa): M<strong>and</strong>elic Acid<br />
Imp. F (Pharm<strong>eu</strong>ropa): 4-(3,4-Dichlorophenyl)-3,4-dihydro-1(2H)-<br />
naphthalenone (Sertraline Tetralone Derivative)<br />
Cl<br />
Cl<br />
O (A) 100 mg<br />
OH<br />
OH<br />
O<br />
(A) 100 mg<br />
Cl<br />
Cl<br />
Sibutramine Hydrochloride<br />
MM 0991.02 N-Monodesmethylsibutramine Hydrochloride<br />
Cl<br />
HN<br />
(A)<br />
100 mg<br />
x HCl<br />
MM 0991.03 N,N-Didesmethylsibutramine Hydrochloride<br />
Cl<br />
NH 2<br />
(A)<br />
100 mg<br />
x HCl<br />
Sildenafil Citrate<br />
MM 0254.00<br />
MM 0254.09<br />
MM 0254.01<br />
MM 0254.02<br />
Sildenafil Citrate<br />
Sildenafil<br />
4-[[2-Ethoxy-5-[(4-methyl-1-piperazinyl)-<br />
sulfonyl]benzoyl]amino]-1-methyl-3-propyl-1Hpyrazole-5-carboxamide<br />
N<br />
O O<br />
S<br />
N<br />
2-Ethoxy-5-[(4-methyl-1-piperazinyl)sulfonyl]benzoic Acid<br />
N<br />
HN<br />
N<br />
O<br />
O<br />
N<br />
O O<br />
S<br />
N<br />
N<br />
N<br />
O O<br />
S<br />
N<br />
N<br />
O<br />
O<br />
O<br />
HO<br />
x HO<br />
HO<br />
HN<br />
O<br />
H 2 N<br />
N<br />
H<br />
O O<br />
S<br />
N<br />
N<br />
O<br />
N<br />
N<br />
O<br />
OH<br />
on request<br />
O<br />
on request<br />
O<br />
N<br />
N<br />
O<br />
(A)<br />
100 mg<br />
O<br />
(A) 100 mg<br />
OH<br />
302 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
<strong>Pharmac<strong>eu</strong>tical</strong> Impurities<br />
Code Product Category Unit<br />
MM 0254.04<br />
MM 0254.05<br />
Sildenafil N-Oxide<br />
4-Amino-1-methyl-3-propyl-1H-pyrazole-5-carboxamide<br />
O<br />
N<br />
O O<br />
S<br />
N<br />
HN<br />
O<br />
H 2 N<br />
O<br />
N<br />
H 2 N<br />
N<br />
N<br />
N<br />
N<br />
(A)<br />
100 mg<br />
O<br />
(A) 100 mg<br />
MM 0254.06<br />
3-(4,7-Dihydro-1-methyl-7-oxo-3-propyl-1H-pyrazolo[4,3-<br />
d]pyrimidin-5-yl)-4-ethoxy-benzenesulfonic Acid<br />
O O<br />
S<br />
HO<br />
HN<br />
O<br />
on request<br />
N<br />
N<br />
N<br />
MM 0254.08<br />
MM 0254.11<br />
1-[[3-(4,7-Dihydro-1-methyl-7-oxo-3-propyl-1H-<br />
pyrazolo[4,3-d]pyrimidin-5-yl)-4-<br />
ethoxyphenyl]sulfonyl]piperazine<br />
(Desmethylsildenafil)<br />
3-(4,7-Dihydro-1-methyl-7-oxo-3-propyl-1H-pyrazolo[4,3-<br />
d]pyrimidin-5-yl)-4-ethoxy-N-[2-(methylamino)ethyl]-<br />
benzenesulfonamide<br />
MM 0254.21 2-Ethoxy-5-(4-methylpiperazine-1-sulfonyl)benzaldehyde (1-<br />
[(4-Ethoxy-3-formylphenyl)sulfonyl]-4-methylpiperazine)<br />
MM 0254.22<br />
Silybin<br />
MM 0472.00<br />
Desethylsildenafil (5-[2-Hydroxy-5-(4-<br />
methylpiperazinylsulfonyl)phenyl]-1-methyl-3-n-propyl-<br />
1,6-dihydro-7H-pyrazolo[4,3-d]pyrimidin-7-one<br />
Silybin<br />
HN<br />
N<br />
HO<br />
NH<br />
O O<br />
S<br />
N<br />
O O<br />
S<br />
N<br />
H<br />
N<br />
O O<br />
S<br />
N<br />
O<br />
O<br />
HN<br />
O<br />
HN<br />
O<br />
O O<br />
S<br />
N<br />
HN<br />
OH<br />
O<br />
O<br />
O<br />
(D) 100 mg<br />
N<br />
N<br />
N<br />
N<br />
N<br />
O<br />
(D) 100 mg<br />
N<br />
N<br />
O<br />
(A) 100 mg<br />
O<br />
O<br />
(D) 100 mg<br />
N<br />
N<br />
OH on request<br />
O<br />
OH<br />
O<br />
OH<br />
OH<br />
Simvastatin<br />
MM 0158.00<br />
Simvastatin<br />
O<br />
O<br />
(A)<br />
100 mg<br />
H O<br />
O<br />
OH<br />
MM 0158.01<br />
Imp. A (EP) as Sodium Salt: (3R,5R)-7-[(1S,2S,6R,8S,8aR)-8-<br />
[(2,2-Dimethylbutanoyl)oxy]-2,6-dimethyl-1,2,6,7,8,8ahexahydronaphthalen-1-yl]-3,5-dihydroxyheptanoic<br />
Acid<br />
OH<br />
Sodium Salt (Simvastatin Hydroxy Acid Sodium Salt) H<br />
O O<br />
O<br />
OH<br />
ONa<br />
(A)<br />
100 mg<br />
MM 0158.02<br />
Imp. B (EP): (1S,3R,7S,8S,8aR)-8-[2-[(2R,4R)-4-(Acetyloxy)-6-<br />
oxotetrahydro-2H-pyran-2-yl]ethyl]-3,7-dimethyl-1,2,3,7,8,8ahexahydronaphthalen-1-yl<br />
2,2-Dimethylbutanoate (Simvastatin<br />
Acetate Ester)<br />
O<br />
O<br />
H O O<br />
O<br />
O<br />
(A)<br />
100 mg<br />
MM 0158.03<br />
O<br />
Imp. C (EP): (1S,3R,7S,8S,8aR)-3,7-Dimethyl-8-[2-[(2R)-6-oxo-3,6-<br />
(A) 100 mg<br />
dihydro-2H-pyran-2-yl]ethyl]-1,2,3,7,8,8a-hexahydronaphthalen-1-yl<br />
O<br />
2,2-Dimethylbutanoate (Anhydrosimvastatin)<br />
H O O<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 303
<strong>Pharmac<strong>eu</strong>tical</strong> Impurities<br />
Code Product Category Unit<br />
MM 0158.05<br />
O<br />
Imp. E (EP): (1S,3R,7S,8S,8aR)-8-[2-[(2R,4R)-4-Hydroxy-6-<br />
oxotetrahydro-2H-pyran-2-yl]ethyl]-3,7-dimethyl-1,2,3,7,8,8ahexahydronaphthalen-1-yl<br />
(2S)-2-Methylbutanoate (Lovastatin)<br />
O<br />
H O O<br />
OH<br />
(A)<br />
100 mg<br />
Sodium Benzoate<br />
MM 0730.00<br />
Sodium Benzoate<br />
O<br />
(A) 500 mg<br />
ONa<br />
Sodium Cromoglicate<br />
MM 0039.00<br />
Sodium Cromoglicate<br />
NaO<br />
O<br />
O<br />
O<br />
O<br />
(A) 500 mg<br />
ONa<br />
O<br />
O<br />
OH<br />
O<br />
O<br />
MM 0039.01 Succinophenone; Diphenacyl O<br />
(A)<br />
100 mg<br />
O<br />
MM 0039.02<br />
1,3-Bis(2-acetyl-3-hydroxyphenoxy)-2-propanol<br />
HO<br />
OH<br />
(A)<br />
100 mg<br />
O<br />
O<br />
OH<br />
O<br />
O<br />
MM 0039.03 2',6'-Dihydroxyacetophenone<br />
OH<br />
O<br />
(B) 100 mg<br />
OH<br />
MM 0039.04<br />
Ethyl Cromoglicate<br />
O<br />
O<br />
O<br />
O<br />
O<br />
(A) 100 mg<br />
O<br />
O<br />
O<br />
OH<br />
O<br />
O<br />
Sodium Cyclamate<br />
MM 0678.05 Cyclamic Acid<br />
H<br />
N<br />
S<br />
OH<br />
O O<br />
(A)<br />
100 mg<br />
MM 0678.02 Imp. B (EP): Aniline (Phenylamine)<br />
NH 2<br />
(B) 100 mg<br />
MM 0678.03 Imp. C (EP): Cyclohexanamine<br />
NH 2<br />
(C) 100 mg<br />
MM 0678.04 Imp. D (EP): N-Cyclohexylcyclohexanamine<br />
H<br />
N (C) 100 mg<br />
Sodium Fluoride<br />
MM 0734.00 Sodium Fluoride NaF (A) 500 mg<br />
Sodium Picosulfate<br />
MM 0054.00 Sodium Picosulfate<br />
NaO O<br />
O ONa<br />
S<br />
S<br />
O O O O<br />
(A) 500 mg<br />
N<br />
MM 0054.01<br />
Imp. A (EP): 4-[(Pyridin-2-yl)(4-<br />
hydroxyphenyl)methyl]phenyl Sodium Sulphate<br />
HO<br />
O<br />
S<br />
ONa<br />
O<br />
O<br />
(A)<br />
100 mg<br />
N<br />
MM 0054.03<br />
Imp. B (EP): 4,4'-[(Pyridin-2-yl)methylene]bisphenol<br />
HO OH<br />
(A) 100 mg<br />
N<br />
MM 0054.02<br />
Imp. C (Pharm<strong>eu</strong>ropa): 2,4'-[(Pyridin-2-yl)-<br />
methylene]bisphenyl Bis(Sodium Sulphate)<br />
O<br />
S ONa<br />
O O<br />
(D)<br />
50 mg<br />
NaO O<br />
S N<br />
O O<br />
304 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
<strong>Pharmac<strong>eu</strong>tical</strong> Impurities<br />
Code Product Category Unit<br />
MM 0054.04 2,4'-[(Pyridin-2-yl)methylene]bisphenol<br />
HO<br />
(A) 50 mg<br />
N<br />
OH<br />
Sodium Thiophene-2-carboxylate<br />
MM 1081.00<br />
Sodium Thiophene-2-carboxylate<br />
S<br />
O<br />
(A) 250 mg<br />
ONa<br />
Sorbic Acid<br />
MM 0954.00 Sorbic Acid<br />
O<br />
Sotalol Hydrochloride<br />
MM 0046.00<br />
MM 0046.01<br />
MM 0046.02<br />
MM 0046.03<br />
Spironolactone<br />
MM 0197.00<br />
Sotalol Hydrochloride<br />
Imp. A (EP) as Hydrochloride: N-[4-[2-<br />
[(1-Methylethyl)amino]ethyl]phenyl]-<br />
methanesulphonamide Hydrochloride<br />
Imp. B (EP) as Hydrochloride: N-[4-[[(1-<br />
Methylethyl)amino]acetyl]phenyl]-<br />
methanesulphonamide Hydrochloride<br />
Imp. C (EP):N-(4-Formylphenyl)methanesulphonamide<br />
Spironolactone<br />
O O<br />
S<br />
N<br />
H<br />
O O<br />
S<br />
N<br />
H<br />
OH<br />
H<br />
N<br />
OH<br />
x HCl<br />
H<br />
N<br />
O O x HCl<br />
S<br />
N<br />
H<br />
O<br />
H<br />
N<br />
O O<br />
S<br />
N<br />
H<br />
x HCl<br />
O<br />
(A)<br />
(A)<br />
(A)<br />
(A)<br />
500 mg<br />
100 mg<br />
100 mg<br />
100 mg<br />
O<br />
(A) 100 mg<br />
O<br />
(A) 500 mg<br />
O<br />
S<br />
Stavudine<br />
MM 0534.01<br />
Imp. A (EP): 5-Methylpyrimidine-2,4(1H,3H)-dione (Thymine)<br />
O<br />
HN<br />
O<br />
(A) 100 mg<br />
MM 0534.03<br />
Imp. C (EP): 1-(2-Deoxy-β-D-erythro-pentofuranosyl)-5-<br />
methylpyrimidine-2,4(1H,3H)-dione (Thymidine)<br />
HO<br />
O<br />
HN<br />
O<br />
O<br />
N<br />
H<br />
O<br />
N<br />
(A)<br />
100 mg<br />
Strychnine Nitrate<br />
MM 0658.00 Strychnine Nitrate<br />
MM 0658.02 Strychnine N-Oxide Hydrochloride<br />
OH<br />
H N<br />
H<br />
N<br />
H<br />
O O<br />
H<br />
N<br />
x HNO 3<br />
(A) 500 mg<br />
O<br />
on request<br />
O<br />
N<br />
H<br />
H<br />
O<br />
x HCl<br />
Sulfacetamide<br />
MM 0579.00<br />
Sulfacetamide<br />
O O O<br />
(A) 500 mg<br />
S N<br />
H<br />
H 2N<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 305
<strong>Pharmac<strong>eu</strong>tical</strong> Impurities<br />
Code Product Category Unit<br />
Sulfacetamide Sodium<br />
MM 1087.00 Sulfacetamide Sodium Monohydrate<br />
MM 1087.01 Imp. A (Pharm<strong>eu</strong>ropa): Sulfanilamide<br />
O O O<br />
S<br />
N x H 2 O<br />
Na<br />
H 2 N<br />
O O<br />
S<br />
NH2<br />
(A) 500 mg<br />
(A) 100 mg<br />
Sulfadiazine<br />
MM 0623.00 Sulfadiazine<br />
Sulfadimethoxine Sodium<br />
MM 1020.00 Sulfadimethoxine Sodium<br />
H 2N<br />
H 2 N<br />
O O<br />
S<br />
N<br />
H<br />
O<br />
N (A) 500 mg<br />
N<br />
(A)<br />
500 mg<br />
H 2 N<br />
O O N<br />
S<br />
N<br />
Na<br />
N<br />
O<br />
Sulfafurazole<br />
MM 0583.00<br />
Sulfafurazole<br />
O O O N (A) 500 mg<br />
S N<br />
H<br />
H 2N<br />
Sulfamerazine<br />
MM 0581.00<br />
Sulfamerazine<br />
H 2N<br />
O O N<br />
S<br />
N N<br />
H<br />
(A)<br />
500 mg<br />
MM 0581.01<br />
Sulphanilamide<br />
O<br />
(A) 100 mg<br />
O<br />
S<br />
NH 2<br />
Sulfamethoxazole<br />
MM 0227.00<br />
MM 0227.01<br />
MM 0227.03<br />
MM 0227.02<br />
MM 0227.04<br />
MM 0227.05<br />
Sulfamethoxazole<br />
Imp. A (EP): N-[4-[(5-Methylisoxazol-3-yl)-<br />
sulphamoyl]phenyl]acetamide<br />
Imp. B (EP): 4-[[(4-Aminophenyl)sulphonyl]amino]-N-<br />
(5-methylisoxazol-3-yl)benzenesulphonamide<br />
Imp. C (EP): 5-Methylisoxazol-3-amine<br />
Imp. D (EP): 4-Aminobenzenesulphonic Acid<br />
(Sulphanilic Acid)<br />
Imp. E (EP): 4-Aminobenzenesulphonamide (Sulphanilamide)<br />
H 2 N<br />
H 2 N<br />
O<br />
N<br />
H<br />
O O<br />
S<br />
N<br />
H<br />
H 2 N<br />
H 2 N<br />
O O<br />
S<br />
N<br />
H<br />
O<br />
S<br />
O<br />
N<br />
H<br />
O O<br />
S<br />
N<br />
H<br />
H 2 N<br />
O<br />
N<br />
O<br />
N<br />
O<br />
N<br />
O<br />
N<br />
S<br />
OH<br />
(A)<br />
(A)<br />
(A)<br />
(B)<br />
500 mg<br />
100 mg<br />
100 mg<br />
100 mg<br />
O O<br />
(A) 100 mg<br />
O O<br />
(A) 100 mg<br />
S<br />
NH 2<br />
H 2 N<br />
306 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
<strong>Pharmac<strong>eu</strong>tical</strong> Impurities<br />
Code Product Category Unit<br />
Sulfamethylphenazole<br />
MM 1108.00<br />
Sulfamethylphenazole<br />
H 2 N<br />
O O<br />
S<br />
N<br />
H<br />
N<br />
N<br />
(A)<br />
100 mg<br />
Sulfaquinoxaline Sodium<br />
MM 0702.00<br />
Sulfathiazole<br />
Sulfaquinoxaline Sodium<br />
N<br />
MM 0578.00 Sulfathiazole O O<br />
N<br />
N<br />
H 2 N<br />
Na<br />
N<br />
S<br />
O<br />
O<br />
S<br />
N<br />
H<br />
NH 2<br />
on request<br />
S<br />
(A)<br />
500 mg<br />
Sulindac<br />
MM 0624.00<br />
Sulindac<br />
OH<br />
(A)<br />
500 mg<br />
S<br />
O<br />
F<br />
O<br />
Sulpiride<br />
MM 0051.00<br />
MM 0051.01<br />
Sulpiride<br />
Imp. A (EP): [(2RS)-1-Ethylpyrrolidin-2-yl]methanamine<br />
O<br />
O<br />
S<br />
H 2 N<br />
O<br />
N<br />
H<br />
O<br />
H 2N<br />
N<br />
N<br />
(A)<br />
(A)<br />
500 mg<br />
100 mg<br />
MM 0051.02<br />
MM 0051.03<br />
MM 0051.04<br />
MM 0051.05<br />
MM 0051.06<br />
MM 0051.07<br />
MM 0051.08<br />
MM 0051.09<br />
Suplatast Tosilate<br />
Imp. B (EP): Methyl 2-Methoxy-5-sulphamoylbenzoate<br />
Imp. C (EP): Ethyl 2-Methoxy-5-sulphamoylbenzoate<br />
Imp. D (EP): 2-Methoxy-5-sulphamoylbenzoic Acid<br />
Imp. E (EP): 2-Methoxy-5-sulphamoylbenzamide<br />
Imp. F (EP): 1-Ethyl-2-[[(2-methoxy-5-<br />
sulphamoylbenzoyl)amino]methyl]pyrrolidine 1<br />
-Oxide (Sulpiride N-Oxide)<br />
Imp. G (EP): (RS)-N-[(1-Ethylpyrrolidin-2-yl)methyl]-2-<br />
hydroxy-5-sulphamoylbenzamide<br />
5-Sulphamoylsalicylic Acid<br />
5-Sulphosalicylic Acid Dihydrate<br />
O<br />
H 2 N<br />
S<br />
O<br />
O<br />
H 2 N<br />
S<br />
O<br />
O NH 2<br />
S<br />
O<br />
O<br />
H 2 N<br />
S<br />
O<br />
O<br />
H 2 N<br />
S<br />
O<br />
O<br />
O<br />
N<br />
H<br />
O<br />
O<br />
O<br />
S<br />
N<br />
H 2 N<br />
H<br />
OH<br />
O<br />
H 2 N<br />
S<br />
O<br />
O<br />
HO<br />
S<br />
O<br />
O<br />
OH<br />
OH<br />
O<br />
O<br />
O<br />
O<br />
O<br />
O<br />
O<br />
O<br />
O<br />
O<br />
OH<br />
NH 2<br />
O<br />
N<br />
O<br />
OH<br />
N<br />
OH<br />
x 2 H 2 O<br />
(A)<br />
(A)<br />
(A)<br />
(A)<br />
(A)<br />
(A)<br />
(A)<br />
(C)<br />
100 mg<br />
100 mg<br />
100 mg<br />
100 mg<br />
100 mg<br />
100 mg<br />
100 mg<br />
100 mg<br />
O O<br />
MM 0722.01 Methyl Toluene-4-sulphonate (B) 100 mg<br />
S<br />
O<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 307
<strong>Pharmac<strong>eu</strong>tical</strong> Impurities<br />
Code Product Category Unit<br />
Tamoxifen Citrate<br />
MM 0053.00 Tamoxifen Citrate<br />
O<br />
O<br />
N HO OH<br />
x HO<br />
HO O<br />
O<br />
(A) 100 mg<br />
MM 0053.02<br />
Imp. B (EP): 1-[4-(2-Dimethylaminoethoxy)phenyl]-1,2-<br />
diphenylbutan-1-ol<br />
O<br />
N<br />
(A)<br />
100 mg<br />
OH<br />
MM 0053.14<br />
Imp. C (EP) Z-Isomer: 2-[4-[(Z)-1,2-Diphenylethenyl]phenoxy]-N,N-dimethylethanamine<br />
O<br />
N<br />
(A)<br />
50 mg<br />
MM 0053.15<br />
Imp. C (EP) E-Isomer: 2-[4-[(E)-1,2-<br />
Diphenylethenyl]phenoxy]-N,N-dimethylethanamine<br />
O<br />
N (A) 50 mg<br />
MM 0053.16<br />
Imp. D (EP) Z-Isomer: 2-[4-[(Z)-1,2-Diphenylprop-1-<br />
enyl]phenoxy]-N,N-dimethylethanamine<br />
O<br />
N<br />
(A)<br />
50 mg<br />
MM 0053.17<br />
Imp. D (EP) E-Isomer: 2-[4-[(E)-1,2-Diphenylprop-1-<br />
enyl]phenoxy]-N,N-dimethylethanamine<br />
O<br />
N (A) 50 mg<br />
MM 0053.05<br />
Imp. E (EP): 2-[2-[(EZ)-1,2-Diphenylbut-1-enyl)phenoxy]-N,Ndimethylethanamine<br />
(A)<br />
100 mg<br />
O<br />
N<br />
MM 0053.12<br />
Imp. F (EP) as Hydrochloride: 2-[4-[(Z)-1,2-Diphenylbut-1-<br />
enyl]phenoxy]-N-methylethanamine Hydrochloride<br />
O<br />
N<br />
H<br />
(A)<br />
100 mg<br />
x HCl<br />
MM 0053.07<br />
Imp. G (EP): (2RS)-1-[4-[2-(Dimethylamino)ethoxy]phenyl]-2-<br />
phenylbutan-1-one<br />
O<br />
N<br />
(A)<br />
100 mg<br />
O<br />
MM 0053.08<br />
1,2-Diphenylbutan-1-one<br />
(A)<br />
100 mg<br />
O<br />
MM 0053.09<br />
1-(4-Methoxyphenyl)-1,2-diphenylbutan-1-ol<br />
O<br />
(A)<br />
100 mg<br />
OH<br />
MM 0053.10<br />
(EZ)-1-(4-Hydroxyphenyl)-1,2-diphenylbut-1-ene<br />
OH<br />
(A)<br />
100 mg<br />
308 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
<strong>Pharmac<strong>eu</strong>tical</strong> Impurities<br />
Code Product Category Unit<br />
MM 0053.18 Tamoxifen N-Oxide<br />
on request<br />
O<br />
N<br />
O<br />
Tamsulosin Hydrochloride<br />
MM 0938.00<br />
Tamsulosin Hydrochloride<br />
O<br />
H<br />
N<br />
O O<br />
S x HCl NH2<br />
on request<br />
MM 0938.03<br />
Imp. B (EP): 5-[(2R)-2-Aminopropyl]-2-<br />
methoxybenzenesulfonamide<br />
O<br />
H 2 N<br />
O<br />
O<br />
(A) 100 mg<br />
O<br />
S<br />
NH2<br />
O<br />
New MM 0938.05<br />
Imp. D (EP) as Hydrochloride: 2-Methoxy-<br />
5-[(2R)-2-[[2-(2-methoxyphenoxy)ethyl]-<br />
amino]propyl]benzenesulfonamide Hydrochloride<br />
O<br />
O<br />
H<br />
N<br />
O O<br />
S x HCl NH2<br />
O<br />
(A)<br />
100 mg<br />
New MM 0938.09<br />
Imp. I (EP): 1-(2-Bromoethoxy)-2-ethoxybenzene<br />
O<br />
Br<br />
(A)<br />
100 mg<br />
O<br />
Temazepam<br />
MM 0087.00<br />
Temazepam [Controlled Substance]<br />
Cl<br />
O<br />
N<br />
OH<br />
N<br />
on request<br />
MM 0087.06<br />
Imp. A (EP): [5-Chloro-2-(methylamino)-<br />
phenyl]phenylmethanone<br />
(5-Chloro-2-(methylamino)benzophenone)<br />
Cl<br />
NH<br />
O<br />
(B)<br />
100 mg<br />
MM 0087.07<br />
Imp. B (EP): Oxazepam<br />
[Controlled Substance]<br />
Cl<br />
H<br />
N<br />
N<br />
O<br />
OH<br />
(D)<br />
100 mg<br />
Tenoxicam<br />
MM 0247.03 Imp. A (EP): Pyridin-2-amine<br />
H 2 N<br />
N<br />
(B)<br />
100 mg<br />
Terazosin Hydrochloride Dihydrate<br />
MM 0843.00<br />
Terazosin Hydrochloride Dihydrate<br />
O<br />
(A)<br />
100 mg<br />
O<br />
O<br />
N<br />
N<br />
N<br />
N<br />
O<br />
x HCl<br />
x 2 H 2 O<br />
NH 2<br />
MM 0843.01<br />
Imp. A (EP): 2-Chloro-6,7-<br />
dimethoxyquinazolin-4-amine<br />
O<br />
O<br />
N Cl<br />
(A) 100 mg<br />
NH 2<br />
N<br />
MM 0843.02<br />
Imp. B (EP): 1-(4-Hydroxy-6,7-dimethoxyquinazolin-2-<br />
yl)-4-[[(2RS)-tetrahydrofuran<br />
-2-yl]carbonyl]piperazine<br />
O<br />
N<br />
N<br />
O<br />
N<br />
O<br />
(A)<br />
100 mg<br />
O<br />
N<br />
OH<br />
MM 0843.03<br />
Imp. C (EP): 6,7-Dimethoxy-<br />
2-(piperazin-1-yl)quinazolin-4-amine<br />
O<br />
N<br />
N<br />
NH (A) 100 mg<br />
O<br />
N<br />
NH 2<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 309
<strong>Pharmac<strong>eu</strong>tical</strong> Impurities<br />
Code Product Category Unit<br />
MM 0843.04<br />
Imp. D (EP) as Hydrochloride: 1-(4-Amino-6,7-<br />
dimethoxyquinazolin-2-yl)-4-formylpiperazine<br />
Hydrochloride<br />
O<br />
N<br />
N<br />
N<br />
O<br />
x HCl<br />
(A)<br />
100 mg<br />
O<br />
N<br />
NH 2<br />
New MM 0843.05<br />
Imp. E (EP): 2,2'-(Piperazine-1,4-diyl)bis(6,7-<br />
dimethoxyquinazolin-4-amine)<br />
N<br />
NH 2<br />
O<br />
(D)<br />
100 mg<br />
O<br />
N<br />
N<br />
N<br />
N<br />
O<br />
O<br />
N<br />
NH 2<br />
MM 0843.11<br />
Imp. K (EP) as Hydrochloride:<br />
Prazosin Hydrochloride<br />
O<br />
N<br />
N<br />
N<br />
O<br />
O<br />
x HCl<br />
(A)<br />
100 mg<br />
O<br />
N<br />
NH 2<br />
MM 0843.13<br />
Imp. L (EP): 1-(Furan-2-ylcarbonyl)piperazine<br />
O<br />
(A)<br />
100 mg<br />
N<br />
HN<br />
O<br />
MM 0843.14<br />
Imp. M (EP): 1,4-Bis(furan-2-<br />
ylcarbonyl)piperazine<br />
O<br />
N<br />
O<br />
N<br />
O<br />
(A)<br />
100 mg<br />
O<br />
MM 0843.15<br />
Imp. N (EP): 1-[[(2RS)-Tetrahydrofuran-2-yl]carbonyl]piperazine<br />
O<br />
(A)<br />
100 mg<br />
N<br />
HN<br />
O<br />
MM 0843.16<br />
Imp. O (EP): 1,4-Bis[(tetrahydrofuran-2-yl)carbonyl]piperazine<br />
O<br />
(A)<br />
100 mg<br />
O<br />
N<br />
N<br />
O<br />
O<br />
Terbinafine Hydrochloride<br />
MM 0696.00<br />
Terbinafine Hydrochloride<br />
(A)<br />
100 mg<br />
N<br />
x HCl<br />
MM 0696.02<br />
Imp. A (EP) as Hydrochloride: N-Methyl-C-(naphthalen-1-<br />
yl)methanamine Hydrochloride (Secundary Amine Hydrochloride)<br />
NH<br />
x HCl<br />
(A)<br />
100 mg<br />
MM 0696.03<br />
Imp. B (EP) as Hydrochloride: (2Z)-N,6,6-Trimethyl-<br />
N-(naphthalen-1-ylmethyl)hept-2-en-4-yn-1-amine<br />
Hydrochloride (cis-Terbinafine Hydrochloride)<br />
N<br />
x HCl<br />
(D)<br />
100 mg<br />
MM 0696.04<br />
Imp. C (EP) as Hydrochloride: (2E)-N,6,6-<br />
Trimethyl-N-(naphthalen-2-ylmethyl)hept-2-en-4-<br />
yn-1-amine Hydrochloride (trans-iso-Terbinafine<br />
Hydrochloride)<br />
N<br />
x HCl<br />
(D)<br />
100 mg<br />
MM 0696.05<br />
Imp. D (EP) as Hydrochloride: (2E)-N,6,6-Trimethyl-<br />
N-[(4-methylnaphthalen-1-yl)methyl]-hept-2-en-4-yn-<br />
1-amine Hydrochloride (4-Methylterbinafine<br />
Hydrochloride<br />
N<br />
x HCl<br />
(D)<br />
100 mg<br />
Terbutaline Sulphate<br />
MM 0708.01<br />
Imp. A (EP): 3,5-Dihydroxybenzoic Acid (α-Resorcylic Acid)<br />
HO<br />
O<br />
(B) 100 mg<br />
OH<br />
OH<br />
MM 0708.03<br />
Imp. B (EP) as Hemisulphate: (4RS)-2-(1,1-<br />
Dimethylethyl)-1,2,3,4-tetrahydroisoquinoline-4,6,8-triol<br />
Hemisulphate<br />
HO<br />
OH<br />
N<br />
x 1/2 H 2 SO 4<br />
(D)<br />
100 mg<br />
OH<br />
310 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
<strong>Pharmac<strong>eu</strong>tical</strong> Impurities<br />
Code Product Category Unit<br />
Terfenadine<br />
MM 0055.00 Terfenadine<br />
(A) 500 mg<br />
N<br />
OH<br />
OH<br />
MM 0055.04<br />
Imp. A (EP): 1-[4-(1,1-Dimethylethyl)phenyl]-4-[4-<br />
(hydroxydiphenylmethyl) piperidin-1-yl]butan-1-one<br />
(Terfenadone)<br />
N<br />
O<br />
(A)<br />
100 mg<br />
OH<br />
MM 0055.07<br />
Imp. B (EP): (1RS)-1-[4-(1,1-Dimethylethyl)phenyl]-<br />
4-[4-(diphenylmethyl)piperidin-1-yl]butan-1-ol<br />
(A)<br />
100 mg<br />
N<br />
OH<br />
MM 0055.12<br />
Imp. E (EP) as Hydrochloride: 1-[(4RS)-4-[4-(1,1-<br />
Dimethylethyl)phenyl]-4-hydroxybutyl]piperidine-4-<br />
carboxylic Acid Hydrochloride<br />
HO<br />
N<br />
OH<br />
(A)<br />
100 mg<br />
O<br />
x HCl<br />
MM 0055.09<br />
Imp. G (EP): [1-[4-[4-(1,1-Dimethylethyl)-<br />
phenyl]but-3-enyl]piperidin-4-<br />
yl]diphenylmethanol<br />
N<br />
on request<br />
OH<br />
MM 0055.10 Imp. H (EP): [1-[4-[4-(1,1-<br />
Dimethylethyl)phenyl]butyl]piperidin-4-<br />
yl]diphenylmethanol<br />
N<br />
(A)<br />
100 mg<br />
OH<br />
MM 0055.02<br />
Imp. I (EP): Diphenyl(piperidin-4-yl)methanol (Azacyclonol)<br />
NH (B) 100 mg<br />
OH<br />
MM 0055.03<br />
Imp. J (EP): Ethyl 1-[(4RS)-4-[4-(1,1-<br />
Dimethylethyl)phenyl]-4-hydroxybutyl]-piperidine-4-<br />
carboxylate<br />
O<br />
N<br />
OH<br />
(A)<br />
100 mg<br />
O<br />
Testosterone<br />
MM 0323.00<br />
Testosterone<br />
OH<br />
(A) 500 mg<br />
O<br />
MM 0323.01<br />
Imp. A (EP): Androst-4-ene-3,17-dione (Androstenedione)<br />
O<br />
(A) 100 mg<br />
O<br />
MM 0323.02<br />
Imp. B (EP): 3-Ethoxy<strong>and</strong>rosta-3,5-dien-17-one (Androstenedione<br />
Ethylenolether)<br />
O<br />
(A) 100 mg<br />
O<br />
MM 0323.03<br />
Imp. C (EP): 17α-Hydroxy<strong>and</strong>rost-4-en-3-one (Epitestosterone)<br />
OH<br />
(A) 100 mg<br />
O<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 311
<strong>Pharmac<strong>eu</strong>tical</strong> Impurities<br />
Code Product Category Unit<br />
MM 0323.04<br />
Imp. D (EP): Androst-4-ene-3β,17β-diol<br />
(∆4-Androstenediol)<br />
OH<br />
(A) 100 mg<br />
HO<br />
MM 0323.05<br />
Imp. E (EP): 3-Oxo<strong>and</strong>rost-4-en-17β-yl Acetate (Testosterone<br />
Acetate)<br />
O<br />
O<br />
(A) 100 mg<br />
O<br />
MM 0323.06<br />
Imp. F (EP): 17β-Hydroxy-5α-<strong>and</strong>rostan-3-one (Androstanolone,<br />
Stanolone)<br />
OH<br />
(A)<br />
250 mg<br />
O<br />
H<br />
MM 0323.07<br />
Imp. G (EP): Androsta-1,4-diene-3,17-dione (Androstadienedione)<br />
O<br />
(A) 100 mg<br />
O<br />
MM 0323.08<br />
Imp. H (EP): 17β-Hydroxy<strong>and</strong>rosta-1,4-dien-3-one (Boldenone)<br />
OH<br />
(A) 100 mg<br />
O<br />
MM 0323.12<br />
Imp. I (EP): 17β-Hydroxy<strong>and</strong>rosta-4,6-dien-3-one (∆6-<br />
testosterone)<br />
OH<br />
(A) 100 mg<br />
O<br />
MM 0323.13<br />
Imp. J (EP): 3-Methoxy<strong>and</strong>rosta-3,5-dien-<br />
17-one (Androstenedione Methylenolether)<br />
O<br />
(A) 100 mg<br />
O<br />
Testosterone Benzoate<br />
MM 0493.00<br />
Testosterone Benzoate<br />
O<br />
O<br />
(D) 250 mg<br />
O<br />
MM 0493.01<br />
Testosterone<br />
OH<br />
(A) 500 mg<br />
O<br />
MM 0493.02<br />
Benzoic Acid<br />
O<br />
(B) 100 mg<br />
OH<br />
Testosterone Enantate<br />
MM 1119.00<br />
Testosterone Enantate<br />
O<br />
O<br />
(A) 100 mg<br />
O<br />
MM 1119.02<br />
Imp. B (EP): 3-Oxo<strong>and</strong>rost-4-en-17β-yl Hexanoate<br />
(Testosterone Caproate)<br />
O<br />
O<br />
(A) 100 mg<br />
MM 1119.04<br />
Imp. D (EP): 17β-Hydroxy<strong>and</strong>rost-4-en-3-one (Testosterone)<br />
O<br />
OH<br />
(A) 500 mg<br />
O<br />
312 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
<strong>Pharmac<strong>eu</strong>tical</strong> Impurities<br />
Code Product Category Unit<br />
Testosterone Isocaproate<br />
O<br />
MM 0863.00 Testosterone Isocaproate<br />
(A) 100 mg<br />
O<br />
MM 0863.05<br />
Imp. A (EP): Testosterone<br />
O<br />
OH<br />
(A) 500 mg<br />
MM 0863.03<br />
Imp. B (EP): 3-Oxo<strong>and</strong>rost-4-en-17β-yl Acetate<br />
(Testosterone Acetate)<br />
O<br />
O<br />
O<br />
(A) 100 mg<br />
MM 0863.04<br />
Imp. C (EP): Testosterone Propionate<br />
O<br />
O<br />
O<br />
(A) 100 mg<br />
MM 0863.07<br />
Imp. D (EP): 3-Oxo<strong>and</strong>rost-4-en-17β-yl 2-Methylpropanoate<br />
(Testosterone Isobutyrate)<br />
O<br />
O<br />
O<br />
(A) 100 mg<br />
MM 0863.08<br />
Imp. E (EP): 3-Oxo<strong>and</strong>rost-4-en-17β-yl Hexanoate<br />
(Testosterone Caproate)<br />
O<br />
O<br />
O<br />
(A) 100 mg<br />
MM 0863.06<br />
Imp. F (EP): Testosterone Enantate<br />
O<br />
O<br />
O<br />
(A) 100 mg<br />
MM 0863.09 Imp. G (EP): 3-Oxo<strong>and</strong>rost-4-en-17α-yl 4-<br />
Methylpentanoate<br />
(Epitestosterone Isocaproate)<br />
O<br />
O<br />
O<br />
(A) 100 mg<br />
Testosterone Propionate<br />
MM 0897.00<br />
Testosterone Propionate<br />
O<br />
O<br />
O<br />
(A) 100 mg<br />
MM 0897.01<br />
Imp. A (EP): 3-Oxo<strong>and</strong>rost-4-en-17β-yl Acetate (Testosterone<br />
Acetate)<br />
O<br />
O<br />
O<br />
(A) 100 mg<br />
MM 0897.03 Imp. C (EP): Testosterone<br />
OH<br />
O<br />
(A)<br />
500 mg<br />
O<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 313
<strong>Pharmac<strong>eu</strong>tical</strong> Impurities<br />
Code Product Category Unit<br />
MM 0897.04 Imp. D (EP): 3-Oxo<strong>and</strong>rosta-1,4-dien-17β-yl Propanoate<br />
O<br />
(A) 100 mg<br />
O<br />
O<br />
MM 0897.05<br />
Imp. E (EP): 3-Oxo<strong>and</strong>rosta-4,6-dien-17β-yl<br />
Propanoate<br />
O<br />
O<br />
(A) 100 mg<br />
O<br />
Tetracaine Hydrochloride<br />
MM 0504.00<br />
Tetracaine Hydrochloride<br />
O<br />
O<br />
N<br />
x HCl<br />
(A)<br />
500 mg<br />
N<br />
H<br />
MM 0504.03<br />
Imp. A (Pharm<strong>eu</strong>ropa): 4-Aminobenzoic Acid<br />
O<br />
(B)<br />
100 mg<br />
OH<br />
H 2 N<br />
MM 0504.01<br />
Imp. B (Pharm<strong>eu</strong>ropa): 4-(Butylamino)benzoic Acid<br />
O<br />
OH<br />
(A)<br />
100 mg<br />
New MM 0504.04<br />
MM 0504.02<br />
Imp. C (Pharm<strong>eu</strong>ropa): Methyl 4-(Butylamino)-<br />
benzoate<br />
Tetracaine N-Oxide<br />
N<br />
H<br />
O<br />
(A) 100 mg<br />
O<br />
N<br />
H<br />
O<br />
N O (A) 100 mg<br />
O<br />
N<br />
H<br />
Tetracycline Hydrochloride<br />
MM 0452.00 Tetracycline Hydrochloride<br />
OH O OH O<br />
OH<br />
O<br />
(A)<br />
500 mg<br />
HO<br />
H<br />
H<br />
N<br />
OH<br />
NH 2<br />
x HCl<br />
Tetramisole Hydrochloride<br />
MM 0703.00<br />
Tetramisole Hydrochloride<br />
N<br />
N<br />
S<br />
x HCl<br />
(A)<br />
500 mg<br />
Tetrazepam<br />
MM 0091.00<br />
Tetrazepam [Controlled Substance]<br />
N<br />
O<br />
(A)<br />
100 mg<br />
Cl<br />
N<br />
MM 0091.06<br />
Imp. B (EP): 7-Chloro-5-cyclohexyl-1,3-dihydro-2H-1,4-<br />
benzodiazepin-2-one<br />
H<br />
N<br />
O<br />
(A)<br />
100 mg<br />
Cl<br />
N<br />
MM 0091.03<br />
7-Chloro-5-cyclohexenyl-1,3-dihydro-2H-1,4-benzodiazepin-2-one<br />
(Nortetrazepam)<br />
H<br />
N<br />
O<br />
(A)<br />
100 mg<br />
Cl<br />
N<br />
MM 0091.04<br />
6-Chloro-2-methyl-4-oxo-4H-3,1-benzoxazine<br />
N<br />
(A)<br />
100 mg<br />
Cl<br />
O<br />
O<br />
314 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
<strong>Pharmac<strong>eu</strong>tical</strong> Impurities<br />
Code Product Category Unit<br />
MM 0091.52 2-Bromo-4'-chloro-2'-(cyclohexylcarbonyl)acetanilide<br />
O<br />
NH<br />
Br on request<br />
Cl<br />
O<br />
Tetryzoline Hydrochloride<br />
MM 0088.00<br />
Tetryzoline Hydrochloride<br />
HN<br />
N<br />
(A)<br />
100 mg<br />
x HCl<br />
MM 0088.03<br />
Imp. A (EP): (1RS)-1,2,3,4-Tetrahydronaphthalene-1-carbonitrile<br />
(α-Cyanotetraline)<br />
N<br />
(A) 100 mg<br />
MM 0088.02 1,2,3,4-Tetrahydro-1-naphthalenecarboxylic Acid<br />
O OH<br />
(A) 100 mg<br />
MM 0088.04 Methyl 1,2,3,4-Tetrahydro-1-naphthalenecarboxylate<br />
O O<br />
(A) 100 mg<br />
MM 0088.05<br />
N-(2-Aminoethyl)-1,2,3,4-tetrahydronaphthalene-1-yl-carboxamide<br />
Hydrochloride<br />
((1,2,3,4-Tetrahydro-1-naphthyl)formylethylenediamine<br />
Hydrochloride)<br />
O<br />
H<br />
N<br />
NH 2<br />
x HCl<br />
(A)<br />
100 mg<br />
Thalidomide<br />
MM 0940.00<br />
Thalidomide<br />
O<br />
(A)<br />
100 mg<br />
Theobromine<br />
MM 0577.00<br />
Theobromine<br />
N<br />
O<br />
NH<br />
O O<br />
O<br />
(A) 500 mg<br />
HN<br />
N<br />
O N N<br />
Theophylline<br />
MM 0176.00<br />
Theophylline<br />
N<br />
O N<br />
O<br />
(A) 500 mg<br />
H<br />
N<br />
N<br />
MM 0176.06<br />
Imp. A (EP): Caffeine<br />
N<br />
O<br />
N<br />
(A)<br />
500 mg<br />
O<br />
N<br />
N<br />
MM 0176.03<br />
Imp. B (EP): 3-Methyl-3,7-dihydro-1H-purine-2,6-dione (3-Methylxanthine)<br />
O<br />
(A) 100 mg<br />
HN<br />
N<br />
O N N H<br />
MM 0176.02<br />
Imp. C (EP): N-(6-Amino-1,3-dimethyl-2,4-<br />
dioxo-1,2,3,4-tetrahydropyrimidin-5-yl)-<br />
formamide<br />
O<br />
N<br />
O N<br />
H<br />
N<br />
O<br />
NH 2<br />
on request<br />
MM 0176.01<br />
Imp. D (EP): N-Methyl-5-(methylamino)-1H-imidazole-4-carboxamide<br />
O<br />
(A) 100 mg<br />
(Theophyllidine) N<br />
N<br />
H<br />
HN N H<br />
MM 0176.08<br />
Imp. F (EP): Etofylline<br />
O<br />
OH<br />
(A) 500 mg<br />
N<br />
N<br />
O<br />
N<br />
N<br />
MM 0176.04<br />
1-Methylxanthine<br />
N<br />
O N<br />
H<br />
O<br />
on request<br />
N<br />
N<br />
H<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 315
<strong>Pharmac<strong>eu</strong>tical</strong> Impurities<br />
Code Product Category Unit<br />
MM 0176.05<br />
7-Methylxanthine<br />
Theophylline-Ethylenediamine<br />
New MM 1050.01<br />
Imp. A (Pharm<strong>eu</strong>ropa): Caffeine<br />
HN<br />
O N<br />
H<br />
N<br />
O<br />
O<br />
(A) 100 mg<br />
N<br />
N<br />
N<br />
(A)<br />
500 mg<br />
O<br />
N<br />
N<br />
New MM 1050.02<br />
Imp. B (Pharm<strong>eu</strong>ropa): 3-Methyl-3,7-dihydro-1H-purine-2,6-dione<br />
(3-Methylxanthine)<br />
HN<br />
O<br />
(A) 100 mg<br />
H<br />
N<br />
O<br />
N<br />
N<br />
New MM 1050.04<br />
Imp. D (Pharm<strong>eu</strong>ropa): N-Methyl-5-<br />
(methylamino)-1H-imidazole-4-<br />
carboxamide (Theophyllidine)<br />
N<br />
H<br />
HN<br />
O<br />
(A) 100 mg<br />
N<br />
H<br />
N<br />
New MM 1050.06<br />
Imp. F (Pharm<strong>eu</strong>ropa): Etofylline<br />
O<br />
OH<br />
(A) 500 mg<br />
N<br />
N<br />
O<br />
N<br />
N<br />
Thiamazole<br />
MM 0889.00<br />
Thiamazole<br />
N<br />
S<br />
(A) 500 mg<br />
NH<br />
MM 0889.02 Imp. B (EP): 1-Methyl-1H-imidazole N<br />
(B)<br />
100 mg<br />
N<br />
MM 0889.03<br />
Imp. C (EP): 1-Methyl-2-(methylsulphanyl)-1H-imidazole<br />
N<br />
N<br />
S<br />
(A) 100 mg<br />
MM 0889.04<br />
Imp. C (EP) as Hydrochloride: 1-Methyl-2-(methylsulphanyl)-1Himidazole<br />
Hydrochloride<br />
N<br />
N<br />
S<br />
x HCl<br />
(A)<br />
100 mg<br />
Thiamine Hydrochloride<br />
MM 0049.00 Thiamine Hydrochloride (Vitamin B 1)<br />
MM 0049.05<br />
S N<br />
HO<br />
N + N x HCl<br />
Cl - NH 2<br />
(A) 500 mg<br />
Imp. E (EP): 3-[(4-Amino-2-methylpyrimidin-5-yl)methyl]-5-(2-<br />
S<br />
S N<br />
(A) 100 mg<br />
hydroxyethyl)-4-methylthiazol-2(3H)-thione (Thioxothiamine) N N<br />
HO<br />
NH 2<br />
MM 0049.02 5-(2-Hydroxyethyl)-4-methylthiazole<br />
N<br />
(A)<br />
100 mg<br />
MM 0049.04 4-Amino-5-hydroxymethyl-2-methylpyrimidine Hydrochloride N<br />
Thiamphenicol<br />
MM 0737.00<br />
Thioctic Acid<br />
MM 0127.00<br />
Thiamphenicol<br />
Thioctic Acid<br />
Thioridazine Hydrochloride<br />
MM 0116.05<br />
2-Methylthiophenothiazine<br />
Cl<br />
Cl<br />
O<br />
S<br />
N<br />
N<br />
H<br />
S<br />
S<br />
OH<br />
NH 2<br />
OH<br />
OH<br />
OH<br />
x HCl<br />
O<br />
S<br />
(A) 100 mg<br />
O<br />
(A) 500 mg<br />
O<br />
(A) 500 mg<br />
OH<br />
(A) 100 mg<br />
S<br />
NH<br />
S<br />
316 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
<strong>Pharmac<strong>eu</strong>tical</strong> Impurities<br />
Code Product Category Unit<br />
Tiabendazole<br />
MM 0602.00<br />
MM 0602.01<br />
Tiabendazole<br />
Imp. A (EP): Benzene-1,2-diamine<br />
H<br />
N<br />
N<br />
S<br />
N<br />
NH 2<br />
(A)<br />
500 mg<br />
NH 2 (C) 100 mg<br />
Tiamulin Hydrogen Fumarate<br />
MM 0394.00<br />
Tiamulin Hydrogen Fumarate<br />
N<br />
S<br />
O<br />
O<br />
H<br />
O<br />
x<br />
HO<br />
O<br />
OH<br />
(A)<br />
100 mg<br />
MM 0394.02<br />
Fumaric Acid<br />
HO<br />
O<br />
HO<br />
O<br />
O<br />
(B) 100 mg<br />
OH<br />
Ticlopidine Hydrochloride<br />
MM 0150.00<br />
Ticlopidine Hydrochloride<br />
N<br />
S<br />
x HCl<br />
(A)<br />
500 mg<br />
Cl<br />
MM 0150.12<br />
Imp. A (EP): Thieno[3,2-c]pyridine<br />
N<br />
S<br />
(A) 100 mg<br />
MM 0150.06<br />
Imp. B (EP): 6,7-Dihydrothieno[3,2-c]pyridin-4(5H)-one<br />
HN<br />
S<br />
(A)<br />
100 mg<br />
MM 0150.01<br />
MM 0150.07<br />
MM 0150.08<br />
MM 0150.09<br />
MM 0150.11<br />
MM 0150.10<br />
MM 0150.04<br />
Imp. C (EP) as Hydrochloride: (2-Chlorophenyl)methanamine<br />
Hydrochloride NH 2 x HCl<br />
Imp. D (EP) as Hydrochloride: 5-Benzyl-4,5,6,7-<br />
tetrahydrothieno[3,2-c]pyridine Hydrochloride<br />
Imp. G (EP) as Hydrochloride: 5-(3-Chlorobenzyl)-4,5,6,7-<br />
tetrahydrothieno[3,2-c]pyridine Hydrochloride<br />
Imp. H (EP) as Hydrochloride: 5-(4-Chlorobenzyl)-4,5,6,7-<br />
tetrahydrothieno[3,2-c]pyridine Hydrochloride<br />
Imp. I (EP) as Hydrochloride: N-(2-Chlorobenzyl)-2-<br />
(thiophen-2-yl)ethanamine Hydrochloride<br />
Imp. J (EP) as Dihydrochloride: N,N'-Bis(2-<br />
chlorobenzyl)ethane-1,2-diamine Dihydrochloride<br />
5-(2-Chlorobenzoyl)-4,5,6,7-tetrahydrothieno[3,2-c]pyridine<br />
Cl<br />
Cl<br />
Cl<br />
Cl<br />
NH<br />
Cl<br />
N<br />
N<br />
NH<br />
N<br />
H<br />
Cl<br />
N<br />
S<br />
S<br />
S<br />
N<br />
S<br />
O<br />
(A)<br />
100 mg<br />
x HCl<br />
(A) 100 mg<br />
x HCl<br />
x HCl<br />
x HCl<br />
x 2 HCl<br />
S<br />
(A)<br />
(A)<br />
(A)<br />
(A)<br />
(A)<br />
100 mg<br />
100 mg<br />
100 mg<br />
100 mg<br />
100 mg<br />
Cl<br />
O<br />
Tilidine Hydrochloride Hemihydrate<br />
MM 0134.00<br />
Tilidine Hydrochloride Hemihydrate [Controlled Substance]<br />
N<br />
(A)<br />
100 mg<br />
x HCl<br />
x 1/2 H 2 O<br />
O O<br />
<strong>and</strong> enantiomer<br />
MM 0134.01<br />
Imp. A (EP): Ethyl (1RS,2RS)-2-(Dimethylamino)-1-phenylcyclohex-<br />
3-enecarboxylate (cis-Tilidine) [Controlled Substance]<br />
N<br />
(D)<br />
100 mg<br />
O O<br />
<strong>and</strong> enantiomer<br />
MM 0134.03<br />
Imp. D (EP) as Hydrochloride: Ethyl (2RS)-3-Dimethylamino-2-<br />
phenylpropanoate Hydrochloride<br />
N<br />
O<br />
x HCl<br />
(A)<br />
100 mg<br />
O<br />
MM 0134.05<br />
Tilidine [Controlled Substance]<br />
N<br />
(A)<br />
100 mg<br />
O O<br />
<strong>and</strong> enantiomer<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 317
<strong>Pharmac<strong>eu</strong>tical</strong> Impurities<br />
Code Product Category Unit<br />
Timolol Maleate<br />
OH<br />
MM 0440.00 Timolol Maleate O<br />
MM 0440.03<br />
N-Benzyl-tert-butylamine<br />
N<br />
S<br />
N<br />
O<br />
N<br />
O<br />
HN<br />
x<br />
O<br />
OH<br />
OH<br />
(A)<br />
(B)<br />
250 mg<br />
100 mg<br />
HN<br />
MM 0440.05 3-Hydroxy-4-morpholino-1,2,5-thiadiazole 1-Oxide N<br />
O<br />
S<br />
N<br />
OH<br />
N<br />
O<br />
(A)<br />
100 mg<br />
Tinidazole<br />
MM 0151.01 Imp. A (EP): 2-Methyl-5-nitro-1H-imidazole<br />
Tolazoline Hydrochloride<br />
MM 0585.00 Tolazoline Hydrochloride<br />
O 2 N<br />
(B) 100 mg<br />
NH<br />
N<br />
N<br />
x HCl<br />
HN<br />
(A) 500 mg<br />
Tolmetin Sodium Dihydrate<br />
MM 0571.00<br />
Tolmetin Sodium Dihydrate<br />
O<br />
N<br />
ONa<br />
O<br />
x 2 H 2 O<br />
on request<br />
Tramadol Hydrochloride<br />
MM 0007.00<br />
Tramadol Hydrochloride<br />
O<br />
OH<br />
N<br />
x HCl<br />
(A)<br />
500 mg<br />
<strong>and</strong> enantiomer<br />
MM 0007.01<br />
Imp. A (EP) as Hydrochloride: (1RS,2SR)-2-<br />
[(Dimethylamino)methyl]-1-(3-methoxyphenyl)-<br />
cyclohexanol Hydrochloride<br />
O<br />
OH<br />
N<br />
x HCl<br />
(A)<br />
100 mg<br />
MM 0007.03<br />
Imp. B (EP) as Hydrochloride: [2-(3-Methoxyphenyl)cyclohex-1-<br />
enyl]-N,N-dimethylmethanamine Hydrochloride<br />
<strong>and</strong> enantiomer<br />
O<br />
(A) 100 mg<br />
x HCl<br />
N<br />
MM 0007.04<br />
Imp. C (EP) as Hydrochloride: (1RS)-[2-(3-Methoxyphenyl)-<br />
cyclohex-2-enyl]-N,N-dimethylmethanamine Hydrochloride<br />
O<br />
(A) 100 mg<br />
N<br />
x HCl<br />
MM 0007.06<br />
Imp. D (EP) as Hydrochloride: (1RS,2RS)-2-[(Dimethylamino)methyl]-1-(3-hydroxyphenyl)cyclohexanol<br />
Hydrochloride<br />
HO<br />
OH<br />
N<br />
x HCl<br />
(A)<br />
100 mg<br />
MM 0007.02<br />
<strong>and</strong> enantiomer<br />
Imp. E (EP) as Hydrochloride: (2RS)-2-[(Dimethylamino)methyl]-<br />
O<br />
(A) 100 mg<br />
cyclohexanone Hydrochloride N x HCl<br />
MM 0007.05 3-Bromoanisole<br />
O Br<br />
(B) 100 mg<br />
MM 0007.07<br />
N-Desmethyltramadol Hydrochloride<br />
O<br />
OH<br />
x HCl<br />
(A)<br />
100 mg<br />
NH<br />
<strong>and</strong> enantiomer<br />
MM 0007.08<br />
N,O-Didesmethyltramadol Hydrochloride<br />
HO<br />
OH<br />
N<br />
H<br />
x HCl<br />
(A)<br />
100 mg<br />
<strong>and</strong> enantiomer<br />
318 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
<strong>Pharmac<strong>eu</strong>tical</strong> Impurities<br />
Code Product Category Unit<br />
MM 0007.09 3-Methoxyphenol<br />
O OH<br />
(B) 100 mg<br />
MM 0007.11<br />
Tramadol N-Oxide<br />
O<br />
OH<br />
(A)<br />
100 mg<br />
N<br />
O<br />
MM 0007.50<br />
[2-(3-Hydroxyphenyl)cyclohex-1-enyl]-N,N-dimethylmethanamine<br />
Hydrochloride<br />
<strong>and</strong> enantiomer<br />
HO<br />
(A) 100 mg<br />
x HCl<br />
N<br />
Tranexamic Acid<br />
MM 0330.00<br />
Tranexamic Acid<br />
H 2N<br />
O<br />
OH<br />
(A)<br />
500 mg<br />
MM 0330.04<br />
Imp. D (EP): 4-Aminomethylbenzoic Acid<br />
H 2 N<br />
O<br />
OH<br />
(B)<br />
100 mg<br />
Trazodone Hydrochloride<br />
MM 0421.00<br />
Trazodone Hydrochloride<br />
(A)<br />
100 mg<br />
N<br />
N<br />
N<br />
N<br />
N<br />
Cl<br />
x HCl<br />
O<br />
MM 0421.13 Imp. A (BP) as Hydrochloride: 4-(3-Chlorophenyl)-1-[3-(3-oxo-2,3-dihydro-1,2,4-<br />
triazolo[4,3-a]pyridin-2-yl)propyl]piperazine<br />
N 1 -oxide Hydrochloride (Trazodone N-Oxide<br />
Hydrochloride)<br />
MM 0421.03 Imp. C (BP) as Dihydrochloride: 2-[3-[4-(4-<br />
Chlorophenyl)piperazin-1-yl]propyl]-1,2,4-<br />
triazolo[4,3-a]pyridin-3(2H)-one Dihydrochloride<br />
N<br />
N<br />
N<br />
O<br />
N<br />
N<br />
N<br />
N<br />
O<br />
N<br />
N<br />
N<br />
Cl<br />
Cl<br />
x HCl<br />
x 2 HCl<br />
(D)<br />
(A)<br />
100 mg<br />
100 mg<br />
O<br />
MM 0421.06<br />
Imp. F (BP) as Hydrochloride: 1-(3-Chlorophenyl)-4-(3-<br />
chloropropyl)piperazine Hydrochloride<br />
Cl<br />
N<br />
N<br />
Cl<br />
x HCl<br />
(A)<br />
100 mg<br />
MM 0421.08<br />
Imp. H (BP) as Dihydrochloride: 1,3-Bis-[4-(3-<br />
chlorophenyl)piperazin-1-yl]propane Dihydrochloride<br />
Cl<br />
N<br />
N<br />
N<br />
N<br />
Cl<br />
x 2 HCl<br />
(A)<br />
100 mg<br />
MM 0421.10<br />
3-[4-(3-Chlorophenyl)piperazin-1-yl]propanol<br />
(A)<br />
100 mg<br />
HO<br />
N<br />
N<br />
Cl<br />
MM 0421.11<br />
1,2,4-Triazolo-[4,3-a]pyridine-3(2H)-one<br />
N<br />
N<br />
NH<br />
(A)<br />
100 mg<br />
O<br />
MM 0421.12<br />
1,4-Bis-3-chlorophenylpiperazine<br />
(A)<br />
100 mg<br />
N<br />
Cl<br />
Cl<br />
N<br />
Triacetin<br />
MM 0966.00<br />
Triacetin<br />
O<br />
(A) 500 mg<br />
O<br />
O<br />
O<br />
O<br />
O<br />
Triamcinolone<br />
MM 0508.00<br />
Triamcinolone<br />
O<br />
OH<br />
(A)<br />
250 mg<br />
HO<br />
OH<br />
OH<br />
O<br />
F<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 319
<strong>Pharmac<strong>eu</strong>tical</strong> Impurities<br />
Code Product Category Unit<br />
MM 0508.01<br />
Imp. A (EP): 9-Fluoro-11β,17-dihydroxy-3,20-dioxopregna-<br />
1,4-diene-16α,21-diyl Diacetate (Triamcinolone 16,21-<br />
Diacetate)<br />
HO<br />
O<br />
O<br />
OH<br />
O<br />
O<br />
(A)<br />
100 mg<br />
MM 0508.03<br />
Imp. C (EP): 9-Fluoro-11β,16α,17,21-tetrahydroxypregn-4-<br />
ene-3,20-dione (Pretriamcinolone)<br />
O<br />
F<br />
HO<br />
O<br />
O<br />
OH<br />
OH<br />
OH<br />
on request<br />
F<br />
O<br />
Triamcinolone Acetonide<br />
MM 0198.00<br />
Triamcinolone Acetonide<br />
O<br />
OH<br />
(A) 250 mg<br />
HO<br />
O<br />
O<br />
F<br />
O<br />
MM 0198.01<br />
Imp. A (EP): Triamcinolone<br />
O<br />
OH<br />
(A) 250 mg<br />
HO<br />
OH<br />
OH<br />
F<br />
O<br />
MM 0198.02<br />
Triamcinolone 16,21-Diacetate<br />
O<br />
O<br />
O<br />
(A) 100 mg<br />
HO<br />
F<br />
OH<br />
O<br />
O<br />
O<br />
MM 0198.05<br />
Triamcinolone Acetonide 21-Aldehyde Hydrate<br />
O<br />
OH<br />
(A)<br />
100 mg<br />
HO<br />
OH<br />
O<br />
O<br />
F<br />
O<br />
Triamcinolone Hexacetonide<br />
MM 0306.00<br />
Triamcinolone Hexacetonide<br />
O<br />
(A) 100 mg<br />
O<br />
O<br />
HO<br />
O<br />
O<br />
F<br />
O<br />
MM 0306.01<br />
Imp. A (EP): Triamcinolone Acetonide<br />
O<br />
OH<br />
(A) 250 mg<br />
HO<br />
O<br />
O<br />
F<br />
O<br />
MM 0306.02<br />
Triamcinolone<br />
O<br />
OH<br />
(A) 250 mg<br />
HO<br />
OH<br />
OH<br />
F<br />
O<br />
Triamterene<br />
MM 0269.00<br />
Triamterene<br />
H 2N N N NH 2 (A) 500 mg<br />
N<br />
N<br />
NH 2<br />
MM 0269.02<br />
Imp. A (Pharm<strong>eu</strong>ropa): 2,4,6-Triamino-5-nitrosopyrimidine<br />
H 2 N N NH 2<br />
(B) 100 mg<br />
ON<br />
N<br />
NH 2<br />
320 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
<strong>Pharmac<strong>eu</strong>tical</strong> Impurities<br />
Code Product Category Unit<br />
MM 0269.01<br />
Tributyl Acetylcitrate<br />
Sodium Hydroxytriamterene Sulphate<br />
O O<br />
S<br />
NaO O<br />
MM 0499.00 Tributyl Acetylcitrate<br />
O O<br />
MM 0499.01<br />
Imp. A (EP): Tributyl 2-Hydroxypropane-1,2,3-<br />
tricarboxylate (Tributyl Citrate)<br />
O<br />
O<br />
H 2 N<br />
O<br />
N<br />
N<br />
O<br />
O O<br />
O O<br />
O<br />
HO<br />
O<br />
N<br />
N<br />
NH 2<br />
NH 2<br />
(A)<br />
(C)<br />
100 mg<br />
on request<br />
100 mg<br />
MM 0499.02<br />
Imp. B (EP) (E-Isomer): Tributyl (E)-Propene-1,2,3-<br />
tricarboxylate (Tributyl (E)-Aconitate)<br />
O O<br />
O O<br />
O<br />
O<br />
(A)<br />
100 mg<br />
O<br />
O<br />
Triclabendazole<br />
MM 0313.00<br />
Triclabendazole<br />
Cl<br />
Cl<br />
O<br />
Cl<br />
H<br />
N<br />
N<br />
S<br />
(D)<br />
100 mg<br />
Triclosan<br />
MM 0610.00<br />
Triclosan<br />
Cl<br />
O<br />
OH<br />
(A)<br />
500 mg<br />
Cl<br />
Cl<br />
Trihexyphenidyl Hydrochloride<br />
MM 0237.00<br />
Trihexyphenidyl Hydrochloride<br />
(A)<br />
500 mg<br />
OH<br />
N<br />
x HCl<br />
MM 0237.03<br />
Imp. A (EP) as Hydrochloride: 1-Phenyl-3-(piperidin-1-<br />
yl)propan-1-one Hydrochloride<br />
O<br />
N<br />
x HCl<br />
(A)<br />
100 mg<br />
MM 0237.01 Acetophenone<br />
O<br />
(B) 100 mg<br />
MM 0237.04<br />
Trihexyphenidyl N-Oxide<br />
(A)<br />
100 mg<br />
OH<br />
O<br />
N<br />
Trimebutine<br />
MM 0417.00<br />
Trimebutine<br />
N<br />
O<br />
O<br />
O<br />
O<br />
O<br />
(A)<br />
500 mg<br />
MM 0417.05<br />
Trimebutine Maleate<br />
N<br />
O<br />
O<br />
O<br />
O<br />
x<br />
O<br />
OH<br />
OH<br />
(A)<br />
500 mg<br />
O<br />
O<br />
MM 0417.01 2-(N,N-Dimethylamino)-2-phenylbutan-1-ol Hydrochloride OH<br />
N<br />
x HCl<br />
(A)<br />
100 mg<br />
MM 0417.06 3,4,5-Trimethoxybenzoic Acid O<br />
O<br />
(B)<br />
100 mg<br />
O<br />
OH<br />
O<br />
Trimeprazine Tartrate<br />
MM 0958.00<br />
Trimeprazine Tartrate<br />
N<br />
S<br />
N<br />
OH O<br />
x HO<br />
OH<br />
O OH<br />
2<br />
(A)<br />
500 mg<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 321
<strong>Pharmac<strong>eu</strong>tical</strong> Impurities<br />
Code Product Category Unit<br />
MM 0958.01 Trimeprazine Sulphone (Oxomemazine)<br />
N<br />
N<br />
(A) 100 mg<br />
MM 0958.02<br />
Trimeprazine Sulphoxide Hydrochloride<br />
S<br />
O O<br />
N<br />
(A)<br />
100 mg<br />
N<br />
x HCl<br />
S<br />
O<br />
MM 0958.04<br />
Trimeprazine Sulphone N-Oxide Hydrochloride<br />
(Oxomemazine N-Oxide Hydrochloride)<br />
N<br />
N O<br />
x HCl<br />
(A)<br />
100 mg<br />
S<br />
O O<br />
Trimetazidine Dihydrochloride<br />
MM 0539.00<br />
Trimetazidine Dihydrochloride<br />
HN<br />
N<br />
O<br />
O<br />
O<br />
x 2 HCl<br />
(A)<br />
100 mg<br />
New MM 0539.01 Imp. A (EP) as Dihydrochloride: 1-(3,4,5-<br />
Trimethoxybenzyl)piperazine Dihydrochloride<br />
HN<br />
N<br />
O<br />
O<br />
O<br />
x 2 HCl<br />
(A)<br />
100 mg<br />
MM 0539.02<br />
Imp. B (EP): 1,4-Bis(2,3,4-trimethoxybenzyl)piperazine<br />
O<br />
O<br />
O<br />
N<br />
N<br />
O<br />
O<br />
O<br />
(A)<br />
100 mg<br />
MM 0539.03<br />
Imp. C (EP): 2,3,4-Trimethoxybenzaldehyde<br />
O<br />
O<br />
O<br />
(B)<br />
100 mg<br />
O<br />
MM 0539.04<br />
Imp. D (EP): (2,3,4-Trimethoxyphenyl)methanol<br />
HO<br />
O<br />
O<br />
(A)<br />
100 mg<br />
O<br />
New MM 0539.05 Imp. E (EP) as Dihydrochloride: 1-(2,4,5-<br />
Trimethoxybenzyl)piperazine Dihydrochloride<br />
HN<br />
N<br />
O<br />
O<br />
x 2 HCl<br />
(A)<br />
100 mg<br />
O<br />
MM 0539.06<br />
Imp. F (EP) as Dihydrochloride: 1-(2,4,6-Trimethoxybenzyl)piperazine<br />
Dihydrochloride<br />
HN<br />
N<br />
O<br />
O<br />
O<br />
x 2 HCl<br />
(A)<br />
100 mg<br />
MM 0539.07 Imp. G (EP) as Hexahydrate: Piperazine Hexahydrate NH<br />
MM 0539.08<br />
Trimethoprim<br />
1-Formyl-4-(2,3,4-trimethoxybenzyl)piperazine<br />
Hydrochloride<br />
MM 0093.00 Trimethoprim O<br />
O<br />
O<br />
N<br />
N<br />
O<br />
HN<br />
O<br />
O<br />
O<br />
x 6 H 2 O<br />
(B) 100 mg<br />
N<br />
x HCl<br />
N NH 2<br />
NH 2<br />
(A)<br />
(A)<br />
100 mg<br />
500 mg<br />
MM 0093.06<br />
Imp. A (EP): N 2 -Methyl-5-(3,4,5-trimethoxybenzyl)pyrimidine-2,4-<br />
diamine<br />
O<br />
O<br />
O<br />
(A) 100 mg<br />
N NH<br />
N<br />
NH 2<br />
MM 0093.01<br />
Imp. B (EP): (2,4-Diaminopyrimidin-5-yl)-(3,4,5-trimethoxyphenyl)methanone<br />
O<br />
O<br />
O<br />
O<br />
N NH 2<br />
N<br />
NH 2<br />
(A)<br />
100 mg<br />
322 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
<strong>Pharmac<strong>eu</strong>tical</strong> Impurities<br />
Code Product Category Unit<br />
MM 0093.08<br />
Imp. C (EP): (RS)-(2,4-Diaminopyrimidin-5-yl)(3,4,5-trimethoxyphenyl)methanol<br />
MM 0093.04 Imp. D (EP): 2-Amino-5-(3,4,5-trimethoxybenzyl)pyrimidin-4-ol O<br />
O<br />
MM 0093.03 Imp. E (EP): 4-Amino-5-(3,4,5-trimethoxybenzyl)pyrimidin-2-ol O<br />
O<br />
MM 0093.09<br />
Imp. F (EP): 5-(3-Bromo-4,5-dimethoxybenzyl)pyrimidine-2,4-<br />
diamine<br />
O<br />
O<br />
O<br />
O<br />
Br<br />
O<br />
O<br />
O<br />
OH<br />
N NH 2<br />
N<br />
NH 2<br />
N NH 2<br />
OH<br />
N<br />
(A)<br />
(A)<br />
100 mg<br />
100 mg<br />
(A) 100 mg<br />
N OH<br />
N<br />
NH 2<br />
N NH 2<br />
N<br />
NH 2<br />
(A)<br />
100 mg<br />
MM 0093.10<br />
Imp. G (EP): 5-(4-Ethoxy-3,5-dimethoxybenzyl)pyrimidine-2,4-<br />
diamine<br />
O<br />
O<br />
O<br />
N NH 2<br />
N<br />
(A)<br />
100 mg<br />
NH 2<br />
MM 0093.11 Imp. H (EP): Methyl 3,4,5-Trimethoxybenzoate O<br />
O<br />
(A)<br />
100 mg<br />
MM 0093.12<br />
Imp. I (EP): 3-(Phenylamino)-2-(3,4,5-trimethoxybenzyl)prop-2-<br />
enenitrile<br />
(E/Z-mixture)<br />
MM 0093.13 Imp. J (EP): 3,4,5-Trimethoxybenzoic Acid O<br />
O<br />
O<br />
O<br />
O<br />
O<br />
O<br />
H<br />
N<br />
O<br />
O<br />
N<br />
OH<br />
O<br />
(A)<br />
(B)<br />
100 mg<br />
100 mg<br />
MM 0093.15 Imp. K (EP): Aniline<br />
NH 2<br />
(B) 100 mg<br />
MM 0093.02 5-(3,4,5-Trimethoxybenzyl)pyrimidin-2,4-diol O<br />
O<br />
N<br />
OH<br />
(A)<br />
100 mg<br />
O<br />
N<br />
OH<br />
MM 0093.05 2-Amino-5-(4-hydroxy-3,5-dimethoxybenzyl)pyrimidin-4-ol O<br />
HO<br />
N NH 2<br />
(A)<br />
100 mg<br />
O<br />
N<br />
OH<br />
MM 0093.07 N 4 -Methyl-5-(3,4,5-trimethoxybenzyl)pyrimidine-2,4-diamine O<br />
O<br />
N NH 2<br />
(A)<br />
100 mg<br />
O<br />
N<br />
NH<br />
Trimipramine Maleate<br />
MM 0240.00<br />
Trimipramine Maleate<br />
O<br />
(A)<br />
500 mg<br />
N<br />
N<br />
x<br />
OH<br />
OH<br />
O<br />
MM 0240.01<br />
Trimipramine<br />
(A)<br />
100 mg<br />
N<br />
N<br />
MM 0240.04<br />
Imp. A (EP): (2RS)-3-(10,11-Dihydro-5H-dibenzo-<br />
[b,f]azepin-5-yl)-N,N,2-trimethylpropan-1-amine<br />
