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The Laboratory of Siam Bheasach Co., Ltd. has been accepted as ...

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<strong>The</strong> <strong>Laboratory</strong> <strong>of</strong> <strong>Siam</strong> <strong>Bhe<strong>as</strong>ach</strong> <strong>Co</strong>., <strong>Ltd</strong>. <strong>h<strong>as</strong></strong> <strong>been</strong> <strong>accepted</strong> <strong>as</strong> an<br />

accredited laboratory in the field <strong>of</strong> drug testing for the following scopes.<br />

Type <strong>of</strong> Sample Test Method<br />

1. Ceftriaxone sodium sterile - Appearance - In-house Method WI-QC-TM-01<br />

Cef-3 Inj. (250-IM)<br />

by visual technique<br />

Cef-3 Inj. (250-IV) - Average weight per unit - In-house Method WI-QC-TM-01<br />

Cef-3 Inj. (500-IM)<br />

by weight technique<br />

Cef-3 Inj. (500-IV)<br />

- Assay & potency<br />

Cef-3 Inj. (1 g-IM)<br />

Cef-3 Inj. (1 g-IV)<br />

- Uniformity <strong>of</strong> dosage unit<br />

- pH<br />

- Water content<br />

- Particulate matter<br />

- Crystallinity<br />

- Sterility<br />

- Bacterial endotoxin<br />

- Identification<br />

- <strong>Co</strong>nstituted solution<br />

USP 30 / NF 25 : 2007<br />

2. Ceftazidime pentahydrate - Appearance - In-house Method WI-QC-TM-01<br />

Buffer (sodium carbonate)<br />

by visual technique<br />

Cef-4 500 mg Inj. - Average weight per unit - In-house Method WI-QC-TM-01<br />

Cef-4 1 g Inj.<br />

by weighing technique<br />

- Assay & Potency<br />

- Uniformity <strong>of</strong> dosage unit USP 30 / NF 25 : 2007<br />

- pH<br />

Bureau <strong>of</strong> <strong>Laboratory</strong> Quality Standards Page 1 <strong>of</strong> 8<br />

Accreditation Number 1012/45<br />

Date <strong>of</strong> Accreditation : 20 January