N-oxide (Trimipramine N-Oxide)<br />
N<br />
N<br />
O<br />
(A)<br />
100 mg<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 323
<strong>Pharmac<strong>eu</strong>tical</strong> Impurities<br />
Code Product Category Unit<br />
MM 0240.02<br />
Imp. B (EP) as Hydrochloride: (2RS)-3-(10,11-<br />
Dihydro-5H-dibenzo[b,f]azepin-5-yl)-N,2-dimethylpropan-1-amine<br />
Hydrochloride<br />
(Desmethyltrimipramine Hydrochloride)<br />
N<br />
N<br />
H<br />
x HCl<br />
(A)<br />
100 mg<br />
MM 0240.06<br />
Imp. D (EP) as Hydrochloride: Imipramine<br />
(A)<br />
500 mg<br />
Hydrochloride<br />
N<br />
N<br />
x HCl<br />
MM 0240.03<br />
Imp. F (EP): 10,11-Dihydro-5H-dibenzo[b,f]azepine (Iminodibenzyl)<br />
(B)<br />
100 mg<br />
NH<br />
Tropicamide<br />
MM 0601.00<br />
MM 0601.01<br />
Tropicamide<br />
Imp. A (EP): N-(Pyridin-4-ylmethyl)ethanamine<br />
O<br />
OH<br />
N<br />
N<br />
(A)<br />
250 mg<br />
HN (A) 100 mg<br />
N<br />
MM 0601.03<br />
Imp. C (EP): (2RS)-3-Hydroxy-2-phenylpropanoic Acid (Tropic Acid)<br />
O<br />
(A)<br />
100 mg<br />
OH<br />
OH<br />
Tropisetron Hydrochloride<br />
MM 0763.01<br />
Imp. A (EP): (1R,3r,5S)-8-Methyl-8-<br />
azabicyclo[3.2.1]oct-3-ol (Tropine)<br />
H<br />
HO<br />
H<br />
(A) 100 mg<br />
N<br />
H<br />
MM 0763.02<br />
Imp. B (EP): 1H-Indole-3-carboxylic Acid<br />
O<br />
(A) 100 mg<br />
HN<br />
OH<br />
Tryptophan<br />
MM 0172.00 L-Tryptophan<br />
H<br />
N<br />
O<br />
NH 2<br />
(A) 500 mg<br />
OH<br />
MM 0172.09<br />
Imp. A (EP): 3,3'-[Ethylidenebis(1H-indole-1,3-<br />
diyl)]bis[(2S)-2-aminopropanoic] Acid<br />
(1,1'-Ethylidenebistryptophan)<br />
HO<br />
NH 2<br />
N<br />
N<br />
NH 2<br />
OH<br />
(D)<br />
100 mg<br />
MM 0172.03<br />
Imp. D (EP): (S)-2-Amino-3-(5-hydroxy-1H-indol-3-yl)propanoic<br />
Acid (5-Hydroxytryptophan)<br />
O<br />
H<br />
N<br />
O<br />
NH 2<br />
OH<br />
(A)<br />
100 mg<br />
HO<br />
O<br />
O<br />
(A) 100 mg<br />
MM 0172.13 N-Acetyltryptophan<br />
H<br />
N<br />
O<br />
HN<br />
OH<br />
Tyrosine<br />
New MM 0634.00 Tyrosine<br />
HO<br />
NH 2<br />
(A) 100 mg<br />
OH<br />
O<br />
Valaciclovir Hydrochloride<br />
MM 0619.01<br />
Imp. A (Pharm<strong>eu</strong>ropa): 2-Amino-1,9-dihydro-6H-purin-6-one (Guanine)<br />
O<br />
HN<br />
H 2 N N<br />
N<br />
H<br />
N<br />
(B)<br />
100 mg<br />
324 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
<strong>Pharmac<strong>eu</strong>tical</strong> Impurities<br />
Code Product Category Unit<br />
MM 0619.02<br />
MM 0619.07<br />
Imp. B (Pharm<strong>eu</strong>ropa): 2-Amino-9-[(2-hydroxyethoxy)methyl]-<br />
1,9-dihydro-6H-purin-6-one<br />
Imp. G (Pharm<strong>eu</strong>ropa): N,N-Dimethylpyridin-4-amine<br />
H 2 N<br />
HN<br />
O<br />
N<br />
N<br />
N<br />
O<br />
OH<br />
(A)<br />
500 mg<br />
N (A) 100 mg<br />
New MM 0619.09<br />
Valproic Acid<br />
Imp. I (Pharm<strong>eu</strong>ropa): 2-[(2-Amino-6-oxo-1,6-<br />
dihydro-9H-purin-9-yl)methoxy]ethyl Acetate<br />
MM 0751.00 Valproic Acid<br />
O<br />
H 2 N<br />
HN<br />
O<br />
N<br />
N<br />
N<br />
O<br />
O<br />
N<br />
O<br />
OH<br />
(A)<br />
(A)<br />
100 mg<br />
500 mg<br />
MM 0751.11 Sodium Valproate<br />
O<br />
ONa<br />
(A)<br />
500 mg<br />
MM 0751.01<br />
MM 0751.02<br />
Imp. A (EP): Pentanoic Acid (Valeric Acid)<br />
Imp. B (EP): (2RS)-2-Ethylpentanoic Acid<br />
O<br />
(C) 100 mg<br />
OH<br />
O<br />
(A) 100 mg<br />
OH<br />
MM 0751.03<br />
Imp. C (EP): (2RS)-2-(1-Methylethyl)pentanoic Acid<br />
O<br />
(A) 100 mg<br />
OH<br />
MM 0751.04<br />
Imp. D (EP): 2,2-Dipropylpentanoic Acid<br />
O<br />
(A) 100 mg<br />
OH<br />
MM 0751.05<br />
MM 0751.06<br />
Imp. E (EP): Pentanamide (Valeramide)<br />
Imp. F (EP): 2-Propylpentanamide<br />
O<br />
(A) 100 mg<br />
NH 2<br />
O<br />
(A) 100 mg<br />
NH 2<br />
MM 0751.07<br />
Imp. G (EP): 2,2-Dipropylpentanamide<br />
O<br />
(A) 100 mg<br />
NH 2<br />
MM 0751.08 Imp. H (EP): Pentanenitrile (Valeronitrile)<br />
N<br />
(C) 100 mg<br />
MM 0751.09 Imp. I (EP): 2-Propylpentanenitrile<br />
N<br />
(A) 100 mg<br />
MM 0751.10 Imp. J (EP): 2,2-Dipropylpentanenitrile<br />
N<br />
(A) 100 mg<br />
Vancomycin Hydrochloride<br />
MM 0239.00<br />
Vancomycin Hydrochloride<br />
HO NH 2<br />
O<br />
O<br />
HO<br />
OH<br />
O<br />
O<br />
Cl<br />
O<br />
O<br />
OH<br />
HN<br />
H<br />
N<br />
O<br />
O<br />
NH<br />
(A)<br />
100 mg<br />
HO<br />
Cl<br />
O<br />
HN<br />
NH<br />
O<br />
O<br />
NH 2<br />
x HCl<br />
O<br />
HO<br />
O<br />
NH<br />
O<br />
N<br />
H<br />
OH<br />
OH<br />
OH<br />
OH<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 325
<strong>Pharmac<strong>eu</strong>tical</strong> Impurities<br />
Code Product Category Unit<br />
Venlafaxine Hydrochloride<br />
MM 0393.00<br />
Venlafaxine Hydrochloride<br />
OH<br />
on request<br />
N<br />
x HCl<br />
O<br />
MM 0393.08<br />
Imp. C (EP) as Hydrochloride: 1-[(1RS)-2-Amino-1-(4-<br />
methoxyphenyl)ethyl]cyclohexanol Hydrochloride<br />
OH<br />
NH 2<br />
x HCl<br />
(A)<br />
100 mg<br />
O<br />
MM 0393.04<br />
Imp. D (EP) as Hydrochloride: 1-[(1RS)-1-(4-<br />
Methoxyphenyl)-2-(methylamino)ethyl]cyclohexanol<br />
Hydrochloride<br />
OH<br />
H<br />
N<br />
x HCl<br />
(A)<br />
100 mg<br />
O<br />
MM 0393.09<br />
Imp. E (EP) as Hydrochloride: (5RS)-5-(4-<br />
Methoxyphenyl)-3-methyl-1-oxa-3-azaspiro-<br />
[5.5]undecane Hydrochloride<br />
O<br />
N<br />
x HCl<br />
(A)<br />
100 mg<br />
O<br />
MM 0393.10<br />
Imp. F (EP) as Hydrochloride: (2RS)-2-<br />
(Cyclohex-1-enyl)-2-(4-methoxyphenyl)-<br />
N,N-dimethylethanamine Hydrochloride<br />
N<br />
x HCl<br />
(A)<br />
100 mg<br />
O<br />
MM 0393.01<br />
O-Desmethylvenlafaxine<br />
OH<br />
(A)<br />
100 mg<br />
N<br />
HO<br />
Verapamil Hydrochloride<br />
MM 0022.00<br />
Verapamil Hydrochloride<br />
O<br />
(A)<br />
500 mg<br />
O<br />
O<br />
O<br />
N<br />
MM 0022.07<br />
MM 0022.08<br />
Imp. A (EP) as Dihydrochloride: N,N'-Bis[2-<br />
(3,4-dimethoxyphenyl)<br />
ethyl]-N,N'-dimethylpropane-1,3-diamine<br />
Dihydrochloride<br />
Imp. B (EP) as Hydrochloride: 2-(3,4-Dimethoxyphenyl)-Nmethylethanamine<br />
Hydrochloride<br />
O<br />
x HCl<br />
O N N O<br />
N<br />
x 2 HCl O (A) 100 mg<br />
O<br />
O<br />
x HCl<br />
NH<br />
(A)<br />
100 mg<br />
New MM 0022.09 Imp. C (EP) as Hydrochloride: 2-(3,4-<br />
Dimethoxyphenyl)-N,N-dimethylethanamine<br />
Hydrochloride<br />
O<br />
O<br />
N<br />
x HCl<br />
(A)<br />
100 mg<br />
MM 0022.02<br />
Imp. D (EP): 3-Chloro-N-[2-(3,4-dimethoxyphenyl)ethyl]-Nmethylpropan-1-amine<br />
O<br />
O N Cl<br />
(A)<br />
100 mg<br />
MM 0022.05 Imp. E (EP): (3,4-Dimethoxyphenyl)methanol<br />
O<br />
MM 0022.04 Imp. G (EP): 3,4-Dimethoxybenzaldehyde<br />
O<br />
OH<br />
(B) 100 mg<br />
O (B) 100 mg<br />
O<br />
O<br />
MM 0022.11<br />
Imp. H (EP) as Hydrochloride: (2RS)-2-(3,4-<br />
Dimethoxyphenyl)-5-[[2-(3,4-<br />
dimethoxyphenyl)ethyl](methyl)amino]-2-<br />
ethylpentanenitrile Hydrochloride<br />
O<br />
O<br />
x HCl<br />
N<br />
O<br />
O<br />
(A)<br />
100 mg<br />
N<br />
MM 0022.01<br />
Imp. J (EP): (2RS)-2-(3,4-Dimethoxyphenyl)-5-<br />
[[2-(3,4-dimethoxyphenyl)ethyl]amino]-2-(1-<br />
methylethyl)pentanenitrile<br />
(N-Norverapamil)<br />
O<br />
O<br />
O N<br />
H<br />
O<br />
(A)<br />
100 mg<br />
N<br />
326 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
<strong>Pharmac<strong>eu</strong>tical</strong> Impurities<br />
Code Product Category Unit<br />
MM 0022.03<br />
Imp. K (EP): (2RS)-2-(3,4-Dimethoxyphenyl)-3-methylbutylnitrile<br />
O (A) 100 mg<br />
O<br />
N<br />
MM 0022.13<br />
Imp. L (EP): 1-(3,4-Dimethoxyphenyl)-2-<br />
methylpropan-1-one<br />
O (A) 100 mg<br />
O<br />
O<br />
New MM 0022.16<br />
Imp. O (EP) as Hydrochloride: (2RS)-2-(3,4-<br />
Dimethoxyphenyl)-5-[2-[2-(3,4-dimethoxyphenyl)ethyl](methyl)amino]-<br />
2-propylpentanenitrile<br />
Hydrochloride<br />
O<br />
O<br />
x HCl<br />
N<br />
O<br />
O<br />
(A)<br />
100 mg<br />
N<br />
MM 0022.06<br />
Diisopropylhomoveratylcyanide<br />
O (D) 100 mg<br />
O<br />
N<br />
MM 0022.18<br />
3,4-Dimethoxyphenylacetonitrile<br />
O<br />
(A)<br />
100 mg<br />
O<br />
N<br />
MM 0022.19<br />
Verapamil N-Oxide Hydrochloride<br />
O<br />
(A)<br />
100 mg<br />
O<br />
O<br />
O<br />
O<br />
N<br />
x HCl<br />
N<br />
Vincamine<br />
MM 0519.00<br />
Vincamine<br />
N<br />
HO<br />
H<br />
N<br />
(A)<br />
100 mg<br />
O<br />
O<br />
Vinpocetine<br />
MM 0406.00<br />
Vinpocetine<br />
O<br />
(D)<br />
100 mg<br />
O<br />
N<br />
N<br />
H<br />
MM 0406.02<br />
Imp. A (EP): Ethyl (12RS,13aSR,13bSR)-13a-<br />
Ethyl-12-hydroxy-2,3,5,6,12,13,13a,13b-octahydro-1H-indolo[3,2,1-de]pyrido[3,2,1-ij][1,5]-<br />
naphthyridine-12-carboxylate (Ethyl Vincaminate)<br />
O<br />
HO<br />
O<br />
N<br />
N<br />
H<br />
(D)<br />
100 mg<br />
<strong>and</strong> enantiomer<br />
MM 0406.01<br />
Imp. B (EP): Methyl (13aS,13bS)-13a-Ethyl-<br />
2,3,5,6,13a,13b-hexahydro-1H-indolo[3,2,1-<br />
de]pyrido[3,2,1-ij][1,5]naphthyridine-12-<br />
carboxylate (Apovincamine)<br />
O<br />
O<br />
N<br />
N<br />
H<br />
(D)<br />
100 mg<br />
Warfarin Sodium<br />
MM 0732.02 Imp. B (Pharm<strong>eu</strong>ropa): 4-Hydroxycoumarin<br />
O O<br />
(A)<br />
100 mg<br />
Xylazine Hydrochloride<br />
OH<br />
MM 0515.00 Xylazine Hydrochloride H<br />
S N<br />
(A)<br />
500 mg<br />
N<br />
x HCl<br />
MM 0515.01<br />
Imp. A (EP): 2,6-Dimethylaniline (2,6-Xylidine)<br />
H 2 N<br />
(B)<br />
100 mg<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 327
<strong>Pharmac<strong>eu</strong>tical</strong> Impurities<br />
Code Product Category Unit<br />
Xylometazoline Hydrochloride<br />
MM 0089.00<br />
Xylometazoline Hydrochloride<br />
N<br />
N<br />
H<br />
x HCl<br />
(A)<br />
500 mg<br />
MM 0089.07<br />
Imp. A (EP) as Hydrochloride: N-(2-<br />
Aminoethyl)-2-[4-(1,1-dimethylethyl)-<br />
2,6-dimethylphenyl]acetamide<br />
Hydrochloride<br />
O<br />
N<br />
H<br />
NH 2<br />
x HCl<br />
(A)<br />
100 mg<br />
MM 0089.04<br />
Imp. B (EP): 2-(Chloromethyl)-5-(1,1-dimethylethyl)-1,3-<br />
dimethylbenzene<br />
Cl<br />
(A)<br />
100 mg<br />
MM 0089.03<br />
Imp. C (EP): [4-(1,1-Dimethylethyl)-2,6-dimethylphenyl]acetonitrile<br />
(A)<br />
100 mg<br />
N<br />
MM 0089.05 Imp. D (EP): 1-(1,1-Dimethylethyl)-3,5-dimethylbenzene (C) 100 mg<br />
MM 0089.02<br />
Imp. F (EP): [4-(1,1-Dimethylethyl)-2,6-dimethylphenyl]acetic Acid<br />
O<br />
(A)<br />
100 mg<br />
OH<br />
Zidovudine<br />
MM 0173.01<br />
Imp. A (EP): 1-[(2R,5S)-5-(Hydroxymethyl)-2,5-dihydrofuran-2-yl)-5-<br />
methylpyrimidine-2,4(1H,3H)-dione<br />
HO<br />
HN<br />
O N<br />
O<br />
O<br />
(A) 100 mg<br />
MM 0173.03<br />
Imp. C (EP): 5-Methylpyrimidine-2,4(1H,3H)dione (Thymine)<br />
O<br />
(A) 100 mg<br />
HN<br />
MM 0173.04<br />
Imp. D (EP): Triphenylmethanol<br />
O<br />
N<br />
H<br />
(A)<br />
100 mg<br />
OH<br />
Zolpidem Tartrate<br />
MM 0333.01<br />
Imp. A (EP): N,N-Dimethyl-2-[7-methyl-2-(4-<br />
methylphenyl)imidazo[1,2-a]pyridin-3-yl]acetamide<br />
N<br />
N<br />
O<br />
N<br />
(D)<br />
100 mg<br />
MM 0333.02<br />
2-[6-Methyl-2-(4-methylphenyl)imidazo-[1,2-a]pyridin-3-yl]acetamide<br />
(A)<br />
100 mg<br />
N<br />
N<br />
O<br />
NH 2<br />
MM 0333.03<br />
2-[6-Methyl-2-(4-methylphenyl)imidazo-[1,2-a]pyridin-3-yl]acetic<br />
Acid<br />
N<br />
N<br />
O<br />
OH<br />
(A)<br />
100 mg<br />
MM 0333.04<br />
Methyl 2-[6-Methyl-2-(4-methylphenyl)imidazo[1,2-a]pyridin-3-<br />
yl]acetate<br />
N<br />
N<br />
O<br />
O<br />
(D)<br />
50 mg<br />
MM 0333.05<br />
6-Methyl-2-(4-methylphenyl)imidazo-[1,2-a]pyridine-3-acetonitrile<br />
(A)<br />
100 mg<br />
N<br />
N<br />
N<br />
328 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
<strong>Pharmac<strong>eu</strong>tical</strong> Impurities<br />
Code Product Category Unit<br />
MM 0333.06<br />
MM 0333.07<br />
Oxozolpidem (N,N,6-Trimethyl-2-(4-methylphenyl)-α-oxo-imidazo<br />
[1,2-a]pyridine-3-acetamide)<br />
Zolpaldehyde (6-Methyl-2-(4-methylphenyl)-imidazo[1,2-a]pyridine-<br />
3-carboxaldehyde)<br />
N<br />
N<br />
N<br />
O<br />
O<br />
N<br />
(D)<br />
(A)<br />
100 mg<br />
100 mg<br />
N<br />
O<br />
MM 0333.08<br />
Zolpyridine (4-Methyl-N-(5-methyl-2-pyridinyl)-benzamide)<br />
H<br />
N<br />
(A)<br />
100 mg<br />
N<br />
O<br />
New MM 0333.09<br />
6-Methyl-2-(4-methylphenyl)-α-oxo-imidazo[1,2-<br />
a]pyridine-3-acetamide<br />
N<br />
N<br />
O<br />
(A)<br />
100 mg<br />
O<br />
NH 2<br />
MM 0333.10<br />
Methyl α-Hydroxy-6-methyl-2-(4-methylphenyl)-<br />
imidazo[1,2-a]pyridine-3-acetate<br />
N<br />
N<br />
HO<br />
O<br />
O<br />
(A)<br />
100 mg<br />
Zopiclone<br />
MM 0149.00<br />
Zopiclone<br />
N<br />
N<br />
O<br />
N<br />
N<br />
O N<br />
O<br />
N<br />
Cl<br />
(D)<br />
100 mg<br />
MM 0149.01<br />
Imp. A (EP): (5RS)-6-(5-Chloropyridin-2-yl)-7-oxo-6,7-dihydro-5Hpyrrolo[3,4-b]pyrazin-5-yl<br />
4-Methylpiperazine-1-carboxylate 4-Oxide<br />
(Zopiclone Oxide)<br />
N<br />
N<br />
O<br />
N<br />
N<br />
O N<br />
O<br />
N<br />
O<br />
Cl<br />
(D)<br />
100 mg<br />
MM 0149.02<br />
Imp. B (EP): (7RS)-6-(5-Chloropyridin-2-yl)-7-hydroxy-6,7-dihydro-<br />
5H-pyrrolo[3,4-b]pyrazin-5-one<br />
N<br />
N<br />
O<br />
N<br />
OH<br />
N<br />
Cl<br />
(D)<br />
100 mg<br />
MM 0149.04<br />
2-Amino-5-chloropyridine<br />
H 2N<br />
N<br />
Cl<br />
(A)<br />
250 mg<br />
MM 0149.05<br />
MM 0149.06<br />
3-(5-Chloropyridine-2-carbamoyl)-2-pyrazinecarboxylic Acid<br />
6-(5-Chloropyridin-2-yl)- 6,7-dihydro-5H-pyrrolo[3,4-b]pyrazin-5,7-<br />
dione<br />
N<br />
N<br />
N<br />
N<br />
O<br />
O<br />
N<br />
N<br />
H<br />
OH<br />
O<br />
O<br />
N<br />
N<br />
Cl<br />
Cl<br />
(A)<br />
on request<br />
100 mg<br />
MM 0149.07<br />
5-(Chloropyridine-2-yl-carbamoyl)pyrazine<br />
N<br />
N<br />
O<br />
N<br />
H<br />
N<br />
Cl<br />
(A) 100 mg<br />
MM 0149.50<br />
2-Acetylamino-5-chloropyridine<br />
O<br />
N<br />
Cl<br />
(A) 100 mg<br />
NH<br />
Extended certificates of analysis from LGC<br />
MMEXTCOA<br />
The certificates from LGC usually contains one identity test via 1 H-NMR or MS.<br />
There is - for 90% of the LGC products - the opportunity to extend the certificates to the following content:<br />
Ia. 1 H-NMR<br />
Ib. 13 C-NMR<br />
Ic. MS<br />
Id. IR<br />
Extended certificates of analysis<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 329
<strong>Pharmac<strong>eu</strong>tical</strong> Impurities<br />
Code Product Category Unit<br />
Certificate construction in contract from LGC<br />
MMCERCON<br />
LGC offers the opportunity to set up a certificate of analysis (COA) for your <strong>substances</strong>. A minimum amount<br />
of 50 mg of substance is needed for analysis. The COA will contain the following:<br />
Identity ( 1 H-NMR, 13 C-NMR, MS, IR)<br />
Purity (HPLC-DAD)<br />
Assay declaration<br />
Incl. documentation with your batch identification<br />
Certificate construction in contract<br />
330 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
Physical<br />
St<strong>and</strong>ards<br />
St<strong>and</strong>ards<br />
Excellence through measurement
Genuine ATCC cultures<br />
<strong>and</strong> bioproducts for the<br />
European pharmac<strong>eu</strong>tical<br />
community<br />
LGC St<strong>and</strong>ards is the exclusive distributor of ATCC<br />
cultures <strong>and</strong> bioproducts in Europe. We are committed<br />
to providing authentic, high-quality ATCC cultures to<br />
support quality control <strong>and</strong> research activities across<br />
the pharmac<strong>eu</strong>tical industry.<br />
With a local stock of all key quality control strains <strong>and</strong><br />
a wide selection of other cultures, LGC St<strong>and</strong>ards<br />
network of offices across Europe is able to offer:<br />
• Faster delivery of ATCC products<br />
• Expert technical support<br />
• Expedited h<strong>and</strong>ling of special forms <strong>and</strong> paperwork<br />
to meet import regulations<br />
• Reduced shipping costs<br />
For further information or to place an order, please visit<br />
our web site or contact your local LGC St<strong>and</strong>ards office.<br />
Quality control strains<br />
Genomic DNA<br />
Animal <strong>and</strong> plant viruses<br />
Cell lines <strong>and</strong> hybridomas<br />
cDNA clones, vectors<br />
<strong>and</strong> libraries<br />
Microbial media,<br />
supplements <strong>and</strong><br />
antibiotics<br />
Cell culture media, sera<br />
<strong>and</strong> reagents<br />
Cryopreservation<br />
products<br />
www.lgcst<strong>and</strong>ards.com/atcc
Introduction<br />
Physical st<strong>and</strong>ards<br />
Introduction<br />
For manufacturers of a wide variety of products, the determination of the physical properties of their<br />
product can be one of the most important steps in assuring quality. This section is a comprehensive<br />
collection of <strong>reference</strong> materials intended purely for the determination of physical properties.<br />
It lists a large range of <strong>reference</strong> materials <strong>and</strong> st<strong>and</strong>ards covering many physical properties including<br />
thermal <strong>and</strong> surface properties, particle shape <strong>and</strong> size, ion activity, viscosity, electrical, <strong>and</strong> polymeric<br />
properties. Of particular interest are products for the determination of optical properties such as molecular<br />
absorption, luminescence, colour measurement <strong>and</strong> refractive index. Also featured are the old favourites<br />
such as melting point st<strong>and</strong>ards <strong>and</strong> st<strong>and</strong>ards for use with differential scanning calorimetry (DSC).<br />
The range includes <strong>reference</strong> materials <strong>and</strong> st<strong>and</strong>ards from commercial sources as well as national <strong>and</strong><br />
international bodies <strong>and</strong> each product is accompanied by a certificate of analysis. This section has<br />
been designed to be simple to use; it provides a brief description of the products with details of the<br />
relevant parameters from the certificate of analysis.<br />
Producers of <strong>reference</strong> materials<br />
IRMM<br />
BCR ® <strong>and</strong> IRMM <strong>reference</strong> materials (BCR ® is a registered trademark of JRC-EC-IRMM) are the products<br />
of both research funding <strong>and</strong> direct action programmes of the European Commission, in which new or<br />
improved measurement or testing methods are developed. These programmes are aimed at improving,<br />
harmonising or st<strong>and</strong>ardising measurements <strong>and</strong> testing in the European Union.<br />
As an authorised distributor of BCR ® <strong>reference</strong> materials LGC St<strong>and</strong>ards currently holds stock of more than<br />
5000 units of certified BCR ® <strong>and</strong> IRMM <strong>reference</strong> materials under carefully controlled <strong>and</strong> monitored<br />
conditions.<br />
European Reference Materials (ERM ® )<br />
The ERM ® range of <strong>reference</strong> materials was launched in May 2004. It is the result of collaboration between<br />
three major <strong>reference</strong> material producers, LGC in the UK, the Institute for Reference Materials <strong>and</strong><br />
Measurement (IRMM) in Belgium <strong>and</strong> Bundesanstalt für Materialforschung und Prüfung (BAM) in Germany.<br />
The partners are committed to using the most advanced principles for the production of certified <strong>reference</strong><br />
materials. The certified values have clearly defined <strong>and</strong> stated traceability <strong>and</strong> are internationally recognized<br />
through participation of the partners in key comparisons organized by the Bureau International des Poids et<br />
Mesures (BIPM). All ERM ® materials are subject to rigorous homogeneity <strong>and</strong> stability testing guaranteeing<br />
the certified values for every unit over its complete shelf life.<br />
The National Institute of St<strong>and</strong>ards <strong>and</strong> Technology (NIST)<br />
NIST produces st<strong>and</strong>ard <strong>reference</strong> materials (SRMs ® ). Based in the United States, NIST has provided<br />
<strong>reference</strong> materials to industry <strong>and</strong> commerce for nearly 100 years. NIST collaborates with companies<br />
to provide academia <strong>and</strong> industry with SRMs for exp<strong>and</strong>ing areas such as air <strong>and</strong> water pollution, which<br />
are international issues.<br />
Others<br />
Materials from the following organisations are also included in this section:<br />
- National Research Centre for Certified Reference Materials, China<br />
- AEA Technology, UK<br />
- Whitehouse Scientific Ltd, UK<br />
- Optiglass Ltd, UK<br />
- Cargille Laboratories Inc., USA<br />
- H & D Fitzgerald Ltd, UK<br />
- GE Sensing, UK<br />
- Poulten Selfe & Lee Ltd, UK<br />
- Stanhope-Seta, UK<br />
- Federal Institute for Materials Research <strong>and</strong> Testing, Germany<br />
- LabSt<strong>and</strong> Production & Service Company, Pol<strong>and</strong><br />
- Central Office of Measures (GUM), Pol<strong>and</strong><br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 333
About proficiency testing (PT)<br />
The use of <strong>reference</strong> materials<br />
Reference materials are instrumental in ensuring the reliability of analytical measurements <strong>and</strong> so avoiding<br />
the use of poor quality data as the basis of decision making.<br />
When choosing a matrix <strong>reference</strong> material for a particular application the analyst should consider the<br />
following factors before selecting a material:<br />
- Matrix match <strong>and</strong> potential interferences<br />
- Analytes<br />
- Measurement range<br />
- Measurement uncertainties<br />
- Certification procedures used by the producer<br />
- Documentation supplied with the material (e.g. certificate or report).<br />
About proficiency testing (PT)<br />
Proficiency testing (PT) is a powerful quality assurance tool for laboratories undertaking analytical<br />
measurements. A PT scheme provider distributes test materials on a regular basis to participating<br />
laboratories for independent testing.The results are returned to the organiser of the scheme who<br />
makes an analysis of the results <strong>and</strong> provides a report to all the participants.<br />
There are a number of benefits of taking part in a PT scheme:<br />
- Provides laboratories with a mechanism to compare their measurements with others<br />
- Enables laboratories to demonstrate the quality of their results to third parties e.g. customers,<br />
regulators <strong>and</strong> accreditation bodies<br />
- Facilitates the monitoring of trends, over time, in the quality of measurements<br />
- Assists the evaluation of methods <strong>and</strong> instrumentation<br />
- Helps <strong>and</strong> educates laboratory staff <strong>and</strong> their customers<br />
The LGC Proficiency Testing Group (incorporating Quality Management Ltd <strong>and</strong> Aquacheck Ltd) is a<br />
major international provider of proficiency testing services. It has over twenty years experience in all<br />
aspects associated with the provision of proficiency testing services to laboratories undertaking chemical<br />
<strong>and</strong> microbiological analysis. Schemes of relevance to a wide range of sectors are available <strong>and</strong> most<br />
of them are run on an international basis. All LGC schemes are accredited by the United Kingdom<br />
Accreditation Service (UKAS).<br />
Current schemes provided include:<br />
Environmental:<br />
· AQUACHECK - chemical analysis of clean waters, waste waters, sludges, sediments <strong>and</strong> soils<br />
· QWAS - microbiological assessment of waters, effluents <strong>and</strong> sludges<br />
· CONTEST - analysis of contaminated soils for a wide range of contaminants<br />
Food:<br />
· QMS - microbiological examination of food <strong>and</strong> food ingredients<br />
· QDCS - composition <strong>and</strong> safety testing in the dairy sector<br />
· QMAS - chemical analysis of meat<br />
· QGS - analysis of gelatine samples<br />
· QCS - microbiological testing of chocolate<br />
· QFCS - chemical testing of food products<br />
Beverage:<br />
· BAPS - chemical, microbiological <strong>and</strong> sensory analysis of a range of beers.<br />
· DAPS - analysis of a wide range of alcoholic beverages (except beer)<br />
· QBS - microbiological <strong>and</strong> chemical testing of soft drinks<br />
· SODAS - chemical analysis of carbonated <strong>and</strong> still soft drinks<br />
· MAPS - analysis of malt <strong>and</strong> barley used by the malting, brewing <strong>and</strong> distilling industries<br />
· SUPS - analysis of raw sugar used in soft drink production.<br />
334 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
Others:<br />
· QMIS - identification of micro organisms<br />
· PHARMASSURE - measurement of a range of analytes in pharmac<strong>eu</strong>tical products<br />
used in hospitals<br />
· QUARTZ - toxicological analysis of drugs in post-mortem blood<br />
· TOYTEST - toy safety testing to the European St<strong>and</strong>ard EN71 <strong>and</strong> American St<strong>and</strong>ard ASTM<br />
F963<br />
In addition to these regular schemes LGC is also able to offer customised or closed proficiency<br />
testing schemes tailored to a specific organisation’s requirements.<br />
LGC schemes are now available either through LGC St<strong>and</strong>ards or through your local distributor.<br />
Please contact your local LGC St<strong>and</strong>ards office to find out more.<br />
Relevant literature<br />
Applications of Reference Materials in Analytical Chemistry VAM<br />
V. Barwick, S. Burke, R. Lawn, P. Roper <strong>and</strong> R. Walker RSC<br />
Reference Materials in Analytical Chemistry – A Guide for Selection <strong>and</strong> Use<br />
A. Zchunke published by Springer-Verlag.<br />
Reference Materials for Chemical Analysis – Certification, Availability <strong>and</strong> Proper Usage<br />
M. Stoeppler, W.R. Wolf, P.J. Jenks published by Wiley-VCH.<br />
Proficiency Testing in Analytical Chemistry, R.Lawn, M.Thompson <strong>and</strong> R.Walker published by<br />
The Royal Society of Chemistry.<br />
Relevant training courses<br />
A range of training courses is available from LGC to help laboratory managers <strong>and</strong> analysts demonstrate<br />
competence in, <strong>and</strong> keep abreast of, quality assurance issues <strong>and</strong> practices. LGC’s analytical quality<br />
training programme includes:<br />
- Achieving traceability in chemical testing<br />
- Using proficiency testing in the analytical laboratory<br />
- Method validation<br />
- Principles <strong>and</strong> practice of measurement uncertainty in chemical testing laboratories<br />
- Quality systems in testing laboratories<br />
- Statistics for analytical chemists<br />
- Further statistical tools for analytical chemists<br />
- Evaluating measurement uncertainty for chemical testing laboratories<br />
The majority of the courses are run in Teddington, South West London, UK. In addition, LGC can provide<br />
training for groups of staff at your own site, where the courses can be customised to meet your exact needs.<br />
For further information, please contact:<br />
Lorraine Didinal<br />
LGC Training Centre<br />
Queens Road<br />
Teddington, Middlesex<br />
TW11 0LY, UK<br />
Tel: +44 (0)20 8943 7631<br />
Fax: +44 (0)20 8943 7314<br />
Email: training@lgc.co.uk<br />
Web: www.lgc.co.uk<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 335
GlowellTM st<strong>and</strong>ards<br />
Glowell TM st<strong>and</strong>ards<br />
The measurement of light output from luminescence <strong>and</strong> fluorescence experiments is amongst the most<br />
common methods used in bio-analytical applications. The Glowell TM range of light output st<strong>and</strong>ards provide<br />
a known <strong>and</strong> traceable light source for the calibration of luminometers, bioimaging systems <strong>and</strong> quantitative<br />
PCR instruments. The st<strong>and</strong>ards are available in a variety of different wavelengths <strong>and</strong> formats to suit many<br />
different applications.<br />
Glowell TM st<strong>and</strong>ards generate a constant light output over a range of different wavelengths <strong>and</strong> intensities<br />
using a gaseous tritium source. A Glowell TM device is particularly useful in experimental applications that<br />
require the comparison of light output data from different experiments or instruments. Each Glowell TM unit<br />
can be placed in a single microplate well <strong>and</strong> can therefore be included in the same plate as the samples<br />
being analysed. Each Glowell TM product is provided with a certificate of analysis <strong>and</strong> is guaranteed to<br />
produce a stable light output for a period of year.<br />
The Glowell TM Low Light Imaging st<strong>and</strong>ards can be used for the calibration of CCD or low light cameras<br />
<strong>and</strong> the validation of experimental data using this equipment.<br />
Code Product Unit<br />
LUX-GLO-001 Glowell 96 Well Microplate St<strong>and</strong>ard (Green Light) KIT<br />
LUX-GLO-002 Glowell 96 Well Microplate St<strong>and</strong>ard (Blue Light) KIT<br />
LUX-GLO-003 Glowell 96 Well Microplate St<strong>and</strong>ard (Red Light) KIT<br />
LUX-GLO-004 Glowell 96 Well Microplate St<strong>and</strong>ard (Yellow Light) KIT<br />
LUX-GLO-010 Glowell 384 Well Microplate St<strong>and</strong>ard (Green Light) KIT<br />
LUX-GLO-011 Glowell 384 Well Microplate St<strong>and</strong>ard (Blue Light) KIT<br />
LUX-GLO-012 Glowell 384 Well Microplate St<strong>and</strong>ard (Red Light) KIT<br />
LUX-GLO-013 Glowell 384 Well Microplate St<strong>and</strong>ard (Yellow Light) KIT<br />
LUX-GLO-014 Glowell Low Light Imaging St<strong>and</strong>ard (Green Light) Unit<br />
LUX-GLO-015 Glowell Low Light Imaging St<strong>and</strong>ard (Blue Light) Unit<br />
LUX-GLO-016 Glowell 96 Well Microplate St<strong>and</strong>ard (2 colour, combination) KIT<br />
Thermal properties<br />
Enthalpy <strong>and</strong> heat capacity<br />
Code Product Unit<br />
LGC2601<br />
LGC2603<br />
LGC2604<br />
LGC2605<br />
LGC2606<br />
LGC2607<br />
Indium - DSC calibration st<strong>and</strong>ard<br />
This certified <strong>reference</strong> material is intended for use in the calibration of differential scanning calorimeters <strong>and</strong><br />
similar instruments.<br />
Certified values<br />
Enthalpy of fusion..................................3.296 kJ/mol Melting temperature...................................156.61 °C<br />
Naphthalene - DSC calibration st<strong>and</strong>ard<br />
This certified <strong>reference</strong> material is intended for use in the calibration of differential scanning calorimeters <strong>and</strong><br />
similar instruments.<br />
Certified values<br />
Enthalpy of fusion................................18.923 kJ/mol Melting temperature.....................................80.23 °C<br />
Benzil - DSC calibration st<strong>and</strong>ard<br />
This certified <strong>reference</strong> material is intended for use in the calibration of differential scanning calorimeters <strong>and</strong><br />
similar instruments.<br />
Certified values<br />
Enthalpy of fusion..................................23.26 kJ/mol Melting temperature.....................................94.85 °C<br />
Acetanilide - DSC calibration st<strong>and</strong>ard<br />
This certified <strong>reference</strong> material is intended for use in the calibration of differential scanning calorimeters <strong>and</strong><br />
similar instruments.<br />
Certified values<br />
Enthalpy of fusion................................21.793 kJ/mol Melting temperature...................................114.34 °C<br />
Benzoic acid - DSC calibration st<strong>and</strong>ard<br />
This certified <strong>reference</strong> material is intended for use in the calibration of differential scanning calorimeters <strong>and</strong><br />
similar instruments.<br />
Certified values<br />
Enthalpy of fusion..................................17.98 kJ/mol Melting temperature...................................122.35 °C<br />
Diphenylacetic acid - DSC calibration st<strong>and</strong>ard<br />
This certified <strong>reference</strong> material is intended for use in the calibration of differential scanning calorimeters <strong>and</strong><br />
similar instruments.<br />
Certified values<br />
Enthalpy of fusion..................................31.16 kJ/mol Melting temperature...................................147.19 °C<br />
500 mg<br />
500 mg<br />
500 mg<br />
500 mg<br />
500 mg<br />
500 mg<br />
336 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
Thermal properties<br />
Code Product Unit<br />
LGC2608<br />
LGC2609<br />
LGC2610<br />
LGC2611<br />
LGC2612<br />
LGC2613<br />
LGC2013<br />
NIST-2232<br />
NIST-2234<br />
NIST-2235<br />
NIST-2225<br />
NIST-705A<br />
NIST-720<br />
NIST-781D2<br />
Lead - DSC calibration st<strong>and</strong>ard<br />
This certified <strong>reference</strong> material is intended for use in the calibration of differential scanning calorimeters <strong>and</strong><br />
similar instruments.<br />
Certified values<br />
Enthalpy of fusion..................................4.765 kJ/mol Melting temperature ..................................327.47 °C<br />
Tin - DSC calibration st<strong>and</strong>ard<br />
This certified <strong>reference</strong> material is intended for use in the calibration of differential scanning calorimeters <strong>and</strong><br />
similar instruments.<br />
Certified values<br />
Enthalpy of fusion..................................7.187 kJ/mol Melting temperature ..................................231.92 °C<br />
Biphenyl - DSC calibration st<strong>and</strong>ard<br />
This certified <strong>reference</strong> material is intended for use in the calibration of differential scanning calorimeters <strong>and</strong><br />
similar instruments.<br />
Certified Values<br />
Enthalpy of fusion..................................18.60 kJ/mol Melting temperature ....................................68.93 °C<br />
Zinc - DSC calibration st<strong>and</strong>ard<br />
This certified <strong>reference</strong> material is intended for use in the calibration of differential scanning calorimeters <strong>and</strong><br />
similar instruments.<br />
Certified values<br />
Enthalpy of fusion..................................7.103 kJ/mol Melting temperature ..................................419.53 °C<br />
Aluminium - DSC calibration st<strong>and</strong>ard<br />
This certified <strong>reference</strong> material is intended for use in the calibration of differential scanning calorimeters <strong>and</strong><br />
similar instruments.<br />
Certified values<br />
Enthalpy of fusion................................10.827 kJ/mol Melting temperature ..................................660.33 °C<br />
Phenyl salicylate - DSC calibration st<strong>and</strong>ard<br />
This certified <strong>reference</strong> material is intended for use in the calibration of differential scanning calorimeters <strong>and</strong><br />
similar instruments.<br />
Certified values<br />
Enthalpy of fusion..................................19.18 kJ/mol Melting temperature ....................................41.79 °C<br />
DSC purity set<br />
A series of mixtures of benzil in biphenyl intended for evaluating various features of the DSC technique (e.g. bias,<br />
repeatability, applicable impurity range) when the technique is used for determining the impurity content of organic<br />
compounds..<br />
Certified values<br />
Total impurity (mole %) Uncertainty (mole %) Total impurity (mole %) Uncertainty (mole %)<br />
0.1 ........................................................................ 0.1 2.1 ........................................................................0.2<br />
1.1 ........................................................................ 0.2 2.6 ........................................................................0.2<br />
1.6 ........................................................................ 0.2 3.1 ........................................................................0.2<br />
Indium - DSC calibration st<strong>and</strong>ard<br />
DSC calibration st<strong>and</strong>ard<br />
Certified values<br />
Enthalpy of fusion....................................... 28.51 J/g Melting temperature ..............................156.5985 °C<br />
Gallium - DSC calibration st<strong>and</strong>ard<br />
Certified values<br />
Enthalpy of fusion....................................80.097 kJ/g<br />
Bismuth - DSC calibration st<strong>and</strong>ard<br />
Certified values<br />
Enthalpy of fusion..................................... 53.146 J/g<br />
Mercury - DSC calibration st<strong>and</strong>ard<br />
Certified values<br />
Enthalpy of fusion................................11.469 kJ/mol<br />
Polystyrene - Heat capacity <strong>and</strong> molecular weight<br />
Fusion temperature .................................302.9146 K<br />
Fusion temperature ...................................544.556 K<br />
Melting temperature ....................................234.30 K<br />
Molecular weight (MW) values, measured using various techniques, <strong>and</strong> limiting viscosity (LV) numbers.<br />
Certified values<br />
M n by membrane osmometry............. 170,900 g/mol LV in benzene (25 °C)...............................74.3 mL/g<br />
M W by light scattering......................... 179,300 g/mol LV in benzene (25 °C)...............................74.5 mL/g<br />
M W by sedimentation equilibrium ....... 189,800 g/mol LV in cyclohexane (25 °C).........................35.4 mL/g<br />
For heat capacity please ask for detailed list<br />
Synthetic sapphire - Enthalpy <strong>and</strong> heat capacity<br />
Relative enthalpy <strong>and</strong> heat capacity from 10 to 2250 K<br />
Molybdenum - Enthalpy <strong>and</strong> heat capacity<br />
Relative enthalpy <strong>and</strong> heat capacity from 273.15 to 2800 K<br />
500 mg<br />
500 mg<br />
500 mg<br />
500 mg<br />
500 mg<br />
500 mg<br />
6 x 500 mg<br />
1 g<br />
2 g<br />
1.5 g<br />
2.5 g<br />
5 g<br />
15 g<br />
each<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 337
Thermal properties<br />
Code Product Unit<br />
NIST-1514<br />
Thermal analysis purity set<br />
Set of 4 x 0.5 g<br />
A set of materials containing pure phenacetin <strong>and</strong> phenacetin doped with nominal 0.7, 2 <strong>and</strong> 5 mol percent of p-<br />
aminobezoic acid<br />
set (4)<br />
Melting, freezing <strong>and</strong> triple points<br />
LGC2411<br />
LGC2401<br />
LGC2402<br />
LGC2403<br />
LGC2404<br />
LGC2405<br />
LGC2406<br />
Phenyl salicylate - Melting point<br />
This certified <strong>reference</strong> material is intended for use in checking <strong>and</strong> calibrating apparatus used for determining<br />
melting points of samples in glass tubes.<br />
Certified values<br />
Thermodynamic melting point..................... 41.50 °C<br />
Dynamic melting points (0.2 °C/min heating rate):<br />
Onset of melting...........41.55 °C<br />
Meniscus point .............41.70 °C<br />
Liquefaction point .........41.85 °C<br />
4-Nitrotoluene - Melting point<br />
This certified <strong>reference</strong> material is intended for use in checking <strong>and</strong> calibrating apparatus used for determining<br />
melting points of samples in glass tubes.<br />
Certified values<br />
Dynamic melting points (0.2 °C/min heating rate):<br />
Onset of melting...........51.36 °C<br />
Meniscus point .............51.58 °C<br />
Liquefaction point .........51.71 °C<br />
Naphthalene - Melting point<br />
This certified <strong>reference</strong> material is intended for use in checking <strong>and</strong> calibrating apparatus used for determining<br />
melting points of samples in glass tubes.<br />
Certified values<br />
Thermodynamic melting point..................... 80.11 °C<br />
Dynamic melting points (0.2 °C/min heating rate):<br />
Onset of melting...........80.20 °C<br />
Meniscus point .............80.37 °C<br />
Liquefaction point .........80.71 °C<br />
Benzil - Melting point<br />
This certified <strong>reference</strong> material is intended for use in checking <strong>and</strong> calibrating apparatus used for determining<br />
melting points of samples in glass tubes.<br />
Certified values<br />
Thermodynamic melting point..................... 94.55 °C<br />
Dynamic melting points (0.2 °C/min heating rate):<br />
Onset of melting...........94.43 °C<br />
Meniscus point .............94.77 °C<br />
Liquefaction point .........95.08 °C<br />
Acetanilide - Melting point<br />
This certified <strong>reference</strong> material is intended for use in checking <strong>and</strong> calibrating apparatus used for determining<br />
melting points of samples in glass tubes.<br />
Certified values<br />
Thermodynamic melting point 113.94 °C<br />
Dynamic melting points (0.2 °C/min heating rate):<br />
Onset of melting.........113.46 °C<br />
Meniscus point ...........113.88 °C<br />
Liquefaction point .......114.27 °C<br />
Benzoic acid - Melting point<br />
This certified <strong>reference</strong> material is intended for use in checking <strong>and</strong> calibrating apparatus used for determining<br />
melting points of samples in glass tubes.<br />
Certified values<br />
Dynamic melting point (0.2 °C/min heating rate)<br />
Onset of melting.........121.80 °C<br />
Meniscus point ...........122.10 °C<br />
Liquefaction point .......122.37 °C<br />
Diphenylacetic acid - Melting point<br />
This certified <strong>reference</strong> material is intended for use in checking <strong>and</strong> calibrating apparatus used for determining<br />
melting points of samples in glass tubes.^<br />
Certified values<br />
Thermodynamic melting point................... 147.05 °C<br />
Dynamic melting points (0.2 °C/min heating rate):<br />
Onset of melting.........147.12 °C<br />
Meniscus point ...........147.21 °C<br />
Liquefaction point .......147.29 °C<br />
500 mg<br />
2 x 250 mg<br />
500 mg<br />
500 mg<br />
500 mg<br />
2 x 0.25 g<br />
500 mg<br />
338 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
Thermal properties<br />
Code Product Unit<br />
LGC2407<br />
LGC2408<br />
LGC2409<br />
LGC2410<br />
NCS AS93109<br />
NCS AS93102B<br />
NCS AS93110<br />
NCS AS93111<br />
NCS AS93103B<br />
NCS AS93112<br />
NCS AS93104B<br />
NCS AS93113<br />
NCS AS93105A<br />
NCS AS93114<br />
NCS AS93115<br />
NCS AS93116<br />
NCS AS93106<br />
Anisic acid - Melting point<br />
This certified <strong>reference</strong> material is intended for use in checking <strong>and</strong> calibrating apparatus used for determining<br />
melting points of samples in glass tubes.<br />
Certified values<br />
Thermodynamic melting point................... 183.09 °C<br />
Dynamic melting points (0.2 °C/min heating rate):<br />
Onset of melting.........183.11 °C<br />
Meniscus point ...........183.29 °C<br />
Liquefaction point.......183.72 °C<br />
2-Chloroanthraquinone - Melting point<br />
This certified <strong>reference</strong> material is intended for use in checking <strong>and</strong> calibrating apparatus used for determining<br />
melting points of samples in glass tubes.<br />
Certified values<br />
Thermodynamic melting point................... 209.12 °C<br />
Dynamic melting points (0.2 °C/min heating rate):<br />
Onset of melting.........209.18 °C<br />
Meniscus point ...........209.50 °C<br />
Liquefaction point.......209.78 °C<br />
Carbazole - Melting point<br />
This certified <strong>reference</strong> material is intended for use in checking <strong>and</strong> calibrating apparatus used for determining<br />
melting points of samples in glass tubes.<br />
Certified values<br />
Thermodynamic melting point..................... 245.4 °C<br />
Dynamic melting points (0.2 °C/min heating rate):<br />
Onset of melting.........244.71 °C<br />
Meniscus point ...........244.23 °C<br />
Liquefaction point.......245.58 °C<br />
Anthraquinone - Melting point<br />
This certified <strong>reference</strong> material is intended for use in checking <strong>and</strong> calibrating apparatus used for determining<br />
melting points of samples in glass tubes.<br />
Certified values<br />
Thermodynamic melting point................... 284.48 °C<br />
Dynamic melting points (0.2 °C/min heating rate):<br />
Onset of melting.........284.08 °C<br />
Meniscus point ...........284.38 °C<br />
Liquefaction point.......284.65 °C<br />
Azobenzol - Melting point<br />
Certified melting point ................................. 68.34 °C<br />
Napthalene - Melting point<br />
Certified melting point ................................. 80.08 °C<br />
Methylprotocatechuic - Melting point<br />
Certified melting point ................................. 81.85 °C<br />
Acetanil - Melting point<br />
Certified melting point ............................... 114.55 °C<br />
Benzoic acid - Melting point<br />
Certified melting point ............................... 122.35 °C<br />
p-Acetophenetidine - Melting point<br />
Certified melting point ............................... 134.96 °C<br />
1,6-Adipic acid - Melting point<br />
Certified melting point ............................... 151.62 °C<br />
Albexan - Melting point<br />
Certified melting point ............................... 164.70 °C<br />
Anisic acid - Melting point<br />
Certified melting point ............................... 183.28 °C<br />
Amber acid - Melting point<br />
Certified melting point ............................... 184.02 °C<br />
Sulfadimidine - Melting point<br />
Certified melting point ............................... 198.32 °C<br />
Cyanoguanidine - Melting point<br />
Certified melting point ............................... 208.62 °C<br />
Anthracene - Melting point<br />
Certified melting point ............................... 215.88 °C<br />
500 mg<br />
500 mg<br />
500 mg<br />
500 mg<br />
2 g<br />
2 g<br />
2 g<br />
2 g<br />
2 g<br />
2 g<br />
2 g<br />
2 g<br />
2 g<br />
2 g<br />
2 g<br />
2 g<br />
2 g<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 339
Thermal properties<br />
Code Product Unit<br />
NCS AS93117<br />
NCS AS93118<br />
NCS AS93107B<br />
NCS AS93101B<br />
NCS AS93119<br />
NCS AS93108B<br />
NIST-741A<br />
NIST-743<br />
NIST-1744<br />
NIST-1745<br />
NIST-1746<br />
NIST-1747<br />
NIST-1748<br />
NIST-740A<br />
NIST-45D<br />
NIST-49E<br />
NIST-742<br />
NIST-1968<br />
NIST-1751<br />
Saccharin - Melting point<br />
Certified melting point ............................... 228.41 °C<br />
Coffeine - Melting point<br />
Certified melting point ............................... 236.26 °C<br />
p-Nitrobenzoic acid - Melting point<br />
Certified melting point ............................... 239.58 °C<br />
4-Nitrotoluene - Melting point<br />
Certified melting point ................................. 51.61 °C<br />
Chocolax - Melting point<br />
Certified melting point ............................... 261.43 °C<br />
Anthraquinone - Melting point<br />
Certified melting point ............................... 284.55 °C<br />
Tin - Freezing point<br />
For use in defining fixed points of the International Temperature Scale of 1990 (ITS-90).<br />
Certified freezing point ............................ 231.928 °C<br />
Mercury - Triple point<br />
For use in defining fixed points of the International Temperature Scale of 1990 (ITS-90).<br />
Certified triple point ................................-38.8344 °C<br />
Aluminium - Freezing point<br />
For use in defining fixed points of the International Temperature Scale of 1990 (ITS-90).<br />
Certified freezing point ............................ 660.323 °C<br />
Indium - Freezing point<br />
For use in defining fixed points of the International Temperature Scale of 1990 (ITS-90).<br />
Certified freezing point .......................... 156.5985 °C<br />
Silver - Freezing point<br />
For use in defining fixed points of the International Temperature Scale of 1990 (ITS-90).<br />
Certified freezing point .............................. 961.78 °C<br />
Tin - Freezing point<br />
A fixed point device for use in the realisation of the International Temperature Scale of 1990 (ITS-90).<br />
Certified freezing point ............................ 231.928 °C<br />
Zinc - Freezing point<br />
A fixed point device for use in the realisation of the International Temperature Scale of 1990 (ITS-90).<br />
Certified freezing point ............................ 419.527 °C<br />
Zinc - Freezing point<br />
For use in defining fixed points of the International Temperature Scale of 1990 (ITS-90).<br />
Certified freezing point ............................ 419.527 °C<br />
Copper - Freezing point<br />
Moderate purity material for use in preparing <strong>reference</strong> point devices <strong>and</strong> for calibrating thermometers,<br />
thermocouples <strong>and</strong> other temperature measuring devices.<br />
Certified freezing point .............................. 1084.6 °C<br />
Lead - Freezing point<br />
Moderate purity material for use in preparing <strong>reference</strong> point devices <strong>and</strong> for calibrating thermometers,<br />
thermocouples <strong>and</strong> other temperature measuring devices.<br />
Certified freezing point ............................ 327.453 °C<br />
Alumina - Melting point<br />
Moderate purity material for use in preparing <strong>reference</strong> point devices <strong>and</strong> for calibrating thermometers,<br />
thermocouples <strong>and</strong> other temperature measuring devices.<br />
Certified melting point .................................. 2052 °C<br />
Gallium - Melting point/triple point<br />
A fixed-point device for use in the realisation of internationally accepted secondary <strong>reference</strong> points <strong>and</strong>/or triple<br />
points. They are not intended for calibration of differential scanning calorimeters.<br />
Certified melting point/triple point............ 29.7646 °C<br />
Gallium - Melting point<br />
This St<strong>and</strong>ard Reference Material (SRM ® ) is intended primarily for use as one of the defining fixed points of the<br />
International Temperature Scale of 1990 (ITS-90). The melting point is realised as the plateau temperature of the<br />
melting curve of slowly-melting, high-purity (mass ≥ fraction 99.9999 % pure) gallium.<br />
Certified melting-point temperature..................29.764 6 °C ± 0.000 07 °C<br />
2 g<br />
2 g<br />
2 g<br />
2 g<br />
2 g<br />
2 g<br />
200 g<br />
680 g<br />
200 g<br />
200 g<br />
300 g<br />
1 cell<br />
1 cell<br />
200 g<br />
450 g<br />
600 g<br />
10 g<br />
unit<br />
200 g<br />
340 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
Thermal properties<br />
Code Product Unit<br />
NIST-1969<br />
NIST-1970<br />
NIST-1971<br />
NIST-1972<br />
Flash point<br />
ERM-FC032<br />
ERM-FC033<br />
LGC2000<br />
Rubidium - Melting point/triple point<br />
A fixed-point device for use in the realisation of internationally accepted secondary <strong>reference</strong> points <strong>and</strong>/or triple<br />
points. They are not intended for calibration of differential scanning calorimeters.<br />
Certified melting point/triple point................ 39.30 °C<br />
Succinonitrile - Melting point/triple point<br />
A fixed-point device for use in the realisation of internationally accepted secondary <strong>reference</strong> points <strong>and</strong>/or triple<br />
points. They are not intended for calibration of differential scanning calorimeters.<br />
Certified melting point/triple point............ 58.0642 °C<br />
Indium - Melting point/triple point<br />
A fixed-point device for use in the realisation of internationally accepted secondary <strong>reference</strong> points <strong>and</strong>/or triple<br />
points. They are not intended for calibration of differential scanning calorimeters.<br />
Certified melting point/triple point............ 156.598 °C<br />
1,3-Dioxolan-2-one (ethylene carbonate) - Melting point/triple point<br />
A fixed-point device for use in the realisation of internationally accepted secondary <strong>reference</strong> points <strong>and</strong>/or triple<br />
points. They are not intended for calibration of differential scanning calorimeters.<br />
Certified melting point/triple point............ 36.3143 °C<br />
n-Nonane<br />
The certified value was determined by the Abel closed cup method described in the Institute of Petrol<strong>eu</strong>m<br />
St<strong>and</strong>ard IP170/95 <strong>and</strong> also published as British St<strong>and</strong>ard BS2000:Part 170: 1995. The certified value is<br />
corrected to st<strong>and</strong>ard barometric pressure at 0°C.<br />
Certified value<br />
Non-equilibrium flash point ........................... 32.5 °C<br />
n-Decane<br />
The certified value was determined by the Abel closed cup method described in the Institute of Petrol<strong>eu</strong>m<br />
St<strong>and</strong>ard IP170/95 <strong>and</strong> also published as British St<strong>and</strong>ard BS2000:Part 170: 1995. The certified value is<br />
corrected to st<strong>and</strong>ard barometric pressure at 0°C.<br />
Certified value<br />
Non-equilibrium flash point .............................. 50 °C<br />
Diethyl phthalate<br />
Combustion calorimetry<br />
NIST-39J<br />
NIST-1656<br />
NIST-1657<br />
NIST-2151<br />
NIST-2152<br />
NIST-2682B<br />
NIST-2684B<br />
This certified <strong>reference</strong> material is intended for use in checking <strong>and</strong> calibrating apparatus used for determining<br />
flash point by closed cup equilibrium methods. The certified value was determined from the results of an<br />
interlaboratory study, where the participants used IP/304 Pensky-Martens Closed Cup or IP/303 Setaflash<br />
methods.<br />
Certified value<br />
Equilibrium closed cup flash point............... 159.0 °C<br />
Benzoic acid - Heat of combustion<br />
Certified value ...... 26.434 MJ/kg<br />
Thianthrene - Heat of combustion<br />
Certified value ...... 33.480 MJ/kg<br />
Synthetic refuse-derived fuel - Heat of combustion<br />
Certified values<br />
HHV* (dry)...................................13.87 ± 0.25 MJ/kg Dry ash .......................................... 20.34 ± 0.54 wt%<br />
HHV* (dry, ash free)....................17.40 ± 0.30 MJ/kg<br />
*HHV (Higher heating value) is the synonym for gross calorific value.<br />
Nicotinic acid - Heat of combustion<br />
Certified value ......................................22.184 MJ/kg<br />
Urea<br />
Certified value ......................................10.536 MJ/kg<br />
Coal (sub-bituminous) - Sulphur, mercury <strong>and</strong> heat of combustion<br />
Certified values<br />
S.................................................................0.4917 %<br />
Indicative values for Ash content, Gross calorific value<br />
Coal (bituminous) - Sulphur, mercury <strong>and</strong> heat of combustion<br />
Certified values<br />
S...................................................................3.076 %<br />
Hg............................................................. 97.4 µg/kg<br />
Indicative values for Ash content, Gross calorific value<br />
Hg........................................................... 108.8 µg/kg<br />
Heat of combustion ............................... 28.56 MJ/kg<br />
unit<br />
unit<br />
60 g<br />
60 g<br />
100 mL<br />
100 mL<br />
500 mL<br />
30 g<br />
30 g<br />
100 g<br />
25 g<br />
25 g<br />
50 g<br />
50 g<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 341
Thermal properties<br />
Code Product Unit<br />
NIST-2685B<br />
NIST-2692b<br />
Solution calorimetry<br />
NIST-1655<br />
Vapour pressure<br />
NIST-746<br />
Thermal conductivity<br />
IRMM-440A<br />
IRMM-440B<br />
IRMM-440C<br />
IRMM-440D<br />
NIST-RM 8420<br />
BCR-039A<br />
BCR-039B<br />
BCR-039C<br />
Coal - Sulphur, mercury <strong>and</strong> heat of combustion<br />
This St<strong>and</strong>ard Reference Material (SRM ® ) is intended primarily for use in the evaluation of techniques employed<br />
in the determination of sulphur, mercury, ash content, <strong>and</strong> calorific value (MJ·kg-1) in coal <strong>and</strong> materials of a<br />
similar matrix. NIST-2685b consists of 50 g of bituminous coal ground to pass a 250 µm (60 mesh) sieve,<br />
homogenized, <strong>and</strong> packaged in an amber glass bottle.<br />
Certified values<br />
S...................................................................4.730 % Cl ..............................................................517 mg/kg<br />
Hg........................................................... 146.2 µg/kg<br />
Indicative values for the ash content, gross calorific value <strong>and</strong> elements<br />
Coal (bituminous) - Sulphur, mercury <strong>and</strong> gross calorific value<br />
Certified values<br />
S..................................................1.170 % ± 0.020 %<br />
Reference values<br />
Ash Content (mass fraction)...........................7.90 %<br />
Potassium chloride - water solution calorimetry<br />
Hg........................................133.3 µg/kg ± 4.1 µg/kg<br />
Gross Calorific Value............................. 32.81 MJ/kg<br />
Intended for use in verifying or comparing results obtained by calorimeters measuring enthalpies of endothermic<br />
solution processes.<br />
Certified value<br />
Heat of solution (absorbed)...................... 235.86 J/g<br />
Cadmium - vapour pressure<br />
Certified values for vapour pressure as a function of temperature (350-594 K)<br />
Resin bonded fibre board (300 x 300 x 35 mm) - Thermal conductivity<br />
Certified value for thermal conductivity between -10°C <strong>and</strong> +50 °C<br />
Resin bonded fibre board (500 x 500 x 35 mm) - Thermal conductivity<br />
Certified value for thermal conductivity between -10°C <strong>and</strong> +50 °C<br />
Resin bonded fibre board (600 x 600 x 35 mm) - Thermal conductivity<br />
Certified value for thermal conductivity between -10°C <strong>and</strong> +50 °C<br />
Resin bonded fibre board (1000 x 1000 x 35 mm) - Thermal conductivity<br />
Certified value for thermal conductivity between -10°C <strong>and</strong> +50 °C<br />
Electrolytic iron rod<br />
0.64 cm (D) x 5.0 cm<br />
Thermal conductivity <strong>and</strong> electrical resistivity as a function of temperature (2-1000 K)<br />
Pyrex glass - Thermal conductivity<br />
30 cm x 30 cm x 20 mm<br />
Certified value (23 °C)<br />
λ .........................1.143 8 W/m.K<br />
The function to calculate λ for temperature between –75 <strong>and</strong> 195 °C is given in the CoA<br />
Pyrex glass - Thermal conductivity<br />
30 cm x 30 cm x 30 mm<br />
Certified value (23 °C)<br />
λ .........................1.143 8 W/m.K<br />
The function to calculate λ for temperature between –75 <strong>and</strong> 195 °C is given in the CoA<br />
Pyrex glass - Thermal conductivity<br />
30 cm x 30 cm x 50 mm<br />
Certified value (23 °C)<br />
λ .........................1.143 8 W/m.K<br />
The function to calculate λ for temperature between –75 <strong>and</strong> 195 °C is given in the CoA<br />
50 g<br />
50 g<br />
30 g<br />
1 rod<br />
board<br />
board<br />
board<br />
board<br />
1 rod<br />
board<br />
board<br />
board<br />
342 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
Thermal properties<br />
Code Product Unit<br />
BCR-724A<br />
BCR-724B<br />
BCR-724C<br />
BCR-724D<br />
BCR-724E<br />
Glass-ceramic - Thermal diffusivity, thermal conductivity<br />
Rod in container (diam.= 13.0 mm height > 18 mm)<br />
Thermal diffusivity, α<br />
Certified value<br />
[m²/s ·10 -6 ]<br />
α = 4.406 - 1.351.10 -2 . T + 2.133 . 10 -5 . T 2 - 1.541 . 10 -8 . T 3 + 4.147 . 10 -12 T 4<br />
Uncertainty:6.1%<br />
Thermal conductivity, λ<br />
Certified value<br />
[W/(m·K)]<br />
λ = 2.332 + 515.1/T<br />
Uncertainty:6.5%<br />
Glass-ceramic - Thermal diffusivity, thermal conductivity<br />
Rod in container (diam.= 13.9 mm height > 21 mm)<br />
Thermal diffusivity, α<br />
Certified value<br />
[m²/s ·10 -6 ]<br />
α = 4.406 - 1.351.10 -2 . T + 2.133 . 10 -5 . T 2 - 1.541 . 10 -8 . T 3 + 4.147 . 10 -12 T 4<br />
Uncertainty:6.1%<br />
Thermal conductivity, λ<br />
Certified value<br />
[W/(m·K)]<br />
λ = 2.332 + 515.1/T<br />
Uncertainty:6.5%<br />
Glass-ceramic - Thermal diffusivity, thermal conductivity<br />
Rod in container (diam.= 25.9 mm height > 22 mm)<br />
Thermal diffusivity, α<br />
Certified value<br />
[m²/s ·10 -6 ]<br />
α = 4.406 - 1.351.10 -2 . T + 2.133 . 10 -5 . T 2 - 1.541 . 10 -8 . T 3 + 4.147 . 10 -12 T 4<br />
Uncertainty:6.1%<br />
Thermal conductivity, λ<br />
Certified value<br />
[W/(m·K)]<br />
λ = 2.332 + 515.1/T<br />
Uncertainty:6.5%<br />
Glass-ceramic - Thermal diffusivity, thermal conductivity<br />
Rod in container (diam.= 26.9 mm height > 22 mm)<br />
Thermal diffusivity, α<br />
Certified value<br />
[m²/s ·10 -6 ]<br />
α = 4.406 - 1.351.10 -2 . T + 2.133 . 10 -5 . T 2 - 1.541 . 10 -8 . T 3 + 4.147 . 10 -12 T 4<br />
Uncertainty:6.1%<br />
Thermal conductivity, λ<br />
Certified value<br />
[W/(m·K)]<br />
λ = 2.332 + 515.1/T<br />
Uncertainty:6.5%<br />
Glass-ceramic - Thermal diffusivity, thermal conductivity<br />
Rod in container (diam.= 50.7 mm height > 25 mm)<br />
Thermal diffusivity, α<br />
Certified value<br />
[m²/s ·10 -6 ]<br />
α = 4.406 - 1.351.10 -2 . T + 2.133 . 10 -5 . T 2 - 1.541 . 10 -8 . T 3 + 4.147 . 10 -12 T 4<br />
Uncertainty:6.1%<br />
Thermal conductivity, λ<br />
Certified value<br />
[W/(m·K)]<br />
λ = 2.332 + 515.1/T<br />
Uncertainty:6.5%<br />
rod<br />
rod<br />
rod<br />
rod<br />
rod<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 343
Thermal properties<br />
Thermal expansion<br />
Code Product Unit<br />
NIST-731L1<br />
NIST-731L2<br />
NIST-731L3<br />
NIST-738<br />
Borosilicate glass<br />
6.4 mm x 51 mm<br />
Certified values for thermal expansion as a function of temperature (80-680 K)<br />
Borosilicate glass<br />
6.4 mm x 102 mm<br />
Certified values for thermal expansion as a function of temperature (80-680 K)<br />
Borosilicate glass<br />
6.4 mm x 152 mm<br />
Certified values for thermal expansion as a function of temperature (80-680 K)<br />
Stainless steel<br />
Certified values for thermal expansion as a function of temperature (293-780 K)<br />
5 cm<br />
10 cm<br />
15 cm<br />
51x6.4 mm<br />
Thermal resistance<br />
NIST-1449<br />
NIST-1459<br />
NIST-1450C<br />
NIST-1452<br />
NIST-1453<br />
Fumed silica board<br />
60 cm x 60 cm x 2.54 cm<br />
Certified values for thermal resistance as a function of density <strong>and</strong> pressure<br />
Fumed silica board<br />
30 cm x 30 cm x 2.45 cm<br />
Certified values for thermal resistance as a function of density <strong>and</strong> pressure<br />
Fibrous glass board<br />
61 cm x 61 cm x 2.54 cm<br />
Certified values for thermal resistance as a function of bulk density <strong>and</strong> temperature (280-340 K)<br />
Fibrous glass blanket for high precison measurements - Thermal resistance<br />
This St<strong>and</strong>ard Reference Material (SRM ® ) is intended for use in evaluation of a guarded hot plate (GHP) or the<br />
calibration of a heat flow meter (HFM). It is supplied as a fibrous glass batt of nominal dimensions 60 x 60 x 2.54<br />
cm. Each unit of NIST-1452 is a individually characterised specimen.<br />
Exp<strong>and</strong>ed polystyrene board<br />
93 cm x 66 cm x 1.34 cm<br />
Certified values for thermal resistance as a function of bulk density <strong>and</strong> temperature (285-310 K)<br />
board<br />
board<br />
board<br />
each<br />
board<br />
Glass liquid temperature<br />
NIST-773<br />
NIST-1416<br />
Soda-lime-silica<br />
2.5 cm x 2.5 cm x 0.6 cm<br />
Intended for checking test methods <strong>and</strong> for calibrating equipment used to determine the liquidus temperature of<br />
glass by the gradient furnace method per ASTM C 829.<br />
A (boat)<br />
Certified value .................988 °C<br />
B (perforated plate)<br />
Certified value .................991 °C<br />
Aluminosilicate glass - Liquidus temperature<br />
Certified value for the gradient liquidus temperature is<br />
1147 ± 4 °C<br />
65 g<br />
250 g<br />
Temperature measuring devices<br />
NIST-934<br />
NIST-1967<br />
NIST-1749<br />
NIST-1750<br />
Clinical laboratory thermometer<br />
Calibrated at 4 temperatures 0, 25, 30 <strong>and</strong> 37 °C<br />
Platinum thermocouple<br />
Platinum wire 0.51 mm diameter <strong>and</strong> 1 m long<br />
Intended for use as a st<strong>and</strong>ard <strong>reference</strong> thermoelement for calibration of base-metal <strong>and</strong> noble-metal<br />
thermocouple materials (-197 °C - 1768 °C)<br />
Gold vs. Platinum Thermocouple Thermometer<br />
Certified Thermometer for the range 0°C to 1000°C on the International Temperature Scale of 1990.<br />
St<strong>and</strong>ard Platinum Resistance Themometer<br />
Certified Thermometer for the range 13.8033 K to 429.7485 K on the International Temperature Scale of 1990.<br />
unit<br />
each<br />
each<br />
capsule<br />
344 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
Particles <strong>and</strong> surface properties<br />
Particles <strong>and</strong> surface properties<br />
Particle size<br />
Code Product Unit<br />
AEA1001<br />
Aerosol fibre analogue shape st<strong>and</strong>ard (aqueous suspension)<br />
Reference values: Particles per vial 1.0 x 10 7 , Particle length 3.09 µm, Particle width 1.67 µm, Particle depth 0.96<br />
µm, Indicative aerodynamic diameter – motion perpendicular to major axis 2.89 µm, Indicative aerodynamic<br />
diameter – motion parallel to major axis 3.14 µm.<br />
10 mL<br />
BCR-066<br />
BCR-066 - BCR-132<br />
For these materials the distribution is expressed as a curve of the cumulative mass of particles undersize<br />
versus particle size. In the case of particles of less than 90 µm diameter their size is expressed as the<br />
equivalent Stokes’ diameter determined from the settling rate of the particles in a viscous fluid. For larger<br />
particles the equivalent volume diameter determined by sieving was preferred.<br />
Quartz - Stokes' diameter<br />
Certified value<br />
Stokes’ diameter ................................0.35 - 3.50 µm<br />
10 g<br />
BCR-067<br />
BCR-068<br />
BCR-069<br />
BCR-070<br />
BCR-130<br />
BCR-131<br />
BCR-132<br />
Quartz - Stokes' diameter<br />
Certified values<br />
Stokes’ diameter .....................................2.4 - 32 µm<br />
Quartz - Volume diameter<br />
Certified values<br />
Volume diameter..................................160 - 630 µm<br />
Quartz - Stokes' diameter<br />
Certified values<br />
Stokes’ diameter ......................................14 - 90 µm<br />
Quartz - Stokes' diameter<br />
Certified values<br />
Stokes’ diameter .....................................1.2 - 20 µm<br />
Quartz - Volume diameter<br />
Certified values<br />
Volume diameter....................................50 - 220 µm<br />
Quartz - Volume diameter<br />
Certified value<br />
Volume diameter................................480 - 1800 µm<br />
Quartz - Volume diameter<br />
Certified value<br />
Volume diameter..............................1400 - 5000 µm<br />
10 g<br />
100 g<br />
10 g<br />
10 g<br />
50 g<br />
200 g<br />
700 g<br />
BCR-165 Latex spheres, nominal 2 µ<br />
Average particle diameter ............. 2.223 ± 0.013 µm<br />
Each vial contains 2 mL of an aqueous suspension of latex spheres at a mass concentration of about 0.2 g/L.<br />
About 0.5% of the particles are agglomerated doublets..<br />
BCR-166 Latex spheres, nominal 4.8 µ<br />
Each vial contains 2 mL of an aqueous suspension of latex spheres at a mass concentration of about 0.2 g/L.<br />
About 0.5% of the particles are agglomerated doublets.<br />
Average particle diameter ............ 4.821 ± 0.019 µm<br />
BCR-167 Latex spheres, nominal 9.6 µ<br />
Each vial contains 2 mL of an aqueous suspension of latex spheres at a mass concentration of about 1.4 g/L.<br />
About 0.5% of the particles are agglomerated doublets.<br />
Average particle diameter ............. 9.475 ± 0.018 µm<br />
vial<br />
vial<br />
vial<br />
NIST-659<br />
NIST-659 - NIST-RM 8010<br />
These materials are for evaluating <strong>and</strong> calibrating specific types of particle size measuring<br />
instruments, including light scattering, electrical zone flow-through counters, optical <strong>and</strong> scanning<br />
electron microscopes, sedimentation systems <strong>and</strong> wire cloth sieving devices.<br />
Silicon nitride - Particle size<br />
Certified value<br />
Particle size..............0.2 - 10 µm<br />
set (5)<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 345
Particles <strong>and</strong> surface properties<br />
Code Product Unit<br />
NIST-1021<br />
NIST-1003C<br />
NIST-1004B<br />
NIST-1017b<br />
NIST-1018B<br />
NIST-1019B<br />
NIST-1690<br />
NIST-1691<br />
NIST-1692<br />
NIST-1961<br />
NIST-1963A<br />
NIST-1964<br />
NIST-1965<br />
NIST-1978<br />
NIST-1982<br />
Glass beads - Particle size<br />
This St<strong>and</strong>ard Reference Material (SRM ® ) is intended for use in the evaluation <strong>and</strong> calibration of equipment used<br />
to measure particle size distributions (PSD) in the 2 µm to 12 µm diameter range. Typical methods for PSD<br />
determination would be laser light scattering (LLS), electrical sensing zone (ESZ), <strong>and</strong> sedimentation. Each unit<br />
of NIST-1021 consists of a single bottle containing approximately 4 g of solid spherical soda-lime glass beads.<br />
Certified value<br />
Particle size.................2 - 12 µm<br />
Glass beads - Particle size<br />
Certified value<br />
Particle size.........18.9 - 43.3 µm<br />
Glass beads - Particle size<br />
Certified value<br />
Particle size.............40 - 150 µm<br />
Glass beads - Particle size<br />
Certified value<br />
Particle size...........100 - 400 µm<br />
Glass beads - Particle size<br />
Certified value<br />
Particle size...........220 - 750 µm<br />
Glass beads - Particle size<br />
Certified value<br />
Particle size.........750 - 2450 µm<br />
Polystyrene (0.5 wt. % in water) - Particle size<br />
Certified value<br />
Particle size.................0.895 µm<br />
Polystyrene (0.5 wt. % in water) - Particle size<br />
Certified value<br />
Particle size.................0.269 µm<br />
Polystyrene (0.25 wt. % in water) - Particle size<br />
Certified value<br />
Particle size.................2.982 µm<br />
Polystyrene (0.5 wt. % in water) - Particle size<br />
Certified value<br />
Particle size.................29.64 µm<br />
Polystyrene (0.5 wt. % in water) - Particle size<br />
This St<strong>and</strong>ard Reference Material (SRM ® ) is intended for the calibration/validation of particle sizing instruments,<br />
including electron microscopes, differential mobility analysers, scanning surface inspection systems, <strong>and</strong> other<br />
light scattering instruments. A unit of NIST-1963a consists of 5 mL of polystyrene spheres in deionized filtered<br />
(0.2 µm pore size) water.<br />
Certified value<br />
Modal sphere diameter ..................... 101.8 ± 1.1 nm<br />
Polystyrene (0.5 wt. % in water) - Particle size<br />
This St<strong>and</strong>ard Reference Material (SRM ® ) is intended for the calibration/validation of particle sizing instruments,<br />
including electron microscopes, differential mobility analysers, scanning surface inspection systems, <strong>and</strong> other<br />
light scattering instruments. A unit of NIST-1964 consists of 5 mL of polystyrene spheres in deionized filtered<br />
(0.2 µm pore size) water.<br />
Certified value<br />
Modal sphere diameter ................... 60.39 ± 0.63 nm<br />
Polystyrene - Particle size<br />
This St<strong>and</strong>ard <strong>reference</strong> material is intended for use as an optical microscopy measurement st<strong>and</strong>ard<br />
<strong>and</strong> teaching tool.<br />
Certified value<br />
Hexagonal array............9.94 µm Unordered clusters ....... 9.89 µm<br />
Zirconium oxide - Particle size<br />
Certified value<br />
Particle size........0.33 – 2.19 µm<br />
Zirconia thermal spray powder - Particle size<br />
Certified value<br />
Particle size.............10 - 150 µm<br />
4 g<br />
28 g<br />
43 g<br />
70 g<br />
87 g<br />
200 g<br />
5 mL<br />
5 mL<br />
5 mL<br />
5 mL<br />
5 mL<br />
5 mL<br />
1 slide<br />
5 g<br />
10 g<br />
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Particles <strong>and</strong> surface properties<br />
Code Product Unit<br />
NIST-1984<br />
NIST-1985<br />
NIST-RM 8010<br />
NIST-2806A<br />
Thermal spray powder - Particle size distribution<br />
This St<strong>and</strong>ard Reference Material ® (SRM ® ) is primarily intended for use in the calibration of equipment used<br />
to measure particle size distributions (PSD) in the 9 µm to 30 µm range. NIST-1984 consists of a single bottle<br />
containing approximately 14 g of tungsten carbide/cobalt powder.<br />
Certified PSD Values by scanning electron microscopy (SEM)<br />
Cumulative Mass Fraction Certified Diameter Uncertainty<br />
(%) (µm) (µm)<br />
10 ............................................................ 10.3 ......................................................... 0.9<br />
25 ............................................................ 13.2 ......................................................... 0.9<br />
50 ............................................................ 17.1 ......................................................... 2.2<br />
75 ............................................................ 21.3 ......................................................... 1.6<br />
90 ............................................................ 26.3 ......................................................... 0.9<br />
Thermal spray powder - Particle size distribution<br />
This St<strong>and</strong>ard Reference Material (SRM) is intended primarily for use in the calibration of equipment used to<br />
measure particle size distributions (PSD) in the 18 µm to 55 µm range. NIST-1985 consists of a single bottle<br />
containing approximately 14 g of tungsten carbide/cobalt powder.<br />
Certified PSD Values by scanning electron microscopy (SEM)<br />
Cumulative Mass Fraction Certified Diameter Uncertainty<br />
(%) (µm) (µm)<br />
10 ............................................................ 20.2 ......................................................... 1.2<br />
25 ............................................................ 27.1 ......................................................... 1.7<br />
50 ............................................................ 36.1 ......................................................... 0.8<br />
75 ............................................................ 44.2 ......................................................... 2.1<br />
90 ............................................................ 50.1 ......................................................... 2.5<br />
S<strong>and</strong> - Particle size<br />
Reference value<br />
Particle size.............30 - 325 µm<br />
Medium test dust (MTD) in hydraulic fluid<br />
NIST-2806a can be used in conjunction with the International Organization for St<strong>and</strong>ardisation (ISO)<br />
method ISO/FDIS 11171, “Hydraulic Fluid Power - Calibration of Liquid Automatic Particle Counters”<br />
Certified values<br />
Particle Projected<br />
Concentration Area u u u u u<br />
Diameter Sampling Volume Length Digitalization Fractionation<br />
(Particles/mL) (µm) (µm) (µm) (µm) (µm)<br />
108400 ................ 1....................... 0.004............ 0.004.............0.0006 ..........0.127 ................0.051<br />
27035 .................. 2....................... 0.006............ 0.006.............0.00003 ........0.123 ................0.049<br />
11209 .................. 3....................... 0.009............ 0.010.............0.0005 ..........0.122 ................0.059<br />
6095 .................... 4....................... 0.011............ 0.013.............0.002 ............0.121 ................0.094<br />
3737 .................... 5....................... 0.012............ 0.015.............0.004 ............0.121 ................0.167<br />
2395 .................... 6....................... 0.016............ 0.016.............0.006 ............0.131 ................0.246<br />
1573 .................... 7....................... 0.019............ 0.017.............0.009 ............0.131 ................0.236<br />
1055 .................... 8....................... 0.024............ 0.018.............0.013 ............0.131 ................0.210<br />
725.8 ................... 9....................... 0.031............ 0.019.............0.017 ............0.131 ................0.235<br />
513.7 ................... 10..................... 0.041............ 0.021.............0.021 ............0.131 ................0.289<br />
374.6 ................... 11..................... 0.052............ 0.023.............0.025 ............0.131 ................0.351<br />
281.0 ................... 12..................... 0.065............ 0.025.............0.029 ............0.131 ................0.467<br />
216.4 ................... 13..................... 0.081............ 0.027.............0.031 ............0.131 ................0.616<br />
170.4 ................... 14..................... 0.101............ 0.030.............0.033 ............0.131 ................0.810<br />
136.8 ................... 15..................... 0.123............ 0.032.............0.033 ............0.131 ................1.090<br />
111.3 ................... 16..................... 0.146............ 0.034.............0.033 ............0.131 ................1.190<br />
91.33 ................... 17..................... 0.168............ 0.035.............0.033 ............0.131 ................1.439<br />
75.29 ................... 18..................... 0.187............ 0.036.............0.034 ............0.131 ................1.706<br />
62.17 ................... 19..................... 0.204............ 0.036.............0.036 ............0.131 ................2.036<br />
51.35 ................... 20..................... 0.219............ 0.036.............0.041 ............0.131 ................2.509<br />
42.40 ................... 21..................... 0.235............ 0.036.............0.047 ............0.131 ................2.473<br />
35.01 ................... 22..................... 0.255............ 0.036.............0.056 ............0.131 ................2.738<br />
28.95 ................... 23..................... 0.281............ 0.037.............0.068 ............0.131 ................2.953<br />
23.99 ................... 24..................... 0.314............ 0.038.............0.081 ............0.131 ................3.267<br />
19.95 ................... 25..................... 0.356............ 0.039.............0.097 ............0.131 ................3.450<br />
16.66 ................... 26..................... 0.408............ 0.040.............0.115 ............0.131 ................3.603<br />
13.98 ................... 27..................... 0.468............ 0.041.............0.135 ............0.131 ................3.983<br />
11.80 ................... 28..................... 0.539............ 0.043.............0.158 ............0.131 ................4.144<br />
10.02 ................... 29..................... 0.618............ 0.045.............0.184 ............0.131 ................4.247<br />
8.568 ................... 30..................... 0.706............ 0.047.............0.212 ............0.131 ................4.914<br />
14 g<br />
14 g<br />
3 x 150 g<br />
2 x 400 mL<br />
NIST-RM 8632<br />
For use in preparing suspensions in other types of oil, further information on request.<br />
This material is intended for use in calibrating the response of particle sizing instrumentation, including<br />
optical counters, in accordance with National Fluid Power Association (NFPA) <strong>and</strong> ISO st<strong>and</strong>ard methods<br />
for determining particle contamination in oils.<br />
NIST-RM 8632 Ultrafine Test Dust 20 g<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 347
Particles <strong>and</strong> surface properties<br />
Particle size calibration st<strong>and</strong>ards from Whitehouse Scientific<br />
Whitehouse Scientific has been producing precision glass microspheres for calibration for 24 years <strong>and</strong> is<br />
the highest ranking European certification laboratory for primary methods of particle size analysis. Having<br />
filled over 1 million bottles using a unique 100 stage spinning riffler system, they are now the world's leading<br />
manufacturer of single-shot glass microsphere st<strong>and</strong>ards.<br />
The <strong>reference</strong>s, nearly all NIST traceable range in size from 0.1µm - 5.0mm <strong>and</strong> are available as single<br />
sizes or broad distribution st<strong>and</strong>ards. In addition to calbration, applications include filter testing, space<br />
research, nuclear fall-out studies, micro-engineering <strong>and</strong> precision spacers.<br />
Whether calibrating a particle sizing instrument or any aperture in the range 0.1 - 10,000 microns,<br />
Whitehouse Scientific has a st<strong>and</strong>ard for every application.<br />
Polydisperse particle st<strong>and</strong>ards<br />
Code Product Unit<br />
WS-PS180 Polydisperse particle st<strong>and</strong>ard - Nominal size: 0.1 - 1 µm 0.01 g<br />
WS-PS181 Polydisperse particle st<strong>and</strong>ard - Nominal size: 0.1 - 1 µm 0.02 g<br />
WS-PS190 Polydisperse particle st<strong>and</strong>ard - Nominal size: 1 - 10 µm 0.025 g<br />
WS-PS191 Polydisperse particle st<strong>and</strong>ard - Nominal size: 1 - 10 µm 0.05 g<br />
WS-PS192 Polydisperse particle st<strong>and</strong>ard - Nominal size: 1 - 10 µm 0.10 g<br />
WS-PS193 Polydisperse particle st<strong>and</strong>ard - Nominal size: 1 - 10 µm 0.25 g<br />
WS-PS194 Polydisperse particle st<strong>and</strong>ard - Nominal size: 1 - 10 µm 0.50 g<br />
WS-PS200 Polydisperse particle st<strong>and</strong>ard - Nominal size: 3 - 30 µm 0.025 g<br />
WS-PS201 Polydisperse particle st<strong>and</strong>ard - Nominal size: 3 - 30 µm 0.05 g<br />
WS-PS202 Polydisperse particle st<strong>and</strong>ard - Nominal size: 3 - 30 µm 0.10 g<br />
WS-PS203 Polydisperse particle st<strong>and</strong>ard - Nominal size: 3 - 30 µm 0.25 g<br />
WS-PS204 Polydisperse particle st<strong>and</strong>ard - Nominal size: 3 - 30 µm 0.50 g<br />
WS-PS205 Polydisperse particle st<strong>and</strong>ard - Nominal size: 3 - 30 µm 1.0 g<br />
WS-PS211 Polydisperse particle st<strong>and</strong>ard - Nominal size: 10 - 100 µm 0.05 g<br />
WS-PS212 Polydisperse particle st<strong>and</strong>ard - Nominal size: 10 - 100 µm 0.10 g<br />
WS-PS213 Polydisperse particle st<strong>and</strong>ard - Nominal size: 10 - 100 µm 0.25 g<br />
WS-PS214 Polydisperse particle st<strong>and</strong>ard - Nominal size: 10 - 100 µm 0.50 g<br />
WS-PS215 Polydisperse particle st<strong>and</strong>ard - Nominal size: 10 - 100 µm 1.0 g<br />
WS-PS222 Polydisperse particle st<strong>and</strong>ard - Nominal size: 50 - 350 µm 0.10 g<br />
WS-PS223 Polydisperse particle st<strong>and</strong>ard - Nominal size: 50 - 350 µm 0.25 g<br />
WS-PS224 Polydisperse particle st<strong>and</strong>ard - Nominal size: 50 - 350 µm 0.50 g<br />
WS-PS225 Polydisperse particle st<strong>and</strong>ard - Nominal size: 50 - 350 µm 1.0 g<br />
WS-PS226 Polydisperse particle st<strong>and</strong>ard - Nominal size: 50 - 350 µm 2.5 g<br />
WS-PS227 Polydisperse particle st<strong>and</strong>ard - Nominal size: 50 - 350 µm 5.0 g<br />
WS-PS232 Polydisperse particle st<strong>and</strong>ard - Nominal size: 150 - 650 µm 0.25 g<br />
WS-PS233 Polydisperse particle st<strong>and</strong>ard - Nominal size: 150 - 650 µm 0.50 g<br />
WS-PS234 Polydisperse particle st<strong>and</strong>ard - Nominal size: 150 - 650 µm 1.0 g<br />
WS-PS235 Polydisperse particle st<strong>and</strong>ard - Nominal size: 150 - 650 µm 2.5 g<br />
WS-PS236 Polydisperse particle st<strong>and</strong>ard - Nominal size: 150 - 650 µm 5.0 g<br />
WS-PS237 Polydisperse particle st<strong>and</strong>ard - Nominal size: 150 - 650 µm 7.0 g<br />
WS-PS240 Polydisperse particle st<strong>and</strong>ard - Nominal size: 500 - 2000 µm 7.0 g<br />
NIST traceable monodisperse particle st<strong>and</strong>ards<br />
WS-MS0009 Monodisperse particle st<strong>and</strong>ard (9.18 µm) 0.1 g<br />
WS-MS0012 Monodisperse particle st<strong>and</strong>ard (11.58 µm) 0.1 g<br />
WS-MS0023 Monodisperse particle st<strong>and</strong>ard (22.81 µm) 0.1 g<br />
WS-MS0026 Monodisperse particle st<strong>and</strong>ard (25.6 µm) 0.1 g<br />
WS-MS0028 Monodisperse particle st<strong>and</strong>ard (28.41 µm) 0.15 g<br />
WS-MS0031 Monodisperse particle st<strong>and</strong>ard (31.33 µm) 0.15 g<br />
WS-MS0036 Monodisperse particle st<strong>and</strong>ard (35.65 µm) 0.2 g<br />
WS-MS0037 Monodisperse particle st<strong>and</strong>ard (37.36 µm) 0.2 g<br />
WS-MS0038 Monodisperse particle st<strong>and</strong>ard (38.38 µm) 0.2 g<br />
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Particles <strong>and</strong> surface properties<br />
Code Product Unit<br />
WS-MS0040 Monodisperse particle st<strong>and</strong>ard (40.15 µm) 0.2 g<br />
WS-MS0042 Monodisperse particle st<strong>and</strong>ard (42.68 µm) 0.2 g<br />
WS-MS0049 Monodisperse particle st<strong>and</strong>ard (49.21 µm) 0.2 g<br />
WS-MS0053 Monodisperse particle st<strong>and</strong>ard (52.47 µm) 0.2 g<br />
WS-MS0056 Monodisperse particle st<strong>and</strong>ard (56.28 µm) 0.2 g<br />
WS-MS0060 Monodisperse particle st<strong>and</strong>ard (59.63 µm) 0.2 g<br />
WS-MS0064 Monodisperse particle st<strong>and</strong>ard (63.86 µm) 0.2 g<br />
WS-MS0065 Monodisperse particle st<strong>and</strong>ard (65.02 µm) 0.2 g<br />
WS-MS0066 Monodisperse particle st<strong>and</strong>ard (66.29 µm) 0.2 g<br />
WS-MS0071 Monodisperse particle st<strong>and</strong>ard (70.89 µm) 0.2 g<br />
WS-MS0074 Monodisperse particle st<strong>and</strong>ard (73.8 µm) 0.2 g<br />
WS-MS0076 Monodisperse particle st<strong>and</strong>ard (76.39 µm) 0.2 g<br />
WS-MS0083 Monodisperse particle st<strong>and</strong>ard (83.43 µm) 0.2 g<br />
WS-MS0090 Monodisperse particle st<strong>and</strong>ard (89.8 µm) 0.2 g<br />
WS-MS0091 Monodisperse particle st<strong>and</strong>ard (91.21 µm) 0.2 g<br />
WS-MS0114 Monodisperse particle st<strong>and</strong>ard (114.4 µm) 0.3 g<br />
WS-MS0128 Monodisperse particle st<strong>and</strong>ard (127.5 µm) 0.3 g<br />
WS-MS0156 Monodisperse particle st<strong>and</strong>ard (155.8 µm) 0.3 g<br />
WS-MS0177 Monodisperse particle st<strong>and</strong>ard (177 µm) 0.3 g<br />
WS-MS0180 Monodisperse particle st<strong>and</strong>ard (180 µm) 0.3 g<br />
WS-MS0193 Monodisperse particle st<strong>and</strong>ard (192.8 µm) 0.4 g<br />
WS-MS0197 Monodisperse particle st<strong>and</strong>ard (197.3 µm) 0.4 g<br />
WS-MS0201 Monodisperse particle st<strong>and</strong>ard (200.9 µm) 0.4 g<br />
WS-MS0210 Monodisperse particle st<strong>and</strong>ard (210.6 µm) 0.4 g<br />
WS-MS0225 Monodisperse particle st<strong>and</strong>ard (224.8 µm) 0.4 g<br />
WS-MS0236 Monodisperse particle st<strong>and</strong>ard (236.2 µm) 0.5 g<br />
WS-MS0259 Monodisperse particle st<strong>and</strong>ard (258.6 µm) 0.6 g<br />
WS-MS0269 Monodisperse particle st<strong>and</strong>ard (268.5 µm) 0.6 g<br />
WS-MS0292 Monodisperse particle st<strong>and</strong>ard (292.5 µm) 0.8 g<br />
WS-MS0298 Monodisperse particle st<strong>and</strong>ard (297.9 µm) 0.8 g<br />
WS-MS0305 Monodisperse particle st<strong>and</strong>ard (304.6 µm) 0.8 g<br />
WS-MS0315 Monodisperse particle st<strong>and</strong>ard (315.3 µm) 1 g<br />
WS-MS0362 Monodisperse particle st<strong>and</strong>ard (361.6 µm) 1 g<br />
WS-MS0406 Monodisperse particle st<strong>and</strong>ard (405.9 µm) 1.5 g<br />
WS-MS0451 Monodisperse particle st<strong>and</strong>ard (451 µm) 2 g<br />
WS-MS0555 Monodisperse particle st<strong>and</strong>ard (555 µm) 2.5 g<br />
WS-MS0589 Monodisperse particle st<strong>and</strong>ard (589 µm) 2.5 g<br />
Image analysis st<strong>and</strong>ards<br />
WS-XX015 Image analysis st<strong>and</strong>ard - Calibration range: 50 - 250 µm 50 g<br />
WS-XX025 Image analysis st<strong>and</strong>ard - Calibration range: 170 - 710 µm 100 g<br />
WS-XX030 Image analysis st<strong>and</strong>ard - Calibration range: 500 - 2000 µm 200 g<br />
WS-XX035 Image analysis st<strong>and</strong>ard - Calibration range: 1400 - 5000 µm 500 g<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 349
Particles <strong>and</strong> surface properties<br />
NIST traceable sieve st<strong>and</strong>ards<br />
Code Product Unit<br />
WS-SS391 Sieve st<strong>and</strong>ard - For sieve size: 20 µm<br />
Mesh.................................................................... 635 Calibration range ................................18.8 - 23.7 µm<br />
WS-SS392 Sieve st<strong>and</strong>ard - For sieve size: 25 µm<br />
Mesh.................................................................... 500 Calibration range ................................21.7 - 30.2 µm<br />
WS-SS393 Sieve st<strong>and</strong>ard - For sieve size: 32 µm<br />
Mesh.................................................................... 450 Calibration range ................................27.8 - 34.1 µm<br />
WS-SS394 Sieve st<strong>and</strong>ard - For sieve size: 36, 38, 40 µm<br />
Mesh.................................................................... 400 Calibration range ................................33.5 - 41.6 µm<br />
WS-SS395 Sieve st<strong>and</strong>ard - For sieve size: 45, 50 µm<br />
Mesh.................................................................... 325 Calibration range ................................42.0 - 50.8 µm<br />
WS-SS396 Sieve st<strong>and</strong>ard - For sieve size: 53, 56 µm<br />
Mesh.................................................................... 270 Calibration range ................................48.4 - 59.5 µm<br />
WS-SS397 Sieve st<strong>and</strong>ard - For sieve size: 63 µm<br />
Mesh.................................................................... 230 Calibration range ................................56.6 - 70.4 µm<br />
WS-SS398 Sieve st<strong>and</strong>ard - For sieve size: 71, 75, 80 µm<br />
Mesh.................................................................... 200 Calibration range ................................67.1 - 82.8 µm<br />
WS-SS399 Sieve st<strong>and</strong>ard - For sieve size: 90 µm<br />
Mesh.................................................................... 170 Calibration range ................................78.8 - 97.6 µm<br />
WS-SS400 Sieve st<strong>and</strong>ard - For sieve size: 100, 106, 112 µm<br />
Mesh.................................................................... 140 Calibration range .................................91.4 - 117 µm<br />
WS-SS401 Sieve st<strong>and</strong>ard - For sieve size: 125 µm<br />
Mesh.................................................................... 120 Calibration range ..................................112 - 139 µm<br />
WS-SS402 Sieve st<strong>and</strong>ard - For sieve size: 140, 150, 160 µm<br />
Mesh.................................................................... 100 Calibration range ..................................134 - 167 µm<br />
WS-SS403 Sieve st<strong>and</strong>ard - For sieve size: 180 µm<br />
Mesh...................................................................... 80 Calibration range ..................................161 - 199 µm<br />
WS-SS404 Sieve st<strong>and</strong>ard - For sieve size: 200, 212, 224 µm<br />
Mesh...................................................................... 70 Calibration range ..................................191 - 237 µm<br />
WS-SS405 Sieve st<strong>and</strong>ard - For sieve size: 250, 280 µm<br />
Mesh...................................................................... 60 Calibration range ..................................226 - 281 µm<br />
WS-SS406 Sieve st<strong>and</strong>ard - For sieve size: 300, 315 µm<br />
Mesh...................................................................... 50 Calibration range ..................................270 - 333 µm<br />
WS-SS407 Sieve st<strong>and</strong>ard - For sieve size: 355 µm<br />
Mesh...................................................................... 45 Calibration range ..................................322 - 398 µm<br />
WS-SS408 Sieve st<strong>and</strong>ard - For sieve size: 400, 425, 450 µm<br />
Mesh...................................................................... 40 Calibration range ..................................377 - 470 µm<br />
WS-SS409 Sieve st<strong>and</strong>ard - For sieve size: 500 µm<br />
Mesh...................................................................... 35 Calibration range ..................................440 - 557 µm<br />
WS-SS410 Sieve st<strong>and</strong>ard - For sieve size: 560, 600, 630 µm<br />
Mesh...................................................................... 30 Calibration range ..................................526 - 657 µm<br />
WS-SS411 Sieve st<strong>and</strong>ard - For sieve size: 710 µm<br />
Mesh...................................................................... 25 Calibration range ..................................658 - 809 µm<br />
WS-SS412 Sieve st<strong>and</strong>ard - For sieve size: 800, 850, 900 µm<br />
Mesh...................................................................... 20 Calibration range ..................................774 - 951 µm<br />
WS-SS413 Sieve st<strong>and</strong>ard - For sieve size: 1000 µm<br />
Mesh...................................................................... 18 Calibration range ................................910 - 1106 µm<br />
WS-SS414 Sieve st<strong>and</strong>ard - For sieve size: 1120, 1180, 1250 µm<br />
Mesh...................................................................... 16 Calibration range ...............................1091- 1335 µm<br />
WS-SS415 Sieve st<strong>and</strong>ard - For sieve size: 1400, 1550 µm<br />
Mesh...................................................................... 14 Calibration range ..............................1292 - 1609 µm<br />
WS-SS416 Sieve st<strong>and</strong>ard - For sieve size: 1600, 1700, 1800 µm<br />
Mesh...................................................................... 12 Calibration range ..............................1515 - 1866 µm<br />
WS-SS417 Sieve st<strong>and</strong>ard - For sieve size: 2000 µm<br />
Mesh...................................................................... 10 Calibration range ..............................1836 - 2236 µm<br />
0.8 g<br />
0.8 g<br />
1.0 g<br />
1.0 g<br />
1.0 g<br />
1.0 g<br />
1.0 g<br />
1.0 g<br />
1.0 g<br />
1.0 g<br />
1.0 g<br />
2.5 g<br />
2.5 g<br />
2.5 g<br />
2.5 g<br />
2.5 g<br />
2.5 g<br />
2.5 g<br />
2.5 g<br />
2.5 g<br />
2.5 g<br />
2.5 g<br />
7.0 g<br />
10.0 g<br />
15.0 g<br />
15.0 g<br />
20.0 g<br />
350 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
Particles <strong>and</strong> surface properties<br />
Code Product Unit<br />
WS-SS418 Sieve st<strong>and</strong>ard - For sieve size: 2240, 2360, 2500 µm<br />
Mesh ....................................................................... 8 Calibration range..............................2148 - 2661 µm<br />
WS-SS419 Sieve st<strong>and</strong>ard - For sieve size: 2800, 3150 µm<br />
Mesh ....................................................................... 7 Calibration range..............................2555 - 3232 µm<br />
WS-SS420 Sieve st<strong>and</strong>ard - For sieve size: 3350, 3550 µm<br />
Mesh ....................................................................... 6 Calibration range..............................3072 - 3783 µm<br />
General purpose glass microspheres<br />
WS-GP0042 General purpose glass microspheres - Sieve fraction: 38 - 45 µm 100 g<br />
WS-GP0049 General purpose glass microspheres - Sieve fraction: 45 - 53 µm 100 g<br />
WS-GP0058 General purpose glass microspheres - Sieve fraction: 53 - 63 µm 100 g<br />
WS-GP0069 General purpose glass microspheres - Sieve fraction: 63 - 75 µm 100 g<br />
WS-GP0083 General purpose glass microspheres - Sieve fraction: 75 - 90 µm 100 g<br />
WS-GP0098 General purpose glass microspheres - Sieve fraction: 90 - 106 µm 100 g<br />
WS-GP0116 General purpose glass microspheres - Sieve fraction: 106 - 125 µm 200 g<br />
WS-GP0138 General purpose glass microspheres - Sieve fraction: 125 - 150 µm 200 g<br />
WS-GP0165 General purpose glass microspheres - Sieve fraction: 150 - 180 µm 200 g<br />
WS-GP0196 General purpose glass microspheres - Sieve fraction: 180 - 212 µm 200 g<br />
WS-GP0231 General purpose glass microspheres - Sieve fraction: 212 - 250 µm 200 g<br />
WS-GP0275 General purpose glass microspheres - Sieve fraction: 250 - 300 µm 200 g<br />
WS-GP0328 General purpose glass microspheres - Sieve fraction: 300 - 355 µm 200 g<br />
WS-GP0335 General purpose glass microspheres - Sieve fraction: 315 - 355 µm 200 g<br />
WS-GP0375 General purpose glass microspheres - Sieve fraction: 350 - 400 µm 200 g<br />
WS-GP0390 General purpose glass microspheres - Sieve fraction: 355 - 425 µm 200 g<br />
WS-GP0463 General purpose glass microspheres - Sieve fraction: 425 - 500 µm 200 g<br />
WS-GP0475 General purpose glass microspheres - Sieve fraction: 450 - 500 µm 200 g<br />
WS-GP0530 General purpose glass microspheres - Sieve fraction: 500 - 560 µm 200 g<br />
WS-GP0550 General purpose glass microspheres - Sieve fraction: 500 - 600 µm 200 g<br />
WS-GP0580 General purpose glass microspheres - Sieve fraction: 560 - 600 µm 200 g<br />
WS-GP0615 General purpose glass microspheres - Sieve fraction: 600 - 630 µm 200 g<br />
WS-GP0650 General purpose glass microspheres - Sieve fraction: 600 - 710 µm 200 g<br />
WS-GP0780 General purpose glass microspheres - Sieve fraction: 710 - 850 µm 200 g<br />
WS-GP0925 General purpose glass microspheres - Sieve fraction: 850 - 1000 µm 200 g<br />
WS-GP1060 General purpose glass microspheres - Sieve fraction: 1000 - 1120 µm 400 g<br />
WS-GP1090 General purpose glass microspheres - Sieve fraction: 1000 - 1180 µm 400 g<br />
WS-GP1150 General purpose glass microspheres - Sieve fraction: 1120 - 1180 µm 400 g<br />
WS-GP1215 General purpose glass microspheres - Sieve fraction: 1180 - 1250 µm 400 g<br />
WS-GP1325 General purpose glass microspheres - Sieve fraction: 1250 - 1400 µm 400 g<br />
WS-GP1500 General purpose glass microspheres - Sieve fraction: 1400 - 1600 µm 400 g<br />
WS-GP1550 General purpose glass microspheres - Sieve fraction: 1400 - 1700 µm 400 g<br />
WS-GP1650 General purpose glass microspheres - Sieve fraction: 1600 - 1700 µm 400 g<br />
WS-GP1700 General purpose glass microspheres - Sieve fraction: 1600 - 1800 µm 400 g<br />
WS-GP1750 General purpose glass microspheres - Sieve fraction: 1700 - 1800 µm 400 g<br />
WS-GP1900 General purpose glass microspheres - Sieve fraction: 1800 - 2000 µm 400 g<br />
WS-GP2200 General purpose glass microspheres - Sieve fraction: 2000 - 2240 µm 400 g<br />
WS-GP2500 General purpose glass microspheres - Sieve fraction: 2300 - 2700 µm 400 g<br />
WS-GP3000 General purpose glass microspheres - Sieve fraction: 2800 - 3200 µm 400 g<br />
WS-GP3455 General purpose glass microspheres - Sieve fraction: 3360 - 3550 µm 400 g<br />
WS-GP3775 General purpose glass microspheres - Sieve fraction: 3350 - 4000 µm 400 g<br />
20.0 g<br />
25.0 g<br />
25.0 g<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 351
Particles <strong>and</strong> surface properties<br />
General purpose basalt microspheres<br />
Code Product Unit<br />
WS-BM0083 General purpose basalt microspheres - Sieve fraction: 75 - 90 µm 100 g<br />
WS-BM0098 General purpose basalt microspheres - Sieve fraction: 90 - 106 µm 100 g<br />
WS-BM0116 General purpose basalt microspheres - Sieve fraction: 106 - 125 µm 100 g<br />
WS-BM0138 General purpose basalt microspheres - Sieve fraction: 125 - 150 µm 100 g<br />
WS-BM0165 General purpose basalt microspheres - Sieve fraction: 150 - 180 µm 100 g<br />
WS-BM0196 General purpose basalt microspheres - Sieve fraction: 180 - 212 µm 100 g<br />
WS-BM0231 General purpose basalt microspheres - Sieve fraction: 212 - 250 µm 100 g<br />
WS-BM0275 General purpose basalt microspheres - Sieve fraction: 250 - 300 µm 100 g<br />
WS-BM0328 General purpose basalt microspheres - Sieve fraction: 300 - 355 µm 100 g<br />
WS-BM0390 General purpose basalt microspheres - Sieve fraction: 355 - 425 µm 100 g<br />
WS-BM0463 General purpose basalt microspheres - Sieve fraction: 425 - 500 µm 100 g<br />
WS-BM0550 General purpose basalt microspheres - Sieve fraction: 500 - 600 µm 100 g<br />
WS-BM0650 General purpose basalt microspheres - Sieve fraction: 600 - 710 µm 100 g<br />
WS-BM0780 General purpose basalt microspheres - Sieve fraction: 710 - 850 µm 100 g<br />
WS-BM0925 General purpose basalt microspheres - Sieve fraction: 800 - 1000 µm 100 g<br />
WS-BM1090 General purpose basalt microspheres - Sieve fraction: 1000 - 1200 µm 100 g<br />
WS-BM1300 General purpose basalt microspheres - Sieve fraction: 1200 - 1400 µm 100 g<br />
WS-BM1500 General purpose basalt microspheres - Sieve fraction: 1400 - 1600 µm 100 g<br />
WS-BM1700 General purpose basalt microspheres - Sieve fraction: 1600 - 1800 µm 100 g<br />
WS-BM1900 General purpose basalt microspheres - Sieve fraction: 1800 - 2000 µm 100 g<br />
WS-BM2200 General purpose basalt microspheres - Sieve fraction: 2000 - 2400 µm 100 g<br />
Surface area<br />
BCR-169<br />
alpha-Alumina - Specific surface area (BET)<br />
60 g<br />
Certified value<br />
Specific surface area (BET) .....................0.104 m 2 /g<br />
BCR-170<br />
alpha-Alumina - Specific surface area (BET)<br />
60 g<br />
Certified value<br />
Specific surface area (BET) .......................1.05 m 2 /g<br />
BCR-171<br />
Alumina - Specific surface area (BET)<br />
50 g<br />
Certified value<br />
Specific surface area (BET) .......................2.95 m 2 /g<br />
BCR-172<br />
Quartz - Specific surface area (BET)<br />
10 g<br />
Certified value<br />
Specific surface area (BET) .......................2.56 m 2 /g<br />
BCR-173<br />
Titania - Specific surface area (BET)<br />
46 g<br />
Certified value<br />
Specific surface area (BET) .......................8.23 m 2 /g<br />
BCR-175<br />
Tungsten - Specific surface area (BET)<br />
200 g<br />
Certified value<br />
Specific surface area (BET) .....................0.181 m 2 /g<br />
BAMPM 101 Silica - Specific surface area (BET)<br />
10 g<br />
Certified values<br />
Specific surface area (BET) .....................0.177 m 2 /g<br />
BAMPM 102 Alpha alumina - Specific surface area (BET)<br />
10 g<br />
Certified values<br />
Specific surface area (BET) .......................5.41 m 2 /g<br />
BAMPM 103 Alumina type 60<br />
10 g<br />
Certified values<br />
Specific surface area (BET) .....................156.0 m 2 /g Mean pore radius..........................................3.18 nm<br />
Specific pore volume..............................0.250 cm 3 /g<br />
BAMPM 104 Alumina type 150<br />
Certified values<br />
10 g<br />
Specific surface area (BET) .......................79.8 m 2 /g Mean pore radius..........................................5.31 nm<br />
Specific pore volume..............................0.210 cm 3 /g<br />
352 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
Particles <strong>and</strong> surface properties<br />
Code Product Unit<br />
NIST-1899<br />
NIST-1900<br />
Silicon nitride - Specific surface area<br />
Intended for use in the calibration of BET instruments used to measure specific surface area (SSA)<br />
in the range 0.1 m 2 /g to 1000m 2 /g.<br />
Certified values<br />
Specific surface area (BET) multipoint ........................10.67 m 2 /g<br />
Specific surface area (BET) single point......................10.52 m 2 /g<br />
Silicon nitride - Specific surface area<br />
Intended for use in the calibration of BET instruments used to measure specific surface area (SSA)<br />
in the range 0.1 m 2 /g to 1000 m 2 /g.<br />
Certified values<br />
Specific surface area (BET) multipoint ..........................2.85 m 2 /g<br />
Specific surface area (BET) single point........................2.79 m 2 /g<br />
4 g<br />
4 g<br />
Micropore volume <strong>and</strong> width<br />
BCR-704<br />
BCR-705<br />
NIST-1917<br />
NIST-1918<br />
Particle flow<br />
BCR-116<br />
Faujasite type zeolite<br />
Adsorption of argon at the temperature of liquid argon (87K) on a microporous material (faujasite type zeolite)<br />
according to DIN 66135-4.<br />
Linde type A zeolite<br />
Adsorption of argon at the temperature of liquid argon (87 K) on a microporous material (Linde type A zeolite)<br />
according to DIN 66135-4.<br />
Alumina - Specific pore volume<br />
This SRM /CRM jointly developed <strong>and</strong> certified by NIST <strong>and</strong> BAM is intended for use in calibrating <strong>and</strong><br />
monitoring the performance of mercury porosimeters. The SRM ® /CRM unit consists of a single bottle containing<br />
approximately 10 g of alumina beads.<br />
®<br />
Certified properties:<br />
A) Pressure-volume curve (mercury intrusion curve) between 0.1 MPa <strong>and</strong> 400 MPa<br />
B) Diameter-volume curve (cumulative pore volume curve) between 3.7 nm <strong>and</strong> 14708 nm<br />
C) Pore volume values at selected intrusion pressure points; (ii) Values for the pore diameter<br />
Certified pore volume values at selected intrusion pressures <strong>and</strong> certified pore diameter<br />
Property x U 2s Unit<br />
Specific Pore Volume at 50 MPa ..................... 69.4.............1.5 ............ 8.0 .............mm 3 g -1<br />
Specific Pore Volume at 100 MPa ................. 625.4.............2.5 .......... 13.6 ............ mm 3 g -1<br />
Specific Pore Volume at 195 MPa ................. 637.1.............2.6 .......... 14.4 ........... mm 3 ·g -1<br />
Specific Pore Volume at 395 MPa ................. 638.6.............3.9 .......... 21.6 ........... mm 3 ·g -1<br />
Mean Pore Diameter d 50 .................................. 24.2.............0.2 ............ 1.0 ....................nm<br />
Most Frequent Pore Diameter d p,m................... 23.9.............0.5 ............ 2.8 ....................nm<br />
x - mean of the laboratory means (certified value)<br />
U - exp<strong>and</strong>ed uncertainty (coverage factor 2)<br />
s - st<strong>and</strong>ard deviation of the certified value<br />
Note: all certified pore volumes are normalized values V'p = Vp(pHg) - Vp(0.1 MPa)<br />
Silica-alumina - Specific pore volume<br />
This St<strong>and</strong>ard Material® Reference (SRM®) is intended for use in the calibration of mercury porosimeter intrusion<br />
analytical instruments. A unit of NIST-1918 consists of one vial containing approximately 12 g of an extruded<br />
silica-alumina compound.<br />
Certified values<br />
Mean Pore Diameter..................... 8.847 ± 0.363 nm<br />
Median Pore Diameter .................. 8.503 ± 0.218 nm<br />
Total Intruded Volume.............0.547 ± 0.018 mm 3 /g<br />
Limestone powders<br />
The flow of powders or granulated materials under the force of gravity affects the design <strong>and</strong> operation of silos<br />
used for their bulk storage. The European Federation of Chemical Engineering (EFCE) therefore developed a test<br />
method, based on the Jenike Shear Cell, to determine the shear strength of powders under different compaction<br />
<strong>and</strong> loading conditions. The complexity of this method is such that errors due to poor technique can easily arise.<br />
This CRM has therefore been produced with which laboratories can verify both their equipment <strong>and</strong> experimental<br />
technique. It is certified for shear stress as a function of normal applied stress for four different powder<br />
compaction stresses.<br />
10 g<br />
10 g<br />
10 g<br />
12 g<br />
3.2 kg<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 353
Particles <strong>and</strong> surface properties<br />
Microhardness<br />
Code Product Unit<br />
NIST-1893<br />
NIST-1893 - NIST-2830<br />
These materials are intended for use in calibrating <strong>and</strong> checking the performance of microhardness testers<br />
<strong>and</strong> may be used in conjunction with ASTM E384.<br />
Bright copper - Hardness (Knoop)<br />
Load 0.245, 0.490, 0.981N<br />
Certified value<br />
Hardness (nominal)................................125 kg/mm 2<br />
each<br />
NIST-1894A<br />
NIST-1895<br />
NIST-1896B<br />
NIST-1905<br />
NIST-1906<br />
NIST-1907<br />
NIST-1908<br />
NIST-1909<br />
NIST-2798A<br />
NIST-2830<br />
Bright copper - Hardness (Vickers)<br />
This St<strong>and</strong>ard Reference Material ® (SRM ® ) is intended primarily for use in calibrating Vickers-type microhardness<br />
testers <strong>and</strong> is certified for mean Vickers hardness values (HV) at loads of 0.245 N, 0.49 N, <strong>and</strong> 0.98 N (0.025 kgf,<br />
0.050 kgf, <strong>and</strong> 0.100 kgf, respectively). NIST-1894a consists of a 1.35 cm square test block of electrodeposited<br />
bright copper, approximately 1750 µm thick, on an AISI 1010 steel substrate, mounted in a thermosetting epoxy.<br />
Five indentations were made on the SRM’s polished surface for each load. Hardness values are reported in<br />
Gigapascal (GPa) <strong>and</strong> kgf/mm2. The SRM ® was individually measured <strong>and</strong> bears a serial number imprinted on<br />
the side of the epoxy mount.<br />
Bright nickel - Hardness (Knoop)<br />
Load 0.245, 0.490, 0.981N<br />
Certified value<br />
Hardness (nominal)................................600 kg/mm 2<br />
Bright nickel - Hardness (Vickers)<br />
Load 0.245, 0.490, 0.981N<br />
Certified value<br />
Hardness (nominal)................................600 kg/mm 2<br />
Bright nickel - Hardness (Knoop)<br />
Load 2.943<br />
Certified value<br />
Hardness (nominal)................................600 kg/mm 2<br />
Bright nickel - Hardness (Knoop)<br />
Load 4.905N<br />
Certified value<br />
Hardness (nominal)................................600 kg/mm 2<br />
Bright nickel - Hardness (Knoop)<br />
Load 9.81N<br />
Certified value<br />
Hardness (nominal)................................600 kg/mm 2<br />
Bright nickel - Hardness (Vickers)<br />
This St<strong>and</strong>ard Reference Material ® (SRM ® ) is intended primarily for use in calibrating Vickers-type microhardness<br />
testers <strong>and</strong> is certified for mean Vickers hardness values (HV) at a load of 2.943 N (0.300 kgf). NIST-1908<br />
consists of a 1.35 cm square test block of electrodeposited bright nickel, approximately 750 µm thick, on an AISI<br />
1010 steel substrate, mounted in a thermosetting epoxy. Five indentations were made on the polished surface of<br />
the SRM ® . Hardness value is reported in gigapascal (GPa) <strong>and</strong> kgf/mm2. The SRM ® was individually measured<br />
<strong>and</strong> bears a serial number imprinted on the side of the epoxy mount.<br />
Bright nickel - Hardness (Vickers)<br />
This St<strong>and</strong>ard Reference Material ® (SRM ® ) is intended primarily for use in calibrating Vickers-type microhardness<br />
testers <strong>and</strong> is certified for mean Vickers hardness values (HV) at a load of 9.81 N (1.000 kgf). NIST-1909 consists<br />
of a 1.35 cm square test block of electrodeposited bright nickel, approximately 750 µm thick, on an AISI 1010<br />
steel substrate, mounted in a thermosetting epoxy. Five indentations were made on the polished surface of the<br />
SRM ® . Hardness value is reported in gigapascal (GPa) <strong>and</strong> kgf/mm2. The SRM ® was individually measured <strong>and</strong><br />
bears a serial number imprinted on the side of the epoxy mount.<br />
Bright nickel - Hardness (Vickers)<br />
This St<strong>and</strong>ard Reference Material (SRM ® ) is intended primarily for use in calibrating Vickers-type microhardness<br />
testers <strong>and</strong> is certified for mean Vickers hardness values (HV) at a load of 4.905 N (0.500 kgf). NIST-2798a<br />
consists of a 1.35 cm square test block of electrodeposited bright nickel, approximately 750 µm thick, on an AISI<br />
1010 steel substrate, mounted in a thermosetting epoxy. Five indentations were made on the polished surface of<br />
the SRM ® . Hardness value is reported in gigapascal (GPa) <strong>and</strong> kgf/mm2. The SRM® was individually measured<br />
<strong>and</strong> bears a serial number imprinted on the side of the epoxy mount.<br />
Ceramic silicon nitride - Hardness (Knoop)<br />
Load 19.6N<br />
Certified value<br />
Hardness (nominal)..............................1500 kg/mm 2<br />
each<br />
each<br />
each<br />
each<br />
each<br />
each<br />
each<br />
each<br />
each<br />
each<br />
354 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
Particles <strong>and</strong> surface properties<br />
Code Product Unit<br />
NIST-2831<br />
Vickers Hardness of Ceramics <strong>and</strong> Hardmetals<br />
This St<strong>and</strong>ard Reference Material (SRM ® ) is intended for use in the calibration of all hardness <strong>and</strong> microhardness<br />
testing machines whereby a Vickers indentation is made <strong>and</strong> then measured with a microscope. The SRM has<br />
five NIST-made indents in the middle of a polished face certified for the individual diagonal lengths, the average<br />
diagonal length, <strong>and</strong> the average hardness value for indentations made at a load of 9.8 N (1 kgf). A unit of NIST-<br />
2831 consists of a 25 mm D × 9.5 mm disk that has a nominal hardness of approximately 15.0 GPa (1530<br />
kgf/mm 2 ) packaged in a wooden box. Each unit is individually certified <strong>and</strong> bears a serial number scribed on the<br />
opposite (bottom) face of the disk. Vickers hardness is calculated as HV = α P/d 2 , where P is the indentation load,<br />
d is the average diagonal size [(d1 + d2 )/2], <strong>and</strong> α is the indenter constant, which, for an ideal Vickers indenter is<br />
1.8544. If P is in units of Newton, <strong>and</strong> d is in units of meters, then HV will be in units of N/m 2 or Pa. A conversion<br />
factor of 1 × 10 -9 may be used to convert HV to units of GPa. In this certificate, older traditional units of hardness<br />
expressed as kgf/mm 2 are also included in parenthesis for the convenience of users..<br />
each<br />
Surface roughness<br />
NIST-2073a<br />
NIST-2074<br />
NIST-2075<br />
NIST-RM 8457<br />
Electroless-nickel coated steel<br />
This St<strong>and</strong>ard Reference Material is certified for roughness average R a <strong>and</strong> surface spatial wavelengh, D, <strong>and</strong> is<br />
intended for use as a st<strong>and</strong>ard for the calibration of stylus instruments that are used to measure surface<br />
®<br />
roughness.<br />
2.4 cm x 3.3 cm<br />
Certified values<br />
Roughness average R a.................................. 3.0 µm Wavelength D...........................................99.099 µm<br />
Electroless-nickel coated steel<br />
This St<strong>and</strong>ard Reference Material is certified for roughness average R a <strong>and</strong> surface spatial wavelengh, D, <strong>and</strong> is<br />
intended for use as a st<strong>and</strong>ard for the calibration of stylus instruments that are used to measure surface<br />
®<br />
roughness.<br />
2.4 cm x 3.3 cm<br />
Certified values<br />
Roughness average R a.................................. 1.0 µm Wavelength D..................................................40 µm<br />
Electroless-nickel coated steel<br />
This St<strong>and</strong>ard Reference Material is certified for roughness average R a <strong>and</strong> surface spatial wavelengh, D, <strong>and</strong> is<br />
intended for use as a st<strong>and</strong>ard for the calibration of stylus instruments that are used to measure surface<br />
®<br />
roughness.<br />
2.4 cm x 3.3 cm<br />
Certified values<br />
Roughness average R a.................................. 1.0 µm Wavelength D................................................800 µm<br />
Ultra high molecular weight polyethylene<br />
This Reference Material (RM), is intended for evaluations of cross-linking induced by radiation exposure, such as<br />
used to improve wear characteristics. Each unit of NIST-RM 8457 consists of 10 cubes of ultra high molecular<br />
weight polyetheylene (UHMWPE) of nominal dimension 0.5 cm. The cubes are sized for measurement of crosslink<br />
density by swelling. The material as supplied has not been irradiated, however.<br />
Reference values<br />
Cube dimension Dimension (cm) Surface roughness (µm)<br />
Faces normal to bar direction ............................0.4919 ± 0.005 .................................5.5 ± 0.6<br />
Faces perpendicular to bar direction..................0.5017 ± 0.006<br />
each<br />
each<br />
each<br />
10 cubes<br />
Surface tension<br />
GUM 11.1<br />
GUM 11.1 - GUM 11.3<br />
Reference materials certified by the Physical Chemistry Division of the Central Office of Measures (GUM),<br />
Warsaw. They are intended for the calibration <strong>and</strong> checking tensiometers. All st<strong>and</strong>ards are supplied with a<br />
certificate showing value of surface tension with an uncertainty 0.1 mN/m <strong>and</strong> value of density with an<br />
uncertainty of 0.1 kg/m 3 . Decimal values are given in the certificate.<br />
Isooctane<br />
Certified value<br />
Surface tension .............................18 mN/m at 20 ºC<br />
30 mL<br />
GUM 11.2<br />
GUM 11.3<br />
Benzene<br />
Certified value<br />
Surface tension .............................28 mN/m at 20 ºC<br />
Glycerol<br />
Certified value<br />
Surface tension .............................63 mN/m at 20 ºC<br />
30 mL<br />
30 mL<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 355
Particles <strong>and</strong> surface properties<br />
Depth profiling<br />
Code Product Unit<br />
BCR-261T Tantalum pentoxide on tantalum foil<br />
Certified values<br />
Areal density of oxygen atoms<br />
2x4 foils<br />
Certified values<br />
Uncertainty<br />
[10 21 m -2 ] [10 21 m -2 ]<br />
Oxide thickness n<br />
30 nm material (nominal) .............. 1.72.......................................................0.07<br />
100 nm material (nominal) ............ 5.40.......................................................0.12<br />
Certified ratio<br />
Uncertainty<br />
[dimensionless]<br />
[dimensionless]<br />
Oxide thickness ratio..................... 0.321.....................................................0.013<br />
NIST-2134<br />
NIST-2135C<br />
NIST-2137<br />
Coatings<br />
NIST-1359B<br />
NIST-1361B<br />
NIST-1362B<br />
NIST-1363B<br />
NIST-1364B<br />
NIST-2321<br />
Abrasive wear<br />
NIST-1857<br />
Arsenic in silicon - Depth profile<br />
each<br />
This St<strong>and</strong>ard Reference Material ® (SRM ® ) is intended for use in calibrating secondary ion response to minor <strong>and</strong><br />
trace levels of arsenic in a silicon matrix by the analytical technique of secondary ion mass spectrometry (SIMS).<br />
NIST-2134 is intended for calibrating the response of a SIMS instrument for arsenic in a silicon matrix under a<br />
specific set of instrumental conditions. It may also be used by a laboratory as a transfer st<strong>and</strong>ard for the<br />
calibration of working st<strong>and</strong>ards of arsenic in silicon. This SRM consists of a 1 cm x 1 cm single crystal silicon<br />
substrate that has been ion implanted with the isotope 75 As at a nominal energy of 100 keV.<br />
NIST-2134 is certified for the retained dose of 75 As atoms. The dose is expressed in units of arsenic mass per<br />
unit area. Additional noncertified information about the concentration of arsenic atoms as a function of depth<br />
below the surface is provided by SIMS.<br />
The total retained dose of 75 As atoms was determined by instrumental n<strong>eu</strong>tron activation analysis.<br />
Certified Retained Dose of 75 As .......................... 0.09120 µg/cm 2 ± 0.00035 µg/cm 2<br />
Using a value of 74.9216 g/mol for the isotopic mass of 75 As, the retained dose is equivalent to<br />
7.330 × 10 14 atoms/cm 2 ± 0.028 × 10 14 atoms/cm 2<br />
Nickel-chromium thin film - Depth profile<br />
each<br />
Intended for calibrating equipment used to measure sputtered depth <strong>and</strong> erosion rates in surface analysis.<br />
Total thickness<br />
Certified values<br />
Cr ..........................206.3 µg/cm 2 Ni .......................... 197.4 µg/cm 2<br />
Single layer thickness<br />
Certified values<br />
Cr ............................41.3 µg/cm 2 Ni ............................ 49.4 µg/cm 2<br />
Boron implant in silicon - Depth profile<br />
Intended for calibrating the secondary ion response to minor <strong>and</strong> trace element levels in a silicon matrix.<br />
Certified value<br />
B-10.......1.018 x 10 15 atoms/cm 2<br />
NIST-1359b - NIST-1364b<br />
These NIST St<strong>and</strong>ard Reference Materials ® are suitable for calibrating instruments used in the measurement<br />
of organics <strong>and</strong> nonmagnetic inorganic coatings on steel. They consist of fine grained copper of varying<br />
thicknesses electrodeposited onto low carbon steel substrates having the properties of AISI 1010 steel.<br />
These uniform coatings are then overplated with a thin protective layer of chromium <strong>and</strong> the total coating<br />
thickness is then certified.<br />
Copper <strong>and</strong> chromium on steel - Coating thickness<br />
45 mm × 45 mm coupons<br />
Copper <strong>and</strong> chromium on steel - Coating thickness<br />
45 mm × 45 mm coupons<br />
Copper <strong>and</strong> chromium on steel - Coating thickness<br />
45 mm × 45 mm coupons<br />
Copper <strong>and</strong> chromium on steel - Coating thickness<br />
45 mm × 45 mm coupons<br />
Copper <strong>and</strong> chromium on steel - Coating thickness<br />
45 mm × 45 mm coupons<br />
Tin-lead alloy on copper<br />
Intended for calibrating X-ray fluorescence equipment. Each unit, which consists of a plate of an electroplated tinlead<br />
alloy coating on a copper substrate, is individually certified for composition <strong>and</strong> mass per unit area.<br />
D-2 Tool steel<br />
0.78 x 2.5 x 7.6 cm<br />
Certified for the ASTM G65 abrasion test<br />
each<br />
set (4)<br />
set (4)<br />
set (4)<br />
set (4)<br />
set (4)<br />
each<br />
2 blocks<br />
356 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
Optical properties<br />
Optical properties<br />
Molecular absorption <strong>and</strong> luminescence<br />
Code Product Unit<br />
ERM-FB011<br />
ERM-FB012<br />
ERM-FB020<br />
ERM-FB021<br />
NIST-930E<br />
NIST-931G<br />
NIST-935A<br />
NIST-936A<br />
GUM 9D.1<br />
NIST-1921B<br />
NIST-2032<br />
UV-Visible absorbance st<strong>and</strong>ard - Sodium nitrate/cobalt chloride/nickel chloride solution<br />
This certified <strong>reference</strong> material is intended for use in the verification <strong>and</strong> calibration of the absorbance scales of<br />
ultraviolet-visible absorption spectrometers.<br />
Certified values<br />
3 st<strong>and</strong>ard + 1 blank<br />
UV-visible absorbance at four wavelengths (299.4, 395.0, 512.5 <strong>and</strong> 719.0 nm) at a 1 nm b<strong>and</strong>width.<br />
IR wavelength st<strong>and</strong>ard - Polystyrene in hexane<br />
This certified <strong>reference</strong> material is intended for use in the verification <strong>and</strong> calibration of infra-red spectrometers,<br />
within the range of spectral b<strong>and</strong>widths quoted<br />
Certified values<br />
IR wavelength positions of four peaks (3026.0, 1601.1, 1028.8 <strong>and</strong> 698.0 cm -1 ).<br />
UV-Visible wavelength st<strong>and</strong>ard for HPLC detectors - Holmium/neodymium oxides solution<br />
The certified <strong>reference</strong> material is intended for use in the verification <strong>and</strong> calibration of the wavelength scale of<br />
ultra-violet/visible HPLC detectors.<br />
Certified values<br />
UV/visible wavelength location of 7 peaks in the spectral range 241 to 797 nm at four spectral b<strong>and</strong>widths (1, 4, 7<br />
<strong>and</strong> 10 nm).<br />
UV-Visible absorbance st<strong>and</strong>ard for HPLC detectors - Sodium nitrate/cobalt chloride/nickel<br />
chloride solution<br />
This certified <strong>reference</strong> material is intended for checking the linearity of the absorbance scales of UV/Visible<br />
HPLC detectors<br />
Certified values<br />
7 st<strong>and</strong>ard + 1 blank<br />
UV/visible absorbance for four wavelengths (299, 395, 512 <strong>and</strong> 719 nm) at 4 b<strong>and</strong>widths (1, 4, 7, <strong>and</strong> 10 nm).<br />
Glass filters<br />
Visible transmittance at 5 wavelengths (440.0, 465.0, 546.1 590.0 <strong>and</strong> 635.0 nm).<br />
Liquid filters<br />
UV-visible absorbance at 4 wavelengths (302, 395, 512 <strong>and</strong> 678 nm).<br />
Liquid Filter<br />
Nominal Wavelength (nm)<br />
302 395 512 678<br />
Level I 0.2925 ± 0.0016 0.3108 ± 0.0017 0.3011 ± 0.0017 0.1169 ± 0.0012<br />
Level II 0.5969 ± 0.0028 0.6223 ± 0.0029 0.5917 ± 0.0029 0.2344 ± 0.0018<br />
Level III 0.9668 ± 0.0043 0.9328 ± 0.0042 0.8969 ± 0.0042 0.3517 ± 0.0024<br />
Potassium dichromate<br />
UV absorbance at 5 wavelengths (235, 257, 313, 345, <strong>and</strong> 350 nm).<br />
Quinine sulphate dihydrate<br />
For use in the evaluation of methods <strong>and</strong> the calibration of fluorescence spectrometers. Certified for the relative<br />
molecular emission spectrum, E (l), in radiometric units for a solution of 1.28 x 10 -6 mol/L quinine sulphate<br />
dihydrate in 0.105 mol/L perchloric acid using an excitation wavelength of 347.5 nm. The values of the<br />
molecular emission spectrum are certified at 5 nm wavelength intervals from 375 nm to 675 nm.<br />
Estrofol film film - Wavenumber st<strong>and</strong>ard for infrared range<br />
This <strong>reference</strong> material from the Central Office of Measures (Pol<strong>and</strong>) is intended for use in the calibration of the<br />
wave number scale of spectrophotometers in the infrared (IR) spectral region from 400 cm -1 to 4000 cm -1 (21<br />
peaks). GUM 9.D1 consists of two cards made of transparent poly(ethylene terephtalate) film 6 mm <strong>and</strong> 50 mm<br />
thick, in holders.<br />
Polystyrene film - IR transmission wavelength<br />
This St<strong>and</strong>ard Reference Material ® (SRM ® ) is intended primarily for use in calibrating the wavelength<br />
(wavenumber) scale of spectrophotometers in the infrared (IR) spectral region from 3.2 µm to 18.5 µm (540 cm-1<br />
to 3125 cm-1). SRM 192lb is a matt finish polystyrene film approximately 38 µm thick with a 25 mm diameter<br />
exposed area, centered 38 mm from the bottom of a cardboard holder, which is 5 cm × 11 cm × 0.2 cm in size.<br />
Heterochromatic stray radiation energy st<strong>and</strong>ard for UV Spectrophotometry<br />
Potassium iodide for use in the assessment of heterochromatic stray radiation energy (stray light) below 260 nm<br />
UV absorbance at 8 wavelengths (240, 245, 250, 255, 260, 265, 270 <strong>and</strong> 275 nm).<br />
cuv. (4)<br />
5 x 1 mL<br />
2 x 3 mL<br />
8 x 3 mL<br />
set<br />
set (12)<br />
15 g<br />
1 g<br />
set (2)<br />
1 card<br />
25 g<br />
NIST-2940 Relative intensity correction st<strong>and</strong>ard for fluorescence spectroscopy (Orange emission) 412<br />
nm<br />
This St<strong>and</strong>ard Reference Material ® (SRM ® ) is intended for use for the evaluation <strong>and</strong> calibration of the relative<br />
spectral responsivity of steady-state fluorescence spectrometers with a continuous excitation source <strong>and</strong> for<br />
determining the day-to-day or instrument-to-instrument intensity variations of a single or similar fluorescence<br />
instrument(s), respectively. This SRM ® is certified for the relative, corrected emission spectrum, E, in relative<br />
power units from emission λ wavelengths EM = 500 nm to 800 nm at 1 nm wavelength intervals at a fixed<br />
excitation (λ wavelength EX) of 412 nm.<br />
1 contain.<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 357
Optical properties<br />
Code Product Unit<br />
NIST-2941 Relative intensity correction st<strong>and</strong>ard for fluorescence spectroscopy (Green emission) 427<br />
nm<br />
This St<strong>and</strong>ard Reference Material ® (SRM ® ) is intended for use for the evaluation <strong>and</strong> calibration of the relative<br />
spectral responsivity of steady-state fluorescence spectrometers with a continuous excitation source <strong>and</strong> for<br />
determining the day-to-day or instrument-to-instrument intensity variations of a single or similar fluorescence<br />
instrument(s), respectively. This SRM ® is certified for the relative, corrected emission spectrum, E, in relative<br />
power units from emission λ wavelengths EM = 450 nm to 650 nm at 1 nm wavelength intervals at a fixed<br />
excitation (λ wavelength EX) of 427 nm.<br />
NIST-2035<br />
Near infrared transmission wavelength st<strong>and</strong>ard<br />
Glass filter certified for the location of the centre of gravity of 7 absorbance b<strong>and</strong>s in the range 10,300 to 5130 cm -<br />
1 , at 6 b<strong>and</strong>widths from 4 to 128 cm -1 .<br />
1 contain.<br />
1 filter<br />
NIST-2036<br />
NIST-2065<br />
NIST-2517A<br />
NIST-2241<br />
NIST-2242<br />
NIST-2243<br />
Near infrared wavelength/reflection st<strong>and</strong>ard<br />
This St<strong>and</strong>ard Reference Material (SRM ® ) is a certified transfer st<strong>and</strong>ard intended for the verification <strong>and</strong><br />
calibration of the wavelength/wavenumber scale of Near-Infrared (NIR) spectrometers operating in diffuse<br />
reflectance mode. NIST-2036 is a glass physically contacted with a piece of sintered polytetrafluoroethylene<br />
(PTFE). The combination of the rare earth oxide glass with a nearly ideal diffuse reflector provides reflectionabsorption<br />
b<strong>and</strong>s that range from approximately 15 % R to 40 % R. NIST-2036 is certified for the 10 % b<strong>and</strong><br />
fraction centroid of seven b<strong>and</strong>s spanning the spectral region from 975 nm to 1946 nm (air wavelength). In<br />
addition, it is certified for the 10 % b<strong>and</strong> fraction centroid location of the same seven b<strong>and</strong>s in the spectral<br />
region from 10300 cm -1 to 5130 cm -1 at 8 cm -1 resolution (vacuum wavenumber).<br />
Ultraviolet-visible-near-infrared transmission wavelength/vacuum wavenumber st<strong>and</strong>ard<br />
This St<strong>and</strong>ard Reference Material (SRM ® ) is a certified st<strong>and</strong>ard intended for the verification <strong>and</strong> calibration<br />
of the wavelenght/wavenumber scale of ultraviolet (UV)-Visible-Near-Infrared (NIR) spectrometers operating in<br />
transmission mode. NIST-2065 is certified for the location of seven absorbance b<strong>and</strong>s (COG) in the spectral<br />
region from 10300 cm -1 to 5130 cm -1 at 4 cm -1 resoltion. NIST-2065 is a glass consisting of a combination of<br />
rare earth oxides. The optical filter is 25 mm in diameter <strong>and</strong> 1.5 mm thick. Please ask for more details.<br />
High resolution wavelength calibration <strong>reference</strong><br />
Intended for wavelength calibration in the spectral region of 1510 nm to 1540 nm. NIST-2517a is a single-mode<br />
optical-fibre-coupled absorption cell containing acetylene ( 12 C 2H 2) gas at a pressure of 6.7 kPa (50 Torr).<br />
The absorption path length is 5 cm <strong>and</strong> the absorption lines are about 7 pm wide.<br />
Relative intensity correction st<strong>and</strong>ard for Raman spectroscopy 785 nm excitation<br />
NIST-2241 is a chromium-doped (0.02 mol % Cr 2O 3) sodium borosilicate matrix glass. One unit of this St<strong>and</strong>ard<br />
Reference Material ® consists of a glass slide that is approximately 10.7 mm in width × 30.4 mm in length × 2.0<br />
mm in thickness, with one surface optically polished <strong>and</strong> the opposite surface ground to a frosted finish using a<br />
400 grit polish.<br />
This St<strong>and</strong>ard Reference Material ® (SRM ® ) is a certified spectroscopic st<strong>and</strong>ard for the correction of the relative<br />
intensity of Raman spectra obtained with instruments employing 785 nm laser excitation. NIST-2241 consists of<br />
an optical glass that emits a broadb<strong>and</strong> luminescence spectrum when excited with 785 nm laser radiation. The<br />
relative spectral intensity of the glass luminescence has been determined through the use of a white-light,<br />
uniform-source, integrating sphere that has been calibrated for its irradiance at NIST. The shape of the<br />
luminescence spectrum of this glass is described by a polynomial expression that relates the relative spectral<br />
intensity to the wavenumber (cm -1 ) expressed as the Raman shift from the excitation wavelength of 785 nm.<br />
This polynomial, together with a measurement of the luminescence spectrum of the st<strong>and</strong>ard, can be used to<br />
determine the spectral intensity-response correction that is unique to each Raman system. The resulting<br />
instrument-intensity-response correction may then be used to obtain Raman spectra that are instrument<br />
independent. This SRM ® is intended for use in measurements over the range of 20 °C to 25 °C <strong>and</strong> with Raman<br />
systems that employ laser excitation at 785 nm. It may also be used for Raman excitation with lasers that range<br />
from 784 nm to 786 nm in excitation wavelength.<br />
Relative Intensity Correction St<strong>and</strong>ard for Raman Spectroscopy<br />
NIST-2242 is a certified spectroscopic st<strong>and</strong>ard for the correction of the relative intensity of Raman spectra<br />
obtained with instruments employing 532 nm laser excitation. It consists of an optical glass that emits a<br />
broadb<strong>and</strong> luminescence spectrum when excited with 532 nm laser radiation. The relative spectral intensity of the<br />
glass luminescence has been determined through the use of a white-light, uniform-source, integrating sphere that<br />
has been calibrated for its irradiance at NIST. The shape of the luminescence spectrum of this glass is described<br />
by a polynomial expression that relates the relative spectral intensity to the wavenumber (cm -1 ) expressed as the<br />
Raman shift from the excitation wavelength of 532 nm. This polynomial, together with a measurement of the<br />
luminescence spectrum of the st<strong>and</strong>ard, can be used to determine the spectral intensity-response correction that<br />
is unique to each Raman system. The resulting instrument-intensity-response correction may then be used to<br />
obtain Raman spectra that are instrument independent. This St<strong>and</strong>ard Reference Material (SRM ® ) is intended for<br />
use in measurements over the range of 20 °C to 25 °C.<br />
Relative Intensity Correction St<strong>and</strong>ard for Raman Spectroscopy<br />
This St<strong>and</strong>ard Reference Material (SRM ® ) is a certified spectroscopic st<strong>and</strong>ard for the correction of the relative<br />
intensity of Raman spectra obtained with instruments employing either 488 nm or 514.5 nm laser excitation. NIST-<br />
2243 consists of an optical glass that emits a broadb<strong>and</strong> luminescence spectrum when excited with either of<br />
these two laser wavelengths. The relative spectral intensity of the glass luminescence, for each excitation<br />
wavelength, has been determined through the use of a white-light, uniform-source, integrating sphere that has<br />
been calibrated for its irradiance at NIST. The shape of the luminescence spectrum of this glass is described by a<br />
polynomial expression that relates the relative spectral intensity to the wavenumber (cm -1 ) expressed as the<br />
Raman shift from the excitation laser wavelength. This polynomial, together with a measurement of the<br />
luminescence spectrum of the st<strong>and</strong>ard, can be used to determine the spectral intensity-response correction that<br />
is unique to each Raman system. The resulting instrument-intensity-response correction may then be used to<br />
obtain Raman spectra that are instrument independent.<br />
1 filter<br />
each<br />
1 cell<br />
each<br />
each<br />
each<br />
358 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
Optical properties<br />
Starna optical <strong>reference</strong> materials<br />
Absorbance / transmission<br />
Starna ® optical <strong>reference</strong> materials produced by Optiglass are now available from LGC Promochem. Optiglass was<br />
one of the first <strong>reference</strong> material producers in the UK to receive accreditation to ISO guide 34. The company has<br />
over 30 years experience in the development <strong>and</strong> production of liquid-filled, heat sealed quartz cells with good long<br />
term stability <strong>and</strong> the optical properties needed to evaluate performance of UV-visible spectrophotometers. The<br />
range also includes robust solid glass filter materials for both absorbance <strong>and</strong> wavelength measurements. These<br />
certified <strong>reference</strong> materials (CRM) for the validation of wavelength accuracy, absorbance accuracy, stray light <strong>and</strong><br />
resolution in the UV <strong>and</strong> visible regions, can be used in analytical, clinical <strong>and</strong> research laboratories. All of the<br />
Starna ® CRMs are traceable to NIST primary st<strong>and</strong>ards. Brief descriptions of the types of products available are<br />
given below with more detailed product descriptions in the pages that follow.<br />
Potassium dichromate - UV absorbance <strong>and</strong> linearity<br />
The use of potassium dichromate solvated in perchloric acid is an established <strong>and</strong> recognised<br />
method for the validation of the absorbance scale of UV <strong>and</strong> visible spectrophotometers. Starna ®<br />
provides sets of certified sealed cells covering absorbance values from 0.2 to 3.0 over the<br />
wavelength range from 235nm to 350nm. For the far UV, nicotinic acid is the recognised st<strong>and</strong>ard<br />
<strong>and</strong> covers from 210nm to 270nm.<br />
Code Product Unit<br />
STRM-0204060810 Potassium dichromate - UV absorbance <strong>and</strong> linearity<br />
STRM-0204060810-<br />
R<br />
Set of 6 cells<br />
Each set consists of one blank (0.001M perchloric acid) <strong>and</strong> five concentrations, with nominal values of 20 mg/L,<br />
40 mg/L, 60 mg/L, 80 mg/L, <strong>and</strong> 100 mg/L.<br />
Recertification: Potassium dichromate - UV absorbance <strong>and</strong> linearity<br />
set<br />
set<br />
STRM-02040608<br />
Potassium dichromate - UV absorbance <strong>and</strong> linearity<br />
Set of 5 sets<br />
Each set consists of one blank (0.001M perchloric acid) <strong>and</strong> four concentrations, with nominal values of 20 mg/L,<br />
40 mg/L, 60 mg/L <strong>and</strong> 80 mg/L.<br />
set<br />
STRM-02040608-R Recertification: Potassium dichromate - UV absorbance <strong>and</strong> linearity<br />
STRM-020406<br />
Potassium dichromate - UV absorbance <strong>and</strong> linearity<br />
Set of 4 cells<br />
Each set consists of one blank (0.001M perchloric acid) <strong>and</strong> three concentrations, with nominal values of 20 mg/L,<br />
40 mg/L <strong>and</strong> 60 mg/L.<br />
set<br />
set<br />
STRM-020406-R Recertification: Potassium dichromate - UV absorbance <strong>and</strong> linearity set<br />
STRM-0204<br />
Potassium dichromate - UV absorbance <strong>and</strong> linearity<br />
Set of 3 cells<br />
Each set consists of one blank (0.001M perchloric acid) <strong>and</strong> two concentrations, with nominal values of 20 mg/L<br />
<strong>and</strong> 40 mg/L.<br />
set<br />
STRM-0204-R Recertification: Potassium dichromate - UV absorbance <strong>and</strong> linearity set<br />
STRM-02<br />
Potassium dichromate - UV absorbance <strong>and</strong> linearity<br />
Set of 2 cells<br />
Each set consists of one blank (0.001M perchloric acid) <strong>and</strong> a solution with a nominal value of 20 mg/L.<br />
set<br />
STRM-02-R Recertification: Potassium dichromate - UV absorbance <strong>and</strong> linearity set<br />
STRM-04<br />
Potassium dichromate - UV absorbance <strong>and</strong> linearity<br />
Set of 2 cells<br />
Each set consists of one blank (0.001M perchloric acid) <strong>and</strong> a solution with a nominal value of 40 mg/L.<br />
set<br />
STRM-04-R Recertification: Potassium dichromate - UV absorbance <strong>and</strong> linearity set<br />
STRM-06<br />
Potassium dichromate - UV absorbance <strong>and</strong> linearity<br />
Set of 2 cells<br />
Each set consists of one blank (0.001M perchloric acid) <strong>and</strong> a solution with a nominal value of 60 mg/L.<br />
set<br />
STRM-06-R Recertification: Potassium dichromate - UV absorbance <strong>and</strong> linearity set<br />
STRM-08<br />
Potassium dichromate - UV absorbance <strong>and</strong> linearity<br />
Set of 2 cells<br />
Each set consists of one blank (0.001M perchloric acid) <strong>and</strong> a solution with a nominal value of 80 mg/L.<br />
set<br />
STRM-08-R Recertification: Potassium dichromate - UV absorbance <strong>and</strong> linearity set<br />
STRM-10<br />
Potassium dichromate - UV absorbance <strong>and</strong> linearity<br />
Set of 2 cells<br />
Each set consists of one blank (0.001M perchloric acid) <strong>and</strong> a solution with a nominal value of 100 mg/L.<br />
set<br />
STRM-10-R Recertification: Potassium dichromate - UV absorbance <strong>and</strong> linearity set<br />
STRM-60<br />
Potassium dichromate - UV absorbance <strong>and</strong> linearity<br />
Set of 2 cells<br />
Each set consists of one blank (0.001M perchloric acid) <strong>and</strong> a solution with a nominal value of 600 mg/L.<br />
set<br />
STRM-60-R Recertification: Potassium dichromate - UV absorbance <strong>and</strong> linearity set<br />
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Optical properties<br />
N<strong>eu</strong>tral density filter - Visible absorbance <strong>and</strong> linearity<br />
Schott NG-type glasses are used for the validation of the absorbance scale <strong>and</strong> linearity of<br />
spectrophotometers in the visible region. Starna ® n<strong>eu</strong>tral density filters are available in sets<br />
covering nominal transmission values from from 0.1% to 90%.<br />
Code Product Unit<br />
STRM-D1D39N<br />
N<strong>eu</strong>tral density filter - Visible absorbance <strong>and</strong> linearity<br />
Set of 3 glass filters <strong>and</strong> a blank holder<br />
Consists of one blank holder <strong>and</strong> three filters with nominal values of 0.1 %T, 0.3 %T, <strong>and</strong> 90 %T.<br />
set<br />
STRM-D1D39N-R Recertification: N<strong>eu</strong>tral density filter - Visible absorbance <strong>and</strong> linearity set<br />
STRM-1N2N3N<br />
N<strong>eu</strong>tral density filter - Visible absorbance <strong>and</strong> linearity<br />
Set of 3 glass filters <strong>and</strong> a blank holder<br />
Consists of one blank holder <strong>and</strong> three filters with nominal values of 10 %T, 20 %T, <strong>and</strong> 30 %T.<br />
set<br />
STRM-1N2N3N-R Recertification: N<strong>eu</strong>tral density filter - Visible absorbance <strong>and</strong> linearity set<br />
STRM-N1N35N<br />
N<strong>eu</strong>tral density filter - Visible absorbance <strong>and</strong> linearity<br />
Set of 3 glass filters <strong>and</strong> a blank holder<br />
Consists of one blank holder <strong>and</strong> three filters with nominal values of 1 %T, 3 %T, <strong>and</strong> 50 %T.<br />
set<br />
STRM-N1N35N-R Recertification: N<strong>eu</strong>tral density filter - Visible absorbance <strong>and</strong> linearity set<br />
STRM-5N<br />
N<strong>eu</strong>tral density filter - Visible absorbance <strong>and</strong> linearity<br />
Set of 1 glass filter <strong>and</strong> a blank holder<br />
Consists of one blank holder <strong>and</strong> one filter with a nominal value 50 %T.<br />
set<br />
STRM-5N-R Recertification: N<strong>eu</strong>tral density filter - Visible absorbance <strong>and</strong> linearity set<br />
Far UV Absorbance/transmission<br />
STRM-1A2A3A4A<br />
Nicotinic acid - UV absorbance <strong>and</strong> linearity<br />
Set of 5 cells<br />
Each set consists of one blank (0.1M hydrochloric acid) <strong>and</strong> four increasing concentrations, with nominal values of<br />
6 mg/L, 12 mg/L, 18 mg/L <strong>and</strong> 24 mg/L.<br />
set<br />
STRM-1A2A3A4A-R Recertification: Nicotinic acid - UV absorbance <strong>and</strong> linearity<br />
set<br />
Wavelength<br />
Starna ® sealed liquid <strong>reference</strong>s are available covering all wavelengths from the far UV to<br />
the visible. For the UV <strong>and</strong> visible, rare earth oxides like holmium oxide, didymium (a mixture<br />
of neodymium <strong>and</strong> praseodymium) <strong>and</strong> samarium solvated in perchloric acid are well<br />
recognised as suitable wavelength <strong>reference</strong>s.<br />
STRM-HL<br />
Holmium oxide - UV <strong>and</strong> visible wavelength<br />
Description: Holmium oxide (4% m/v) in 10% v/v perchloric acid.<br />
Primary usage: Assessment of wavelength scale accuracy in both UV <strong>and</strong> visible regions.<br />
Useable range: 240 nm to 650 nm, instruments with spectral b<strong>and</strong>width of less than 3 nm.<br />
Physical configuration: Far UV quartz cells that have been permanently heat sealed.<br />
Consists of one sealed cell, with certified peak at spectral b<strong>and</strong>width values of 0.10 nm, 0.25 nm, 0.50 nm, 1.00<br />
nm, 1.50 nm, 2.00 nm <strong>and</strong> 3.00 nm.<br />
1 cell<br />
STRM-HL-R Recertification: Holmium oxide - UV <strong>and</strong> visible wavelength 1 cell<br />
STRM-DL<br />
Didymium (neodymium & praesodymium) - UV <strong>and</strong> visible wavelength<br />
Description: Didymium (neodymium praesodymium) in perchloric acid.<br />
Primary usage: Assessment of wavelength scale accuracy in both UV <strong>and</strong> visible regions.<br />
Useable range: 290 nm to 870 nm, instruments with spectral b<strong>and</strong>width of less than 5 nm.<br />
Physical configuration: Far UV quartz cells that have been permanently heat sealed.<br />
Consists of one sealed cell, with certified peak at spectral b<strong>and</strong>width values of 0.10 nm, 0.25 nm, 0.50 nm, 1.00<br />
nm, 1.50 nm, 2.00 nm <strong>and</strong> 3.00 nm.<br />
1 cell<br />
STRM-DL-R Recertification: Didymium (neodymium & praesodymium) - UV <strong>and</strong> visible wavelength 1 cell<br />
STRM-SL<br />
Samarium - UV <strong>and</strong> visible wavelength<br />
Description: Samarium (III) oxide in perchloric acid.<br />
Primary usage: Assessment of wavelength scale accuracy in both UV <strong>and</strong> visible regions.<br />
Useable range: 230 nm to 560 nm, instruments with spectral b<strong>and</strong>width of less than 5 nm.<br />
Physical configuration: Far UV quartz cells that have been permanently heat sealed.<br />
Consists of one sealed cell, with certified peak at spectral b<strong>and</strong>width values of 0.10 nm, 0.25 nm, 0.50 nm, 1.00<br />
nm, 1.50 nm, 2.00 nm <strong>and</strong> 3.00 nm.<br />
1 cell<br />
STRM-SL-R Recertification: Samarium - UV <strong>and</strong> visible wavelength 1 cell<br />
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Optical properties<br />
Code Product Unit<br />
STRM-HG<br />
Holmium glass filter - UV <strong>and</strong> visible wavelength<br />
Description: Holmium glass filter.<br />
Primary usage: Assessment of wavelength scale accuracy in the UV <strong>and</strong> visible regions.<br />
Useable range: 270 nm to 640 nm, instruments with spectral b<strong>and</strong>width of less than 10 nm.<br />
Physical configuration: Glass filters 'stress free' mounted in anodised aluminium holder.<br />
Consists of one filter, 'stress free' mounted in a proprietary NIST design, with certified peak at spectral b<strong>and</strong>width<br />
values of 0.10 nm, 0.25 nm, 0.50 nm, 1.00 nm, 1.50 nm, 2.00 nm, <strong>and</strong> 3.00 nm.<br />
1 filter<br />
STRM-HG-R Recertification: Holmium glass filter - UV <strong>and</strong> visible wavelength 1 filter<br />
STRM-DG<br />
Didymium glass - UV wavelength<br />
Description: Didymium glass filter.<br />
Primary usage: Assessment of wavelength scale accuracy in the visible/near infrared region.<br />
Useable range: 430 nm to 890 nm, instruments with spectral b<strong>and</strong>width of less than 10 nm.<br />
Physical configuration: Glass filters 'stress free' mounted in anodised aluminium holder.<br />
Consists of one filter, “stress free” mounted in a proprietary NIST design, with certified peak at spectral b<strong>and</strong>width<br />
values of 0.10 nm, 0.25 nm, 0.50 nm, 1.00 nm, 1.50 nm, 2.00 nm, <strong>and</strong> 3.00 nm.<br />
1 filter<br />
STRM-DG-R Recertification: Didymium glass - UV wavelength 1 filter<br />
Far UV wavelength<br />
STRM-RE<br />
Rare earth - UV <strong>and</strong> visible wavelength<br />
Description: Rare earth oxide in dilute sulphuric acid.<br />
Primary Usage: Assessment of wavelength scale accuracy in the UV region.<br />
Useable range: 200nm to 300nm, instruments with spectral b<strong>and</strong>width of less than 5nm.<br />
Physical Configuration: Far UV quartz cells that have been permanently heat sealed.<br />
Consists of one sealed cell, with certified peak at spectral b<strong>and</strong>pass values of 0.1 nm, 0.2 nm, 0.5 nm, 1.0 nm, 1.5<br />
nm, 2.0 nm <strong>and</strong> 3.0 nm.<br />
1 cell<br />
STRM-RE-R Recertification: Rare earth - UV <strong>and</strong> visible wavelength 1 cell<br />
Stray light<br />
Inorganic cut-off filters – UV stray light<br />
This is a subtle source of error in UV <strong>and</strong> visible spectrophotometry. A variety of materials is<br />
available for measuring this parameter at several different wavelengths in the form of<br />
inorganic cut-off filters. They are designed with sharp cut-offs in transmissions at specified<br />
wavelengths which will enable any stray light to be measured.<br />
Description: Materials with sharp cut-offs in transmission at specified wavelengths.<br />
Primary usage: Detection of stray light in the UV region.<br />
Useable range: 200 nm to 260 nm, depending on the material.<br />
Physical configuration: Far UV quartz cells that have been permanently heat sealed.<br />
STRM-AC Inorganic cut-off filter (acetone) - UV stray light (cut-off at 326 nm) set<br />
STRM-AC-R Recertification: Inorganic cut-off filter - UV stray light (cut-off at 326 nm) set<br />
STRM-KI Inorganic cut-off filter (potassium iodide; 1% aqueous) - UV stray light (cut-off at 260 nm) set<br />
STRM-KI-R Recertification: Inorganic cut-off filter - UV stray light (cut-off at 260 nm) set<br />
STRM-LC Inorganic cut-off filter (lithium carbonate; saturated aqueous) - UV stray light (cut-off at 227<br />
nm)<br />
STRM-LC-R Recertification: Inorganic cut-off filter - UV stray light (cut-off at 227 nm) set<br />
STRM-KC Inorganic cut-off filter (potassium chloride; 1.2% aqueous) - UV stray light (cut-off at 200 nm) set<br />
STRM-KC-R Recertification: Inorganic cut-off filter - UV stray light (cut-off at 200 nm) set<br />
STRM-SC Inorganic cut-off filter (sodium chloride; 1% aqueous) - UV stray light (cut-off at 205 nm) set<br />
STRM-SC-R Recertification: Inorganic cut-off filter - UV stray light (cut-off at 205 nm) set<br />
STRM-SI Inorganic cut-off filter (sodium iodide; 1% aqueous) - UV stray light (cut-off at 260 nm) set<br />
STRM-SI-R Recertification: Inorganic cut-off filter - UV stray light (cut-off at 260 nm) set<br />
STRM-SN Inorganic cut-off filter (sodium nitrite; 5% aqueous) - UV stray light (cut-off at 390 nm) set<br />
STRM-SN-R Recertification: Inorganic cut-off filter - UV stray light (cut-off at 390 nm) set<br />
STRM-AQ Inorganic cut-off filter (water) - UV stray light (blank) 1 cell<br />
set<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 361
Optical properties<br />
Resolution<br />
Code Product Unit<br />
STRM-TX<br />
Accurate absorbance <strong>and</strong> wavelength measurements can only be achieved if due<br />
consideration is given to the resolution of the monochromator in use. In modern instruments<br />
with grating monochromators, the resolution relates directly to the slit chosen. The smaller<br />
the slit <strong>and</strong> its associated spectral b<strong>and</strong>width, the greater the resolution. Simple checks on<br />
the resolution power of a spectrophotometer with Starna ® resolution CRMs such as benzene<br />
vapour or toluene in hexane will provide useful <strong>reference</strong>s. Benzene vapour is used to<br />
validate the resolution of instruments with b<strong>and</strong>pass less than 1nm. Even this material can<br />
be supplied heat sealed into a quartz cell. An alternative liquid <strong>reference</strong>, toluene in hexane,<br />
helps users to meet the recommendations of the current European Pharmacopoeia.<br />
Toluene in hexane - resolution<br />
Description: 0.020% v/v solution of toluene in hexane.<br />
Primary usage: Determination of spectral b<strong>and</strong>width in the UV region.<br />
Useable range: 265 nm to 270 nm, instruments with a spectral b<strong>and</strong>width of less than 3 nm.<br />
Physical configuration: Far UV quartz cells that have been permanently sealed.<br />
This formulation is described <strong>and</strong> used in the European Pharmacopoeia where the ratio of the peak<br />
maximum at 269 nm to the minimum at 266 nm gives a measure of the resolution of the instrument.<br />
Ratio table:<br />
SBW (nm): 0.5 1.0 1.5 2.0 3.0<br />
Ratio: 2.5 2.1 1.6 1.4 1.0<br />
STRM-TX-R Recertification: Toluene in hexane - resolution set<br />
STRM-BZ<br />
Benzene vapour<br />
Description: 0.1 mL benzene in the vapour state.<br />
Primary usage: Determination of spectral b<strong>and</strong>width in the UV region.<br />
Useable range: 230 nm to 270 nm, instruments with a spectral b<strong>and</strong>width of less than 1 nm.<br />
Physical configuration: Far UV quartz cells that have been permanently heat sealed.<br />
At spectral b<strong>and</strong>widths less than 1 nm, the benzene vapour spectrum provides a useful <strong>reference</strong> that has<br />
characteristic features that may or may not be displayed – dependent upon the current spectrophotometer<br />
spectral b<strong>and</strong>width. Benzene vapour will not work well with a photodiode array spectrophotometer as this<br />
instrument type does not measure a continuum <strong>and</strong> the peaks will not be resolved well enough to be useable.<br />
STRM-BZ-R Recertification: Benzene vapour 1 cell<br />
Sets<br />
STRM-06HL<br />
The certified <strong>reference</strong> material sets have been assembled to make your verification task<br />
easier, <strong>and</strong> meet specific regulatory requirements.<br />
In addition, set prices do offer price savings over the purchase of individual certified <strong>reference</strong> materials.<br />
STRM-06 + STRM-HL<br />
STRM-06 Potassium dichromate - UV absorbance <strong>and</strong> linearity<br />
Set of 2 cells: Each set consists of one blank (0.001M perchloric acid) <strong>and</strong> a<br />
solution with a nominal value of 60 mg/L.<br />
STRM-HL Holmium oxide - UV <strong>and</strong> visible wavelength (Holmium oxide (4% m/v) in 10%<br />
v/v perchloric acid)<br />
Consists of one sealed cell, with certified peak at spectral b<strong>and</strong>width values of<br />
0.10 nm, 0.25 nm, 0.50 nm, 1.00 nm, 1.50 nm, 2.00 nm <strong>and</strong> 3.00 nm.<br />
STRM-06HL-R Recertification: STRM-06 + STRM-HL set<br />
STRM-06DLKI STRM-06 + STRM-DL + STRM-KI<br />
set<br />
STRM-06 Potassium dichromate - UV absorbance <strong>and</strong> linearity<br />
Set of 2 cells: Each set consists of one blank (0.001M perchloric acid) <strong>and</strong> a<br />
solution with a nominal value of 60 mg/L.<br />
STRM-DL Didymium (neodymium & praesodymium) - UV <strong>and</strong> visible wavelength<br />
Didymium (neodymium praesodymium) in perchloric acid<br />
Consists of one sealed cell, with certified peak at spectral b<strong>and</strong>width values of<br />
0.10 nm, 0.25 nm, 0.50 nm, 1.00 nm, 1.50 nm, 2.00 nm <strong>and</strong> 3.00 nm.<br />
STRM-KI Inorganic cut-off filter (potassium iodide; 1% aqueous) - UV stray light (cut-off at<br />
260 nm)<br />
STRM-06DLKI-R Recertification: STRM-06 + STRM-DL + STRM-KI set<br />
STRM-06HLKI STRM-06 + STRM-HL + STRM-KI<br />
set<br />
STRM-06 Potassium dichromate - UV absorbance <strong>and</strong> linearity<br />
Set of 2 cells: Each set consists of one blank (0.001M perchloric acid) <strong>and</strong> a<br />
solution with a nominal value of 60 mg/L.<br />
STRM-HL Holmium oxide - UV <strong>and</strong> visible wavelength (Holmium oxide (4% m/v) in 10%<br />
v/v perchloric acid)<br />
Consists of one sealed cell, with certified peak at spectral b<strong>and</strong>width values of<br />
0.10 nm, 0.25 nm, 0.50 nm, 1.00 nm, 1.50 nm, 2.00 nm <strong>and</strong> 3.00 nm.<br />
STRM-KI Inorganic cut-off filter (potassium iodide; 1% aqueous) - UV stray light (cut-off at<br />
260 nm)<br />
STRM-06HLKI-R Recertification: STRM-06 + STRM-HL + STRM-KI set<br />
set<br />
1 cell<br />
set<br />
362 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
Optical properties<br />
Code Product Unit<br />
STRM-06HLSC STRM-06 + STRM-HL + STRM-SC<br />
set<br />
STRM-06 Potassium dichromate - UV absorbance <strong>and</strong> linearity<br />
Set of 2 cells: Each set consists of one blank (0.001M perchloric acid) <strong>and</strong> a<br />
solution with a nominal value of 60 mg/L.<br />
STRM-HL Holmium oxide - UV <strong>and</strong> visible wavelength (Holmium oxide (4% m/v) in 10<br />
v/v perchloric acid)<br />
Consists of one sealed cell, with certified peak at spectral b<strong>and</strong>width values of<br />
0.10 nm, 0.25 nm, 0.50 nm, 1.00 nm, 1.50 nm, 2.00 nm <strong>and</strong> 3.00 nm.<br />
STRM-SC Inorganic cut-off filter (sodium chloride; 1% aqueous) - UV stray light (cut-off at<br />
205 nm)<br />
STRM-06HLSC-R Recertification: STRM-06 + STRM-HL + STRM-SC set<br />
STRM-06HLKIBZ<br />
STRM-06 + STRM-HL + STRM-KI + STRM-BZ<br />
STRM-06 Potassium dichromate - UV absorbance <strong>and</strong> linearity<br />
Set of 2 cells: Each set consists of one blank (0.001M perchloric acid) <strong>and</strong> a<br />
solution with a nominal value of 60 mg/L.<br />
STRM-HL Holmium oxide - UV <strong>and</strong> visible wavelength (Holmium oxide (4% m/v) in 10%<br />
v/v perchloric acid)<br />
Consists of one sealed cell, with certified peak at spectral b<strong>and</strong>width values of<br />
0.10 nm, 0.25 nm, 0.50 nm, 1.00 nm, 1.50 nm, 2.00 nm <strong>and</strong> 3.00 nm.<br />
STRM-KI Inorganic cut-off filter (potassium iodide; 1% aqueous) - UV stray light (cut-off at<br />
260 nm)<br />
STRM-BZ Benzene vapour (0.1 mL benzene in the vapour state)<br />
STRM-06HLKIBZ-R Recertification: STRM-06 + STRM-HL + STRM-KI + STRM-BZ<br />
STRM-06HLKIKC STRM-06 + STRM-HL + STRM-KI + STRM-KC<br />
STRM-06 Potassium dichromate - UV absorbance <strong>and</strong> linearity<br />
Set of 2 cells: Each set consists of one blank (0.001M perchloric acid) <strong>and</strong> a<br />
solution with a nominal values of 60 mg/L.<br />
STRM-HL Holmium oxide - UV <strong>and</strong> visible wavelength (Holmium oxide (4% m/v) in 10%<br />
v/v perchloric acid)<br />
Consists of one sealed cell, with certified peak at spectral b<strong>and</strong>width values of<br />
0.10 nm, 0.25 nm, 0.50 nm, 1.00 nm, 1.50 nm, 2.00 nm <strong>and</strong> 3.00 nm.<br />
STRM-KI Inorganic cut-off filter (potassium iodide; 1% aqueous) - UV stray light (cut-off at<br />
260 nm)<br />
STRM-KC Inorganic cut-off filter (potassium chloride; 1.2% aqueous) - UV stray light (cut<br />
off at 200 nm)<br />
STRM-06HLKIKC-R Recertification: STRM-06 + STRM-HL + STRM-KI + STRM-KC<br />
STRM-06KIKCTX<br />
STRM-06 + STRM-KI + STRM-KC + STRM-TX<br />
STRM-06<br />
STRM-KI<br />
STRM-KC<br />
STRM-TX<br />
Potassium dichromate - UV absorbance <strong>and</strong> linearity<br />
Set of 2 cells: Each set consists of one blank (0.001M perchloric acid) <strong>and</strong> a<br />
solution with a nominal value of 60 mg/L.<br />
Inorganic cut-off filter (potassium iodide; 1% aqueous) - UV stray light (cut-off at<br />
260 nm)<br />
Inorganic cut-off filter (potassium chloride; 1.2% aqueous) - UV stray light (cutoff<br />
at 200 nm)<br />
Toluene in hexane - Resolution (0.020% v/v solution of toluene in hexane)<br />
STRM-06KIKCTX-R Recertification: STRM-06 + STRM-KI + STRM-KC + STRM-TX<br />
STRM-06HLKITX<br />
STRM-06 + STRM-HL + STRM-KI + STRM-TX<br />
STRM-06 Potassium dichromate - UV absorbance <strong>and</strong> linearity<br />
Set of 2 cells: Each set consists of one blank (0.001M perchloric acid) <strong>and</strong> a<br />
solution with a nominal value of 60 mg/L.<br />
STRM-HL Holmium oxide - UV <strong>and</strong> visible wavelength (Holmium oxide (4% m/v) in 10%<br />
v/v perchloric acid)<br />
Consists of one sealed cell, with certified peak at spectral b<strong>and</strong>width values of<br />
0.10 nm, 0.25 nm, 0.50 nm, 1.00 nm, 1.50 nm, 2.00 nm <strong>and</strong> 3.00 nm.<br />
STRM-KI Inorganic cut-off filter (potassium iodide; 1% aqueous) - UV stray light (cut-off at<br />
260 nm)<br />
STRM-TX Toluene in hexane - Resolution (0.020% v/v solution of toluene in hexane)<br />
STRM-06HLKITX-R Recertification: STRM-06 + STRM-HL + STRM-KI + STRM-TX<br />
STRM-06HLKCBZ<br />
STRM-06 + STRM-HL + STRM-KC + STRM-BZ<br />
STRM-06 Potassium dichromate - UV absorbance <strong>and</strong> linearity<br />
Set of 2 cells: Each set consists of one blank (0.001M perchloric acid) <strong>and</strong> a<br />
solution with a nominal value of 60 mg/L.<br />
STRM-HL Holmium oxide - UV <strong>and</strong> visible wavelength (Holmium oxide (4% m/v) in 10%<br />
v/v perchloric acid)<br />
consists of one sealed cell, with certified peak at spectral b<strong>and</strong>width values of<br />
0.10 nm, 0.25 nm, 0.50 nm, 1.00 nm, 1.50 nm, 2.00 nm <strong>and</strong> 3.00 nm.<br />
STRM-KC Inorganic cut-off filter (potassium chloride; 1.2% aqueous) - UV stray light (cutoff<br />
at 200 nm)<br />
STRM-BZ Benzene vapour (0.1 mL benzene in the vapour state)<br />
STRM-06HLKCBZ-R Recertification: STRM-06 + STRM-HL + STRM-KC + STRM-BZ<br />
set<br />
set<br />
set<br />
set<br />
set<br />
set<br />
set<br />
set<br />
set<br />
set<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 363
Optical properties<br />
Code Product Unit<br />
STRM-06SLLCBZ<br />
STRM-06 + STRM-SL + STRM-LC + STRM-BZ<br />
STRM-06<br />
STRM-SL<br />
STRM-LC<br />
STRM-BZ<br />
Potassium dichromate - UV absorbance <strong>and</strong> linearity<br />
Set of 2 cells: Each set consists of one blank (0.001M perchloric acid) <strong>and</strong> a<br />
solution with a nominal value of 60 mg/L.<br />
Samarium - UV <strong>and</strong> visible wavelength (Samarium (III) oxide in perchloric acid)<br />
consists of one sealed cell, with certified peak at spectral b<strong>and</strong>width values of<br />
0.10 nm, 0.25 nm, 0.50 nm, 1.00 nm, 1.50 nm, 2.00 nm <strong>and</strong> 3.00 nm.<br />
Inorganic cut-off filter (lithium carbonate; saturated aqueous) - UV stray light (cut<br />
off at 227 nm)<br />
Benzene vapour (0.1 mL benzene in the vapour state)<br />
STRM-06SLLCBZ-R Recertification: STRM-06 + STRM-SL + STRM-LC + STRM-BZ<br />
STRM-06HLSLKC STRM-06 + STRM-HL+ STRM-SL + STRM-KC<br />
STRM-06 Potassium dichromate - UV absorbance <strong>and</strong> linearity<br />
Set of 2 cells: Each set consists of one blank (0.001M perchloric acid) <strong>and</strong> a<br />
solution with a nominal value of 60 mg/L.<br />
STRM-HL Holmium oxide - UV <strong>and</strong> visible wavelength (Holmium oxide (4% m/v) in 10%<br />
v/v perchloric acid)<br />
Consists of one sealed cell, with certified peak at spectral b<strong>and</strong>width values of<br />
0.10 nm,0.25 nm, 0.50 nm, 1.00 nm, 1.50 nm, 2.00 nm <strong>and</strong> 3.00 nm.<br />
STRM-SL Samarium - UV <strong>and</strong> visible wavelength (Samarium (III) oxide in perchloric acid)<br />
Consists of one sealed cell, with certified peak at spectral b<strong>and</strong>width values of<br />
0.10 nm, 0.25 nm, 0.50 nm, 1.00 nm, 1.50 nm, 2.00 nm <strong>and</strong> 3.00 nm.<br />
STRM-KC Inorganic cut-off filter (potassium chloride; 1.2% aqueous) - UV stray light (cutoff<br />
at 200 nm)<br />
STRM-06HLSLKC-R Recertification: STRM-06 + STRM-HL+ STRM-SL + STRM-KC<br />
STRM-06HLKCSITX UV single absorbance instrument spec. kit<br />
Each set consists on STRM-06 + STRM-HL + STRM-KC + STRM-SI + STRM-TX<br />
STRM-06 Potassium dichromate - UV absorbance <strong>and</strong> linearity<br />
Set of 2 cells: Each set consists of one blank (0.001M perchloric acid) <strong>and</strong> a<br />
solution with a nominal value of 60 mg/L.<br />
STRM-HL Holmium oxide - UV <strong>and</strong> visible wavelength (Holmium oxide (4% m/v) in 10%<br />
v/v perchloric acid)<br />
Consists of one sealed cell, with certified peak at spectral b<strong>and</strong>width values of<br />
0.10 nm,0.25 nm, 0.50 nm, 1.00 nm, 1.50 nm, 2.00 nm <strong>and</strong> 3.00 nm.<br />
STRM-KC Inorganic cut-off filter (potassium chloride; 1.2% aqueous) - UV stray light (cutoff<br />
at 200 nm)<br />
STRM-SI Inorganic cut-off filter (sodium iodide; 1% aqueous) - UV stray light (cut-off at<br />
260 nm)<br />
STRM-TX Toluene in hexane - Resolution (0.020% v/v solution of toluene in hexane)<br />
STRM-<br />
06HLKCSITX-R<br />
STRM-<br />
0660HLKCSITX<br />
STRM-<br />
0660HLKCSITX-R<br />
STRM-06HLKCTX<br />
Recertification: UV single absorbance instrument spec. kit<br />
UV <strong>and</strong> visible instrument spec. kit<br />
Each set consists on STRM-06 + STRM-60 + STRM-HL + STRM-KC + STRM-SI + STRM-TX<br />
STRM-06 Potassium dichromate - UV absorbance <strong>and</strong> linearity<br />
Set of 2 cells: Each set consists of one blank (0.001M perchloric acid) <strong>and</strong> a<br />
solution with a nominal value of 60 mg/L.<br />
STRM-60 Potassium dichromate - UV absorbance <strong>and</strong> linearity<br />
Set of 2 cells: Each set consists of one blank (0.001M perchloric acid) <strong>and</strong> a<br />
solution with a nominal value of 600 mg/L<br />
STRM-HL Holmium oxide - UV <strong>and</strong> visible wavelength (Holmium oxide (4% m/v) in 10% v/v<br />
perchloric acid)<br />
Consists of one sealed cell, with certified peak at spectral b<strong>and</strong>width values of<br />
0.10 nm, 0.25 nm, 0.50 nm, 1.00 nm, 1.50 nm, 2.00 nm <strong>and</strong> 3.00 nm.<br />
STRM-KC Inorganic cut-off filter (potassium chloride; 1.2% aqueous) - UV stray light (cut-off<br />
at 200 nm)<br />
STRM-SI Inorganic cut-off filters (sodium iodide; 1% aqueous) - UV stray light (cut-off at<br />
260 nm)<br />
STRM-TX Toluene in hexane - Resolution (0.020% v/v solution of toluene in hexane)<br />
Recertification: UV <strong>and</strong> visible instrument spec. kit<br />
Pharmacopoeia kit<br />
Each set consists on STRM-06 + STRM-HL + STRM-KC + STRM-TX<br />
STRM-06 Potassium dichromate - UV absorbance <strong>and</strong> linearity<br />
Set of 2 cells: Each set consists of one blank (0.001M perchloric acid) <strong>and</strong> a<br />
solution with a nominal value of 60 mg/L.<br />
STRM-HL Holmium oxide - UV <strong>and</strong> visible wavelength (Holmium oxide (4% m/v) in 10%<br />
v/v perchloric acid)<br />
Consists of one sealed cell, with certified peak at spectral b<strong>and</strong>width values of<br />
0.10 nm, 0.25 nm, 0.50 nm, 1.00 nm, 1.50 nm, 2.00 nm <strong>and</strong> 3.00 nm.<br />
STRM-KC Inorganic cut-off filter (potassium chloride; 1.2% aqueous) - UV stray light (cutoff<br />
at 200 nm)<br />
STRM-TX Toluene in hexane - Resolution (0.020% v/v solution of toluene in hexane)<br />
STRM-06HLKCTX-R Recertification: Pharmacopoeia kit<br />
set<br />
set<br />
set<br />
set<br />
set<br />
set<br />
set<br />
set<br />
set<br />
set<br />
364 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
Optical properties<br />
Code Product Unit<br />
STRM-<br />
Upgrade/recert. of pharmacopoeia kit (STRM-06HLKCTX) to E.P. 5.2<br />
0660HLKCTX/R/UG In version 5.2 of the Euro. Pharm., in section 2.2.25, they added an additional Absorbance verification<br />
using a 600 mg/l solution of potassium dichromate at 430 nm.<br />
The upgrade price adds this 600 mg/L <strong>reference</strong> to the existing Euro. Pharm. set, <strong>and</strong> re-certifies all<br />
the existing materials.<br />
STRM-0660HLKCTX E.P. 5.2 Pharmacopoeia kit<br />
Each set consists on STRM-06 + STRM-60 + STRM-HL + STRM-KC + STRM-TX<br />
STRM-06 Potassium dichromate - UV absorbance <strong>and</strong> linearity<br />
Set of 2 cells: Each set consists of one blank (0.001M perchloric acid) <strong>and</strong> a<br />
solution with a nominal value of 60 mg/L.<br />
STRM-60 Potassium dichromate - UV absorbance <strong>and</strong> linearity<br />
Set of 2 cells: Each set consists of one blank (0.001M perchloric acid) <strong>and</strong> a<br />
solution with a nominal value of 600 mg/L<br />
STRM-HL Holmium oxide - UV <strong>and</strong> visible wavelength (Holmium oxide (4% m/v) in 10%<br />
v/v perchloric acid)<br />
Consists of one sealed cell, with certified peak at spectral b<strong>and</strong>width values of<br />
0.10 nm,0.25 nm, 0.50 nm, 1.00 nm, 1.50 nm, 2.00 nm <strong>and</strong> 3.00 nm.<br />
STRM-KC Inorganic cut-off filter (potassium chloride; 1.2% aqueous) - UV stray light (cutoff<br />
at 200 nm)<br />
STRM-TX Toluene in hexane - Resolution (0.020% v/v solution of toluene in hexane)<br />
STRM-<br />
0660HLKCTX-R<br />
STRM-<br />
1A2A3A4ARE<br />
STRM-<br />
1A2A3A4ARE-R<br />
STRM-<br />
020610HLKCTX<br />
STRM-<br />
020610HLKCTX-R<br />
Refractive index<br />
ERM-BD011<br />
ERM-BD012<br />
ERM-BD013<br />
ERM-BD014<br />
Recertification: E.P. 5.2 Pharmacopoeia kit<br />
Far UV combination kit<br />
Each set consists on STRM-1A2A3A4A + STRM-RE<br />
Recertification: Far UV combination kit<br />
Single Box 3-point linearity full spec. kit ( 9 cells )<br />
Each set consists on STRM-02 + STRM-06 + STRM-10 + STRM-HL + STRM-KC + STRM-TX<br />
STRM-02 Potassium dichromate - UV absorbance <strong>and</strong> linearity<br />
Set of 2 cells: Each set consists of one blank (0.001M perchloric acid) <strong>and</strong> a<br />
solution with a nominal value of 20 mg/L.<br />
STRM-06 Potassium dichromate - UV absorbance <strong>and</strong> linearity<br />
Set of 2 cells: Each set consists of one blank (0.001M perchloric acid) <strong>and</strong> a<br />
solution with a nominal value of 60 mg/L.<br />
STRM-10 Potassium dichromate - UV absorbance <strong>and</strong> linearity<br />
Set of 2 cells: Each set consists of one blank (0.001M perchloric acid) <strong>and</strong> a<br />
solution with a nominal values of 100 mg/L.<br />
STRM-HL Holmium oxide - UV <strong>and</strong> visible wavelength (Holmium oxide (4% m/v) in 10%<br />
v/v perchloric acid)<br />
Consists of one sealed cell, with certified peak at spectral b<strong>and</strong>width values of<br />
0.10 nm,0.25 nm, 0.50 nm, 1.00 nm, 1.50 nm, 2.00 nm <strong>and</strong> 3.00 nm.<br />
STRM-KC Inorganic cut-off filter (potassium chloride; 1.2% aqueous) - UV stray light (cutoff<br />
at 200 nm)<br />
STRM-TX Toluene in hexane - Resolution (0.020% v/v solution of toluene in hexane)<br />
Recertification: Single Box 3-point linearity full spec. kit ( 9 cells )<br />
Orange juice<br />
This certified <strong>reference</strong> material is intended for use in the development, validation or quality control of analytical<br />
methods for the determination of degrees Brix or Refractive Index of sugar solutions <strong>and</strong> food extracts.<br />
Certified values<br />
Degrees Brix .......................1.26 Refractive index.............. 1.3348<br />
Orange juice<br />
This certified <strong>reference</strong> material is intended for use in the development, validation or quality control of analytical<br />
methods for the determination of degrees Brix or Refractive Index of sugar solutions <strong>and</strong> food extracts.<br />
Certified values<br />
Degrees Brix .....................12.72 Refractive index.............. 1.3521<br />
Orange juice<br />
This certified <strong>reference</strong> material is intended for use in the development, validation or quality control of analytical<br />
methods for the determination of degrees Brix or Refractive Index of sugar solutions <strong>and</strong> food extracts.<br />
Certified values<br />
Degrees Brix .....................22.07 Refractive index.............. 1.3673<br />
Orange juice<br />
This certified <strong>reference</strong> material is intended for use in the development, validation or quality control of analytical<br />
methods for the determination of degrees Brix or Refractive Index of sugar solutions <strong>and</strong> food extracts.<br />
Certified values<br />
Degrees Brix .....................55.55 Refractive index.............. 1.4320<br />
set<br />
set<br />
set<br />
set<br />
set<br />
set<br />
set<br />
3 mL<br />
3 mL<br />
3 mL<br />
3 mL<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 365
Optical properties<br />
Code Product Unit<br />
ERM-BD015<br />
NIST-1822A<br />
NIST-1922<br />
PRG 7.21<br />
PRG 7.1<br />
PRG 7.11<br />
PRG 7.2<br />
Orange juice<br />
This certified <strong>reference</strong> material is intended for use in the development, validation or quality control of analytical<br />
methods for the determination of degrees Brix or Refractive Index of sugar solutions <strong>and</strong> food extracts.<br />
Certified values<br />
Degrees Brix .....................64.73 Refractive index.............. 1.4529<br />
Refractive index st<strong>and</strong>ard<br />
Certified values<br />
Vacuum Wavelength (nm) Refractive Index (n) Vacuum Wavelength (nm) Refractive Index (n)<br />
at 22 °C at 22 °C<br />
480.1254 ................................. 1.526132 ± 0.000016 546.2260..................................1.521629 ± 0.000016<br />
501.7077 ................................. 1.524468 ± 0.000016 587.7254..................................1.519535 ± 0.000016<br />
508.7240 ................................. 1.523971 ± 0.000016 644.0250..................................1.517277 ± 0.000016<br />
Liquid refractive index - Mineral oil<br />
Intended for use as a calibration material for refractometers, especially for the refractive index range applicable to<br />
solutions of sugar <strong>and</strong> water.<br />
Certified values are given for refractive indices at 6 wavelengths, in the visible light range, at 20°C <strong>and</strong> for the<br />
change in refractive index with respect to temperature.<br />
PRG 7.21 - PRG 7.9<br />
This group of 11 liquid <strong>reference</strong> materials, produced by LGC Promochem <strong>and</strong> certified by the<br />
Laboratory of Refractometry <strong>and</strong> Polarimetry of the Central Office of Measures (GUM), Warsaw,<br />
covers the wide range of refractive index from 1.333 (water) to 1.702 (1-Iodonaphthalene).<br />
The n values were determined on a Pulfrich refractometer, previously calibrated with solid Class<br />
1 CRMs, for which values were established using goniometric procedures.<br />
All <strong>reference</strong> materials are supplied with a certificate. Certified values to 5 significant figures for<br />
the refractive index λ at = 589.3 nm, t = 20°C <strong>and</strong> associated uncertainties are given.<br />
Reference liquids are packed in glass ampoules (7.1, 7.2, 7.5, 7.6, 7.8, 7.9) or plastic drop-bottles<br />
(7.11, 7.12, 7.13, 7.20, 7.21).<br />
Water<br />
Refractive index ................................. 1.333 at 20 °C<br />
2,2,4-Trimethylpentane<br />
Refractive index ................................. 1.391 at 20 °C<br />
Methylsilicone oil<br />
Refractive index ................................. 1.405 at 20 °C<br />
Methylcyclohexane<br />
Refractive index ................................. 1.423 at 20 °C<br />
3 mL<br />
plate<br />
30 mL<br />
10 mL<br />
10 mL<br />
10 mL<br />
10 mL<br />
PRG 7.12 Silicone oil DC 556<br />
Refractive index ................................. 1.462 at 20 °C<br />
10 mL<br />
PRG 7.20<br />
PRG 7.5<br />
PRG 7.6<br />
Paraffin oil<br />
Refractive index ................................. 1.475 at 20 °C<br />
Toluene<br />
Refractive index ................................. 1.496 at 20 °C<br />
Chlorobenzene<br />
Refractive index ................................. 1.524 at 20 °C<br />
10 mL<br />
10 mL<br />
10 mL<br />
PRG 7.13 Silicone oil AN 140<br />
Refractive index .................................. 1.560 at 20°C<br />
10 mL<br />
PRG 7.8<br />
PRG 7.9<br />
RPC18061<br />
RPC18062<br />
RPC18065<br />
RPC1806X<br />
1-Bromonaphthalene<br />
Refractive index ................................. 1.657 at 20 °C<br />
1-Iodonaphthalene<br />
Refractive index ................................. 1.702 at 20 °C<br />
Refractive index liquids<br />
Refractive index range: 1.400-1.458 (interval 0.002)<br />
Refractive index liquids<br />
Refractive index range: 1.400-1.458 (interval 0.004)<br />
Refractive index liquids<br />
Refractive index range: 1.400-1.458 (interval 0.01)<br />
Refractive index liquid<br />
Any individual st<strong>and</strong>ard*<br />
Refractive index range: 1.400-1.458 (interval 0.002)<br />
10 mL<br />
10 mL<br />
30 x 7 mL<br />
15 x 7 mL<br />
6 x 7 mL<br />
1 x 7 mL<br />
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Optical properties<br />
Code Product Unit<br />
RPC1806Y<br />
RPC18091<br />
RPC18092<br />
RPC18095<br />
RPC1809X<br />
RPC1809Y<br />
RPC18121<br />
RPC18122<br />
RPC18125<br />
RPC1812X<br />
RPC1812Y<br />
Refractive index liquid<br />
Any individual st<strong>and</strong>ard<br />
Refractive index range: 1.400-1.458 (interval 0.002)<br />
Refractive index liquids<br />
Refractive index range: 1.460-1.640 (interval 0.002)<br />
Refractive index liquids<br />
Refractive index range: 1.460-1.640 (interval 0.004)<br />
Refractive index liquids<br />
Refractive index range: 1.460-1.640 (interval 0.01)<br />
Refractive index liquid<br />
Any individual st<strong>and</strong>ard*<br />
Refractive index range: 1.460-1.640 (interval 0.002)<br />
Refractive index liquid<br />
Any individual st<strong>and</strong>ard*<br />
Refractive index range: 1.460-1.640 (interval 0.002)<br />
Refractive index liquids<br />
Refractive index range: 1.642-1.700 (interval 0.002)<br />
Refractive index liquids<br />
Refractive index range: 1.642-1.700 (interval 0.004)<br />
Refractive index liquids<br />
Refractive index range: 1.642-1.700 (interval 0.01)<br />
Refractive index liquids<br />
Any individual st<strong>and</strong>ard*<br />
Refractive index range: 1.642-1.700 (interval 0.002)<br />
Refractive index liquid<br />
Any individual st<strong>and</strong>ard*<br />
Refractive index range: 1.642-1.700 (interval 0.002)<br />
1 x 30 mL<br />
91 x 7 mL<br />
46 x 7 mL<br />
19 x 7 mL<br />
1 x 7 mL<br />
1 x 30 mL<br />
30 x 7 mL<br />
15 x 7 mL<br />
6 x 7 mL<br />
1 x 7 mL<br />
1 x 30 mL<br />
Optical rotation<br />
*For individual st<strong>and</strong>ards please state in brackets after the catalogue number the refractive index required.<br />
GUM 8.1<br />
Optical fibres<br />
NIST-2520<br />
NIST-2522<br />
NIST-2523<br />
Sucrose (Saccharose)<br />
Certified values<br />
Optical rotation at 20 ºC<br />
546 nm ............................78.34 ° 589 nm............................ 66.52 °<br />
Optical fibre diameter st<strong>and</strong>ard - Diameter<br />
Intended for calibrating video microscopes or gray-scale systems used for fibre geometry measurements.<br />
The material consists of bare fibre in aluminium housing. Each sample is individually calibrated.<br />
Pin Guage for Optical Fibre Ferrul<br />
This St<strong>and</strong>ard Reference Material (SRM ® ) is intended primarily for use in calibrating instruments which measure<br />
small diameter artifacts such as pin gages, used for optical fibre ferrule hole calibration. Each SRM is individually<br />
certified <strong>and</strong> consists of a 60 mm long steel wire.<br />
Optical Fibre Ferrule Geometry<br />
This St<strong>and</strong>ard Reference Material (SRM ® ) is intended primarily for use in calibrating instruments which measure<br />
small diameter artifacts such as optical fibre ferrules. Each SRM is individually certified <strong>and</strong> consists of a single<br />
ceramic optical fibre ferrule.<br />
100 g<br />
unit<br />
each<br />
each<br />
Colour measurement<br />
BCR-400<br />
BCR-406A<br />
Red ceramic tile (Tomato paste colour)<br />
100 mm x 100 mm<br />
A ceramic tile the colour of which is defined by Hunter L, a <strong>and</strong> b values. Each tile is individually certified. The tile<br />
is intended for the purpose of calibration <strong>and</strong> does not represent a st<strong>and</strong>ard tomato paste colour.<br />
Nominal Hunter values: L 26, a 33, b 14.5<br />
BCR-406A <strong>and</strong> BCR-406B<br />
A <strong>reference</strong> for colorimeters <strong>and</strong> spectrophotometers measuring colour in reflection.<br />
The spectral reflectance is certified at 13 wavelengths between 400 nm <strong>and</strong> 1200 nm with<br />
a value higher than 93% between 450 nm <strong>and</strong> 800 nm.<br />
Opal glass<br />
50 mmD x 14 mm thick<br />
tile<br />
disc<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 367
Ion activity<br />
Code Product Unit<br />
BCR-406B<br />
Photography<br />
NIST-1010A<br />
NIST-5001<br />
NIST-2059<br />
Microscopy<br />
NIST-2800<br />
NIST-1867<br />
NIST-1866B<br />
Opal glass<br />
100 mmD x 14 mm thick<br />
Microcopy resolution test chart<br />
Intended to be used to determine the resolving power of microcopy systems in the photographic industry.<br />
Designed to meet the general requirements for ISO test chart No. 2 as described in ISO 3334: 1989.<br />
Two-Dimensional Grid Photomask St<strong>and</strong>ard<br />
This St<strong>and</strong>ard Reference Material (SRM ® ) is intended primarily for calibrating high accuracy two dimensional (X-Y)<br />
photomask/reticle registration metrology tools such as the IPRO, the IPRO II <strong>and</strong> the Leica 2020 as well as older<br />
tools such as the Nicon 5i.<br />
Photomask linewidth calibration st<strong>and</strong>ard<br />
NIST-2059 is an antireflecting etched chrome binary photomask on a nominal 152.4 mm x 152.4 mm x 6.35 mm<br />
(the industry st<strong>and</strong>ard 6.0 in. x 6.0 in. x 0.25 in.) quartz substrate. It consists of patterns of clear <strong>and</strong> opaque<br />
isolated lines with nominal dimensions ranging from 0.25 µm to 32 µm <strong>and</strong> linespacing (pitch) patterns ranging<br />
from 0.5 µm to 250 µm. Each mask is individually calibrated, with certified values given for isolated linewidths<br />
(both clear <strong>and</strong> opaque) <strong>and</strong> center-to-center line spacings for one of the eight repeated patterns on the SRM.<br />
All measurements are averaged over the central 2 µm of each feature to reduce the influence of line edge<br />
roughness. The certified values are traceable to the definition of the meter with an exp<strong>and</strong>ed (k=2) uncertainty<br />
less than 25 nm for linewidths <strong>and</strong> spacewidths <strong>and</strong> less than 9 nm for pitch.<br />
Other small objects of interest, such as features on IC wafers, magnetic read/write head gaps, biological<br />
materials, phase shift photomasks, etc., will image differently in a microscope. Consequently, this SRM is<br />
intended for measurements on binary photomasks only, which represent more than 85 % of all photomasks<br />
manufactured worldwide in the most recent survey,<br />
Microscope magnification st<strong>and</strong>ard<br />
This St<strong>and</strong>ard Reference Material ® (SRM ® ) is intended primarily for use in calibrating the magnification or scale of<br />
microscopes used to make dimensional measurements. These microscopes include optical <strong>and</strong> scanning electron<br />
microscopes, imaging in either transmission or reflection modes, <strong>and</strong> scanning probe microscopes. NIST-2800<br />
consists of a pattern of parallel lines whose nominal distances from the centerline range from ± 1 µm to ± 5 mm<br />
(see Figure 1). Certified values are given for the centre-to-centre distance of each line from the centreline; the<br />
linewidths are not certified. The pattern is printed in chrome on a fused-quartz substrate with nominal dimensions<br />
of 25 mm × 75 mm × 2.3 mm (1 in × 3 in × 0.09 in) using photomask production techniques.<br />
Uncommon commercial asbestos<br />
This St<strong>and</strong>ard Reference Material (SRM ® ) comprises three uncommon commercial asbestos materials (tremolite,<br />
actinolite asbestos, <strong>and</strong> anthophyllte asbestos) intended for use in the identification of these minerals by polarised<br />
light microscopy (PLM).<br />
Common commercial asbestos<br />
This st<strong>and</strong>ard <strong>reference</strong> material (SRM ® ) is comprised of three commercial-grade asbestos materials: chrysotile,<br />
asbestiform grunerite (amosite), <strong>and</strong> asbestiform riebeckite (crocidolite). These are the types of asbestos that<br />
were, or are, commonly used in commerce. These asbestos materials are typical of the asbestos found in bulk<br />
samples during routine asbestos inspections of building materials. The optical properties of these materials have<br />
been characterized so that this SRM may serve as a primary calibration st<strong>and</strong>ard in the identification of asbestos<br />
with polarized light microscopy (PLM). However, various conditions, such as geographic origin or acid/heat<br />
treatment<br />
of the asbestos, could cause the optical properties of the asbestos in bulk insulation samples to vary considerably<br />
from the materials comprising this SRM. A unit of NIST-1866b consists of a set of three bottles: one bottle<br />
containing chrysotile, one bottle containing asbestiform grunerite (amosite), <strong>and</strong> one bottle containing asbestiform<br />
riebeckite (crocidolite). Each bottle contains between 1 gram <strong>and</strong> 3 grams of material.<br />
disc<br />
set (5)<br />
each<br />
each<br />
each<br />
set (3)<br />
set (3)<br />
Ion activity<br />
pH calibration<br />
Code Product Unit<br />
NIST-185h<br />
NIST-186G<br />
Potassium hydrogen phthalate<br />
This St<strong>and</strong>ard Reference Material (SRM) is intended for use in preparing solutions for calibrating electrodes for<br />
pH measuring systems.<br />
Certified value<br />
pH (25 °C) .........................4.003<br />
Certified values of the pH at other temperatures are given in the CoA.<br />
pH St<strong>and</strong>ards<br />
Potassium dihydrogen phosphate (186Ig)<br />
Disodium hydrogen phosphate (186IIg)<br />
NIST-186g is intended for use in preparing solutions for calibrating electrodes for pH measuring systems. NIST-<br />
186 g consists of two components, each prepared to ensure high purity <strong>and</strong> uniformity: KH 2PO 4, potassium<br />
dihydrogen phosphate (186-I-g) <strong>and</strong> Na 2HPO 4, disodium hydrogen phosphate (186-II-g). A unit of NIST-186g<br />
consists of 30 g of potassium dihydrogen phosphate (186-I-g) <strong>and</strong> 45 g of disodium hydrogen phosphate<br />
(186-II-g), each contained in its respective clear glass bottle.<br />
60 g<br />
set<br />
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Ion activity<br />
Code Product Unit<br />
NIST-187E<br />
NIST-2193A<br />
NIST-188<br />
NIST-191C<br />
NIST-RM 8040<br />
Sodium tetraborate decahydrate (Borax)<br />
This St<strong>and</strong>ard Reference Material (SRM) is intended for use in preparing solutions for calibrating electrodes for<br />
pH measuring systems.<br />
Calcium carbonate pH st<strong>and</strong>ard<br />
This St<strong>and</strong>ard Reference Material ® (SRM ® ) is intended for use in preparing solutions for calibrating electrodes for<br />
pH measuring systems at pH values above 11.0. This lot of calcium carbonate (CaCO 3) was selected for its low<br />
level of alkali metal <strong>impurities</strong>. However, this SRM ® is certified ONLY as a pH st<strong>and</strong>ard, NOT as a pure<br />
substance. Before use for pH calibrations, a freshly filtered, saturated (at 25 °C) solution of Ca(OH) 2 must be<br />
prepared from NIST-2193a. The certified pH(S) <strong>and</strong> U of this solution as a function of temperature are given<br />
below.<br />
t/°C pH(S) uc(measurement) uc(y) k U<br />
5 ..................................................................... 13.232...................... 0.0030 0.0058 2.0 0.011<br />
10 ................................................................... 13.026...................... 0.0025 0.0056 2.0 0.011<br />
15 ................................................................... 12.830...................... 0.0025 0.0056 2.0 0.011<br />
20 ................................................................... 12.645...................... 0.0024 0.0056 2.0 0.011<br />
25 ................................................................... 12.469...................... 0.0024 0.0055 2.0 0.011<br />
30 ................................................................... 12.303...................... 0.0071 0.0087 2.0 0.017<br />
35 ................................................................... 12.145...................... 0.0071 0.0087 2.0 0.017<br />
37 ................................................................... 12.084...................... 0.0071 0.0087 2.0 0.017<br />
40 ................................................................... 11.995...................... 0.0071 0.0087 2.0 0.017<br />
45 ................................................................... 11.853...................... 0.0072 0.0087 2.0 0.017<br />
50 ................................................................... 11.717...................... 0.0074 0.0089 2.0 0.017<br />
Potassium hydrogen tartrate<br />
Certified value<br />
pH (25 °C) .........................3.557<br />
Other certified values of pH at different temperatures are given in the CoA.<br />
pH St<strong>and</strong>ards (Carbonate buffers; sodium bicarbonate <strong>and</strong> sodium carbonate)<br />
This St<strong>and</strong>ard Reference Material ® (SRM ® ) is intended for use in preparing solutions for calibrating electrodes for<br />
pH measuring systems. NIST-191c consists of two components, each prepared to ensure high purity <strong>and</strong><br />
uniformity: Sodium bicarbonate, NaHCO 3 (191-I-c) <strong>and</strong> sodium carbonate, Na 2CO 3 (191-II-c).A unit of NIST-191c<br />
consists of 25 g of sodium bicarbonate (191-I-c) <strong>and</strong> 30 grams of sodium carbonate (191-II-c), each contained in<br />
its respective clear glass bottle.<br />
Certified value<br />
pH (25 °C) .......................10.012<br />
Certified values of pH at 15 °C, 20 °C <strong>and</strong> 35 °C are given in the CoA.<br />
Sodium oxalate (Reductometric)<br />
This Reference Material (RM) was prepared to provide material of uniform, high purity for use as a working<br />
st<strong>and</strong>ard for oxidation-reduction reactions. The material conforms to the American Chemical Society specification<br />
for reagent-grade material, but should not be considered as entirely free from <strong>impurities</strong> such as moisture, sodium<br />
hydrogen oxalate <strong>and</strong> sodium hydrogen carbonate. A unit of RM 8040 consists of one bottle containing 60 g of<br />
crystalline sodium oxalate.<br />
Reference value<br />
Reductometric Assay (mass fraction): 99.951 % ± 0.038 %<br />
30 g<br />
30 g<br />
60 g<br />
25 g<br />
60 g<br />
Biological buffer systems<br />
NIST-2181<br />
NIST-2182 - NIST-2184<br />
These materials are intended for use in calibrating clinical instruments (e.g. blood pH measurements), in<br />
the physiologically important range of pH 7-8. They are based on a biological buffer system for clinical pH<br />
measurements <strong>and</strong> are certified for use as an admixture only. The pH values for the buffer solutions are<br />
certified at 0.05 <strong>and</strong> 0.08 M with respect to the free acid <strong>and</strong> the sodium salt admixture as a function of<br />
temperature. The certified temperature range is from 0-50 °C.<br />
NIST-2181 <strong>and</strong> NIST-2182<br />
Both materials are required to prepare a st<strong>and</strong>ard solution.<br />
HEPES free acid<br />
Certified values<br />
0.05M<br />
pH (0-50 °C)............7.832-7.216<br />
0.08M<br />
pH (0-50 °C)............7.853-7.222<br />
60 g<br />
NIST-2182<br />
HEPES Sodium Salt<br />
Certified values<br />
0.05M<br />
pH (0-50 °C)............7.832-7.216<br />
0.08M<br />
pH (0-50 °C)............7.853-7.222<br />
60 g<br />
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Ion activity<br />
Code Product Unit<br />
NIST-2183<br />
NIST-2184<br />
pD calibration<br />
NIST-2185<br />
NIST-2186II<br />
NIST-2191A<br />
NIST-2192A<br />
NIST-2183 <strong>and</strong> NIST-2184<br />
Both materials are required to prepare a st<strong>and</strong>ard solution.<br />
MOPSO free acid<br />
Certified values<br />
0.05M<br />
pH (0-50 °C) ............7.260-6.528<br />
0.08M<br />
pH (0-50 °C) ............7.268-6.528<br />
NaMOPSOate<br />
Certified values<br />
0.05M<br />
pH (0-50 °C) ............7.260-6.528<br />
0.08M<br />
pH (0-50 °C) ............7.268-6.524<br />
Potassium hydrogen phthalate<br />
Certified value<br />
pD (25 °C) .........................4.518<br />
Disodium Hydrogen Phosphate<br />
Required to prepare a st<strong>and</strong>ard solution.<br />
Certified value<br />
pD (25 °C) .........................7.428<br />
Other certified values at different temperatures are given in the CoA.<br />
Sodium bicarbonate<br />
Required to prepare a st<strong>and</strong>ard solution.<br />
Certified value<br />
pD (25 °C) .........................10.73<br />
Other certified values at different temperatures are given in the CoA.<br />
Sodium carbonate<br />
Required to prepare a st<strong>and</strong>ard solution.<br />
Certified value<br />
pD (25 °C) .......................10.732<br />
Other certified values at different temperatures are given in the CoA.<br />
50 g<br />
50 g<br />
60 g<br />
30 g<br />
30 g<br />
30 g<br />
Ion-selective electrode calibration<br />
NIST-2201<br />
NIST-2202<br />
NIST-2203<br />
Sodium chloride<br />
Certified values for activity coefficients, at 25°C, of the sodium <strong>and</strong> chloride ions at various concentrations <strong>and</strong> the<br />
related values of pNa <strong>and</strong> pCl.<br />
Potassium chloride<br />
Certified values for activity coefficients, at 25°C, of the potassium <strong>and</strong> chloride ions at various concentrations <strong>and</strong><br />
the related values of pK <strong>and</strong> pCl.<br />
Potassium fluoride<br />
Certified values for activity coefficients, at 25°C, of the potassium <strong>and</strong> fluoride ions at various concentrations <strong>and</strong><br />
the related value of pF.<br />
125 g<br />
160 g<br />
125 g<br />
Electrolytic conductivity<br />
NIST-3199<br />
NIST-3192<br />
NIST-3193<br />
KCl in n-propanol/de-ionised water<br />
Certified value<br />
Electrolytic conductivity (25 °C).............15.36 µS/cm<br />
KCl in de-ionised water<br />
Certified value<br />
Electrolytic conductivity (25 °C)...........496.73 µS/cm<br />
KCl in de-ionised water<br />
Certified value<br />
Electrolytic conductivity (25°C)............996.70 µS/cm<br />
GUM 5.2 - GUM 5.6<br />
500 mL<br />
8 x 50 mL<br />
8 x 50 mL<br />
These Reference Materials have been certified by the Physical Chemistry Division of the Central Office of<br />
Measures in Pol<strong>and</strong>. They are intended for calibration of conductivity cells or use in electrolytic conductivity<br />
measurement as a control sample. These RMs are certified in conformity with st<strong>and</strong>ard <strong>reference</strong> data published<br />
by the International Organisation of Legal Metrology (OIML). All Reference Materials are supplied with a certificate.<br />
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Ion activity<br />
Code Product Unit<br />
GUM 5.1<br />
GUM 5.2<br />
GUM 5.3<br />
GUM 5.4<br />
GUM 5.5<br />
GUM 5.6<br />
KCI solution<br />
Certified value<br />
Electrolytic conductivity...............11.13 S/m at 25 ºC<br />
KCI Solution<br />
Certified value<br />
Electrolytic conductivity...............1.285 S/m at 25 ºC<br />
KCI solution<br />
Certified value<br />
Electrolytic conductivity.............0.1410 S/m at 25 ºC<br />
KCI solution<br />
Certified value<br />
Electrolytic conductivity......... 0.01483 S/m at 25 °C<br />
KCI solution<br />
Certified value<br />
Electrolytic conductivity.................0.0720 S/m 25 °C<br />
KCI solution<br />
Certified value<br />
Electrolytic conductivity.............0.0293 S/m at 25 ºC<br />
100 mL<br />
100 mL<br />
100 mL<br />
100 mL<br />
100 mL<br />
100 mL<br />
Reagecon electrolytic conductivity st<strong>and</strong>ards<br />
St<strong>and</strong>ard values<br />
REACSKC84<br />
REACSKCS<br />
REACSKCL<br />
REACSKC12880<br />
REACSKC13<br />
REACSKC136<br />
REACSKC5<br />
REACSKC10<br />
REACSKC20<br />
REACSKC50<br />
REACSKC100<br />
REACSKC200<br />
REACSKC500<br />
REACSKC1000<br />
REACSKC5M<br />
REACSKC10M<br />
REACSKC20M<br />
Conductivity st<strong>and</strong>ard<br />
Electrolytic conductivity.................84 µS/cm at 25°C<br />
Conductivity st<strong>and</strong>ard<br />
Electrolytic conductivity...............147 µS/cm at 25°C<br />
Conductivity st<strong>and</strong>ard<br />
Electrolytic conductivity............1413 µS/cm at 25°C<br />
Conductivity st<strong>and</strong>ard<br />
Electrolytic conductivity..........12880 µS/cm at 25°C<br />
Conductivity st<strong>and</strong>ard<br />
Electrolytic conductivity..............1.30 µS/cm at 25°C<br />
Conductivity st<strong>and</strong>ard<br />
Electrolytic conductivity..............1.30 µS/cm at 25°C<br />
Conductivity st<strong>and</strong>ard<br />
Electrolytic conductivity...................5 µS/cm at 25°C<br />
Conductivity st<strong>and</strong>ard<br />
Electrolytic conductivity.................10 µS/cm at 25°C<br />
Conductivity st<strong>and</strong>ard<br />
Electrolytic conductivity.................20 µS/cm at 25°C<br />
Conductivity st<strong>and</strong>ard<br />
Electrolytic conductivity.................50 µS/cm at 25°C<br />
Conductivity st<strong>and</strong>ard<br />
Electrolytic conductivity...............100 µS/cm at 25°C<br />
Conductivity st<strong>and</strong>ard<br />
Electrolytic conductivity...............200 µS/cm at 25°C<br />
Conductivity st<strong>and</strong>ard<br />
Electrolytic conductivity...............500 µS/cm at 25°C<br />
Conductivity st<strong>and</strong>ard<br />
Electrolytic conductivity.............1000 µS/cm at 25°C<br />
Conductivity st<strong>and</strong>ard<br />
Electrolytic conductivity.............5000 µS/cm at 25°C<br />
Conductivity st<strong>and</strong>ard<br />
Electrolytic conductivity...........10000 µS/cm at 25°C<br />
Conductivity st<strong>and</strong>ard<br />
Electrolytic conductivity...........20000 µS/cm at 25°C<br />
500 mL<br />
500 mL<br />
500 mL<br />
500 mL<br />
250 mL<br />
6 x 250 mL<br />
500 mL<br />
500 mL<br />
500 mL<br />
500 mL<br />
500 mL<br />
500 mL<br />
500 mL<br />
500 mL<br />
500 mL<br />
500 mL<br />
500 mL<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 371
Electrical properties<br />
Code Product Unit<br />
REACSKC50M<br />
REACSKC100M<br />
REACSKC150M<br />
REACSKC200M<br />
REACSKC300M<br />
REACSKC350M<br />
REACSKC450M<br />
REACSKC500M<br />
Conductivity st<strong>and</strong>ard<br />
Electrolytic conductivity ...........50000 µS/cm at 25°C<br />
Conductivity st<strong>and</strong>ard<br />
Electrolytic conductivity .........100000 µS/cm at 25°C<br />
Conductivity st<strong>and</strong>ard<br />
Electrolytic conductivity .........150000 µS/cm at 25°C<br />
Conductivity st<strong>and</strong>ard<br />
Electrolytic conductivity .........200000 µS/cm at 25°C<br />
Conductivity st<strong>and</strong>ard<br />
Electrolytic conductivity .........300000 µS/cm at 25°C<br />
Conductivity st<strong>and</strong>ard<br />
Electrolytic conductivity ........350.000 µS/cm at 25°C<br />
Conductivity st<strong>and</strong>ard<br />
Electrolytic conductivity .........450000 µS/cm at 25°C<br />
Conductivity st<strong>and</strong>ard<br />
Electrolytic conductivity .........500000 µS/cm at 25°C<br />
500 mL<br />
500 mL<br />
500 mL<br />
500 mL<br />
500 mL<br />
500 mL<br />
500 mL<br />
500 mL<br />
Conductivity st<strong>and</strong>ards according to the European Pharmacopoeia (Chapter 2)<br />
REAEP1330<br />
REAEP133<br />
REAEP266<br />
Conductivity st<strong>and</strong>ard<br />
Electrolytic conductivity .............1330 µS/cm at 20°C<br />
Resistivity...................................................752 Ω⋅cm<br />
Conductivity st<strong>and</strong>ard<br />
Electrolytic conductivity ...............133 µS/cm at 20°C<br />
Resistivity.................................................7519 Ω⋅cm<br />
Conductivity st<strong>and</strong>ard<br />
Electrolytic conductivity ..............26.6 µS/cm at 20°C<br />
Resistivity...............................................37594 Ω⋅cm<br />
500 mL<br />
500 mL<br />
500 mL<br />
Electrical properties<br />
Electrical resistivity <strong>and</strong> conductivity<br />
Code Product Unit<br />
NIST-624<br />
NIST-2541<br />
NIST-2546<br />
NIST-2547<br />
Lead-silica - dc Resistivity<br />
Intended for checking test methods <strong>and</strong> for calibrating equipment used to determine the dc volume resistivity of<br />
glass per ASTM C 657.<br />
Certified value:<br />
Resistivity Temperature<br />
log 10ρ 11.07 Ω·cm ............250°C<br />
log 10ρ 9.9Ω·cm .................300°C<br />
log 10ρ 8.88 Ω·cm ..............350°C<br />
NIST-2541 - NIST-2547<br />
Single wafers intended for use as <strong>reference</strong> st<strong>and</strong>ards for sheet resistance <strong>and</strong> resistivity<br />
measurements utilising the four-point probe method.<br />
Silicon chip - Resistivity<br />
100 mm (D) x 0.625 mm<br />
Czochralski-grown, boron-doped silicon wafer with (100) crystallographic orientation.<br />
Certified value<br />
Resistivity....................0.1 Ω-cm<br />
Silicon chip - Resistivity<br />
100 mm (D) x 0.625 mm<br />
Float zone silicon with (111) orientation <strong>and</strong> phosphorus-doped by the n<strong>eu</strong>tron transmutation doping process.<br />
Certified value<br />
Resistivity...................100 Ω-cm<br />
Silicon chip - Resistivity<br />
100 mm (D) x 0.625 mm<br />
Float zone silicon with (111) orientation <strong>and</strong> phosphorus-doped by the n<strong>eu</strong>tron transmutation doping process.<br />
Certified value<br />
Resistivity...................200 Ω-cm<br />
200 g<br />
1 wafer<br />
1 wafer<br />
1 wafer<br />
372 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
Viscosity<br />
Code Product Unit<br />
NIST-RM 8420<br />
Electrolytic iron rod<br />
0.64 cm (D) x 5.0 cm<br />
Thermal conductivity <strong>and</strong> electrical resistivity as a function of temperature (2-1000 K)<br />
1 rod<br />
Superconducting critical current<br />
NIST-1457<br />
Niobium-titanium wire - Critical current<br />
8.7 cm diameter spool<br />
Intended for checking the performance of measurement systems used in superconductor technology. It consists of<br />
2.2 m of a multifilamentary niobium titanium, copper-stabilised superconducting wire wound in a single layer onto<br />
a spool with a core diameter of 8.7 cm.<br />
Certified values for critical current at 4.2 k <strong>and</strong> 0.2 µV/cm<br />
each<br />
Dielectric constant<br />
NIST-774<br />
Lead-silica - Dielectric constant<br />
5 cm x 5 cm x 2.5 cm<br />
Intended for checking methods used to determine dielectric constant <strong>and</strong> ac loss characteristics of insulating<br />
materials per ASTM D 150.<br />
Certified value: K ~7.47 at 100 Hz<br />
each<br />
Viscosity<br />
Viscosity of glass<br />
Code Product Unit<br />
NIST-717A<br />
NIST-717a<br />
Intended for checking the performance of high temperature viscosity equipment (rotating cylinders)<br />
<strong>and</strong> low temperature viscosity equipment (fibre elongation, beam bending, parallel plates, etc).<br />
Borosilicate<br />
Certified log 10 viscosity values (1.00-4.50) versus temperature (1555-880 °C)<br />
Indicative values for softening point, annealing point, strain point<br />
450 g<br />
Viscosity fixpoints<br />
NIST-709<br />
NIST-709 - NIST-717a<br />
Intended for calibration of equipment for the determination of the softening, annealing <strong>and</strong><br />
strain points of glass.<br />
Extra dense lead<br />
Certified values<br />
Softening point ................384 °C Annealing point............... 328 °C Strain point......................311 °C<br />
500 g<br />
NIST-713 Dense barium crown glass 620/603<br />
Certified values<br />
Softening point ................738 °C Annealing point............... 631 °C Strain point......................599 °C<br />
225 g<br />
NIST-714<br />
NIST-716<br />
NIST-717A<br />
Alkaline earth alumina silicate<br />
Certified values<br />
Softening point ................908 °C Annealing point............... 710 °C Strain point......................662 °C<br />
N<strong>eu</strong>tral glass<br />
Certified values<br />
Softening point ................794 °C Annealing point............... 574 °C Strain point......................530 °C<br />
Borosilicate<br />
Certified log 10 viscosity values (1.00-4.50) versus temperature (1555-880 °C)<br />
Indicative values for softening point, annealing point, strain point<br />
225 g<br />
225 g<br />
450 g<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 373
Viscosity<br />
Viscosity oil st<strong>and</strong>ards<br />
Code Product Unit<br />
PSL2700V01<br />
PSL2700V01 - PSL2700V19<br />
These st<strong>and</strong>ards are calibrated by the PSL Calibration Accredited Laboratory No. 0247 to ISO 17025.<br />
The St<strong>and</strong>ards will be supplied complete with UKAS calibration certificates <strong>and</strong> have direct traceability<br />
to NIST <strong>and</strong> other international laboratories. Uncertainties of measurement are stated on the calibration<br />
certificates. Long shelf lives are provided by using stable base oils.The viscosity oil st<strong>and</strong>ards are suitable<br />
for the calibration <strong>and</strong> verification of the following:<br />
- Glass Capillary viscometers<br />
- Automated Kinematic Viscometer Systems<br />
- Rotational/Cone & Plate Viscometers<br />
- Low Temperature Viscometer Systems<br />
- Cold Cranking Simulators<br />
- Flow Cups<br />
N4 - Viscosity oil st<strong>and</strong>ard<br />
Kinematic viscosity (nominal)<br />
0.47 mm 2 /s,cSt (20 °C) 0.45 mm 2 /s,cSt (25 °C) 0.40 mm 2 /s,cSt (40 °C)<br />
Dynamic viscosity (nominal)<br />
0.31 mPa.s,cP (20 °C) 0.29 mPa.s,cP (25 °C) 0.26 mPa.s,cP (40°C)<br />
500 mL<br />
PSL2700V02<br />
PSL2700V03<br />
PSLN2<br />
PSL2700V04<br />
PSL2700V05<br />
PSL2700V06<br />
PSL2700V07<br />
N8 - Viscosity oil st<strong>and</strong>ard<br />
Kinematic viscosity (nominal)<br />
1. mm 2 /s,cSt (20 °C) 0.89 mm 2 /s,cSt (25 °C) 0.75 mm 2 /s,cSt (40 °C)<br />
Dynamic viscosity (nominal)<br />
0.77 mPa.s,cP (20 °C) 0.72 mPa.s,cP (25 °C) 0.56 mPa.s,cP (40 °C)<br />
N1.0 - Viscosity oil st<strong>and</strong>ard<br />
Kinematic viscosity (nominal)<br />
1.3 mm 2 /s,cSt (20 °C) 1.2 mm 2 /s,cSt (25 °C) 0.97 mm 2 /s,cSt (40 °C)<br />
Dynamic viscosity (nominal)<br />
1.0 mPa.s,cP (20 °C) 0.93 mPa.s,cP (25 °C) 0.76 mPa.s,cP (40 °C)<br />
N2 - Viscosity oil st<strong>and</strong>ard<br />
Kinematic viscosity (nominal)<br />
2.9 mm 2 /s,cSt (20 °C) 2.6 mm 2 /s,cSt (25 °C) 2.0 mm 2 /s,cSt (40 °C) 1.7 mm 2 /s,cSt (50 °C)<br />
Dynamic viscosity (nominal)<br />
2.2 mPa.s,cP (20 °C) 2.0 mPa.s,cP (25 °C) 1.5 mPa.s,cP (40 °C) 1.3 mPa.s,cP (50 °C)<br />
S3 - Viscosity oil st<strong>and</strong>ard<br />
Kinematic viscosity (nominal)<br />
5.0 mm 2 /s,cSt (20 °C) 2.9 mm 2 /s,cSt (40 °C) 1.3 mm 2 /s,cSt (100 °C)<br />
4.4 mm 2 /s,cSt (25 °C) 2.6 mm 2 /s,cSt (50 °C)<br />
Dynamic viscosity (nominal)<br />
4.1 mPa.s,cP (20 °C) 2.4 mPa.s,cP (40 °C) 0.98 mPa.s,cP (100 °C)<br />
3.6 mPa.s,cP (25 °C) 2.1 mPa.s,cP (50 °C)<br />
S6 - Viscosity oil st<strong>and</strong>ard<br />
Kinematic viscosity (nominal)<br />
11 mm 2 /s,cSt (20 °C) 5.7 mm 2 /s,cSt (40 °C) 1.9 mm 2 /s,cSt (100 °C)<br />
8.9 mm 2 /s,cSt (25 °C) 4.6 mm 2 /s,cSt (50 °C)<br />
Dynamic viscosity (nominal)<br />
8.8 mPa.s,cP (20 °C) 4.8 mPa.s,cP (40 °C) 1.5 mPa.s,cP (100 °C)<br />
7.4 mPa.s,cP (25 °C) 3.7 mPa.s,cP (50 °C)<br />
N10 - Viscosity oil st<strong>and</strong>ard<br />
Kinematic viscosity (nominal)<br />
21 mm 2 /s,cSt (20 °C) 10 mm 2 /s,cSt (40 °C) 2.7 mm 2 /s,cSt (100 °C)<br />
17 mm 2 /s,cSt (25 °C) 7.5 mm 2 /s,cSt (50 °C)<br />
Dynamic viscosity (nominal)<br />
17 mPa.s,cP (20 °C) 9.0 mPa.s,cP (40 °C) 2.1 mPa.s,cP (100 °C)<br />
14 mPa.s,cP (25 °C) 6.2 mPa.s,cP (50 °C)<br />
S20 - Viscosity oil st<strong>and</strong>ard<br />
Kinematic viscosity (nominal)<br />
47 mm 2 /s,cSt (20 °C) 18 mm 2 /s,cSt (40 °C) 4.0 mm 2 /s,cSt (100 °C)<br />
37 mm 2 /s,cSt (25 °C) 13 mm 2 /s,cSt (50 °C)<br />
Dynamic viscosity (nominal)<br />
40 mPa.s,cP (20 °C) 16 mPa.s,cP (40 °C) 3.2 mPa.s,cP (100 °C)<br />
31 mPa.s,cP (25 °C) 11 mPa.s,cP (50 °C)<br />
500 mL<br />
500 mL<br />
500 mL<br />
500 mL<br />
500 mL<br />
500 mL<br />
500 mL<br />
374 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
Viscosity<br />
Code Product Unit<br />
PSL2700V08<br />
PSL2700V09<br />
PSL2700V10<br />
PSLN140<br />
PSL2700V11<br />
PSLN230<br />
PSL2700V12<br />
PSLN415<br />
PSL2700V13<br />
N35 - Viscosity oil st<strong>and</strong>ard<br />
Kinematic viscosity (nominal)<br />
95 mm 2 /s,cSt (20 °C) 32 mm 2 /s,cSt (40 °C) 5.8 mm 2 /s,cSt (100 °C)<br />
72 mm 2 /s,cSt (25 °C) 23 mm 2 /s,cSt (50 °C)<br />
Dynamic viscosity (nominal)<br />
82 mPa.s,cP (20 °C) 27 mPa.s,cP (40 °C) 4.7 mPa.s,cP (100 °C)<br />
62 mPa.s,cP (25 °C) 19 mPa.s,cP (50 °C)<br />
S60 - Viscosity oil st<strong>and</strong>ard<br />
Kinematic viscosity (nominal)<br />
160 mm 2 /s,cSt (20 °C) 54 mm 2 /s,cSt (40 °C) 7.7 mm 2 /s,cSt (100 °C)<br />
120 mm 2 /s,cSt (25 °C) 35 mm 2 /s,cSt (50 °C)<br />
Dynamic viscosity (nominal)<br />
140 mPa.s,cP (20 °C) 47 mPa.s,cP (40 °C) 6.3 mPa.s,cP (100 °C)<br />
104 mPa.s,cP (25 °C) 30 mPa.s,cP (50 °C)<br />
N100 - Viscosity oil st<strong>and</strong>ard<br />
Kinematic viscosity (nominal)<br />
320 mm 2 /s,cSt (20 °C) 97 mm 2 /s,cSt (40 °C) 11.0 mm 2 /s,cSt (100 °C)<br />
230 mm 2 /s,cSt (25 °C) 59 mm 2 /s,cSt (50 °C)<br />
Dynamic viscosity (nominal)<br />
280 mPa.s,cP (20 °C) 84 mPa.s,cP (40 °C) 9.1 mPa.s,cP (100 °C)<br />
200 mPa.s,cP (25 °C) 51 mPa.s,cP (50 °C)<br />
N140 - Viscosity oil st<strong>and</strong>ard<br />
Kinematic viscosity (nominal)<br />
400 mm 2 /s,cSt (20 °C) 140 mm 2 /s,cSt (40 °C) 18.0 mm 2 /s,cSt (100 °C)<br />
300 mm 2 /s,cSt (25 °C) 90 mm 2 /s,cSt (50 °C)<br />
Dynamic viscosity (nominal)<br />
350 mPa.s,cP (20 °C) 120 mPa.s,cP (40 °C) 15.0 mPa.s,cP (100 °C)<br />
260 mPa.s,cP (25 °C) 77 mPa.s,cP (50 °C)<br />
S200 - Viscosity oil st<strong>and</strong>ard<br />
Kinematic viscosity (nominal)<br />
660 mm 2 /s,cSt (20 °C) 180 mm 2 /s,cSt (40 °C) 17 mm 2 /s,cSt (100 °C)<br />
460 mm 2 /s,cSt (25 °C) 110 mm 2 /s,cSt (50 °C)<br />
Dynamic viscosity (nominal)<br />
590 mPa.s,cP (20 °C) 150 mPa.s,cP (40 °C) 14 mPa.s,cP (100 °C)<br />
410 mPa.s,cP (25 °C) 91 mPa.s,cP (50 °C)<br />
N230 - Viscosity oil st<strong>and</strong>ard<br />
Kinematic viscosity (nominal)<br />
860 mm 2 /s,cSt (20 °C) 230 mm 2 /s,cSt (40 °C) 21 mm 2 /s,cSt (100 °C)<br />
600 mm 2 /s,cSt (25 °C) 145 mm 2 /s,cSt (50 °C)<br />
Dynamic viscosity (nominal)<br />
770 mPa.s,cP (20 °C) 190 mPa.s,cP (40 °C) 17.0 mPa.s,cP (100 °C)<br />
535 mPa.s,cP (25 °C) 120 mPa.s,cP (50 °C)<br />
N350 - Viscosity oil st<strong>and</strong>ard<br />
Kinematic viscosity (nominal)<br />
1400 mm 2 /s,cSt (20 °C) 310 mm 2 /s,cSt (40 °C) 24 mm 2 /s,cSt (100 °C)<br />
920 mm 2 /s,cSt (25 °C) 180 mm 2 /s,cSt (50 °C)<br />
Dynamic viscosity (nominal)<br />
1200 mPa.s,cP (20 °C) 270 mPa.s,cP (40 °C) 20 mPa.s,cP (100 °C)<br />
790 mPa.s,cP (25 °C) 150 mPa.s,cP (50 °C)<br />
N415 - Viscosity oil st<strong>and</strong>ard<br />
Kinematic viscosity (nominal)<br />
1900 mm 2 /s,cSt (20 °C) 415 mm 2 /s,cSt (40 °C) 34 mm 2 /s,cSt (100 °C)<br />
1240 mm 2 /s,cSt (25 °C) 240 mm 2 /s,cSt (50 °C)<br />
Dynamic viscosity (nominal)<br />
1630 mPa.s,cP (20 °C) 360 mPa.s,cP (40 °C) 28.0 mPa.s,cP (100 °C)<br />
1065 mPa.s,cP (25 °C) 200 mPa.s,cP (50 °C)<br />
S600 - Viscosity oil st<strong>and</strong>ard<br />
Kinematic viscosity (nominal)<br />
2400 mm 2 /s,cSt (20 °C) 520 mm 2 /s,cSt (40 °C) 35 mm 2 /s,cSt (100 °C)<br />
1600 mm 2 /s,cSt (25 °C) 290 mm 2 /s,cSt (50 °C)<br />
Dynamic viscosity (nominal)<br />
2100 mPa.s,cP (20 °C) 450 mPa.s,cP (40 °C) 29 mPa.s,cP (100 °C)<br />
1400 mPa.s,cP (25 °C) 240 mPa.s,cP (50 °C)<br />
500 mL<br />
500 mL<br />
500 mL<br />
500 mL<br />
500 mL<br />
500 mL<br />
500 mL<br />
500 mL<br />
500 mL<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 375
Viscosity<br />
Code Product Unit<br />
PSLN730<br />
PSL2700V14<br />
PSLN1300<br />
PSL2700V15<br />
PSL2700V16<br />
PSL2700V17<br />
PSL2700V18<br />
PSL2700V19<br />
N730 - Viscosity oil st<strong>and</strong>ard<br />
Kinematic viscosity (nominal)<br />
3390 mm 2 /s,cSt (20 °C) 730 mm 2 /s,cSt (40 °C) 49 mm 2 /s,cSt (100 °C)<br />
2260 mm 2 /s,cSt (25 °C) 410 mm 2 /s,cSt (50 °C)<br />
Dynamic viscosity (nominal)<br />
2970 mPa.s,cP (20 °C) 630 mPa.s,cP (40 °C) 40.0 mPa.s,cP (100 °C)<br />
1980 mPa.s,cP (25 °C) 340 mPa.s,cP (50 °C)<br />
N1000 - Viscosity oil st<strong>and</strong>ard<br />
Kinematic viscosity (nominal)<br />
4800 mm 2 /s,cSt (20 °C) 940 mm 2 /s,cSt (40 °C) 55 mm 2 /s,cSt (100 °C)<br />
3100 mm 2 /s,cSt (25 °C) 520 mm 2 /s,cSt (50 °C)<br />
Dynamic viscosity (nominal)<br />
4100 mPa.s,cP (20 °C) 800 mPa.s,cP (40°C) 45 mPa.s,cP (100 °C)<br />
2700 mPa.s,cP (25 °C) 450 mPa.s,cP (50°C)<br />
N1300 - Viscosity oil st<strong>and</strong>ard<br />
Kinematic viscosity (nominal)<br />
6760 mm 2 /s,cSt (20 °C) 1320 mm 2 /s,cSt (40 °C) 77 mm 2 /s,cSt (100 °C)<br />
4365 mm 2 /s,cSt (25 °C) 730 mm 2 /s,cSt (50 °C)<br />
Dynamic viscosity (nominal)<br />
5775 mPa.s,cP (20 °C) 1120 mPa.s,cP (40 °C) 63.0 mPa.s,cP (100 °C)<br />
3800 mPa.s,cP (25 °C) 630 mPa.s,cP (50 °C)<br />
S2000 - Viscosity oil st<strong>and</strong>ard<br />
Kinematic viscosity (nominal)<br />
8600 mm 2 /s,cSt (20 °C) 1700 mm 2 /s,cSt (40 °C) 81 mm 2 /s,cSt (100 °C)<br />
5600 mm 2 /s,cSt (25 °C) 880 mm 2 /s,cSt (50 °C)<br />
Dynamic viscosity (nominal)<br />
7500 mPa.s,cP (20 °C) 1500 mPa.s,cP (40 °C) 68 mPa.s,cP (100 °C)<br />
4800 mPa.s,cP (25 °C) 760 mPa.s,cP (50 °C)<br />
N4000 - Viscosity oil st<strong>and</strong>ard<br />
Kinematic viscosity (nominal)<br />
18000 mm 2 /s,cSt (20 °C) 3400 mm 2 /s,cSt (40 °C) 130 mm 2 /s,cSt (100 °C)<br />
11000 mm 2 /s,cSt (25 °C) 1700 mm 2 /s,cSt (50 °C)<br />
Dynamic viscosity (nominal)<br />
16000 mPa.s,cP (20 °C) 2900 mPa.s,cP (40 °C) 112 mPa.s,cP (100 °C)<br />
10000 mPa.s,cP (25 °C) 1500 mPa.s,cP (50 °C)<br />
S8000 - Viscosity oil st<strong>and</strong>ard<br />
Kinematic viscosity (nominal)<br />
35000 mm 2 /s,cSt (20 °C) 6700 mm 2 /s,cSt (40 °C) 220 mm 2 /s,cSt (100 °C)<br />
22000 mm 2 /s,cSt (25 °C) 3200 mm 2 /s,cSt (50 °C)<br />
Dynamic viscosity (nominal)<br />
31000 mPa.s,cP (20 °C) 5900 mPa.s,cP (40 °C) 190 mPa.s,cP (100 °C)<br />
20000 mPa.s,cP (25 °C) 2700 mPa.s,cP (50 °C)<br />
N15000 - Viscosity oil st<strong>and</strong>ard<br />
Kinematic viscosity (nominal)<br />
65000 mm 2 /s,cSt (20 °C) 13000 mm 2 /s,cSt (40 °C) 370 mm 2 /s,cSt (100 °C)<br />
41000 mm 2 /s,cSt (25 °C) 5800 mm 2 /s,cSt (50 °C)<br />
Dynamic viscosity (nominal)<br />
58000 mPa.s,cP (20 °C) 11000 mPa.s,cP (40 °C) 320 mPa.s,cP (100 °C)<br />
37000 mPa.s,cP (25 °C) 5100 mPa.s,cP (50 °C)<br />
S30000-Viscosity oil st<strong>and</strong>ard<br />
Kinematic viscosity (nominal)<br />
82000 mm 2 /s,cSt (25 °C) 23000 mm 2 /s,cSt (40 °C) 11000 mm 2 /s,cSt (50 °C) 670 mm 2 /s,cSt (100 °C)<br />
Dynamic viscosity (nominal)<br />
74000 mPa.s,cP (25 °C) 21000 mPa.s,cP (40 °C) 9900 mPa.s,cP (50 °C) 580 mPa.s,cP (100 °C)<br />
500 mL<br />
500 mL<br />
500 mL<br />
500 mL<br />
500 mL<br />
500 mL<br />
500 mL<br />
500 mL<br />
376 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
Polymeric properties<br />
Individual molecular weight polymer st<strong>and</strong>ards<br />
Polymeric properties<br />
Code Product Unit<br />
NIST-2885<br />
NIST-2886<br />
NIST-2887<br />
NIST-1482A<br />
Polyethylene<br />
Certified value<br />
Molar Mass....... 6.28 x 10 3 g/mol<br />
Polyethylene<br />
Certified value<br />
Molar Mass....... 87.0 x 10 3 g/mol<br />
Polyethylene<br />
Certified value<br />
Molar Mass..... 196.4 x 10 3 g/mol<br />
Polyethylene<br />
Certified values<br />
Mass-average molar mass................... 13,600 g/mol<br />
Number-average molar mass .............. 11,400 g/mol<br />
Molecular weight <strong>and</strong> melt flow<br />
NIST-705A<br />
NIST-706A<br />
NIST-1473B<br />
NIST-1474A<br />
NIST-1475A<br />
NIST-1476A<br />
NIST-1478<br />
Polystyrene - Heat capacity <strong>and</strong> molecular weight<br />
Intrinsic viscosity .......................................40.1 mL/g<br />
Molecular weight (MW) values, measured using various techniques, <strong>and</strong> limiting viscosity (LV) numbers.<br />
Certified values<br />
M n by membrane osmometry............. 170,900 g/mol LV in benzene (25 °C)...............................74.3 mL/g<br />
M W by light scattering......................... 179,300 g/mol LV in benzene (25 °C)...............................74.5 mL/g<br />
M W by sedimentation equilibrium ....... 189,800 g/mol LV in cyclohexane (25 °C).........................35.4 mL/g<br />
For heat capacity please ask for detailed list<br />
Polystyrene - Broad molecular weight distribution<br />
Certified values<br />
Mass-average molar mass (M w)......... 285,000 g/mol<br />
Indicative values for intrinsic viscosity in benzene at 25 °C <strong>and</strong> cyclohexane at 35 °C<br />
Low densitiy polyethylene resin<br />
This material is certified for melt flow rate using ASTM D 1238-00, Test Method for Flow Rates of Thermoplastics<br />
by Extrusion Plastometer St<strong>and</strong>ard Test Condition 190/2.16. The flow rate of the melt was determined at 190.0 °C<br />
± 0.1 °C <strong>and</strong> a load of 2.16 kg by procedure A of the ASTM method. A manually operated extrusion plastometer<br />
was used.<br />
Certified value<br />
Melt flow rate (FR)............................... 1.13 g/10 min<br />
Polyethylene resin - Melt flow rate<br />
Certified for melt flow rate, FR-190/2.16, using ASTM Method D 1238-86 at 190 °C.<br />
Certified value<br />
Melt flow rate (FR)............................... 5.10 g/10 min<br />
Polyethylene, linear - Melt flow rate<br />
Certified for melt flow rate, FR-190/2.16, using ASTM Method D 1238-90b, <strong>and</strong> Limiting viscosity (LV).<br />
Certified values<br />
Melt flow rate.........................................................................................2.02 g/10 min<br />
Weight average MW (light scattering)....................................................52,000 g/mol<br />
Number average MW (size exclusion chromatography) ........................18,310 g/mol<br />
Weight average MW (size exclusion chromatography) .........................53,070 g/mol<br />
Z-average MW (size exclusion chromatography).................................138,000 g/mol<br />
LV in 1-chloronaphthalene (130 °C)............................................................89.0 mL/g<br />
LV in 1,2,4-trichlorobenzene (130 °C).......................................................101.0 mL/g<br />
LV in decahydronapthalene (130 °C)........................................................118.0 mL/g<br />
density..................................................................................................0.97844 g/cm 3<br />
Branched polyethylene resin - Melt flow rate<br />
This St<strong>and</strong>ard Reference Material ® (SRM ® ) is intended for use in calibration <strong>and</strong> performance evaluation of<br />
instruments used in polymer technology <strong>and</strong> science for the determination of the melt flow rate using ASTM<br />
Method D1238-00. It is supplied as white pellets of polyethylene.<br />
This material is certified for melt flow rate using ASTM Method D1238-00 condition 190/2.16. Under this condition<br />
the melt flow rate is 1.23 g/10 min with a st<strong>and</strong>ard deviation of 0.036 g/10 min <strong>and</strong> with 29 degrees of freedom.<br />
The certified measurement uncertainty is found to be 0.110 g/10 min <strong>and</strong> is expressed as a combined exp<strong>and</strong>ed<br />
uncertainty with a coverage factor k = 2, calculated in accordance with ISO <strong>and</strong> NIST Guides procedure.<br />
Polystyrene - narrow molecular weight distribution<br />
Certified values<br />
Number average MW (membrane osmometry) ....................................................35,800 g/mol<br />
Weight average MW (sedimentation equilibrium ultracentrifugation) ...................37,400 g/mol<br />
Limiting viscosity in toluene (25 °C) .........................................................................23.06 mL/g<br />
300 mg<br />
300 mg<br />
300 mg<br />
0.3 g<br />
5 g<br />
18 g<br />
60 g<br />
60 g<br />
50 g<br />
12 g<br />
2 g<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 377
Polymeric properties<br />
Code Product Unit<br />
NIST-1479<br />
NIST-2888<br />
NIST-1480<br />
Polystyrene - narrow molecular weight distribution<br />
Certified value<br />
Weight average MW (light scattering)................. 1,050,000 g/mol<br />
Polystyrene<br />
Certified value<br />
Mass-average molar mass (M w)...... 7.19 x 10 3 g/mol<br />
Polyurethane<br />
Certified value<br />
Weight average MW (light scattering)...................... 47,300 g/mol<br />
Indicative value for limiting viscosity<br />
2 g<br />
0.3 g<br />
1 g<br />
NIST-1483A<br />
Polyethylene, linear<br />
Certified values<br />
Mass-Average Molecular Mass (M w)<br />
Number Average Molecular Mass (M n)<br />
Intrinsic Viscosity<br />
32100 g/mol<br />
28900 g/mol<br />
80.0 mL/g<br />
300 mg<br />
NIST-1484A<br />
NIST-1487<br />
NIST-1488<br />
NIST-1489<br />
NIST-1496<br />
NIST-1923<br />
NIST-1924<br />
NIST-2491<br />
Polyethylene, linear - narrow molecular weight distribution<br />
Certified values<br />
Number-average MW (membrane osmometry) .................... 100,500 g/mol<br />
Weight average MW (light scattering)................................... 119,600 g/mol<br />
Limiting viscosity in 1,2,4-trichlorobenzene (130 °C) ................197.9 mL/g<br />
Limiting viscosity in 1-chloronaphthalene (130 °C) ....................169.4 mL/g<br />
Poly(methylmethacrylate)<br />
Certified values<br />
Weight-average molecular weight (sedimentation equilibrium ultracentrifugation)............. 63,000 g/mol<br />
Limiting viscosity number in tetrahydrofuran (25 °C) ................................................................. 7.9 mL/g<br />
Poly(methylmethacrylate)<br />
Certified values<br />
Number-average molecular weight (membrane osmometry).................29,300 g/mol<br />
Limiting viscosity in tetrahydrofuran (25 °C)................................................15.8 mL/g<br />
Poly(methylmethacrylate)<br />
Certified values<br />
Number-average molecular weight (membrane osmometry)...............115,000 g/mol<br />
Limiting viscosity in tetrahydrofuran (25 °C)................................................37.4 mL/g<br />
Polyethylene gas pipe resin (unpigmented)<br />
Certified values<br />
Melt flow rate (FR-190/2.16, using ASTM Method D 1238-82) .............0.26 g/10 min<br />
Intrinsic viscosity in 1,2,4-trichlorobenzene (140 °C) ...................................210 mL/g<br />
Poly(ethylene oxide) - molecular weight<br />
Certified value<br />
Weight average molecular weight........ 26,900 g/mol<br />
Poly(ethylene oxide) - molecular weight<br />
Certified value<br />
Weight average molecular weight...... 120,900 g/mol<br />
Non-Newtonian polymer melt for rheology<br />
This St<strong>and</strong>ard Reference Material ® (SRM ® ) is intended primarily for use in calibration <strong>and</strong> performance evaluation<br />
of instruments used to determine the viscosity <strong>and</strong> first normal stress difference in steady shear, or to determine<br />
the dynamic mechanical storage <strong>and</strong> loss moduli <strong>and</strong> shift factors through time-temperature superposition. NIST-<br />
2491 consists of polydimethylsiloxane. The supplier identifies the polydimethylsiloxane as having a number<br />
average molecular mass of 308,000 g/mol. Certified values of the viscosity <strong>and</strong> first normal stress difference as<br />
functions of shear rate are given in the certificate at temperatures of 0 °C, 25 °C, <strong>and</strong> 50 °C, respectively. The<br />
exp<strong>and</strong>ed combined uncertainties in the certified values of the viscosity <strong>and</strong> first normal stress difference are also<br />
listed.<br />
The certified values of the storage modulus G’ <strong>and</strong> loss modulus G” as functions of frequency at 0 °C, 10 °C, 20<br />
°C, 30 °C, 40 °C, <strong>and</strong> 50 °C, respectively are also given in the certificate.<br />
300 mg<br />
2 g<br />
2 g<br />
2 g<br />
900 g<br />
200 mg<br />
200 mg<br />
100 mL<br />
378 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
Miscellaneous<br />
Relative humidity<br />
Miscellaneous<br />
HM11 - HM90<br />
Please specify the type of hygrometer to be used to enable the appropriate adapter to be supplied.<br />
Code Product Unit<br />
HM11<br />
HM22<br />
HM33<br />
HM54<br />
HM75<br />
HM80<br />
HM90<br />
Relative humidity st<strong>and</strong>ard<br />
Nominal relative humidity..................................11 %<br />
Relative humidity st<strong>and</strong>ard<br />
Nominal relative humidity..................................22 %<br />
Relative humidity st<strong>and</strong>ard<br />
Nominal relative humidity..................................33 %<br />
Relative humidity st<strong>and</strong>ard<br />
Nominal relative humidity..................................54 %<br />
Relative humidity st<strong>and</strong>ard<br />
Nominal relative humidity..................................75 %<br />
Relative humidity st<strong>and</strong>ard<br />
Nominal relative humidity..................................80 %<br />
Relative humidity st<strong>and</strong>ard<br />
Nominal relative humidity..................................90 %<br />
Scanning electron microscope<br />
NIST-2069B<br />
NIST-RM 8091<br />
X-ray diffraction<br />
NIST-656<br />
SEM Performance St<strong>and</strong>ard<br />
Graphitised rayon fibres with smooth <strong>and</strong> uniform edges on a 12.5 mm diameter SEM specimen mount with a 3<br />
mm peg. One edge of a single fibre is used as a clearly defined boundary across which the electron beam is<br />
scanned. The slope of the resultant detector signal waveform is a measure of the SEM performance that can be<br />
related to the resolution capability of the SEM.<br />
Scanning Electron Microscope Sharpness St<strong>and</strong>ard<br />
This Reference Material (RM) is intended primarily for use in checking the sharpness of scanning electron<br />
microscopes. It is supplied as a small (3mm x 2 mm) diced semiconductor chip. Please ask for further details.<br />
Silicon nitride<br />
unit<br />
unit<br />
unit<br />
unit<br />
unit<br />
unit<br />
unit<br />
each<br />
each<br />
2 x 10 g<br />
This St<strong>and</strong>ard Reference Material (SRM ® ) consists of two powders intended for quantitative analysis of α the<br />
β <strong>and</strong> polymorphs of silicon nitride via powder diffraction methods. The powders are combinations of α the<br />
β <strong>and</strong> polymorphs; one is high in α the phase (α content 656), while the other contains a larger amount of the<br />
polymorph (β 656).<br />
β<br />
NIST-674B<br />
NIST-675<br />
NIST-1976<br />
X-Ray powder diffraction intensity set<br />
This St<strong>and</strong>ard Reference Material (SRM ® ) consists of four oxide powders intended primarily for use as internal<br />
st<strong>and</strong>ards for quantitative X-ray diffraction analysis. The powders are ZnO (wurtzite structure), TiO 2 (rutile<br />
structure), Cr 2O 3 (corundum structure), <strong>and</strong> CeO 2 (fluorite structure). These four oxides offer a range of linear<br />
attenuations Cu-Kα for radiation: 279 cm -1 , 536 cm -1 , 912 cm -1 , <strong>and</strong> 2203 cm -1 , respectively, that allow the user to<br />
nominally match that of st<strong>and</strong>ard to the unknown in order to minimize the effects of microabsorption. A unit of<br />
NIST-674b consists of approximately 10 g of each powder, bottled in an argon atmosphere.<br />
Certified values<br />
Phase purity <strong>and</strong> uncertainty<br />
Crystalline component Phase Purity Crystalline component Phase Purity<br />
ZnO ...............................................95.28 % ± 0.64 % Cr 2O 3 ............................................ 95.91 % ± 0.60 %<br />
TiO 2...............................................89.47 % ± 0.62 % CeO 2............................................. 91.36 % ± 0.55 %<br />
Mica x-ray diffraction<br />
Intended for use as an external or internal low 2 (large d-spacing) calibration st<strong>and</strong>ard for powder diffractometry.<br />
Certified value ..................d(001) 9.98104 Å (based on the average of 28 refined d values at 25 °C<br />
uncorrected for refraction)<br />
Alumina plate, sintered<br />
Intended for use in the calibration of powder X-ray equipment for diffraction intensity as a function of 2θ angle<br />
(instrument sensitivity).<br />
Certified values (for lattice parameters)<br />
a ......................................................... 0.4758846 nm c............................................................1.299306 nm<br />
σ............................................................... 0.0000109 σ ............0.0000238 (where (CuKα 1) 0.1540629 nm)<br />
set<br />
7.5 g<br />
plate<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 379
Miscellaneous<br />
Code Product Unit<br />
NIST-1990<br />
NIST-1994<br />
Density<br />
NIST-211D<br />
Single Crystal Diffractometer Alignment St<strong>and</strong>ard - Ruby Sphere<br />
St<strong>and</strong>ard Reference Material (SRM ® ) 1990 is intended primarily for use as an alignment st<strong>and</strong>ard for single crystal<br />
diffractometry. One unit consists of three chromium-doped single crystal aluminum oxide (ruby) spheres. The<br />
spheres are nominally 152 mm in diameter with 1.3 mm sphericity. The spherical geometry was chosen to<br />
facilitate alignment <strong>and</strong> to avoid corrections for absorption. These spheres produce reflections at high angles for<br />
copper <strong>and</strong> molybdenum radiation. The space group is R3c.<br />
Certified lattice parameters of NIST-1990 at 25 °C are:<br />
a: 0.476080 nm ± 0.000029 nm<br />
c: 1.299568 nm ± 0.000087 nm<br />
St<strong>and</strong>ard silicon single crystal wafer for crystalline orientation<br />
This St<strong>and</strong>ard Reference Material (SRM ® ) is intended for use in the calibration of instruments (X-ray<br />
diffractometers) used to measure the crystal orientation of wafers relative to the crystal surface. The SRM unit<br />
consists of a 100-mm diameter silicon wafer. The crystal orientation of the (001) silicon crystal planes relative to<br />
the surface normal has been measured both parallel <strong>and</strong> perpendicular to an edge flat that is manufactured into<br />
the wafer.<br />
Toluene<br />
Certified values<br />
Temperature [°C] Density [kg/m 3 ]<br />
15 .................................................... 871.476 ± 0.025<br />
20 .................................................... 866.828 ± 0.025<br />
25 ................................................... 862.170 ± 0.025<br />
3 spheres<br />
wafer<br />
4 x 5 mL<br />
NIST-2214<br />
Isooctane (2, 2, 4-Trimethylpentane) - Density<br />
4x5mL<br />
Certified Values of NIST-2214 at three sample temperatures<br />
Temperature °C Density, Temperature °C Density,<br />
15.000 ...................................695.969 ± 0.035 kg/m 3 25.000....................................687.753 ± 0.035 kg/m 3<br />
20.000 ...................................691.872 ± 0.035 kg/m 3<br />
HDF01<br />
HDF02<br />
HDF01 - HDF-012<br />
Certified densities were determined by means of hydrostatic weighing.<br />
2,2,4-Trimethylpentane<br />
Temperature range 15-25 °C<br />
Certified value<br />
Liquid density (20 °C)................................692 kg/m 3<br />
Dodecane<br />
Temperature range 10-50 °C<br />
Certified value<br />
Liquid density (20 °C)................................750 kg/m 3<br />
10 mL<br />
10 mL<br />
HDF04 Base lubricating oil approx. 8 mPa.s at 40°C<br />
Temperature range 15-50 °C<br />
Certified value<br />
Liquid density (20 °C)................................868 kg/m 3<br />
HDF05 Base lubricating oil approx. 30 mPa s at 40°C<br />
Temperature range 15-50 °C<br />
Certified value<br />
Liquid density (20 °C)................................870 kg/m 3<br />
HDF06 Base lubricating oil approx. 110 mPa s at 40°C<br />
Temperature range 15-50 °C<br />
Certified value<br />
Liquid density (20 °C)................................882 kg/m 3<br />
HDF07 Lubricating oil A90 approx. 160 mPa s at 40°C<br />
Temperature range 15-50 °C<br />
Certified value<br />
Liquid density (20 °C)................................887 kg/m 3<br />
10 mL<br />
10 mL<br />
10 mL<br />
10 mL<br />
HDF08<br />
HDF09<br />
Ethanol in water approx. 41 % ABV<br />
Use of this material is not recommended unless required by fiscal authorities.<br />
Certified value<br />
Liquid density (20 °C)................................948 kg/m 3<br />
Ethanol in water approx. 11 % ABV<br />
Use of this material is not recommended unless required by fiscal authorities.<br />
Certified value<br />
Liquid density (20 °C)................................985 kg/m 3<br />
10 mL<br />
10 mL<br />
380 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
Miscellaneous<br />
Code Product Unit<br />
HDF15<br />
HDF10<br />
Water<br />
Certified value<br />
Liquid density (20°C).................................998 kg/m 3<br />
Dextrose in water approx. 10 % by weight<br />
Use of this material is not recommended unless required by fiscal authorities.<br />
Certified value<br />
Liquid density (20 °C)..............................1037 kg/m 3<br />
10 mL<br />
10 mL<br />
HDF11 Dimethylphthalate approx. 17 mPa s at 20°C<br />
Temperature range 15 to 25°C<br />
Certified value<br />
Liquid density (20 °C)..............................1191 kg/m 3<br />
10 mL<br />
HDF13<br />
HDF14<br />
HDF12<br />
Sodium bromide in water<br />
Temperature range 15-25 °C<br />
Certified value<br />
Liquid density (20 °C)..............................1264 kg/m 3<br />
Caesium chloride in water approx. 47% by weight<br />
Certified value<br />
Liquid density (20°C)...............................1525 kg/m 3<br />
Tetrachloroethylene<br />
Temperature range 15-50 °C<br />
Certified value<br />
Liquid density (20 °C)..............................1623 kg/m 3<br />
10 mL<br />
10 mL<br />
10 mL<br />
GUM 1.1<br />
GUM1.1 - GUM1.11<br />
Liquid density st<strong>and</strong>ards certified by the Central Office of Measures (GUM). Intended for calibration <strong>and</strong><br />
checking densimeters used for measuring density of liquids. Supplied with a certificate showing density<br />
values at temperatures from 20 °C to 50 °C, with an uncertainty 0.05 kg/m 3 . Values for the first <strong>and</strong> second<br />
decimal place are given in the certificate for particular series.<br />
n-Hexane<br />
Certified value<br />
Density ..........659 kg/m³ at 20°C<br />
10 mL<br />
GUM 1.2<br />
GUM 1.3<br />
GUM 1.4<br />
GUM 1.5<br />
GUM 1.6<br />
GUM 1.7<br />
GUM 1.8<br />
GUM 1.10<br />
GUM 1.11<br />
n-Heptane<br />
Certified value<br />
Density ..........683 kg/m³ at 20°C<br />
2,2,4-Trimethylpentane<br />
Certified value<br />
Density ..........691 kg/m³ at 20°C<br />
n-Nonane<br />
Certified value<br />
Density ..........717 kg/m³ at 20°C<br />
n-Octane<br />
Certifed value<br />
Density ..........702 kg/m³ at 20°C<br />
Methylcyclohexane<br />
Certified value<br />
Density ..........769 kg/m³ at 20°C<br />
Cyclohexane<br />
Certified value<br />
Density ..........778 kg/m³ at 20°C<br />
Toluene<br />
Certified value<br />
Density ..........866 kg/m³ at 20°C<br />
2,4-Dichlorotoluene<br />
Certified value<br />
Density ........1249 kg/m³ at 20°C<br />
Tetrachloroethylene<br />
Certified value<br />
Density ........1623 kg/m³ at 20°C<br />
10 mL<br />
10 mL<br />
10 mL<br />
10 mL<br />
10 mL<br />
10 mL<br />
10 mL<br />
10 mL<br />
10 mL<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 381
Miscellaneous<br />
Code Product Unit<br />
Chemical resistance (durability) of glass<br />
NIST-622<br />
NIST-622 <strong>and</strong> NIST-623<br />
These NIST St<strong>and</strong>ard Reference Materials ® are for checking test methods <strong>and</strong> calibrating equipment used to<br />
determine the resistance of glass containers to chemical attack. The values given represent the volume of<br />
fiftieth-normal sulphuric acid used to titrate to the methyl red end point of the alkaline extract from a crushed<br />
sample of glass after exposure to high purity water at 121 0 C.<br />
Soda lime silica (durability)<br />
Certified value<br />
Volume of 0.02N H 2SO 4............................... 7.67 mL<br />
2.2 kg<br />
NIST-623<br />
Borosilicate glass<br />
Certified value<br />
Volume of 0.02N H 2SO 4............................... 0.34 mL<br />
2.2 kg<br />
Multi-test verification materials (MTVMs)<br />
The Multi-Test Verification Materials (MTVMs) are unique because they enable a laboratory to use a single<br />
sample to validate different tests <strong>and</strong> instrumentation. Each unit is supplied with data for multiple types of<br />
internationally accepted test methods.<br />
SS99850-0<br />
SS99851-0<br />
SS99852-0<br />
SS99853-0<br />
SETA MTVM Kerosine (Jet turbine fuel)<br />
Test Name ASTM-IP Method Range Amount/test<br />
Distillation IBP ......................... D86-IP123......................... 140-180 °C................. 100 mL<br />
Distillation 10 %....................... D86-IP123......................... 159-188 °C................. 100 mL<br />
Distillation 50 % ...................... D86-IP123......................... 192-218 °C................. 100 mL<br />
Distillation 90 %....................... D86-IP123......................... 220-247 °C................. 100 mL<br />
Distillation FBP........................ D86-IP123......................... 244-268 °C................. 100 mL<br />
Distillation residue................... D86-IP123....................... 1.1-1.3 %vol................. 100 mL<br />
Distillation loss ........................ D86-IP123....................... 0.4-0.7 %vol................. 100 mL<br />
Flashpoint........................................IP170............................. 35-60 °C................... 85 mL<br />
Freezing point........................ D2386-IP16....................... –62 to -44°C................... 25 mL<br />
Aromatics FIA...................... D1319-IP156................... 18.1-22.7 %vol................ 0.75 mL<br />
Smoke point ...................................D1322........................... 20-25 mm................... 20 mL<br />
Acid number........................ D3242-IP354..............
Miscellaneous<br />
Code Product Unit<br />
SS99854-0<br />
SS99856-0<br />
Mechanical properties<br />
ERM-FA013<br />
ERM-FA014<br />
ERM-FA015<br />
ERM-FA016<br />
ERM-FA415<br />
SETA MTVM motor gasoline<br />
Test Name ASTM-IP Method Range Amount/test<br />
Motor octane no. ............................D2700.................................. 83-90<br />
Research octane no.......................D2699................................ 96-101<br />
Density at 15 °C .................. D1298-IP160...................0.71-0.763 kg/L ........................200 mL<br />
Distillation IBP......................... D86-IP123....................... 32.0-39.0 °C ........................100 mL<br />
Distillation 70 °C...................... D86-IP123..........................15-36 %vol ........................100 mL<br />
Distillation 100 °C.................... D86-IP123..........................36-58 %vol ........................100 mL<br />
Distillation 150 °C.................... D86-IP123..........................75-90 %vol ........................100 mL<br />
Distillation FBP........................ D86-IP123......................... 175-205 °C .........................100mL<br />
Aromatics FIA ..................... D1319-IP156..........................19-42 %vol .......................0.75 mL<br />
Olefins FIA .......................... D1319-IP156.........................1.5-15 %vol .......................0.75 mL<br />
Saturates FIA ...................... D1319-IP156..........................42-72 %vol .......................0.75 mL<br />
Vapour Pressure ................ D5191; IP394....................... 50 to 85 kPa ............................3 mL<br />
SETA MTVM bitumen<br />
Test Name ASTM-IP Method Range Amount/test<br />
Softening point ..................................IP58...................... 37-54 °C..................7.5 mL<br />
Needle penetration............................IP49..................41-200 Pen.................130 mL<br />
Charpy specimens 30 J (bars)<br />
A unit consists of five Charpy V-notch test pieces, which are rectangular steel bars of nominal dimensions 55 mm<br />
x 10 mm x 10 mm, with one V-notch, accurately machined to tolerances imposed in EN 10045-1 <strong>and</strong> ISO 148.<br />
Absorbed energy (KV) at 20 ± 2 °C........30J nominal<br />
Charpy specimens 60 J (bars)<br />
A unit consists of five Charpy V-notch test pieces, which are rectangular steel bars of nominal dimensions 55 mm<br />
x 10 mm x 10 mm, with one V-notch, accurately machined to tolerances imposed in EN 10045-1 <strong>and</strong> ISO 148.<br />
Absorbed energy (KV) at 20 ± 2 °C........60J nominal<br />
Charpy specimens 80 J (bars)<br />
A unit consists of five Charpy V-notch test pieces, which are rectangular steel bars of nominal dimensions 55 mm<br />
x 10 mm x 10 mm, with one V-notch, accurately machined to tolerances imposed in EN 10045-1 <strong>and</strong> ISO 148.<br />
Absorbed energy (KV) at 20 ± 2 °C........80J nominal<br />
Charpy specimens 120 J (bars)<br />
A unit consists of five Charpy V-notch test pieces, which are rectangular steel bars of nominal dimensions 55 mm<br />
x 10 mm x 10 mm, with one V-notch, accurately machined to tolerances imposed in EN 10045-1 <strong>and</strong> ISO 148.<br />
Absorbed energy (KV) at 20 ± 2 °C......120J nominal<br />
Charpy specimens 160 J<br />
A unit consists of five Charpy V-notch test pieces, which are rectangular steel bars of nominal dimensions 55 mm<br />
x 10 mm x 10 mm, with one V-notch, accurately machined to tolerances imposed in EN 10045-1 <strong>and</strong> ISO 148.<br />
Absorbed energy (KV) at 20 ± 2 °C......160J nominal<br />
NIST-2092 Low-Energy Charpy (10 -20 J)<br />
NIST-2092 is intended primarily for the verification of Charpy V-Notch machines in accordance with the current<br />
ASTM St<strong>and</strong>ard E23.<br />
NIST-2096 High Energy Charpy (88 - 136J)<br />
NIST-2096 is intended primarily for the verification of Charpy V-Notch machines in accordance with the current<br />
ASTM St<strong>and</strong>ard E23.<br />
NIST-2098 Super High-Energy Charpy (176 - 244J)<br />
BCR-425<br />
BCR-661A<br />
NIST-2098 is intended primarily for the verification of Charpy V-Notch machines in accordance with the current<br />
ASTM St<strong>and</strong>ard E23.<br />
Nimonic 75 - Creep rate<br />
150 mm long 14 mm diameter bars of Nimonic 75.<br />
Testing conditions: T = 600 σ °C, = 160 Mpa<br />
Certified values<br />
Creep rate at 400 h .................................. 72 x 10 -6 /h<br />
time to 2 % strain ............................................. 278 h<br />
Nimonic 75 for ambient air tensile properties<br />
time to 4 % strain .............................................557 h<br />
The material is Nimonic 75 nickel base alloy. It will be issued in units of three bars each about<br />
150 mm long x 14 mm diameter, sufficient for the manufacture of three test-pieces.<br />
Certified values for tensile properties according to EN10002-1<br />
0.2% Proof stress R p0.2 .........................300 ± 7 MPa Elongation at fracture A.........................40.9 ± 0.9 %<br />
0.5% Proof stress R p0.5 .........................318 ± 7 MPa Reduction in area at fracture Z....................60 ± 4 %<br />
Tensile strength R m.............................750 ± 13 MPa<br />
500 mL<br />
500 mL<br />
set (5)<br />
set (5)<br />
set (5)<br />
set (5)<br />
set (5)<br />
set<br />
set<br />
set<br />
set (3)<br />
set (3)<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 383
Miscellaneous<br />
Code Product Unit<br />
BCR-661B<br />
BCR-692<br />
NIST-2100<br />
Nimonic 75 for ambient air tensile properties<br />
The material is Nimonic 75 nickel base alloy. It will be issued as one bar with about 500 mm long x 14 mm<br />
diameter.<br />
Certified values for tensile properties according to EN10002-1<br />
0.2% Proof stress R p0.2..........................300 ± 7 MPa Elongation at fracture A.........................40.9 ± 0.9 %<br />
0.5% Proof stress R p0.5..........................318 ± 7 MPa Reduction in area at fracture Z....................60 ± 4 %<br />
Tensile strength R m .............................750 ± 13 MPa<br />
Scratch test <strong>reference</strong> material<br />
A <strong>reference</strong> material certified for critical loads for cohesive/adhesive failures during scratch testing (prEN 1071-3).<br />
The <strong>reference</strong> samples are (30x30x5) mm steel coupons coated with a diamond-like carbon coating (DLC)applied<br />
by plasma-assisted chemical vapour deposition. The coupons are distributed in a r<strong>eu</strong>sable plastic box containing<br />
desiccant.<br />
Fracture Toughness of Ceramics<br />
NIST-2100 is intended for verification of fracture toughness testing procedures <strong>and</strong> consists of a set of five hotpressed<br />
silicon nitride flexure specimens cut from a single billet (plate) of material. This SRM may be used with<br />
any fracture toughness test method, but is optimized for beam bending testing configurations.<br />
The SRM may be used in conjunction with American Society of Testing <strong>and</strong> Materials (ASTM) fracture toughness<br />
st<strong>and</strong>ard C1421-99 (or the Provisional St<strong>and</strong>ard PS070-97 which preceded it) [1]. This SRM may also be used<br />
with two International Organization for St<strong>and</strong>ardization (ISO) st<strong>and</strong>ard tests under development by ISO Technical<br />
Committee TC 206, Fine Ceramics.<br />
rod<br />
coupons<br />
5 bars<br />
Physico-chemical properties<br />
Magnetic moment<br />
NIST-762<br />
NIST-764A<br />
NIST-2853<br />
NIST-772A<br />
Miscellaneous<br />
NIST-953<br />
NIST-963A<br />
NIST-1002D<br />
Magnetic moment st<strong>and</strong>ard - Nickel disk<br />
This St<strong>and</strong>ard Reference Material (SRM ) is intended for use in the calibration of magnetometers (such as<br />
vibrating sample magnetometers) used in the measurement of the magnetic properties of materials. NIST-762<br />
® ®<br />
consists of a nickel disk nominally 6 mm in diameter with a thickness of 0.127 mm <strong>and</strong> a mass of 32 mg ± 1 mg.<br />
The NIST-762 lot was produced from rolled nickel sheet with a purity of 99.999 %. Disks were punched from the<br />
sheet. Before measurement, the disks were ultrasonically cleaned in acetone, then methyl alcohol.<br />
The certified value for σ specific magnetization, at 298 K <strong>and</strong> in an applied magnetic field of 398 kA/m (5000<br />
oersted, Oe) with the magnetic field aligned parallel to the plane of the disk is:<br />
σ= 54.78 A m 2 /kg ± 0.15 A m 2 /kg (54.78 emu/g ± 0.15 emu/g)<br />
Magnetic susceptibility st<strong>and</strong>ard - Platinum cylinder<br />
This St<strong>and</strong>ard Reference Material (SRM ® ) is intended for use in the calibration of magnetometers (such as<br />
vibrating sample magnetometers) used in the measurement of the magnetic properties of materials. NIST-764a<br />
consists of<br />
a platinum (Pt) cylinder with a nominal diameter of 3 mm, a nominal length of 3.42 mm, <strong>and</strong> a nominal mass of<br />
620 mg. NIST-764a lot was produced by slicing a pure (99.99 %) platinum rod into 3.42 mm long pieces.<br />
Magnetic moment st<strong>and</strong>ard yttrium iron garnet sphere<br />
This St<strong>and</strong>ard Reference Material (SRM ® ) is intended for use in calibrating of magnetometers (such as vibrating<br />
sample magnetometers) used in the measurement of the magnetic propterties of materials. NIST-2883 consists<br />
of a yttrium iron garnet (YIG) sphere with a nominal diameter of 1 mm <strong>and</strong> a nominal mass of 2.8 mg.<br />
Nickel sphere for magnetic moment<br />
This St<strong>and</strong>ard Reference Material (SRM) is intended for use in the calibration of magnetometers (such as<br />
vibrating sample magnetometers) used in the measurement of the magnetic properties of materials. SRM 772a<br />
consists of a nickel sphere 2.383 mm in diameter with a mass of 63.16 mg. The SRM 772a lot was produced from<br />
annealed nickel wire with a purity of 99.999 %. The wire was ground into spheres. The spheres were then<br />
ultrasonically cleaned in acetone <strong>and</strong> methyl alcohol <strong>and</strong> annealed at 1220 K in a dry hydrogen atmosphere for 2<br />
h. The microstructure is equiaxed with an average grain size of about 100 µm.<br />
The certified value for magnetic moment, m, at 298 K <strong>and</strong> in an applied field of 398 kA/m (5000 Oe) is<br />
m = 3.47 mA•m 2 ± 0.01 mA•m 2 (3.47 emu ± 0.01 emu)<br />
Cobalt in aluminium - N<strong>eu</strong>tron density monitor wire<br />
The st<strong>and</strong>ard is provided as a <strong>reference</strong> source of cobalt in aluminium alloy to serve as a n<strong>eu</strong>tron density monitor<br />
wire st<strong>and</strong>ard.<br />
Fission track glass<br />
This St<strong>and</strong>ard Reference Material (SRM ® ) was produced <strong>and</strong> certified for use in uranium fission track analysis<br />
<strong>and</strong> monitoring n<strong>eu</strong>tron fluences. The SRM is made up of: four unirradiated glass wafers, two irradiated glass<br />
wafers, a muscovite mica <strong>and</strong> polycarbonate detectors.<br />
Hard Board - Surface flammability<br />
This St<strong>and</strong>ard Reference Material (SRM ® ) is intended for use in checking the operation of radiant-panel<br />
equipment in accordance with the calibration <strong>and</strong> st<strong>and</strong>ardisation technique describes in ASTM St<strong>and</strong>ard E162-78<br />
Test for Surface Flammibility using a Radiant Heat Source.<br />
6 mm dia.<br />
3 mm dia.<br />
each<br />
each<br />
1 m<br />
set (6)<br />
set (4)<br />
384 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
Miscellaneous<br />
Code Product Unit<br />
NIST-1082<br />
NIST-1006D<br />
NIST-1810A<br />
Cigarette ignition strength st<strong>and</strong>ard<br />
This St<strong>and</strong>ard Reference Material (SRM ® ) is intended for use by test laboratories to assess <strong>and</strong> control their<br />
testing of cigarette ignition strength in accordance with ASTM St<strong>and</strong>ard Methods E 2187-04 (or ASTM E2187-<br />
02b). The SRM unit consists of one carton of cigarettes containing 10 packs of 20 cigarettes each.<br />
Certified value<br />
Measur<strong>and</strong> ASTM Method Certified Value <strong>and</strong> Exp<strong>and</strong>ed Uncertainty<br />
Ignition Strength............................ E 2187-04(a).......................... 12.6 % ± 3.3 %<br />
(on 10 layers of filter paper)<br />
Smoke density chamber st<strong>and</strong>ard for non-flaming exposure condition<br />
This St<strong>and</strong>ard Reference Material consists of paper sheets, principally -cellulose, derived from wood chips. The<br />
SRM is intended primarily for checking the operation of smoke density chambers under non-flaming exposure<br />
conditions in accordance with the prescribed calibration <strong>and</strong> st<strong>and</strong>ardization techniques outlined in the American<br />
Society for Testing <strong>and</strong> Materials (ASTM) St<strong>and</strong>ard Test Method E 662-95 “St<strong>and</strong>ard Test Method for Specific<br />
Optical Density of Smoke Generated by Solid Materials”, <strong>and</strong> in National Fire Protection Association (NFPA) 258-<br />
1998, “St<strong>and</strong>ard Research Test Method for Determining Smoke Generation of Solid Materials”. A unit consists of<br />
nine single layer sheets, each 172 mm x 254 mm x 1.65 mm thick.<br />
The certified value <strong>and</strong> exp<strong>and</strong>ed uncertainty [3] for maximum specific optical density of a single layer thickness<br />
is:<br />
Dm = 210 ± 18 (without correction for window deposit)<br />
Dm corr. = 193 ± 20<br />
Linerboard - Tape adhesion testing (sheet form)<br />
This St<strong>and</strong>ard Reference Material (SRM ® ) is intended to provide a uniform source of linerboard for use with ASTM<br />
D 2860 St<strong>and</strong>ard Test Method for Adhesion of pressure-sensitive tape to fiberboard at 90 degree angle <strong>and</strong><br />
constant stress. Each unit consists fo fifty 21.6 cm x 28 cm (8.5 in x 11 in) linerboard sheets of Mosinee 696-C<br />
paper, sealed in a moisture resistent foil-lined package.<br />
10 packs<br />
9 sheets<br />
50 each<br />
NIST-2490 Non-Newtonian Polymer Solution for Rheology - Polyisobutylene Dissolved in 2,6,10,14-<br />
Tetramethylpentadecane<br />
Please ask for details<br />
100 mL<br />
NIST-2810<br />
NIST-2811<br />
NIST-2812<br />
NIST-RM 8130<br />
NIST-RM 8458<br />
Rockwell C Scale Hardness (High Range)<br />
This St<strong>and</strong>ard Reference Material (SRM ® ) is a transfer st<strong>and</strong>ard intended primarily for use in calibration <strong>and</strong><br />
verification of the performance of Rockwell hardness equipment using the Rockwell C Hardness Scale (HRC).<br />
Rockwell C Scale Hardness (High Range)<br />
This St<strong>and</strong>ard Reference Material (SRM ® ) is a transfer st<strong>and</strong>ard intended primarily for use in calibration <strong>and</strong><br />
verification of the performance of Rockwell hardness equipment using the Rockwell C Hardness Scale (HRC).<br />
Rockwell C Scale Hardness (High Range)<br />
This St<strong>and</strong>ard Reference Material (SRM ® ) is a transfer st<strong>and</strong>ard intended primarily for use in calibration <strong>and</strong><br />
verification of the performance of Rockwell hardness equipment using the Rockwell C Hardness Scale (HRC).<br />
Coplanar waveguide calibration set<br />
This Reference Material (RM) is intended for use by industrial laboratories that wish to implement the procedure<br />
described in Part 1 of the NIST/Industrial MMIC Consortium´s "Proposed Procedures for Verifying Probe Station<br />
Integrity <strong>and</strong> On-wafer Measurement Accuracy" for the measurement of microwave probe station stability <strong>and</strong> for<br />
verifying the ability to repeat on-wafer microwave measurements performed at NIST.<br />
Artificial flaw for eddy current nondestructive evaluation<br />
This Research Material (RM), the Capobianco, Dube, Fizer (CDF) notch, provides a reproducibility flaw of a<br />
known size <strong>and</strong> geometry that closely resembles an actual fatigue crack. It is intended to produce a response<br />
suitable for calibrating an eddy current nondestructive evaluation (NDE) system.<br />
each<br />
each<br />
each<br />
each<br />
each<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 385
Miscellaneous<br />
We constantly add new products to our range, so<br />
please call us to find out about new products <strong>and</strong><br />
services <strong>and</strong> to make sure you are automatically<br />
kept up to date by subscribing to our free newsletter.<br />
Just send an email to<br />
pharma-news@lgcst<strong>and</strong>ards.com<br />
386 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
High Purity<br />
Solvents<br />
St<strong>and</strong>ards<br />
Excellence through measurement
Reference materials for<br />
physical properties<br />
LGC St<strong>and</strong>ards, Europe’s most comprehensive single<br />
source of <strong>reference</strong> materials, offers over 750 <strong>reference</strong><br />
materials for physical properties. For manufacturers, the<br />
determination of the physical properties of their product<br />
can be one of the most important steps in quality<br />
assurance.<br />
Our range covers many physical properties including<br />
thermal, surface properties, particle shape <strong>and</strong> size, ion<br />
activity, viscosity, electrical, <strong>and</strong> polymeric properties.<br />
Of particular interest are the products for determination<br />
of optical properties such as molecular absorption,<br />
luminescence, colour measurement <strong>and</strong> refractive index.<br />
• Materials <strong>and</strong> st<strong>and</strong>ards from commercial sources<br />
<strong>and</strong> international bodies<br />
• Fast delivery of high quality materials<br />
• Expert local customer service <strong>and</strong> technical support<br />
Thermal properties<br />
Optical properties<br />
Surface properties<br />
Particle shape <strong>and</strong> size<br />
Ion activity<br />
Viscosity<br />
Electrical properties<br />
Polymeric properties<br />
www.lgcst<strong>and</strong>ards.com
Introduction<br />
Picograde ® solvents for residue analysis<br />
Introduction<br />
Picograde ® solvents form the heart of the LGC St<strong>and</strong>ards solvent range. Each batch undergoes rigorous<br />
testing in order to meet the dem<strong>and</strong>ing requirements of organic trace analysis every time.<br />
Environmental analysts are now expected to detect trace levels of an increasingly wide range of organic<br />
environmental contaminants including pesticides. PAHs, PCBs, PCDDs/PCDFs <strong>and</strong> so on. with the highest<br />
possible accuracy. Consequently even the lowest levels of impurity in the solvent can affect the precision of<br />
analytical results. Picograde ® solvents are specifically tailored to this application.<br />
Carefully selected raw materials are chemically pre-treated <strong>and</strong> then fractionated in glass in the absence of<br />
air. Distillation <strong>and</strong> filling are similarly carried out in air free conditions. The glass bottles are sterile <strong>and</strong> dust<br />
free <strong>and</strong> are rinsed with the appropriate solvent prior to filling. Caps used to seal the bottles are subjected to<br />
the same stringent cleaning processes. The specification of the solvent includes the determination of water<br />
content, residue on evaporation <strong>and</strong> a comprehensive gas chromatographic analysis.<br />
To confirm the absence of contaminants samples of the solvent are concentrated to varying degrees <strong>and</strong><br />
then analysed by gas chromatography. Flame ionisation <strong>and</strong> electron capture detectors (ECD) are used for<br />
the quantification of the contaminants. The specification of the Picograde ® solvent guarantees that no signal<br />
due to contamination will be larger than the internal st<strong>and</strong>ard peak (10 pg/mL heptachlor-epoxide) in the<br />
retention time window from 1,4-dichlorobenzene to decachlorobiphenyl. The very high specification of the<br />
Picograde ® solvents allows them to be used for residue analysis of trace quantities of organic contaminants<br />
right down to ppb <strong>and</strong> ppt levels.<br />
Optigrade ® - High purity solvents for HPLC<br />
High performance liquid chromatography is now an essential analytical tool especially in the areas of<br />
research <strong>and</strong> development, pharmac<strong>eu</strong>tical quality control <strong>and</strong> analysis in the food <strong>and</strong> environmental<br />
sectors. This technique dem<strong>and</strong>s the highest quality solvents to allow reproducible separations. The basic<br />
requirements include a high UV-transmission factor, low particle levels, slight acidity <strong>and</strong> alkalinity coupled<br />
with low levels of water <strong>and</strong> other non-volatile components. In addition there must be consistency between<br />
batches.<br />
Solvents for isocratic analytical HPLC together with gradient grade quality solvents are included in the HPLC<br />
range. Gradient grade has the highest purity <strong>and</strong> is specially designed for use with gradient elution HPLC<br />
using reversed phase materials <strong>and</strong> UV or fluorescence detection. Quality assurance procedures allow<br />
LGC St<strong>and</strong>ards to offer a consistently premium quality product. Each batch is checked to make sure that<br />
the solvent has the required high level of UV-transmission in the wavelength range 190-350 nm.<br />
Solvents for LC/MS<br />
The presence of alkali <strong>and</strong> alkaline earth metals in the mobile phase when using LC/MS can make the<br />
interpretation of the mass spectrum very difficult. LGC St<strong>and</strong>ards offers solvents designed for this technique<br />
with extremely low levels of these metals, at 0.1 ppm <strong>and</strong> less.<br />
Solvents for ULC/MS<br />
ULTRA Liquid Chromatography (ULC) requires solvents of superior quality. A new range of ULC/MSsolvents<br />
from LGC St<strong>and</strong>ards has been designed to allow high resolution <strong>and</strong> sensitivity. Such ULC/MS<br />
solvents combine the highest specification for: UV, low gradient shift, minimal peak <strong>impurities</strong> <strong>and</strong> lowest<br />
ionic background for MS detection. All ULC/MS solvents are micro filtered at 0.1 µm, have a residue<br />
following evaporation of max 1 ppm <strong>and</strong> are packed under inert gas for improved shelf life. For mobile phase<br />
preparation selected buffers are also available. In addition several ULC/MS blends of water <strong>and</strong> acetonitrile<br />
with formic acid, acetic acid <strong>and</strong> trifluoroacetic acid are offered.<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 389
Introduction<br />
Specialist solvents<br />
Solvents for VOCs <strong>and</strong> aromatic hydrocarbons<br />
It has become increasingly necessary to be able to determine a range of organic compounds in<br />
environmental samples including volatile organic compounds (VOCs) <strong>and</strong> BTEX-aromatics. Various<br />
extraction techniques are used for the separation <strong>and</strong> concentration of organic trace constituents from the<br />
sample matrix <strong>and</strong> it is essential to use solvents with very low levels of contamination. LGC St<strong>and</strong>ards can<br />
provide the solvents to meet these exacting requirements.<br />
Solvents for GC headspace techniques<br />
Analysis of volatile organic <strong>impurities</strong> using the GC headspace technique, has become an important quality<br />
control tool in pharmac<strong>eu</strong>tical <strong>and</strong> food related industries. The International Conference on Harmonization of<br />
technical requirements for registration of pharmac<strong>eu</strong>ticals for Human use (ICH) has issued<br />
recommendations concerning the safe levels of residual solvents in pharmac<strong>eu</strong>tical compounds.<br />
These solvents are divided into 3 classes according to their toxicity. Limit values of residual solvents in<br />
pharmac<strong>eu</strong>tical products are specified by the United States <strong>and</strong> European Pharmacopeia. The quality of the<br />
solvent used to dissolve the sample is of prime importance. It must be of the highest purity <strong>and</strong> show virtually<br />
no background signal with both polar <strong>and</strong> non polar GC capillary columns. The new headspace solvents are<br />
high boiling point solvents, specifically developed, analysed <strong>and</strong> packed for the headspace analysis of<br />
volatile solvent <strong>impurities</strong>.<br />
Solvents for the analysis of nitrosamines<br />
When extracting trace levels of nitrosamines in samples it is important to use a solvent that is free of<br />
nitrosamine contamination. For this application LGC St<strong>and</strong>ards has solvents with a maximum level of<br />
0.1ppb of specific nitrosamines.<br />
Solvents for the tobacco-industry<br />
High purity acids<br />
LGC St<strong>and</strong>ards offers the most frequently used mineral acids for trace analysis: hydrochloric acid, nitric acid,<br />
hydrofluoric acid, sulfuric acid, perchloric acid <strong>and</strong> acetic acid. These are produced by subboiling distillation<br />
of very pure starting materials. This purification results in most metallic <strong>impurities</strong> reduced to (or bellow) ppb<br />
ranges. The acids are delivered in special bottles (long - term leached borosilicate glass or modified HDPE)<br />
which ensure minimum contamination of the acid from the material of the bottle.<br />
Important note: Element concentrations are at the point of bottling. Concentrations of some elements may<br />
increase due to the storage container.<br />
Cyclotainer ®<br />
The Cyclotainer ® is a stainless steel re-usable container that is available to customers on a loan basis.<br />
Cyclotainer ® are not available in all countries. Please contact your local office for more details.<br />
Trademarks<br />
Cyclotainer ® , Picograde ® <strong>and</strong> Optigrade ® are registered trademarks of the LGC St<strong>and</strong>ards company.<br />
FLORISIL ® is a registered trademark of U.S.SILICA COMPANY.<br />
390 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
Reagents / Sorbents<br />
Reagents / Sorbents<br />
Code Product Unit<br />
SC-4592-A005<br />
SC-4568-A005<br />
SC-4569-A005<br />
SC-4181-B005<br />
SC-4181-S010<br />
SC-4182-B005<br />
SC-4182-S010<br />
SC-4182-S020<br />
SC-9700-B005<br />
ICN-Aluminia A - Super I (acid)<br />
(50 - 200 µm)<br />
ICN-Alumina B - Super I (basic)<br />
(50 - 200 µm)<br />
ICN-Alumina B - Super I (50 - 200 µm)<br />
for dioxin analysis<br />
FLORISIL ® (St<strong>and</strong>ard), 60 - 100 mesh<br />
(150 - 250 µm)<br />
FLORISIL ® (St<strong>and</strong>ard), 60 - 100 mesh<br />
(150 - 250 µm)<br />
FLORISIL ® PR for residue analysis,<br />
60 - 100 mesh (150 - 250 µm)<br />
FLORISIL ® PR for residue analysis,<br />
60 - 100 mesh (150 - 250 µm)<br />
FLORISIL ® PR for residue analysis<br />
60 - 100 mesh (150 - 250 µm)<br />
FLORISIL ® (St<strong>and</strong>ard), 60 - 100 mesh<br />
(suitable for ISO 9377-2/H53)<br />
SC-9982-B010 Silica gel 60 (63 - 200 µm) 1 kg<br />
500 g<br />
500 g<br />
500 g<br />
500 g<br />
10 kg<br />
500 g<br />
10 kg<br />
20 kg<br />
500 g<br />
SC-9950-B005<br />
SC-9950-B025<br />
SC-8024-B005<br />
SC-8024-B025<br />
SC-8024-S025<br />
SC-1024-B005<br />
SC-1024-B005<br />
Sodium sulfate anhydrous,<br />
for analysis (ACS), powder<br />
Sodium sulfate anhydrous,<br />
for analysis (ACS), powder<br />
Sodium sulfate anhydrous,<br />
in granular form<br />
Sodium sulfate anhydrous,<br />
for analysis (ACS), in granular form<br />
Sodium sulfate anhydrous,<br />
for analysis (ACS), in granular form<br />
Sodium sulfate Picograde ® anhydrous,<br />
for residue analysis (ACS), in granular form<br />
Sodium sulfate Picograde ® anhydrous,<br />
for residue analysis (ACS), in granular form<br />
500 g<br />
2.5 kg<br />
500 g<br />
2.5 kg<br />
25 kg<br />
500 g<br />
2.5 kg<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 391
LC-MS additives<br />
LC-MS additives<br />
Code Product Unit<br />
SO-9685-B001 Ammonium acetate ULC-MS Optigrade ®<br />
100 g<br />
CAS number 631-61-8<br />
Assay (GC, on anhydrous basis) ................... 99-100 %<br />
Water (KF) ........................................................ 0-0.1 %<br />
Filter test (1M in water) ...............................Passes test<br />
pH (1M in water)................................................. 6.0-7.5<br />
Transmission<br />
at 260 nm (1M in water) ................................. 96-100 %<br />
at 280 nm (1M in water) ................................. 98-100 %<br />
Chloride (Cl)................................................. 0-0.0005%<br />
Sulfate (SO 4)..................................................... 0-001%<br />
Al ..................................................................... 0-1 ppm<br />
Ca .................................................................... 0-5 ppm<br />
Fe..................................................................... 0-1 ppm<br />
K....................................................................... 0-5 ppm<br />
Mg .................................................................... 0-1 ppm<br />
Na .................................................................... 0-5 ppm<br />
SO-9679-B001 Formic acid ULC-MS Optigrade ®<br />
100 mL<br />
UN 1779<br />
CAS number 64-18-6<br />
Assay (T, on anhydrous basis)...............................99-100 %<br />
Water (KF) ...................................................................0-1 %<br />
Residue after evaporation.............................. 0-0.001 %w/w<br />
Color (APHA) .................................................................0-10<br />
Gradient specification<br />
HPLC gradient at 254 nm - H. Peak ...................0-0.005 AU<br />
HPLC gradient at 254 nm - Drift ...........................0-0.02 AU<br />
Transmission<br />
at 260 nm ...............................................................15-100 %<br />
at 270 nm ...............................................................83-100 %<br />
at 280 nm ...............................................................90-100 %<br />
at 300 nm ...............................................................97-100 %<br />
at 320 nm ...............................................................98-100 %<br />
SO-9668-B001 Trifluoroacetic acid ULC- MS Optigrade ®<br />
100 mL<br />
UN 2699<br />
CAS number 76-05-1<br />
Assay (T)...........................................................99.95-100 %<br />
Water (KF) ..............................................................0-0.02 %<br />
Residue after evaporation.............................. 0-0.001 %w/w<br />
Color (APHA) .................................................................0-10<br />
Gradient specification<br />
HPLC gradient at 254 nm - H. Peak ...................0-0.002 AU<br />
HPLC gradient at 254 nm - Drift .........................0-0.010 AU<br />
Fluorescence at 254 nm (25%, as quinine) ..............0-1 ppb<br />
Fluorescence at 365 nm (25%, as quinine) ..............0-1 ppb<br />
Transmission<br />
at 260 nm ...............................................................10-100 %<br />
at 270 nm ...............................................................79-100 %<br />
at 280 nm ...............................................................93-100 %<br />
at 300 nm ...............................................................95-100 %<br />
at 320 nm ...............................................................96-100 %<br />
392 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
High purity solvents <strong>and</strong> acids<br />
High purity solvents <strong>and</strong> acids<br />
Code Product Unit<br />
Acetic acid<br />
HPA-0050-B010 Acetic acid for trace analysis min 99.5 % (glass bottle)<br />
1 L<br />
Acetone<br />
UN 2789<br />
Assay ..........................................................> 99.5 % Chloride.....................................................< 0.4 ppm<br />
Colour (APHA) ................................................... < 10 Phosphate .................................................< 0.5 ppm<br />
Residue........................................................ < 2 ppm Sulfate .......................................................< 0.4 ppm<br />
Ag................................< 0.1 ppb Cr................................ < 0.1 ppb Ni.................................< 0.1 ppb<br />
Al.................................< 0.1 ppb Cu ............................... < 0.1 ppb Pb................................< 0.1 ppb<br />
As................................< 0.1 ppb Fe ............................... < 0.5 ppb Se................................< 0.5 ppb<br />
Ba................................< 0.1 ppb K ................................. < 0.1 ppb Sn................................< 0.1 ppb<br />
Be................................< 0.1 ppb Li................................. < 0.1 ppb Sr.................................< 0.1 ppb<br />
Bi.................................< 0.1 ppb Mg............................... < 0.1 ppb Th................................< 0.1 ppb<br />
Ca................................< 0.5 ppb Mn............................... < 0.1 ppb Ti .................................< 0.1 ppb<br />
Cd................................< 0.1 ppb Mo............................... < 0.1 ppb V..................................< 0.1 ppb<br />
Co................................< 0.1 ppb Na ............................... < 0.5 ppb Zn................................< 0.5 ppb<br />
Hydrochloric acid stored in glass bottles will see a rise in: Al, B, Ca, K, Mg, Mn, Na <strong>and</strong> Si.<br />
SO-2435-B010 Acetone HPLC Optigrade ® 1 L<br />
SO-2435-B025 Acetone HPLC Optigrade ® 2.5 L<br />
SO-2435-B040 Acetone HPLC Optigrade ®<br />
4 L<br />
UN 1090<br />
CAS number 67-64-1<br />
C 3H 6O<br />
Assay ...................................................... 99.5% min.<br />
Water ....................................................... 0.5% max.<br />
Non-volatile matter............................. 0.0005% max.<br />
Filtered through 0.2 µm<br />
1 L = 0.792 kg (at 20°C)<br />
Optical absorbance<br />
wavelength<br />
1.0 max. ........................................................ 330 nm<br />
0.1................................................................. 340 nm<br />
0.05............................................................... 350 nm<br />
0.01............................................................... 370 nm<br />
SO-1142-B010 Acetone Picograde ® for residue analysis 1 L<br />
SO-1142-B025 Acetone Picograde ® for residue analysis 2.5 L<br />
SO-1142-B040 Acetone Picograde ® for residue analysis 4 L<br />
SO-1142-C011 Acetone Picograde ® for residue analysis ( Cyclotainer ® ) 10 L<br />
SO-1142-C032 Acetone Picograde ® for residue analysis ( Cyclotainer ® )<br />
30 L<br />
UN 1090<br />
CAS number 67-64-1<br />
C 3H 6O<br />
Assay<br />
99.0% min.<br />
Water ....................................................... 0.5% max.<br />
Non-volatile matter............................. 0.0005% max.<br />
1 L = 0.792 kg (at 20°C)<br />
Specification<br />
GC/ECD<br />
In the GC-ECD chromatogram there are no interfering single signals in the retention time interval between 1,4-<br />
dichlorobenzene <strong>and</strong> decachlorobiphenyl, by a 500-fold concentration greater than that, given by 10 pg/mL<br />
heptachlor-epoxide.<br />
GC/FID<br />
In the GC-FID chromatogram there are no interfering single signals in the retention time interval between n-octane<br />
(C 8) <strong>and</strong> n-tetracontane (C 40), by a 500-fold concentration greater than that, given by 50 ng/mL n-undecane (C 11).<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 393
High purity solvents <strong>and</strong> acids<br />
Code Product Unit<br />
Acetonitrile<br />
SO-9128-B010 Acetonitrile HPLC Optigrade ® Gradient Grade 1 L<br />
SO-9128-B025 Acetonitrile HPLC Optigrade ® Gradient Grade 2.5 L<br />
SO-9128-B040 Acetonitrile HPLC Optigrade ® Gradient Grade 4 L<br />
SO-9128-C012 Acetonitrile HPLC Optigrade ® Gradient Grade (Cyclotainer ® ) 10 L<br />
SO-9128-C032 Acetonitrile HPLC Optigrade ® Gradient Grade (Cyclotainer ® ) 30 L<br />
SO-9128-C200 Acetonitrile HPLC Optigrade ® Gradient Grade<br />
200 L<br />
UN 1648<br />
CAS number 75-05-8<br />
C 2H 3N<br />
Assay ..................................................... 99.8% min.<br />
Water ..................................................... 0.02% max.<br />
Non-volatile matter............................. 0.0003% max.<br />
Gradient specification (210 nm)......... 3.0 mAU max.<br />
Fluorescence (as quinine at 254 nm).......1 ppb max.<br />
Filtered through 0.2 µm<br />
1 L = 0.783 kg (at 20°C)<br />
Optical absorbance<br />
Wavelength<br />
0.7 max ......................................................... 190 nm<br />
0.21 ............................................................... 193 nm<br />
0.12 ............................................................... 195 nm<br />
0.05 .............................................................. 210 nm<br />
0.02 .............................................................. 220 nm<br />
0.009 ............................................................. 230 nm<br />
0.005 ............................................................. 235 nm<br />
This solvent in glass bottles fulfills the specifications according to chapter 4 of the European Pharmacopoeia.<br />
SO-9154-B010 Acetonitrile HPLC Optigrade ® Super Gradient Grade 1 L<br />
SO-9154-B025 Acetonitrile HPLC Optigrade ® Super Gradient Grade 2.5 L<br />
SO-9154-C012 Acetonitrile HPLC Optigrade ® Super Gradient Grade (Cyclotainer ® )<br />
10 L<br />
UN 1648<br />
CAS number 75-05-8<br />
C 2H 3N<br />
Assay ...................................................... 99.8% min.<br />
Water ..................................................... 0.02% max.<br />
Non-volatile matter............................. 0.0003% max.<br />
Gradient specification (210 nm)..........3.0 mAE max.<br />
Fluorescence (as quinine at 254 nm).......1 ppb max.<br />
Filtered through 0.2 µm<br />
1 L = 0.783 kg (at 20°C)<br />
Optical absorbance<br />
Wavelength<br />
0.4 max ......................................................... 190 nm<br />
0.3 ................................................................. 191 nm<br />
0.18 ............................................................... 193 nm<br />
0.08 ............................................................... 195 nm<br />
0.02 ............................................................... 200 nm<br />
0.009 ............................................................. 215 nm<br />
0.005 ............................................................. 230 nm<br />
This solvent in glass bottles fulfills the specifications according to chapter 4 of the European Pharmacopoeia.<br />
394 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
High purity solvents <strong>and</strong> acids<br />
Code Product Unit<br />
SO-2856-B010 Acetonitrile HPLC Optigrade ® 1 L<br />
SO-2856-B025 Acetonitrile HPLC Optigrade ® 2.5 L<br />
SO-2856-B040 Acetonitrile HPLC Optigrade ® 4 L<br />
SO-2856-C012 Acetonitrile HPLC Optigrade ® (Cyclotainer ® ) 10 L<br />
SO-2856-C032 Acetonitrile HPLC Optigrade ® (Cyclotainer ® )<br />
30 L<br />
UN 1648<br />
CAS number 75-05-8<br />
C 2H 3N<br />
Assay ..................................................... 99.8% min.<br />
Water ..................................................... 0.02% max.<br />
Non-volatile matter............................. 0.0003% max.<br />
Filtered through 0.2 µm<br />
1 L = 0.783 kg (at 20°C)<br />
Optical absorbance<br />
Wavelength<br />
1.0 max ......................................................... 190 nm<br />
0.1................................................................. 200 nm<br />
0.05............................................................... 210 nm<br />
0.02............................................................... 220 nm<br />
0.01............................................................... 230 nm<br />
0.005............................................................. 235 nm<br />
SO-9184-B010 Acetonitrile HPLC Optigrade ®<br />
(for analysis of PAHs <strong>and</strong> pesticides)<br />
SO-9184-B025 Acetonitrile HPLC Optigrade ®<br />
(for analysis of PAHs <strong>and</strong> pesticides)<br />
1 L<br />
2.5 L<br />
UN 1648<br />
CAS number 75-05-8<br />
C 2H 3N<br />
Assay ....................................................... 99.8% min<br />
Water ..................................................... 0.02% max.<br />
Non-volatile matter............................. 0.0003% max.<br />
Filtered through 0.2 µm<br />
1 L = 0.783 kg (at 20°C)<br />
Optical absorbance<br />
Wavelength<br />
0.097 max ..................................................... 195 nm<br />
0.018............................................................. 200 nm<br />
0.009............................................................. 215 nm<br />
0.004............................................................. 230 nm<br />
SO-9340-B010 Acetonitrile for LC-MS Optigrade ® 1 L<br />
SO-9340-B025 Acetonitrile for LC-MS Optigrade ®<br />
2.5 L<br />
UN 1648<br />
CAS number 75-05-8<br />
C 2H 3N<br />
Assay ....................................................... 99.8% min<br />
Water ..................................................... 0.02% max.<br />
Non-volatile matter............................. 0.0003% max.<br />
Filtered through 0.2 µm<br />
1 L = 0.783 kg (at 20°C)<br />
Ca ........................................................0.1 ppm max.<br />
K ..........................................................0.1 ppm max.<br />
Mg........................................................0.1 ppm max.<br />
Na ........................................................0.1 ppm max.<br />
Transmission<br />
at 195 nm.................................................. 78 % min.<br />
at 200 nm.................................................. 95 % min.<br />
at 220 nm.................................................. 98 % min.<br />
at 240 nm.................................................. 99 % min.<br />
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High purity solvents <strong>and</strong> acids<br />
Code Product Unit<br />
SO-9640-B010 Acetonitrile ULC-MS Optigrade ®<br />
1 L<br />
UN 1648<br />
CAS number 75-05-8<br />
C 2H 3N<br />
Assay (GC, on anhydrous basis) .............................99.97-100 %<br />
Water (KF) .....................................................................0-0.01 %<br />
Residue after evaporation....................................0-0.0001 %w/w<br />
Acidity (as acetic acid ) ................................................0-0.001 %<br />
Alkalinity (as ammonia)..............................................0-0.0001 %<br />
Color (APHA) .......................................................................... 0-5<br />
Gradient specification<br />
HPLC gradient at 210 nm - Drift ................................ 0-0.006 AU<br />
HPLC gradient at 254 nm - Drift ................................ 0-0.002 AU<br />
HPLC gradient at 210 nm - H. Peak .......................... 0-0.001 AU<br />
HPLC gradient at 254 nm - H. Peak ........................ 0-0.0003 AU<br />
Fluorescence at 254 nm (as quinine)............................ 0-0.3 ppb<br />
Fluorescence at 365 nm (as quinine)............................ 0-0.3 ppb<br />
1 L = 0.792 kg (at 20°C)<br />
Transmission<br />
at 191 nm ......................................................................30-100 %<br />
at 195 nm ......................................................................85-100 %<br />
at 200 nm ......................................................................97-100 %<br />
at 215 nm ......................................................................98-100 %<br />
at >230 nm....................................................................99-100 %<br />
Al ................................................................................... 0-20 ppb<br />
Ca .................................................................................. 0-50 ppb<br />
Fe................................................................................... 0-20 ppb<br />
K..................................................................................... 0-50 ppb<br />
Mg .................................................................................. 0-20 ppb<br />
Na ................................................................................ 0-100 ppb<br />
Microfiltered through 0.1 µm/bottled under inert gas<br />
SO-4680-B025 Acetonitrile 0.1 % formic acid ULC-MS Optigrade ®<br />
1 L<br />
UN 1648<br />
CAS number 75-05-8<br />
C 2H 3N<br />
Assay .....................................................................0.095-0.105 %<br />
Water (KF) ......................................................................0-0.02 %<br />
Purity of ACN (GC) ...................................................99.97-100 %<br />
Purity of formic acid ....................................................99.0-100 %<br />
Gradient specification<br />
HPLC gradient at 254 nm - H. Peak ........................... 0-0.002 AU<br />
Fluorescence at 254 nm (as quinine)............................. 0-0.5 ppb<br />
Fluorescence at 365 nm (as quinine)............................. 0-0.5 ppb<br />
Transmission<br />
at 210 nm .........................................................................5-100 %<br />
at 230 nm .......................................................................15-100 %<br />
at 254 nm .......................................................................90-100 %<br />
Al .................................................................................... 0-30 ppb<br />
Ca ................................................................................. 0-100 ppb<br />
Fe.................................................................................... 0-50 ppb<br />
K.................................................................................... 0-100 ppb<br />
Mg ................................................................................... 0-30 ppb<br />
Na ................................................................................. 0-100 ppb<br />
Microfiltered through 0.1 µm/bottled under inert gas<br />
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High purity solvents <strong>and</strong> acids<br />
Code Product Unit<br />
SO-4686-B025 Acetonitrile 0.1 % acetic acid ULC-MS Optigrade ®<br />
1 L<br />
UN 1648<br />
CAS number 75-05-8<br />
C 2H 3N<br />
Assay ..................................................................... 0.095-0.105 %<br />
Purity of ACN (GC) ................................................... 99.97-100 %<br />
Purity of acetic acid (GC)............................................ 99.9-100 %<br />
Gradient specification<br />
HPLC gradient at 254 nm - H. Peak ........................... 0-0.002 AU<br />
HPLC gradient at 254 nm - Drift ................................. 0-0.010 AU<br />
Fluorescence at 254 nm (as quinine) ............................ 0-0.5 ppb<br />
Fluorescence at 365 nm (as quinine) ............................ 0-0.5 ppb<br />
Transmission<br />
at 210 nm....................................................................... 20-100 %<br />
at 230 nm....................................................................... 50-100 %<br />
at 254 nm....................................................................... 98-100 %<br />
Al .................................................................................... 0-30 ppb<br />
Ca ................................................................................. 0-100 ppb<br />
Fe.................................................................................... 0-50 ppb<br />
K ................................................................................... 0-100 ppb<br />
Mg................................................................................... 0-30 ppb<br />
Na ................................................................................. 0-100 ppb<br />
Microfiltered through 0.1 µm/bottled under inert gas<br />
SO-4692-B025 Acetonitrile 0.1 % trifluoroacetic acid ULC-MS Optigrade ®<br />
1 L<br />
SO-9186-B025<br />
UN 1648<br />
CAS number 75-05-8<br />
C 2H 3N<br />
Assay ..................................................................... 0.095-0.105 %<br />
Water (KF) ...................................................................... 0-0.02 %<br />
Purity of ACN (GC) ................................................... 99.97-100 %<br />
Purity of trifluoroacetic acid....................................... 99.95-100 %<br />
Gradient specification<br />
HPLC gradient at 254 nm - H. Peak ......................... 0-0.0002 AU<br />
Fluorescence at 254 nm (as quinine) ............................ 0-0.5 ppb<br />
Fluorescence at 365 nm (as quinine) ............................ 0-0.5 ppb<br />
Transmission<br />
at 210 nm....................................................................... 20-100 %<br />
at 230 nm....................................................................... 50-100 %<br />
at 254 nm....................................................................... 90-100 %<br />
Al .................................................................................... 0-30 ppb<br />
Ca ................................................................................. 0-100 ppb<br />
Fe.................................................................................... 0-50 ppb<br />
K ................................................................................... 0-100 ppb<br />
Mg................................................................................... 0-30 ppb<br />
Na ................................................................................. 0-100 ppb<br />
Microfiltered through 0.1 µm/bottled under inert gas<br />
Acetonitrile DNA. max. 0.001% water<br />
2.5 L<br />
UN 1648<br />
CAS number 75-05-8<br />
C 2H 3N<br />
Assay ...................................................... 99.9% min.<br />
Water by Karl Fischer titration ............. 0.001% max.<br />
Non-volatile matter............................. 0.0005% max.<br />
1 L = 0.783 kg (at 20°C)<br />
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High purity solvents <strong>and</strong> acids<br />
Code Product Unit<br />
SO-9180-B025 Acetonitrile DNA. max. 0.003% water<br />
2.5 L<br />
UN 1648<br />
CAS number 75-05-8<br />
C 2H 3N<br />
Assay ...................................................... 99.9% min.<br />
Water by Karl Fischer titration ............. 0.003% max.<br />
Non-volatile matter............................. 0.0005% max.<br />
1 L = 0.783 kg (at 20°C)<br />
SO-1151-B010 Acetonitrile Picograde ® for residue analysis 1 L<br />
SO-1151-B025 Acetonitrile Picograde ® for residue analysis 2.5 L<br />
SO-1151-B040 Acetonitrile Picograde ® for residue analysis<br />
4 L<br />
UN 1648<br />
CAS number 75-05-8<br />
C 2H 3N<br />
Assay ...................................................... 99.5% min.<br />
Water ..................................................... 0.02% max.<br />
Non-volatile matter............................... 0.001% max.<br />
1 L = 0.783 kg (at 20°C)<br />
Specification<br />
GC/ECD<br />
In the GC-ECD chromatogram there are no interfering single signals in the retention time interval between 1,4-<br />
dichlorobenzene <strong>and</strong> decachlorobiphenyl, by a 500-fold concentration greater than that, given by 10 pg/mL<br />
heptachlor-epoxide.<br />
GC/FID<br />
In the GC-FID chromatogram there are no interfering single signals in the retention time interval between n-octane<br />
(C 8) <strong>and</strong> n-tetracontane (C 40), by a 500-fold concentration greater than that, given by 50 ng/mL n-undecane (C 11).<br />
Ammonia solution<br />
HPA-0070-B010<br />
Ammonia solution for trace analysis (glass bottle)<br />
1 L<br />
Benzene<br />
UN 2672<br />
Assay..............................................................> 21 % Chloride .....................................................< 500 ppb<br />
Colour (Hazen)...................................................< 10 Phosphate ...................................................< 50 ppb<br />
Carbonate .................................................< 10 ppm Sulfat/Sulfate .............................................< 500 ppb<br />
Al .................................< 0.5 ppb Cu ............................... < 0.5 ppb Se................................< 0.1 ppb<br />
As ................................< 0.1 ppb Fe................................ < 0.5 ppb Ag................................< 0.1 ppb<br />
Ba................................< 0.1 ppb Pb ............................... < 0.1 ppb Na................................< 0.5 ppb<br />
Be................................< 0.1 ppb Li................................. < 0.1 ppb Sr.................................< 0.1 ppb<br />
Bi .................................< 0.1 ppb Mg............................... < 0.2 ppb Th ................................< 0.1 ppb<br />
Cd................................< 0.1 ppb Mn............................... < 0.1 ppb Sn................................< 0.1 ppb<br />
Ca................................< 0.5 ppb Mo............................... < 0.1 ppb Ti .................................< 0.1 ppb<br />
Cr ................................< 0.1 ppb Ni ................................ < 0.1 ppb V..................................< 0.1 ppb<br />
Co................................< 0.1 ppb K ................................. < 0.2 ppb Zn ................................< 0.2 ppb<br />
SO-1163-B010 Benzene Picograde ® for residue analysis 1 L<br />
SO-1163-B025<br />
Benzene Picograde ® for residue analysis<br />
2.5 L<br />
UN 1114<br />
CAS number 71-43-2<br />
C 6H 6<br />
Assay ...................................................... 99.0% min.<br />
Water ..................................................... 0.05% max.<br />
Non-volatile matter............................. 0.0005% max.<br />
1 L = 0.871 kg (at 20°C)<br />
Specification<br />
GC/ECD<br />
In the GC-ECD chromatogram there are no interfering single signals in the retention time interval between 1,4-<br />
dichlorobenzene <strong>and</strong> decachlorobiphenyl, by a 500-fold concentration greater than that, given by 10 pg/mL<br />
heptachlor-epoxide.<br />
GC/FID<br />
In the GC-FID chromatogram there are no interfering single signals in the retention time interval between n-octane<br />
(C 8) <strong>and</strong> n-tetracontane (C 40), by a 500-fold concentration greater than that, given by 50 ng/mL n-undecane (C 11).<br />
398 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
High purity solvents <strong>and</strong> acids<br />
Code Product Unit<br />
Benzyl alcohol<br />
SO-9505-B005<br />
Benzyl alcohol for the analysis of highly volatile halogenated compounds <strong>and</strong> EOX<br />
500 mL<br />
CAS number 100-51-6<br />
C 7H 8O<br />
Assay ...................................................... 99.0% min.<br />
Water ....................................................... 0.1% max.<br />
Non-volatile matter................................. 0.05% max.<br />
1 L = 1.05 kg (at 20°C)<br />
Specification<br />
Highly volatile halogenated hydrocarbons<br />
In the GC/ECD chromatorgram there are no interfering single signals in the retention time interval between 1,1-<br />
dichloroethene <strong>and</strong> tribromomethane greater than that, given by 5 µg/L parathion-methyl.<br />
BTEX for FID<br />
In the GC-FID chromatogram the sum of the signals of BTEX-compounds is not greater than the signal,<br />
given by 10 µg/L n-Decane.<br />
Coulometric determination of EOX gives a halogen content as chloride of less than 0.3 mg/L.<br />
Carbon disulfide<br />
SO-9056-B005<br />
Carbon disulfide free from aromatic hydrocarbons (max. 0.5 ppm)<br />
500 mL<br />
UN 1131<br />
CAS number 75-15-0<br />
CS 2<br />
Assay ...................................................... 99.8% min.<br />
Water ..................................................... 0.03% max.<br />
Non-volatile matter............................. 0.0005% max.<br />
1 L = 1.261 kg (at 20°C)<br />
Specification<br />
BTEX for FID<br />
In the GC-FID chromatogram the sum of the signals of BTEX-compounds is not greater than the signal,<br />
given by 10 µg/L n-Decane.<br />
Chloroform<br />
SO-4443-B010 Chloroform HPLC Optigrade ® (alcohol-free. stab. with amylene) 1 L<br />
SO-4443-B025 Chloroform HPLC Optigrade ® (alcohol-free. stab. with amylene ) 2.5 L<br />
SO-4443-B040 Chloroform HPLC Optigrade ® (alcohol-free. stab. with amylene)<br />
4 L<br />
UN 1888<br />
CAS number 67-66-3<br />
CHCl 3<br />
Assay ...................................................... 99.9% min.<br />
Water ..................................................... 0.03% max.<br />
Non-volatile matter............................. 0.0002% max.<br />
Filtered through 0.2 µm<br />
1 L = 1.475 kg (at 20°C)<br />
stabilised with 60 - 100 ppm amylene<br />
Optical absorbance<br />
Wavelength<br />
1.0 max ......................................................... 245 nm<br />
0.15............................................................... 255 nm<br />
0.05............................................................... 260 nm<br />
0.02............................................................... 270 nm<br />
0.01............................................................... 290 nm<br />
SO-1174-B010<br />
SO-1174-B025<br />
Chloroform Picograde ® for residue analysis<br />
(stab.with 0.2 - 1.8 % ethanol)<br />
Chloroform Picograde ® for residue analysis<br />
(stab. with 0.2 - 1.8 % ethanol)<br />
1 L<br />
2.5 L<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 399
High purity solvents <strong>and</strong> acids<br />
Code Product Unit<br />
SO-1174-B040<br />
Chloroform Picograde ® for residue analysis<br />
(stab. with 0.2 - 1.8 % ethanol)<br />
4 L<br />
UN 1888<br />
CAS number 67-66-3<br />
CHCl 3<br />
Assay ...................................................... 99.8% min.<br />
Acid <strong>and</strong> phosgene (as HCI).............. 0.0005% max.<br />
Non-volatile matter............................. 0.0005% max.<br />
1 L = 1.475 kg (at 20°C)<br />
stabilised with 0.2 - 1.8% Ethanol<br />
Specification<br />
GC/ECD<br />
In the GC-ECD chromatogram there are no interfering single signals in the retention time interval between 1,4-<br />
dichlorobenzene <strong>and</strong> decachlorobiphenyl, by a 500-fold concentration greater than that, given by 10 pg/mL<br />
heptachlor-epoxide.<br />
GC/FID<br />
In the GC-FID chromatogram there are no interfering single signals in the retention time interval between n-octane<br />
(C 8) <strong>and</strong> n-tetracontane (C 40), by a 500-fold concentration greater than that, given by 50 ng/mL n-undecane (C 11).<br />
Cyclohexane<br />
SO-9052-B010 Cyclohexane HPLC Optigrade ® 1 L<br />
SO-9052-B025 Cyclohexane HPLC Optigrade ®<br />
2.5 L<br />
UN 1145<br />
CAS number 110-82-7<br />
C 6H 12<br />
Assay ...................................................... 99.5% min.<br />
Water ..................................................... 0.02% max.<br />
Non-volatile matter............................. 0.0003% max.<br />
Filtered through 0.2 µm<br />
1 L = 0.779 kg (at 20°C)<br />
Optical absorbance................................ Wavelength<br />
0.700 max ..................................................... 210 nm<br />
0.320 ............................................................. 220 nm<br />
0.125 ............................................................. 230 nm<br />
0.025 ............................................................. 245 nm<br />
0.005 ............................................................. 260 nm<br />
SO-1179-B010 Cyclohexane Picograde ® for residue analysis 1 L<br />
SO-1179-B025 Cyclohexane Picograde ® for residue analysis 2.5 L<br />
SO-1179-B040 Cyclohexane Picograde ® for residue analysis 4 L<br />
SO-1179-C011 Cyclohexane Picograde ® for residue analysis (Cyclotainer ® ) 10 L<br />
SO-1179-C032 Cyclohexane Picograde ® for residue analysis (Cyclotainer ® )<br />
30 L<br />
UN 1145<br />
CAS number 110-82-7<br />
C 6H 12<br />
Assay ...................................................... 99.0% min.<br />
Water ..................................................... 0.01% max.<br />
Non-volatile matter............................. 0.0005% max.<br />
1 L = 0.779 kg (at 20°C)<br />
Specification<br />
GC/ECD<br />
In the GC-ECD chromatogram there are no interfering single signals in the retention time interval between 1,4-<br />
dichlorobenzene <strong>and</strong> decachlorobiphenyl, by a 500-fold concentration greater than that, given by 10 pg/mL<br />
heptachlor-epoxide.<br />
GC/FID<br />
In the GC-FID chromatogram there are no interfering single signals in the retention time interval between n-octane<br />
(C 8) <strong>and</strong> n-tetracontane (C 40), by a 500-fold concentration greater than that, given by 50 ng/mL n-undecane (C 11).<br />
400 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
High purity solvents <strong>and</strong> acids<br />
Code Product Unit<br />
Cyclopentane<br />
SO-6157-B010 Cyclopentane HPLC Optigrade ®<br />
1 L<br />
UN 1146<br />
CAS number 287-92-3<br />
C 5H 10<br />
Assay ......................................................... 75% min.<br />
Water ................................................... 0.005% max.<br />
Non-volatile matter............................. 0.0001% max.<br />
Filtered through 0.2 µm<br />
1 L = 0.751 kg (at 20°C)<br />
Optical absorbance<br />
Wavelength<br />
1.0 max ......................................................... 200 nm<br />
0.3................................................................. 215 nm<br />
0.02............................................................... 225 nm<br />
0.005............................................................. 300 nm<br />
n-Decane<br />
SO-1182-B010<br />
n-Decane Picograde ® for residue analysis<br />
1 L<br />
UN 2247<br />
CAS number 124-18-5<br />
CH 3(CH 2) 8CH 3<br />
Assay ...................................................... 97.0% min.<br />
Water ..................................................... 0.01% max.<br />
Non-volatile matter............................. 0.0005% max.<br />
1 L = 0.731 kg (at 20°C)<br />
Specification<br />
In the GC-ECD chromatogram there are no interfering single signals in the retention time interval between 1,4-<br />
dichlorobenzene <strong>and</strong> decachlorobiphenyl, by a 500-fold concentration greater than that, given by 10 pg/mL<br />
heptachlor-epoxide.<br />
GC/FID<br />
In the GC-FID chromatogram there are no interfering single signals in the retention time interval between n-octane<br />
(C 8) <strong>and</strong> n-tetracontane (C 40), by a 500-fold concentration greater than that, given by 50 ng/mL n-undecane (C 11).<br />
Dichloromethane<br />
SO-4879-B010 Dichloromethane HPLC Optigrade ® (stab. with amylene) 1 L<br />
SO-4879-B025 Dichloromethane HPLC Optigrade ® (stab. with amylene) 2.5 L<br />
SO-4879-B040 Dichloromethane HPLC Optigrade ® (stab. with amylene)<br />
4 L<br />
UN 1593<br />
CAS number 75-09-2<br />
CH 2Cl 2<br />
Assay ...................................................... 99.8% min.<br />
Water ..................................................... 0.02% max.<br />
Non-volatile matter............................. 0.0003% max.<br />
Filtered through 0.2 µm<br />
1 L = 1.335 kg (at 20°C)<br />
stabilised with 60 - 100 ppm amylene<br />
Optical absorbance<br />
Wavelength<br />
1.0 max ......................................................... 233 nm<br />
0.15............................................................... 240 nm<br />
0.01............................................................... 254 nm<br />
0.005............................................................. 280 nm<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 401
High purity solvents <strong>and</strong> acids<br />
Code Product Unit<br />
SO-1185-B010<br />
SO-1185-B025<br />
SO-1185-B040<br />
Dichloromethane Picograde ® for residue analysis<br />
(stab. with amylene)<br />
Dichloromethane Picograde ® for residue analysis<br />
(stab. with amylene)<br />
Dichloromethane Picograde ® for residue analysis<br />
(stab. with amylene)<br />
SO-1185-C011 Dichloromethane Picograde ® for residue analysis (Cyclotainer ® )<br />
(stab. with amylene)<br />
SO-1185-C032 Dichloromethane Picograde ® for residue analysis (Cyclotainer ® )<br />
(stab. with amylene)<br />
1 L<br />
2.5 L<br />
4 L<br />
10 L<br />
30 L<br />
UN 1593<br />
CAS number 75-09-2<br />
CH 2Cl 2<br />
Assay ...................................................... 99.5% min.<br />
Water ..................................................... 0.02% max.<br />
Non-volatile matter............................. 0.0002% max.<br />
1 L = 1.335 kg (at 20°C)<br />
stabilised with 60 - 100 ppm amylene<br />
Specification<br />
GC/ECD<br />
In the GC-ECD chromatogram there are no interfering single signals in the retention time interval between 1,4-<br />
dichlorobenzene <strong>and</strong> decachlorobiphenyl, by a 500-fold concentration greater than that, given by 10 pg/mL<br />
heptachlor-epoxide.<br />
GC/FID<br />
In the GC-FID chromatogram there are no interfering single signals in the retention time interval between n-octane<br />
(C 8) <strong>and</strong> n-tetracontane (C 40), by a 500-fold concentration greater than that, given by 50 ng/mL n-undecane (C 11).<br />
SO-9800-B025 Dichloromethane nitrosamine-free 2.5 L<br />
SO-9800-B040 Dichloromethane nitrosamine-free<br />
4 L<br />
Specification<br />
N-Nitrosodimethylamine........................0.1 ppb max.<br />
N-Nitrosodiethylamine...........................0.1 ppb max.<br />
N-Nitrosodi-n-propylamine ....................0.1 ppb max.<br />
N-Nitrosodi-i-propylamine .....................0.1 ppb max.<br />
N-Nitrosodi-n-butylamine ......................0.1 ppb max.<br />
N-Nitrosopiperidine ...............................0.1 ppb max.<br />
N-Nitrosopyrrolidine ..............................0.1 ppb max.<br />
N-Nitrosomorpholine.............................0.1 ppb max.<br />
Diethyl ether<br />
SO-9012-B010 Diethyl ether HPLC Optigrade ® (stab. with ethanol) 1 L<br />
SO-9012-B025 Diethyl ether HPLC Optigrade ® (stab. with ethanol)<br />
2.5 L<br />
UN 1155<br />
CAS number 60-29-7<br />
C 4H 10O<br />
Assay ...................................................... 99.0% min.<br />
Water ..................................................... 0.01% max.<br />
Non-volatile matter............................. 0.0005% max.<br />
Peroxide................................................ 5 ppm max.<br />
Filtered through 0.2 µm<br />
1 L = 0.713 kg (at 20°C)<br />
stabilised with 2% ethanol<br />
Optical absorbance<br />
Wavelength<br />
1.0 max ......................................................... 215 nm<br />
0.3 ................................................................. 230 nm<br />
0.08 ............................................................... 254 nm<br />
0.04 ............................................................... 270 nm<br />
0.02 ............................................................... 280 nm<br />
0.005 ............................................................. 300 nm<br />
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High purity solvents <strong>and</strong> acids<br />
Code Product Unit<br />
SO-2854-B010 Diethyl ether HPLC Optigrade ® (not stabilised)<br />
1 L<br />
UN 1155<br />
CAS number 60-29-7<br />
C 4H 10O<br />
Assay ...................................................... 99.0% min.<br />
Water ..................................................... 0.01% max.<br />
Non-volatile matter............................. 0.0005% max.<br />
Peroxide..................................................5 ppm max.<br />
Filtered through 0.2 µm<br />
1 L = 0.713 kg (at 20°C)<br />
not stabilised<br />
Optical absorbance<br />
Wavelength<br />
1.0 max ......................................................... 215 nm<br />
0.08............................................................... 254 nm<br />
0.02............................................................... 280 nm<br />
SO-1187-B010<br />
SO-1187-B025<br />
Diethyl ether Picograde ® for residue analysis<br />
(stab. with 1.5 - 2.5 % ethanol)<br />
Diethyl ether Picograde ® for residue analysis<br />
(stab. with 1.5 - 2.5 % ethanol)<br />
1 L<br />
2.5 L<br />
UN 1155<br />
CAS number 60-29-7<br />
C 4H 10O<br />
Assay ...................................................... 99.0% min.<br />
Water ........................................................ 0.1%max.<br />
Non-volatile matter................................ 0.001%max.<br />
Peroxide..................................................5 ppm max.<br />
1 L = 0.6502 kg (at 20°C)<br />
stabilised with 1.5 - 2.5% ethanol<br />
Specification<br />
GC/ECD<br />
In the GC-ECD chromatogram there are no interfering single signals in the retention time interval between 1,4-<br />
dichlorobenzene <strong>and</strong> decachlorobiphenyl, by a 500-fold concentration greater than that, given by 10 pg/mL<br />
heptachlor-epoxide.<br />
GC/FID<br />
In the GC-FID chromatogram there are no interfering single signals in the retention time interval between n-octane<br />
(C 8) <strong>and</strong> n-tetracontane (C 40), by a 500-fold concentration greater than that, given by 50 ng/mL n-undecane (C 11).<br />
N.N-Dimethylacetamide<br />
SO-5407-B025 N.N-Dimethylacetamide HPLC Optigrade ® 2.5 L<br />
SO-5407-B040 N.N-Dimethylacetamide HPLC Optigrade ®<br />
4 L<br />
CAS number 127-19-5<br />
C 4H 9NO<br />
Assay ...................................................... 99.0% min.<br />
Water ..................................................... 0.03% max.<br />
Non-volatile matter............................. 0.0006% max.<br />
Filtered through 0.2 µm<br />
1 L = 0.937 kg (at 20°C)<br />
Optical absorbance<br />
Wavelength<br />
1.0 max ......................................................... 270 nm<br />
0.3................................................................. 280 nm<br />
0.15............................................................... 290 nm<br />
0.05............................................................... 310 nm<br />
0.01............................................................... 360 nm<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 403
High purity solvents <strong>and</strong> acids<br />
Code Product Unit<br />
SO-3240-B010 N,N-Dimethylacetamide Headspace Grade<br />
1 L<br />
CAS number 127-19-5<br />
C 4H 9NO<br />
Assay (GC, on anhydrous basis)...........99.99-100 %<br />
Acidity (as acetic acid) ............................ 0-0-0.05 %<br />
Water (KF) ..................................................0-0.03 %<br />
UV cutoff wavelength .............................190-268 nm<br />
Transmission<br />
at 268 nm ...................................................10-100 %<br />
at 275 nm ...................................................55-100 %<br />
at 300 nm ...................................................85-100 %<br />
at 350 nm ...................................................98-100 %<br />
at 400 nm ...................................................99-100 %<br />
Headspace test for O.V.I.........................passes test<br />
N.N-Dimethylformamide<br />
SO-5356-B025 N.N-Dimethylformamide HPLC Optigrade ® 2.5 L<br />
SO-5356-B040 N.N-Dimethylformamide HPLC Optigrade ®<br />
4 L<br />
UN 2265<br />
CAS number 68-12-2<br />
C 3H 7NO<br />
Assay ...................................................... 99.7% min.<br />
Water ..................................................... 0.05% max.<br />
Non-volatile matter............................. 0.0006% max.<br />
Filtered through 0.2 µm<br />
1 L = 0.951 kg (at 20°C)<br />
Optical absorbance<br />
Wavelength<br />
1.0 max ......................................................... 270 nm<br />
0.3 ................................................................. 275 nm<br />
0.1 ................................................................. 295 nm<br />
0.05 ............................................................... 310 nm<br />
0.01 ............................................................... 340 nm<br />
SO-1189-B010 N.N-Dimethylformamide Picograde ® for residue analysis 1 L<br />
SO-1189-B025 N.N-Dimethylformamide Picograde ® for residue analysis<br />
2.5 L<br />
UN 2265<br />
CAS number 68-12-2<br />
C 3H 7NO<br />
Assay ...................................................... 99.0% min.<br />
Water ....................................................... 0.2% max.<br />
Non-volatile matter............................... 0.001% max.<br />
1 L = 0.951 kg (at 20°C)<br />
Specification<br />
GC/ECD<br />
In the GC-ECD chromatogram there are no interfering single signals in the retention time interval between 1,4-<br />
dichlorobenzene <strong>and</strong> decachlorobiphenyl, by a 500-fold concentration greater than that, given by 10 pg/mL<br />
heptachlor-epoxide.<br />
GC/FID<br />
In the GC-FID chromatogram there are no interfering single signals in the retention time interval between n-octane<br />
(C 8) <strong>and</strong> n-tetracontane (C 40), by a 500-fold concentration greater than that, given by 50 ng/mL n-undecane (C 11).<br />
404 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
High purity solvents <strong>and</strong> acids<br />
Code Product Unit<br />
SO-3230-B010 N,N-Dimethylformamide Headspace Grade<br />
1 L<br />
UN 2265<br />
CAS number 68-12-2<br />
C 3H 7NO<br />
Assay (GC, on anhydrous basis) ..........99.99-100 %<br />
Refractive index (20 °C)......................... 1.430-1.440<br />
Water (KF) ..................................................0-0.03 %<br />
UV cutoff wavelength .............................190-268 nm<br />
Transmission<br />
at 270 nm ...................................................30-100 %<br />
at 275 nm ...................................................60-100 %<br />
at 300 nm ...................................................90-100 %<br />
at 320 nm ...................................................97-100 %<br />
Headspace test for O.V.I.........................passes test<br />
1,3-Dimethyl-2-imidazolidinone (N,N'-Dimethylethylen<strong>eu</strong>rea)<br />
SO-3260-B005<br />
1,3-Dimethyl-2-imidazolidinone (DMI) Headspace Grade<br />
500 ml<br />
Assay (GC, on anhydrous basis) ............99.5-100 %<br />
Refractive index (20 °C).......................... 1.470-1473<br />
Water (KF) ....................................................0-0.1 %<br />
UV cutoff wavelength .............................190-270 nm<br />
Transmission<br />
at 275 nm ...................................................40-100 %<br />
at 300 nm ...................................................85-100 %<br />
at 325 nm ...................................................95-100 %<br />
at >350 nm .................................................98-100 %<br />
Headspace test for O.V.I.........................passes test<br />
Dimethylsulfoxide (DMSO)<br />
SO-3210-B010<br />
Dimethylsulfoxide Headspace Grade<br />
1 L<br />
CAS-Nr 67-68-5<br />
Assay (GC, on anhydrous basis) ..........99.99-100 %<br />
Refractive index (20 °C)......................... 1.477-1.480<br />
Water (KF) ..................................................0-0.04 %<br />
UV cutoff wavelength .............................190-265 nm<br />
Transmission<br />
at 268 nm ...................................................30-100 %<br />
at 275 nm ...................................................60-100 %<br />
at 300 nm ...................................................85-100 %<br />
at 350 nm ...................................................95-100 %<br />
at 400 nm ...................................................98-100 %<br />
Headspace test for O.V.I.........................passes test<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 405
High purity solvents <strong>and</strong> acids<br />
Code Product Unit<br />
1.4-Dioxan<br />
SO-9002-B010 1.4-Dioxan HPLC Optigrade ® (not stabilised) 1 L<br />
SO-9002-B025<br />
1.4-Dioxan HPLC Optigrade ® (not stabilised)<br />
2.5 L<br />
UN 1165<br />
CAS number 123-91-1<br />
C 4H 8O 2<br />
Assay ...................................................... 99.5% min.<br />
Water ..................................................... 0.05% max.<br />
Non-volatile matter............................. 0.0002% max.<br />
Filtered through 0.2 µm<br />
1 L = 1.034 kg (at 20°C)<br />
not stabilised<br />
Optical absorbance<br />
Wavelength<br />
0.5 max ......................................................... 225 nm<br />
0.25 .............................................................. 250 nm<br />
0.1 ................................................................. 270 nm<br />
0.05 .............................................................. 280 nm<br />
0.01 ............................................................... 295 nm<br />
Ethanol<br />
SO-9063-B010 Ethanol HPLC Optigrade ® 1 L<br />
SO-9063-B025 Ethanol HPLC Optigrade ®<br />
2.5 L<br />
UN 1170<br />
CAS number 64-17-5<br />
C 2H 5OH<br />
Assay ...................................................... 99.7% min.<br />
Water ....................................................... 0.1% max.<br />
Non-volatile matter............................ 0.0004% max.<br />
Filtered through 0.2 µm<br />
1 L = 0.789 kg (at 20°C)<br />
Optical absorbance<br />
Wavelength<br />
0.7 max ......................................................... 210 nm<br />
0.1 ................................................................. 240 nm<br />
0.01 ............................................................... 260 nm<br />
SO-9812-B025<br />
Ethanol nitrosamine-free<br />
Specification<br />
N-Nitrosodimethylamine........................0.1 ppb max.<br />
N-Nitrosodiethylamine...........................0.1 ppb max.<br />
N-Nitrosodi-n-propylamine ....................0.1 ppb max.<br />
N-Nitrosodi-i-propylamine .....................0.1 ppb max.<br />
N-Nitrosodi-n-butylamine ......................0.1 ppb max.<br />
N-Nitrosopiperidine ...............................0.1 ppb max.<br />
N-Nitrosopyrrolidine ..............................0.1 ppb max.<br />
N-Nitrosomorpholine.............................0.1 ppb max.<br />
2.5 L<br />
2-Ethoxyethanol<br />
SO-2925-B025 2-Ethoxyethanol HPLC Optigrade ®<br />
2.5 L<br />
UN 1171<br />
CAS number 110-80-5<br />
C 4H 10O 2<br />
Assay ...................................................... 99.5% min.<br />
Water ..................................................... 0.08% max.<br />
Non-volatile matter............................. 0.0002% max.<br />
Filtered through 0.2 µm<br />
1 L = 0.932 kg (at 20°C)<br />
Optical absorbance<br />
Wavelength<br />
1.0 max....................................................... .. 222 nm<br />
0.75 ............................................................... 225 nm<br />
0.25 ............................................................... 250 nm<br />
0.01 ............................................................... 300 nm<br />
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High purity solvents <strong>and</strong> acids<br />
Code Product Unit<br />
Ethyl acetate<br />
SO-3442-B010 Ethyl acetate HPLC Optigrade ® 1 L<br />
SO-3442-B025 Ethyl acetate HPLC Optigrade ® 2.5 L<br />
SO-3442-B040 Ethyl acetate HPLC Optigrade ®<br />
4 L<br />
UN 1173<br />
CAS number 141-78-6<br />
CH 3COOC 2H 5<br />
Assay ...................................................... 99.5% min.<br />
Water ..................................................... 0.05% max.<br />
Non-volatile matter............................. 0.0005% max.<br />
Filtered through 0.2 µm<br />
1 L = 0.897 kg (at 20°C)<br />
Optical absorbance<br />
Wavelength<br />
1.0 max ......................................................... 255 nm<br />
0.1................................................................. 260 nm<br />
0.05............................................................... 280 nm<br />
0.01............................................................... 300 nm<br />
SO-9345-B010 Ethyl acetate for LC-MS Optigrade ® 1 L<br />
SO-9345-B025 Ethyl acetate for LC-MS Optigrade ®<br />
2.5 L<br />
UN 1173<br />
CAS number 141-78-6<br />
CH 3COOC 2H 5<br />
Assay ...................................................... 99.5% min.<br />
Water ..................................................... 0.05% max.<br />
Non-volatile matter............................. 0.0005% max.<br />
Filtered through 0.2 µm<br />
1 L = 0.897 kg (at 20°C)<br />
Ca ........................................................0.1 ppm max.<br />
K ..........................................................0.1 ppm max.<br />
Mg........................................................0.1 ppm max.<br />
Na ........................................................0.1 ppm max.<br />
Transmission<br />
at 260 nm.................................................. 70 % min.<br />
at 280 nm.................................................. 99 % min.<br />
SO-1191-B010 Ethyl acetate Picograde ® for residue analysis 1 L<br />
SO-1191-B025 Ethyl acetate Picograde ® for residue analysis 2.5 L<br />
SO-1191-B040 Ethyl acetate Picograde ® for residue analysis 4 L<br />
SO-1191-C011 Ethyl acetate Picograde ® for residue analysis (Cyclotainer ® ) 10 L<br />
SO-1191-C032 Ethyl acetate Picograde ® for residue analysis (Cyclotainer ® )<br />
30 L<br />
UN 1173<br />
CAS number 141-78-6<br />
CH 3COOC 2H 5<br />
Assay ...................................................... 99.0% min.<br />
Water ..................................................... 0.05% max.<br />
Non-volatile matter............................. 0.0005% max.<br />
1 L = 0.897 kg (at 20°C)<br />
Specification<br />
GC/ECD<br />
In the GC-ECD chromatogram there are no interfering single signals in the retention time interval between 1,4-<br />
dichlorobenzene <strong>and</strong> decachlorobiphenyl, by a 500-fold concentration greater than that, given by 10 pg/mL<br />
heptachlor-epoxide.<br />
GC/FID<br />
In the GC-FID chromatogram there are no interfering single signals in the retention time interval between n-octane<br />
(C 8) <strong>and</strong> n-tetracontane (C 40), by a 500-fold concentration greater than that, given by 50 ng/mL n-undecane (C 11).<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 407
High purity solvents <strong>and</strong> acids<br />
Code Product Unit<br />
n-Heptane<br />
SO-5139-B010 n-Heptane HPLC Optigrade ® 1 L<br />
SO-5139-B025 n-Heptane HPLC Optigrade ® 2.5 L<br />
SO-5139-B040 n-Heptane HPLC Optigrade ®<br />
4 L<br />
UN 1206<br />
CAS number 142-82-5<br />
C 7H 16<br />
Assay ...................................................... 95.0% min.<br />
Water ..................................................... 0.02% max.<br />
Non-volatile matter............................. 0.0003% max.<br />
Filtered through 0.2 µm<br />
1 L = 0.685 kg (at 20°C)<br />
Optical absorbance<br />
Wavelength<br />
1.0 max...........................................…...........197 nm<br />
0.4.................................................................210 nm<br />
0.1.................................................................225 nm<br />
0.01...............................................................254 nm<br />
SO-1210-B025<br />
n-Heptane Picograde ® for residue analysis<br />
2.5 L<br />
UN 1206<br />
CAS number 142-82-5<br />
C 7H 16<br />
Assay ...................................................... 97.0% min.<br />
Water ..................................................... 0.01% max.<br />
Non-volatile matter............................. 0.0002% max.<br />
1 L = 0.682 kg (at 20°C)<br />
Specification<br />
GC/ECD<br />
In the GC-ECD chromatogram there are no interfering single signals in the retention time interval between 1,4-<br />
dichlorobenzene <strong>and</strong> decachlorobiphenyl, by a 500-fold concentration greater than that, given by 10 pg/mL<br />
heptachlor-epoxide.<br />
GC/FID<br />
In the GC-FID chromatogram there are no interfering single signals in the retention time interval between n-octane<br />
(C 8) <strong>and</strong> n-tetracontane (C 40), by a 500-fold concentration greater than that, given by 50 ng/mL n-undecane (C 11).<br />
n-Hexane<br />
SO-5167-B010 n-Hexane HPLC Optigrade ® 1 L<br />
SO-5167-B025 n-Hexane HPLC Optigrade ® 2.5 L<br />
SO-5167-B040 n-Hexane HPLC Optigrade ® 4 L<br />
SO-5167-C012 n-Hexane HPLC Optigrade ® (Cyclotainer ® ) 10 L<br />
SO-5167-C032 n-Hexane HPLC Optigrade ® (Cyclotainer ® )<br />
30 L<br />
UN 1208<br />
CAS number 110-54-3<br />
C 6H 14<br />
Assay (of C 6-isomers) ............................. 99.8% min.<br />
Water ....................................................... 0.1% max.<br />
Non-volatile matter............................. 0.0003% max.<br />
Filtered through 0.2 µm<br />
1 L = 0.659 kg (at 20°C)<br />
Optical absorbance<br />
Wavelength<br />
1.0 max ......................................................... 195 nm<br />
0.25 ............................................................... 210 nm<br />
0.1 ................................................................. 220 nm<br />
0.01 ............................................................... 254 nm<br />
0.005 ............................................................. 280 nm<br />
0.005 ............................................................. 350 nm<br />
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High purity solvents <strong>and</strong> acids<br />
Code Product Unit<br />
SO-1244-B010 n-Hexane Picograde ® for residue analysis 1 L<br />
SO-1244-B025 n-Hexane Picograde ® for residue analysis 2.5 L<br />
SO-1244-B040 n-Hexane Picograde ® for residue analysis 4 L<br />
SO-1244-C011 n-Hexane Picograde ® for residue analysis (Cyclotainer ® ) 10 L<br />
SO-1244-C032 n-Hexane Picograde ® for residue analysis (Cyclotainer ® )<br />
UN 1208<br />
CAS number 110-54-3<br />
C 6H 14<br />
Assay (of C 6-isomers)............................. 97.0% min.<br />
Water ..................................................... 0.01% max.<br />
Non-volatile matter............................. 0.0002% max.<br />
1 L = 0.659 kg (at 20°C)<br />
Specification<br />
GC/ECD<br />
In the GC-ECD chromatogram there are no interfering single signals in the retention time interval between 1,4-<br />
dichlorobenzene <strong>and</strong> decachlorobiphenyl, by a 500-fold concentration greater than that, given by 10 pg/mL<br />
heptachlor-epoxide.<br />
GC/FID<br />
In the GC-FID chromatogram there are no interfering single signals in the retention time interval between n-octane<br />
(C 8) <strong>and</strong> n-tetracontane (C 40), by a 500-fold concentration greater than that, given by 50 ng/mL n-undecane (C 11).<br />
30 L<br />
SO-9500-B010 n-Hexane for the analysis of highly volatile halogenated hydrocarbons <strong>and</strong> EOX 1 L<br />
SO-9500-B025 n-Hexane for the analysis of highly volatile halogenated hydrocarbons <strong>and</strong> EOX<br />
2.5 L<br />
UN 1208<br />
CAS number 110-54-3<br />
C 6H 14<br />
Assay (of C 6-isomers)............................. 95.0% min.<br />
Water ..................................................... 0.01% max.<br />
Non-volatile matter............................. 0.0002% max.<br />
1 L = 0.651 kg (at 20°C)<br />
Specification<br />
Highly volatile halogenated hydrocarbons/EOX<br />
In the GC/ECD chromatorgram there are no interfering single signals in the retention time interval between 1,1-<br />
dichloroethene <strong>and</strong> tribromomethane greater than that, given by 5 µg/L parathion-methyl.<br />
Coulometric determination of EOX gives a halogen content as chloride of less than 0.3 mg/L.<br />
SO-9823-B040<br />
Hexane nitrosamine-free<br />
4 L<br />
Specification<br />
N-Nitrosodimethylamine .......................0.1 ppb max.<br />
N-Nitrosodiethylamine ..........................0.1 ppb max.<br />
N-Nitrosodi-n-propylamine....................0.1 ppb max.<br />
N-Nitrosodi-i-propylamine .....................0.1 ppb max.<br />
N-Nitrosodi-n-butylamine ......................0.1 ppb max.<br />
N-Nitrosopiperidine ...............................0.1 ppb max.<br />
N-Nitrosopyrrolidine ..............................0.1 ppb max.<br />
N-Nitrosomorpholine.............................0.1 ppb max.<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 409
High purity solvents <strong>and</strong> acids<br />
Code Product Unit<br />
Iso-Hexane<br />
SO-9043-B025 Iso-Hexane HPLC Optigrade ®<br />
2.5 L<br />
UN 1208<br />
CAS number 107-83-5<br />
C 6H 14<br />
Assay (of C 6-isomers) ............................. 95.0% min.<br />
Water ..................................................... 0.01% max.<br />
Non-volatile matter............................. 0.0002% max.<br />
1 L = 0.653 kg (at 20°C)<br />
Optical absorbance<br />
Wavelength<br />
1.0 max ......................................................... 195 nm<br />
0.25 ............................................................... 210 nm<br />
0.2 ................................................................. 217 nm<br />
0.125 ............................................................. 220 nm<br />
0.02 ............................................................... 245 nm<br />
SO-1251-B025<br />
Iso-Hexane Picograde ® for residue analysis<br />
2.5 L<br />
UN 1208<br />
CAS number 107-83-5<br />
C 6H 14<br />
Assay (of C 6-isomers) ............................. 95.0% min.<br />
Water ..................................................... 0.01% max.<br />
Non-volatile matter............................. 0.0002% max.<br />
1 L = 0.653 kg (at 20°C)<br />
Specification<br />
GC/ECD<br />
In the GC-ECD chromatogram there are no interfering single signals in the retention time interval between 1,4-<br />
dichlorobenzene <strong>and</strong> decachlorobiphenyl, by a 500-fold concentration greater than that, given by 10 pg/mL<br />
heptachlor-epoxide.<br />
GC/FID<br />
In the GC-FID chromatogram there are no interfering single signals in the retention time interval between n-octane<br />
(C 8) <strong>and</strong> n-tetracontane (C 40), by a 500-fold concentration greater than that, given by 50 ng/mL n-undecane (C 11).<br />
Hydrochloric acid<br />
HPA-0010-B010<br />
Hydrochloric acid for trace analysis min. 36 % (glass bottle)<br />
1 L<br />
UN 1789<br />
Assay..............................................................> 36 %<br />
Residue ........................................................< 3 ppm<br />
Colour (APHA) ...................................................< 10<br />
Bromide......................................................< 50 ppm<br />
free chlorine...............................................< 0.5 ppm<br />
Phosphate ...............................................< 0.05 ppm<br />
Sulfite ........................................................< 0.5 ppm<br />
Sulfate .......................................................< 0.5 ppm<br />
Ag................................< 0.1 ppb Cu ............................... < 0.1 ppb Sb................................< 0.1 ppb<br />
Al .................................< 0.5 ppb Fe................................... < 1 ppb Se................................< 0.1 ppb<br />
As ................................< 0.1 ppb Hg ............................... < 0.2 ppb Sn................................< 0.1 ppb<br />
B.....................................< 1 ppb K ................................. < 0.1 ppb Sr.................................< 0.1 ppb<br />
Ba................................< 0.1 ppb Li................................. < 0.1 ppb Th ................................< 0.1 ppb<br />
Be................................< 0.1 ppb Mg............................... < 0.5 ppb Ti .................................< 0.1 ppb<br />
Bi .................................< 0.1 ppb Mn............................... < 0.1 ppb U..................................< 0.1 ppb<br />
Ca................................< 0.5 ppb Mo............................... < 0.1 ppb V..................................< 0.1 ppb<br />
Cd................................< 0.1 ppb Na ............................... < 0.5 ppb Zn ................................< 0.5 ppb<br />
Co................................< 0.1 ppb Ni ................................ < 0.1 ppb Zr.................................< 0.1 ppb<br />
Cr ................................< 0.1 ppb Pb ............................... < 0.1 ppb<br />
Hydrochloric acid stored in glass bottles will see a rise in: Al, B, Ca, K, Mg, Mn, Na <strong>and</strong> Si.<br />
410 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
High purity solvents <strong>and</strong> acids<br />
Code Product Unit<br />
Hydrofluoric acid<br />
HPA-0030-B010 Hydrofluoric acid for trace analysis min. 48 % ( HDPE bottle)<br />
1 L<br />
Methanol<br />
SO-9510-B010<br />
UN 1790<br />
Assay .............................................................> 48 % Phosphate .................................................< 0.1 ppm<br />
Colour (HAZEN)................................................. < 10 Sulfate .......................................................< 0.5 ppm<br />
Chloride........................................................ < 1 ppm Hexafluorosilicate.......................................< 20 ppm<br />
Ag...................................< 1 ppb Cu .................................. < 1 ppb Pb...................................< 1 ppb<br />
Al....................................< 1 ppb Fe .................................. < 1 ppb Se...................................< 1 ppb<br />
As...................................< 1 ppb Hg .................................. < 1 ppb Si....................................< 1 ppb<br />
Ba...................................< 1 ppb K .................................... < 1 ppb Sn...................................< 1 ppb<br />
Be...................................< 1 ppb Li.................................... < 1 ppb Sr....................................< 1 ppb<br />
Bi....................................< 1 ppb Mg.................................. < 1 ppb Ti ....................................< 1 ppb<br />
Ca...................................< 1 ppb Mn.................................. < 1 ppb V.....................................< 1 ppb<br />
Cd...................................< 1 ppb Mo.................................. < 1 ppb Zn...................................< 1 ppb<br />
Co...................................< 1 ppb Na .................................. < 1 ppb<br />
Cr ...................................< 1 ppb Ni ................................... < 1 ppb<br />
Hydrofluoric acid stored in polyethylene bottles will see a rise in: Al, Ca, Fe, Na <strong>and</strong> Zn.<br />
Methanol Purge & Trap<br />
1 L<br />
UN 1230<br />
CAS number 67-56-1<br />
CH 3OH<br />
Assay ...................................................... 99.9% min.<br />
Water .......................................................... < 1 mg/L<br />
Non-volatile matter....................................... < 0.10%<br />
2-Butanone (GC/MS; P&T)........................ < 10 µg/L<br />
Other volatile <strong>impurities</strong> ........................ passes tests<br />
1 L = 0.792 kg (at 20°C)<br />
SO-9260-B010 Methanol HPLC Optigrade ® Gradient Grade 1 L<br />
SO-9260-B025 Methanol HPLC Optigrade ® Gradient Grade 2.5 L<br />
SO-9260-C012 Methanol HPLC Optigrade ® Gradient Grade (Cyclotainer ® ) 10 L<br />
SO-9260-C032 Methanol HPLC Optigrade ® Gradient Grade (Cyclotainer ® )<br />
30 L<br />
UN 1230<br />
CAS number 67-56-1<br />
CH 3OH<br />
Assay ...................................................... 99.9% min.<br />
Water ..................................................... 0.05% max.<br />
Non-volatile matter............................. 0.0003% max.<br />
Gradient specification (235 nm).........0.002 AE max.<br />
Gradient specification (254 nm).........0.001 AE max.<br />
Fluorescence (as quinine at 254 nm) ......1 ppb max.<br />
Filtered through 0.2 µm<br />
1 L = 0.792 kg (at 20°C)<br />
Optical absorbance<br />
Wavelength<br />
0.43 max ....................................................... 210 nm<br />
0.25............................................................... 220 nm<br />
0.12............................................................... 230 nm<br />
0.08............................................................... 235 nm<br />
0.015............................................................. 254 nm<br />
0.005............................................................. 280 nm<br />
This solvent in glass bottles fulfills the specifications according to chapter 4 of the European Pharmacopoeia.<br />
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High purity solvents <strong>and</strong> acids<br />
Code Product Unit<br />
SO-3041-B010 Methanol HPLC Optigrade ® 1 L<br />
SO-3041-B025 Methanol HPLC Optigrade ® 2.5 L<br />
SO-3041-B040 Methanol HPLC Optigrade ® 4 L<br />
SO-3041-C012 Methanol HPLC Optigrade ® (Cyclotainer ® ) 10 L<br />
SO-3041-C032 Methanol HPLC Optigrade ® (Cyclotainer ® )<br />
30 L<br />
UN 1230<br />
CAS number 67-56-1<br />
CH 3OH<br />
Assay ...................................................... 99.9% min.<br />
Water ..................................................... 0.05% max.<br />
Non-volatile matter............................. 0.0003% max.<br />
Filtered through 0.2 µm<br />
1 L = 0.792 kg (at 20°C)<br />
Optical absorbance<br />
Wavelength<br />
1.0 max ......................................................... 205 nm<br />
0.25 ............................................................... 220 nm<br />
0.05 ............................................................... 240 nm<br />
0.015 ............................................................. 254 nm<br />
0.005 ............................................................. 280 nm<br />
0.005 ............................................................. 350 nm<br />
This solvent in glass bottles fulfills the specifications according to chapter 4 of the European Pharmacopoeia.<br />
SO-9658-B010 Methanol ULC-MS Optigrade ®<br />
1 L<br />
UN 1230<br />
CAS number 67-56-1<br />
CH 3OH<br />
Assay (GC, on anhydrous basis)...............................99.98-100 %<br />
Water (KF) .......................................................................0-0.03%<br />
Residue after evaporation .....................................0-0.0001 %w/w<br />
Acidity (as acetic acid) ..................................................0-0.002 %<br />
Alkalinity (as ammonia)...............................................0-0.0001 %<br />
Color (APHA) ...........................................................................0-5<br />
Gradient specification<br />
HPLC gradient at 220 nm - Drift....................................0-0.01 AU<br />
HPLC gradient at 235 nm - Drift..................................0-0.005 AU<br />
HPLC gradient at 220 nm - H. Peak ...........................0-0.004 AU<br />
HPLC gradient at 235 nm - H. Peak ...........................0-0.002 AU<br />
Fluorescence at 254 nm (as quinine).............................0-0.5 ppb<br />
Fluorescence at 365 nm (as quinine).............................0-0.3 ppb<br />
1 L = 0.783 kg (at 20°C)<br />
Transmission<br />
at 210 nm .......................................................................40-100 %<br />
at 220 nm .......................................................................65-100 %<br />
at 230 nm .......................................................................80-100 %<br />
at 260 nm .......................................................................98-100 %<br />
Al ....................................................................................0-20 ppb<br />
Ca..................................................................................0-100 ppb<br />
Fe ....................................................................................0-20 ppb<br />
K......................................................................................0-50 ppb<br />
Mg ...................................................................................0-20 ppb<br />
Na..................................................................................0-100 ppb<br />
Microfiltered through 0.1 µm/bottled under inert gas<br />
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High purity solvents <strong>and</strong> acids<br />
Code Product Unit<br />
SO-9356-B010 Methanol for LC-MS Optigrade ® 1 L<br />
SO-9356-B025 Methanol for LC-MS Optigrade ®<br />
2.5 L<br />
UN 1230<br />
CAS number 67-56-1<br />
CH 3OH<br />
Assay ...................................................... 99.9% min.<br />
Water ..................................................... 0.05% max.<br />
Non-volatile matter............................. 0.0003% max.<br />
Filtered through 0.2 µm<br />
1 L = 0.792 kg (at 20°C)<br />
Ca ........................................................0.1 ppm max.<br />
K ..........................................................0.1 ppm max.<br />
Mg........................................................0.1 ppm max.<br />
Na ........................................................0.1 ppm max.<br />
Transmission<br />
at 210 nm.................................................. 40 % min.<br />
at 220 nm.................................................. 60 % min.<br />
at 235 nm.................................................. 80 % min.<br />
at 260 nm.................................................. 98 % min.<br />
SO-1263-B010 Methanol Picograde ® for residue analysis 1 L<br />
SO-1263-B025 Methanol Picograde ® for residue analysis 2.5 L<br />
SO-1263-B040 Methanol Picograde ® for residue analysis 4 L<br />
SO-1263-C011 Methanol Picograde ® for residue analysis (Cyclotainer ® )<br />
10 L<br />
UN 1230<br />
CAS number 67-56-1<br />
CH 3OH<br />
Assay ...................................................... 99.0% min.<br />
Water ....................................................... 0.1% max.<br />
Non-volatile matter............................. 0.0005% max.<br />
1 L = 0.792 kg (at 20°C)<br />
Specification<br />
GC/ECD<br />
In the GC-ECD chromatogram there are no interfering single signals in the retention time interval between 1,4-<br />
dichlorobenzene <strong>and</strong> decachlorobiphenyl, by a 500-fold concentration greater than that, given by 10 pg/mL<br />
heptachlor-epoxide.<br />
GC/FID<br />
In the GC-FID chromatogram there are no interfering single signals in the retention time interval between n-octane<br />
(C 8) <strong>and</strong> n-tetracontane (C 40), by a 500-fold concentration greater than that, given by 50 ng/mL n-undecane (C 11).<br />
SO-9835-B010 Methanol nitrosamine-free 1 L<br />
SO-9835-B040 Methanol nitrosamine-free<br />
4 L<br />
Specification<br />
N-Nitrosodimethylamine .......................0.1 ppb max.<br />
N-Nitrosodiethylamine ..........................0.1 ppb max.<br />
N-Nitrosodi-n-propylamine....................0.1 ppb max.<br />
N-Nitrosodi-i-propylamine .....................0.1 ppb max.<br />
N-Nitrosodi-n-butylamine ......................0.1 ppb max.<br />
N-Nitrosopiperidine ...............................0.1 ppb max.<br />
N-Nitrosopyrrolidine ..............................0.1 ppb max.<br />
N-Nitrosomorpholine.............................0.1 ppb max.<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 413
High purity solvents <strong>and</strong> acids<br />
Code Product Unit<br />
2-Methoxyethanol<br />
SO-9509-B010<br />
2-Methoxyethanol for the analysis of highly volatile halogenated hydrocarbons<br />
UN 1188<br />
CAS number 109-86-4<br />
C 3H 8O 2<br />
Assay ...................................................... 99.7% min.<br />
Water ..................................................... 0.08% max.<br />
Non-volatile matter............................. 0.0006% max.<br />
1 L = 0.961 kg (at 20°C)<br />
Specification<br />
Highly volatile halogenated hydrocarbons<br />
In the GC/ECD chromatorgram there are no interfering single signals in the retention time interval between 1,1-<br />
dichloroethene <strong>and</strong> tribromomethane greater than that, given by 5 µg/L parathion-methyl.<br />
BTEX for FID<br />
In the GC-FID chromatogram the sum of the signals of BTEX-compounds is not greater than the signal, given by<br />
10 µg/L n-Decane.<br />
1 L<br />
Methyl-tert-butyl ether<br />
SO-5398-B025 Methyl-tert-butyl ether HPLC Optigrade ®<br />
2.5 L<br />
UN 2398<br />
CAS number 1634-04-4<br />
C 5H 12O<br />
Assay ...................................................... 99.7% min.<br />
Water ..................................................... 0.05% max.<br />
Non-volatile matter............................. 0.0006% max.<br />
Filtered through 0.2 µm<br />
1 L = 0.742 kg (at 20°C)<br />
Optical absorbance<br />
Wavelength<br />
1.0 max ......................................................... 270 nm<br />
0.3 ................................................................. 275 nm<br />
0.1 ................................................................. 295 nm<br />
0.05 ............................................................... 310 nm<br />
0.01 ............................................................... 340 nm<br />
SO-1265-B010 Methyl-tert-butyl ether for residue analysis Picograde ® 1 L<br />
SO-1265-B025 Methyl-tert-butyl ether for residue analysis Picograde ®<br />
UN 2398<br />
CAS number 1634-04-4<br />
C 5H 12O<br />
Assay ...................................................... 99.8% min.<br />
Water ..................................................... 0.05% max.<br />
Non-volatile matter............................. 0.0005% max.<br />
1 L = 0.742 kg (at 20°C)<br />
Specification<br />
GC/ECD<br />
In the GC-ECD chromatogram there are no interfering single signals in the retention time interval between 1,4-<br />
dichlorobenzene <strong>and</strong> decachlorobiphenyl, by a 500-fold concentration greater than that, given by 10 pg/mL<br />
heptachlor-epoxide.<br />
GC/FID<br />
In the GC-FID chromatogram there are no interfering single signals in the retention time interval between n-octane<br />
(C 8) <strong>and</strong> n-tetracontane (C 40), by a 500-fold concentration greater than that, given by 50 ng/mL n-undecane (C 11).<br />
2.5 L<br />
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High purity solvents <strong>and</strong> acids<br />
Code Product Unit<br />
Nitric acid<br />
HPA-0020-B010 Nitric acid for trace analysis min 67 % (glass bottle)<br />
1 L<br />
n-Nonane<br />
UN 2031<br />
Assay .............................................................> 67 % Phosphate .................................................< 0.1 ppm<br />
Residue........................................................ < 1 ppm Sulfate .......................................................< 0.5 ppm<br />
Chloride................................................... < 0.08 ppm<br />
Ag................................< 0.1 ppb Cu ............................... < 0.1 ppb Pb................................< 0.1 ppb<br />
Al.................................< 0.5 ppb Fe ............................... < 0.5 ppb Se................................< 0.1 ppb<br />
As................................< 0.1 ppb Hg ............................... < 0.2 ppb Sn................................< 0.1 ppb<br />
Ba................................< 0.1 ppb K ................................. < 0.2 ppb Sr.................................< 0.1 ppb<br />
Be................................< 0.1 ppb Li................................. < 0.1 ppb Th................................< 0.1 ppb<br />
Bi.................................< 0.1 ppb Mg............................... < 0.5 ppb Ti .................................< 0.1 ppb<br />
Ca................................< 0.5 ppb Mn............................... < 0.1 ppb V..................................< 0.1 ppb<br />
Cd................................< 0.1 ppb Mo............................... < 0.1 ppb Zn................................< 0.5 ppb<br />
Co................................< 0.1 ppb Na ............................... < 0.5 ppb<br />
Cr ................................< 0.2 ppb Ni ................................ < 0.1 ppb<br />
Nitric Acid stored in glass bottles will see a rise in: Al, B, Ca, K, Mg, Mn, Na <strong>and</strong> Si.<br />
SO-4436-B010 n-Nonane HPLC Optigrade ®<br />
1 L<br />
UN 1920<br />
CAS number 111-84-2<br />
C 9H 20<br />
Assay ......................................................... 95% min.<br />
Water ..................................................... 0.01% max.<br />
Non-volatile matter............................. 0.0003% max.<br />
Filtered through 0.2 µm<br />
1 L = 0.719 kg (at 20°C)<br />
Optical absorbance<br />
Wavelength<br />
1.0 max ......................................................... 200 nm<br />
0.1................................................................. 225 nm<br />
0.05............................................................... 250 nm<br />
0.005............................................................. 300 nm<br />
SO-1271-B010 n-Nonane Picograde ® for residue analysis 1 L<br />
SO-1271-B025 n-Nonane Picograde ® for residue analysis<br />
2.5 L<br />
UN 1920<br />
CAS number 111-84-2<br />
C 9H 20<br />
Assay ...................................................... 95.0% min.<br />
Water ..................................................... 0.01% max.<br />
Non-volatile matter............................. 0.0005% max.<br />
1 L = 0.719 kg (at 20°C)<br />
Specification<br />
GC/ECD<br />
In the GC-ECD chromatogram there are no interfering single signals in the retention time interval between 1,4-<br />
dichlorobenzene <strong>and</strong> decachlorobiphenyl, by a 500-fold concentration greater than that, given by 10 pg/mL<br />
heptachlor-epoxide.<br />
GC/FID<br />
In the GC-FID chromatogram there are no interfering single signals in the retention time interval between n-octane<br />
(C 8) <strong>and</strong> n-tetracontane (C 40), by a 500-fold concentration greater than that, given by 50 ng/mL n-undecane (C 11).<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 415
High purity solvents <strong>and</strong> acids<br />
Code Product Unit<br />
n-Octane<br />
SO-1279-B010<br />
n-Octane Picograde ® for residue analysis<br />
1 L<br />
UN 1262<br />
CAS number 111-65-9<br />
CH 3(CH 2) 6CH 3<br />
Assay ...................................................... 95.0% min.<br />
Water ..................................................... 0.01% max.<br />
Non-volatile matter............................. 0.0005% max.<br />
1 L = 0.703 kg (at 20°C)<br />
Specification<br />
GC/ECD<br />
In the GC-ECD chromatogram there are no interfering single signals in the retention time interval between 1,4-<br />
dichlorobenzene <strong>and</strong> decachlorobiphenyl, by a 500-fold concentration greater than that, given by 10 pg/mL<br />
heptachlor-epoxide.<br />
GC/FID<br />
In the GC-FID chromatogram there are no interfering single signals in the retention time interval between n-octane<br />
(C 8) <strong>and</strong> n-tetracontane (C 40), by a 500-fold concentration greater than that, given by 50 ng/mL n-undecane (C 11).<br />
n-Pentane<br />
SO-9081-B010 n-Pentane HPLC Optigrade ®<br />
1 L<br />
UN 1265<br />
CAS number 109-66-0<br />
C 5H 12<br />
Assay ...................................................... 99.0% min.<br />
Water ..................................................... 0.01% max.<br />
Non-volatile matter............................... 0.001% max.<br />
Filtered through 0.2 µm<br />
1 L = 0.626 kg (at 20°C)<br />
Optical absorbance<br />
Wavelength<br />
1.0 max ......................................................... 200 nm<br />
0.7 ................................................................. 210 nm<br />
0.3 ................................................................. 215 nm<br />
0.05 ............................................................... 225 nm<br />
0.01 ............................................................... 240 nm<br />
SO-1282-B010 n-Pentane Picograde ® for residue analysis 1 L<br />
SO-1282-B025 n-Pentane Picograde ® for residue analysis 2.5 L<br />
SO-1282-B040 n-Pentane Picograde ® for residue analysis<br />
4 L<br />
UN 1265<br />
CAS number 109-66-0<br />
C 5H 12<br />
Assay ...................................................... 98.0% min.<br />
Water ..................................................... 0.01% max.<br />
Non-volatile matter............................. 0.0005% max.<br />
1 L = 0.626 kg (at 20°C)<br />
Specification<br />
GC/ECD<br />
In the GC-ECD chromatogram there are no interfering single signals in the retention time interval between 1,4-<br />
dichlorobenzene <strong>and</strong> decachlorobiphenyl, by a 500-fold concentration greater than that, given by 10 pg/mL<br />
heptachlor-epoxide.<br />
GC/FID<br />
In the GC-FID chromatogram there are no interfering single signals in the retention time interval between n-octane<br />
(C 8) <strong>and</strong> n-tetracontane (C 40), by a 500-fold concentration greater than that, given by 50 ng/mL n-undecane (C 11).<br />
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High purity solvents <strong>and</strong> acids<br />
Code Product Unit<br />
SO-9501-B010 n-Pentane for the analysis of highly volatile halogenated hydrocarbons<br />
1 L<br />
UN 1265<br />
CAS number 109-66-0<br />
C 5H 12<br />
Assay ...................................................... 95.0% min.<br />
Water ..................................................... 0.01% max.<br />
Non-volatile matter............................. 0.0005% max.<br />
1 L = 0.632 kg (at 20°C)<br />
Specification<br />
Highly volatile halogenated hydrocarbons<br />
In the GC/ECD chromatorgram there are no interfering single signals in the retention time interval between 1,1-<br />
dichloroethene <strong>and</strong> tribromomethane greater than that, given by 5 µg/L parathion-methyl.<br />
SO-9610-B005<br />
n-Pentane for the analysis of highly volatile halogenated hydrocarbons, aromatic<br />
hydrocarbons <strong>and</strong> EOX<br />
500 mL<br />
UN 1265<br />
CAS number 109-66-0<br />
C 5H 12<br />
Assay ...................................................... 98.0% min.<br />
Water ..................................................... 0.01% max.<br />
Non-volatile matter............................. 0.0005% max.<br />
1 L = 0.626 kg (at 20°C)<br />
Specification<br />
Highly volatile halogenated hydrocarbons<br />
In the GC/ECD chromatorgram there are no interfering single signals in the retention time interval between 1,1-<br />
dichloroethene <strong>and</strong> tribromomethane greater than that, given by 5 µg/L parathion-methyl.<br />
BTEX for FID<br />
In the GC-FID chromatogram the sum of the signals of BTEX-compounds is not greater than the signal, given by<br />
10 µg/L n-Decane.<br />
Coulometric determination of EOX gives a halogen content as chloride of less than 0.3 mg/L.<br />
Perchloric acid<br />
HPA-0060-B010<br />
Perchloric acid for trace analysis min 68 % (glass bottle)<br />
1 L<br />
UN 1802<br />
Assay .............................................................> 68 % Sulfate ..........................................................< 5 ppm<br />
Colour (APHA) ................................................... < 10 Total nitrogen .............................................< 10 ppm<br />
Phosphate................................................. < 0.1 ppm<br />
Ag................................< 0.1 ppb Cu ............................... < 0.1 ppb Ni.................................< 0.1 ppb<br />
Al.................................< 0.5 ppb Fe ............................... < 0.5 ppb Pb................................< 0.1 ppb<br />
Ba................................< 0.1 ppb K ................................. < 0.5 ppb Sn................................< 0.1 ppb<br />
Be................................< 0.1 ppb Li................................. < 0.1 ppb Sr.................................< 0.1 ppb<br />
Bi.................................< 0.1 ppb Mg............................... < 0.5 ppb Th................................< 0.1 ppb<br />
Ca................................< 0.5 ppb Mn............................... < 0.1 ppb Tl .................................< 0.1 ppb<br />
Cd................................< 0.1 ppb Mo............................... < 0.1 ppb V..................................< 0.5 ppb<br />
Co................................< 0.1 ppb Na ............................... < 0.5 ppb Zn................................< 0.5 ppb<br />
Perchloric acid stored in glass bottles will see a rise in: Al, B, Ca, K, Mg, Mn, Na <strong>and</strong> Si.<br />
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High purity solvents <strong>and</strong> acids<br />
Code Product Unit<br />
Petrol<strong>eu</strong>m ether<br />
SO-1320-B010 Petrol<strong>eu</strong>m ether Picograde ® for residue analysis (30 - 60°C) 1 L<br />
SO-1320-B025 Petrol<strong>eu</strong>m ether Picograde ® for residue analysis (30 - 60°C) 2.5 L<br />
SO-1320-B040 Petrol<strong>eu</strong>m ether Picograde ® for residue analysis (30 - 60°C) 4 L<br />
SO-1320-C011 Petrol<strong>eu</strong>m ether Picograde ® for residue analysis (Cyclotainer ® ) (30 - 60°C) 10 L<br />
SO-1320-C032<br />
Petrol<strong>eu</strong>m ether Picograde ® for residue analysis (Cyclotainer ® ) (30 - 60°C)<br />
UN 1268<br />
CAS number 8032-32-4<br />
Boiling point range ............................. 30 - 60°C min.<br />
Water ..................................................... 0.01% max.<br />
Non-volatile matter............................. 0.0005% max.<br />
1 L = 0.625...0.655 kg (at 20°C)<br />
Specification<br />
GC/ECD<br />
In the GC-ECD chromatogram there are no interfering single signals in the retention time interval between 1,4-<br />
dichlorobenzene <strong>and</strong> decachlorobiphenyl, by a 500-fold concentration greater than that, given by 10 pg/mL<br />
heptachlor-epoxide.<br />
GC/FID<br />
In the GC-FID chromatogram there are no interfering single signals in the retention time interval between n-octane<br />
(C 8) <strong>and</strong> n-tetracontane (C 40), by a 500-fold concentration greater than that, given by 50 ng/mL n-undecane (C 11).<br />
30 L<br />
SO-9502-B010<br />
SO-9502-B025<br />
Petrol<strong>eu</strong>m ether for the analysis of highly volatile halogenated hydrocarbons <strong>and</strong> EOX<br />
(40 - 60°C)<br />
Petrol<strong>eu</strong>m ether for the analysis of highly volatile halogenated hydrocarbons <strong>and</strong> EOX<br />
(40 - 60°C)<br />
1 L<br />
2.5 L<br />
UN 1268<br />
CAS number 8032-32-4<br />
Boiling point ....................................... 40 - 60°C min.<br />
Water ..................................................... 0.01% max.<br />
Non-volatile matter............................. 0.0005% max.<br />
1 L = 0.625...0.655 kg (at 20°C)<br />
Specification<br />
Highly volatile halogenated hydrocarbons/EOX<br />
In the GC/ECD chromatorgram there are no interfering single signals in the retention time interval between 1,1-<br />
dichloroethene <strong>and</strong> tribromomethane greater than that, given by 5 µg/L parathion-methyl.<br />
Coulometric determination of EOX gives a halogen content as chloride of less than 0.3 mg/L.<br />
Propan-1-ol<br />
SO-5351-B025 Propan-1-ol HPLC Optigrade ®<br />
2.5 L<br />
UN 1274<br />
CAS number 71-23-8<br />
CH 3CH 2CH 2OH<br />
Assay ...................................................... 99.8% min.<br />
Water ..................................................... 0.05% max.<br />
Non-volatile matter............................... 0.001% max.<br />
Filtered through 0.2 µm<br />
1 L = 0.804 kg (at 20°C)<br />
Optical absorbance<br />
Wavelength<br />
0.5 max ......................................................... 225 nm<br />
0.05 ............................................................... 250 nm<br />
0.01 ............................................................... 270 nm<br />
0.005 ............................................................. 300 nm<br />
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High purity solvents <strong>and</strong> acids<br />
Code Product Unit<br />
Propan-2-ol<br />
SO-3043-B010 Propan-2-ol HPLC Optigrade ® 1 L<br />
SO-3043-B025 Propan-2-ol HPLC Optigrade ® 2.5 L<br />
SO-3043-B040 Propan-2-ol HPLC Optigrade ® 4 L<br />
SO-3043-C012 Propan-2-ol HPLC Optigrade ® (Cyclotainer ® ) 10 L<br />
SO-3043-C032 Propan-2-ol HPLC Optigrade ® (Cyclotainer ® )<br />
30 L<br />
UN 1219<br />
CAS number 67-63-0<br />
C 3H 8O<br />
Assay ...................................................... 99.5% min.<br />
Water ..................................................... 0.05% max.<br />
Non-volatile matter............................. 0.0006% max.<br />
Filtered through 0.2 µm<br />
1 L = 0.786 kg (at 20°C)<br />
Optical absorbance<br />
Wavelength<br />
1.0 max ......................................................... 205 nm<br />
0.3................................................................. 220 nm<br />
0.15............................................................... 230 nm<br />
0.02............................................................... 254 nm<br />
0.01............................................................... 350 nm<br />
SO-9352-B010 Propan-2-ol for LC-MS Optigrade ® 1 L<br />
SO-9352-B025 Propan-2-ol for LC-MS Optigrade ®<br />
2.5 L<br />
UN 1219<br />
CAS number 67-63-0<br />
C 3H 8O<br />
Assay ...................................................... 99.5% min.<br />
Water ..................................................... 0.05% max.<br />
Non-volatile matter............................. 0.0006% max.<br />
Filtered through 0.2 µm<br />
1 L = 0.786 kg (at 20°C)<br />
Ca ........................................................0.1 ppm max.<br />
K ..........................................................0.1 ppm max.<br />
Mg........................................................0.1 ppm max.<br />
Na ........................................................0.1 ppm max.<br />
Transmission<br />
at 220 nm.................................................. 60 % min.<br />
at 250 nm.................................................. 99 % min.<br />
SO-1334-B010 Propan-2-ol Picograde ® for residue analysis 1 L<br />
SO-1334-B025 Propan-2-ol Picograde ® for residue analysis 2.5 L<br />
SO-1334-B040 Propan-2-ol Picograde ® for residue analysis<br />
4 L<br />
UN 1219<br />
CAS number 67-63-0<br />
C 3H 8O<br />
Assay ..................................................... 99.5% min.<br />
Water ....................................................... 0.2% max.<br />
Non-volatile matter............................. 0.0005% max.<br />
1 L = 0.786 kg (at 20°C)<br />
Specification<br />
GC/ECD<br />
In the GC-ECD chromatogram there are no interfering single signals in the retention time interval between 1,4-<br />
dichlorobenzene <strong>and</strong> decachlorobiphenyl, by a 500-fold concentration greater than that, given by 10 pg/mL<br />
heptachlor-epoxide.<br />
GC/FID<br />
In the GC-FID chromatogram there are no interfering single signals in the retention time interval between n-octane<br />
(C 8) <strong>and</strong> n-tetracontane (C 40), by a 500-fold concentration greater than that, given by 50 ng/mL n-undecane (C 11).<br />
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High purity solvents <strong>and</strong> acids<br />
Code Product Unit<br />
SO-3044-B040 Propan-2-ol for the tobacco industry<br />
4 L<br />
contains<br />
n-Heptadecane ............... 0.3 g/L<br />
Ethanol............................ 2.0 g/L<br />
SO-3046-B040 Propan-2-ol for the tobacco industry<br />
4 L<br />
contains<br />
n-Hept<strong>and</strong>ecane ............. 0.8 g/L<br />
Ethanol abs..................... 4.0 g/L<br />
Water ................................0.1 %<br />
SO-3047-B040 Propan-2-ol for the tobacco industry<br />
contains<br />
n-Hept<strong>and</strong>ecane ............. 0.4 g/L<br />
Ethanol abs.................... 2.0 g/ L<br />
4 L<br />
Sulfuric acid<br />
HPA-0040-B010 Sulfuric acid min 95 % (glass bottle)<br />
1 L<br />
Tetrahydrofuran<br />
UN 1830<br />
Assay.................................................................95 % Chloride ........................................................< 0.1 pp<br />
Density ..................................................... 1.83 g/mL Phosphate .................................................< 0.5 ppm<br />
Colour (APHA) ...................................................< 10 Nitrate......................................................< 0.07 ppm<br />
Residue ........................................................< 2 ppm<br />
Ag................................< 0.1 ppb Fe................................ < 0.5 ppb Se..................................< 5 ppb<br />
Al .................................< 0.5 ppb Hg .................................. < 1 ppb Sn................................< 0.1 ppb<br />
As ...................................< 1 ppb K ................................. < 0.5 ppb Sr.................................< 0.1 ppb<br />
Ba................................< 0.1 ppb Li................................. < 0.1 ppb Th ................................< 0.1 ppb<br />
Be................................< 0.1 ppb Mg............................... < 0.5 ppb Ti ....................................< 1 ppb<br />
Bi .................................< 0.1 ppb Mn............................... < 0.1 ppb U..................................< 0.1 ppb<br />
Ca................................< 0.5 ppb Mo............................... < 0.1 ppb V..................................< 0.1 ppb<br />
Cd................................< 0.1 ppb Na ............................... < 0.5 ppb Zn ................................< 0.1 ppb<br />
Co................................< 0.1 ppb Ni ................................ < 0.1 ppb Zr.................................< 0.1 ppb<br />
Cr ................................< 0.1 ppb Pb ............................... < 0.1 ppb<br />
Cu................................< 0.1 ppb Sb ............................... < 0.1 ppb<br />
Sulfuric acid stored in glass bottles will see a rise in: Al, B, Ca, K, Mg, Mn, Na <strong>and</strong> Si.<br />
SO-2858-B010 Tetrahydrofuran HPLC Optigrade ® (not stabilised) 1 L<br />
SO-2858-B025 Tetrahydrofuran HPLC Optigrade ® (not stabilised) 2.5 L<br />
SO-2858-B040 Tetrahydrofuran HPLC Optigrade ® (not stabilised)<br />
4 L<br />
UN 2056<br />
CAS number 109-99-9<br />
C 4H 8O<br />
Assay ...................................................... 99.8% min.<br />
Water ..................................................... 0.03% max.<br />
Non-volatile matter............................. 0.0007% max.<br />
Filtered through 0.2 µm<br />
1 L = 0.887 kg (at 20°C)<br />
not stabilised<br />
Optical absorbance<br />
Wavelength<br />
1.0 max ......................................................... 212 nm<br />
0.5 ................................................................. 225 nm<br />
0.17 ............................................................... 250 nm<br />
0.01 ............................................................... 300 nm<br />
420 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
High purity solvents <strong>and</strong> acids<br />
Code Product Unit<br />
SO-9364-B010 Tetrahydrofuran for LC-MS Optigrade ® (not stabilised) 1 L<br />
SO-9364-B025 Tetrahydrofuran for LC-MS Optigrade ® (not stabilised)<br />
2.5 L<br />
UN 2056<br />
CAS number 109-99-9<br />
C 4H 8O<br />
Assay ...................................................... 99.8% min.<br />
Water ..................................................... 0.03% max.<br />
Non-volatile matter............................. 0.0007% max.<br />
Filtered through 0.2 µm<br />
1 L = 0.887 kg (at 20°C)<br />
not stabilised<br />
Ca ........................................................0.1 ppm max.<br />
K ..........................................................0.1 ppm max.<br />
Mg........................................................0.1 ppm max.<br />
Na ........................................................0.1 ppm max.<br />
Transmission<br />
at 250 nm.................................................. 80 % min.<br />
at 290 nm.................................................. 99 % min.<br />
Toluene<br />
SO-4483-B010 Toluene HPLC Optigrade ® 1 L<br />
SO-4483-B025 Toluene HPLC Optigrade ® 2.5 L<br />
SO-4483-B040 Toluene HPLC Optigrade ®<br />
4 L<br />
UN 1294<br />
CAS number 108-88-3<br />
C 7H 8<br />
Assay ...................................................... 99.7% min.<br />
Water ..................................................... 0.03% max.<br />
Non-volatile matter............................. 0.0005% max.<br />
1 L = 0.866 kg (at 20°C)<br />
Optical absorbance<br />
Wavelength<br />
1.0 max ......................................................... 285 nm<br />
0.4................................................................. 288 nm<br />
0.15............................................................... 300 nm<br />
0.02............................................................... 335 nm<br />
0.01............................................................... 350 nm<br />
SO-1350-B010 Toluene Picograde ® for residue analysis 1 L<br />
SO-1350-B025 Toluene Picograde ® for residue analysis 2.5 L<br />
SO-1350-B040 Toluene Picograde ® for residue analysis 4 L<br />
SO-1350-C011 Toluene Picograde ® for residue analysis (Cyclotainer ® ) 10 L<br />
SO-1350-C032 Toluene Picograde ® for residue analysis (Cyclotainer ® )<br />
30 L<br />
UN 1294<br />
CAS number 108-88-3<br />
C 7H 8<br />
Assay ...................................................... 99.8% min.<br />
Water ..................................................... 0.02% max.<br />
Non-volatile matter............................. 0.0005% max.<br />
1 L = 0.866 kg (at 20°C)<br />
Specification<br />
GC/ECD<br />
In the GC-ECD chromatogram there are no interfering single signals in the retention time interval between 1,4-<br />
dichlorobenzene <strong>and</strong> decachlorobiphenyl, by a 500-fold concentration greater than that, given by 10 pg/mL<br />
heptachlor-epoxide.<br />
GC/FID<br />
In the GC-FID chromatogram there are no interfering single signals in the retention time interval between n-octane<br />
(C 8) <strong>and</strong> n-tetracontane (C 40), by a 500-fold concentration greater than that, given by 50 ng/mL n-undecane (C 11).<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 421
High purity solvents <strong>and</strong> acids<br />
Code Product Unit<br />
1,1,2-Trichloro-1,2,2-trifluoroethane<br />
SO-9145-B025<br />
1,1,2-Trichloro-1,2,2-trifluoroethane for IR-spectroscopy<br />
2.5 L<br />
UN 3082<br />
CAS number 76-13-1<br />
C 2Cl 3F 3<br />
Assay ...................................................... 99.8% min.<br />
Non-volatile matter................................ 2 mg/L max.<br />
Water .................................................10 mg/kg max.<br />
Hydrocarbons.......................................5 mg/kg max.<br />
1 L = 1.57 kg (at 20°C)<br />
2,2,4-Trimethylpentane<br />
SO-6043-B010 2,2,4-Trimethylpentane (Isooctane) HPLC Optigrade ® 1 L<br />
SO-6043-B025 2,2,4-Trimethylpentane (Isooctane) HPLC Optigrade ® 2.5 L<br />
SO-6043-B040 2,2,4-Trimethylpentane (Isooctane) HPLC Optigrade ®<br />
4 L<br />
UN 1262<br />
CAS number 540-84-1<br />
C 8H 18<br />
Assay ...................................................... 99.5% min.<br />
Water ..................................................... 0.02% max.<br />
Non-volatile matter............................. 0.0005% max.<br />
Filtered through 0.2 µm<br />
1 L = 0.690 kg (at 20°C)<br />
Optical absorbance<br />
Wavelength<br />
1.0 max ......................................................... 205 nm<br />
0.2 ................................................................. 220 nm<br />
0.1 ................................................................. 230 nm<br />
0.01 ............................................................... 254 nm<br />
SO-1364-B010 2,2,4-Trimethylpentane (Isooctane) Picograde ® for residue analysis 1 L<br />
SO-1364-B025 2,2,4-Trimethylpentane (Isooctane) Picograde ® for residue analysis 2.5 L<br />
SO-1364-B040 2,2,4-Trimethylpentane (Isooctane) Picograde ® for residue analysis<br />
4 L<br />
UN 1262<br />
CAS number 540-84-1<br />
C 8H 18<br />
Assay ...................................................... 95.0% min.<br />
Water ..................................................... 0.02% max.<br />
Non-volatile matter............................. 0.0005% max.<br />
1 L = 0.690 kg (at 20°C)<br />
Specification<br />
GC/ECD<br />
In the GC-ECD chromatogram there are no interfering single signals in the retention time interval between 1,4-<br />
dichlorobenzene <strong>and</strong> decachlorobiphenyl, by a 500-fold concentration greater than that, given by 10 pg/mL<br />
heptachlor-epoxide.<br />
GC/FID<br />
In the GC-FID chromatogram there are no interfering single signals in the retention time interval between n-octane<br />
(C 8) <strong>and</strong> n-tetracontane (C 40), by a 500-fold concentration greater than that, given by 50 ng/mL n-undecane (C 11).<br />
422 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
High purity solvents <strong>and</strong> acids<br />
Code Product Unit<br />
Water<br />
SO-6795-B025 Water HPLC Optigrade ® 2.5 L<br />
SO-6795-B040 Water HPLC Optigrade ®<br />
4 L<br />
CAS number 7732-18-5<br />
H 2O<br />
Fluorescence (as quinine at 450 nm) .................... 1.10-7 g max.<br />
Non-volatile matter....................................................1 mg/L max.<br />
Filtered through 0.2 µm<br />
pH ................................................................................... 5.0 - 8.0<br />
This solvent in glass bottles fulfills the specifications according to chapter 4 of the European Pharmacopoeia.<br />
SO-9662-B010 Water ULC-MS Optigrade ®<br />
1 L<br />
CAS number 7732-18-5<br />
H 2O<br />
Residue after evaporation.....................................0-0.0001 %w/w<br />
Acidity (as Acetic acid)..................................................0-0.002 %<br />
Alkalinity (as Ammonia) ............................................0-0.00005 %<br />
Resistivity (at manuf.).....................................18.2-100 Mohm*cm<br />
Gradient specification<br />
HPLC gradient at 210 nm - H. Peak ........................... 0-0.002 AU<br />
HPLC gradient at 254 nm - H. Peak ......................... 0-0.0005 AU<br />
Fluorescence at 254 nm (as quinine)............................. 0-0.5 ppb<br />
Fluorescence at 365 nm (as quinine)............................. 0-0.5 ppb<br />
TOC ................................................................................ 0-10 ppb<br />
Filter test .....................................................................Passes test<br />
Ca.................................................................................. 0-0.1 ppm<br />
K.................................................................................... 0-0.1 ppm<br />
Mg ................................................................................. 0-0.1 ppm<br />
Na.................................................................................. 0-0.1 ppm<br />
Microfiltered through 0.1 µm/bottled under inert gas<br />
SO-4661-B025 Water 0.1 % formic acid ULC-MS Optigrade ®<br />
2.5 L<br />
Assay .....................................................................0.095-0.105 %<br />
Purity of formic acid (GC)............................................99.0-100 %<br />
Gradient specification<br />
HPLC gradient at 254 nm - H. Peak ........................... 0-0.002 AU<br />
HPLC gradient at 254 nm - Drift.................................. 0-0.010 AU<br />
Fluorescence at 254 nm (as quinine)............................. 0-0.5 ppb<br />
Fluorescence at 365 nm (as quinine)............................. 0-0.5 ppb<br />
Transmission<br />
at 210 nm .........................................................................5-100 %<br />
at 230 nm .......................................................................45-100 %<br />
at 254 nm .......................................................................99-100 %<br />
Al .................................................................................... 0-30 ppb<br />
Ca.................................................................................. 0-100 ppb<br />
Fe.................................................................................... 0-50 ppb<br />
K.................................................................................... 0-100 ppb<br />
Mg ................................................................................... 0-30 ppb<br />
Na.................................................................................. 0-100 ppb<br />
Microfiltered through 0.1 µm/bottled under inert gas<br />
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High purity solvents <strong>and</strong> acids<br />
Code Product Unit<br />
SO-4667-B025 Water 0.1 % acetic acid ULC-MS Optigrade ®<br />
2.5 L<br />
Assay......................................................................0.095-0.105 %<br />
pH.......................................................................................3.2-3.4<br />
Purity of acetic acid (GC) ............................................99.9-100 %<br />
Gradient specification<br />
HPLC gradient at 254 nm - H. Peak ...........................0-0.002 AU<br />
HPLC gradient at 254 nm - Drift..................................0-0.010 AU<br />
Fluorescence at 254 nm (as quinine).............................0-0.5 ppb<br />
Fluorescence at 365 nm (as quinine).............................0-0.5 ppb<br />
Transmission<br />
at 210 nm .......................................................................20-100 %<br />
at 230 nm .......................................................................75-100 %<br />
at 254 nm .......................................................................99-100 %<br />
Al ....................................................................................0-30 ppb<br />
Ca..................................................................................0-100 ppb<br />
Fe ....................................................................................0-50 ppb<br />
K....................................................................................0-100 ppb<br />
Mg ...................................................................................0-30 ppb<br />
Na..................................................................................0-100 ppb<br />
Microfiltered through 0.1 µm/bottled under inert gas<br />
SO-4673-B025 Water 0.1 % trifluoroacetic acid ULC-MS Optigrade ®<br />
2.5 L<br />
Assay......................................................................0.095-0.105 %<br />
Purity of trifluoroacetic acid (GC) ..............................99.95-100 %<br />
Gradient specification<br />
HPLC gradient at 254 nm - H. Peak ...........................0-0.002 AU<br />
HPLC gradient at 254 nm - Drift..................................0-0.010 AU<br />
Fluorescence at 254 nm (as quinine).............................0-0.5 ppb<br />
Fluorescence at 365 nm (as quinine).............................0-0.5 ppb<br />
Transmission<br />
at 210 nm .......................................................................25-100 %<br />
at 230 nm .......................................................................85-100 %<br />
at 254 nm .......................................................................99-100 %<br />
Al ....................................................................................0-30 ppb<br />
Ca..................................................................................0-100 ppb<br />
Fe ....................................................................................0-50 ppb<br />
K....................................................................................0-100 ppb<br />
Mg ...................................................................................0-30 ppb<br />
Na..................................................................................0-100 ppb<br />
Microfiltered through 0.1 µm/bottled under inert gas<br />
SO-9368-B010 Water for LC-MS Optigrade ® 1 L<br />
SO-9368-B025 Water for LC-MS Optigrade ®<br />
2.5 L<br />
CAS number 7732-18-5<br />
H 2O<br />
Fluorescence (as quinine at 450 nm)...1x10 -7 g max.<br />
Non-volatile matter................................ 1 mg/L max.<br />
pH ................................................................ 5.0 - 8.0<br />
Filtered through 0.2 µm<br />
Ca ....................................................... 0.1 ppm max.<br />
K.......................................................... 0.1 ppm max.<br />
Mg ....................................................... 0.1 ppm max.<br />
Na ....................................................... 0.1 ppm max.<br />
Transmission<br />
at 200 nm - 400 nm................................... 99 % min.<br />
424 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com Edition 2008
Solvent mixtures<br />
Solvent mixtures<br />
Code Product Unit<br />
SO-9534-B040 Mixture cyclohexane/ethyl acetate 1:1 Picograde ® for residue analysis 4 L<br />
SO-9534-C011 Mixture cyclohexane/ethyl acetate 1:1 Picograde ® for residue analysis (Cyclotainer ® ) 10 L<br />
SO-9534-C201<br />
Mixture cyclohexane/ethyl acetate 1:1 Picograde ® for residue analysis<br />
Specification<br />
GC/ECD<br />
In the GC-ECD chromatogram there are no interfering single signals in the retention time interval between 1,4-<br />
dichlorobenzene <strong>and</strong> decachlorobiphenyl, by a 500-fold concentration greater than that, given by 10 pg/mL<br />
heptachlor-epoxide.<br />
GC/FID<br />
In the GC-FID chromatogram there are no interfering single signals in the retention time interval between n-octane<br />
(C 8) <strong>and</strong> n-tetracontane (C 40), by a 500-fold concentration greater than that, given by 50 ng/mL n-undecane (C 11).<br />
200 L<br />
Edition 2008 All your needs for pharmac<strong>eu</strong>tical analysis - email pharma@lgcst<strong>and</strong>ards.com 425
Solvent mixtures<br />
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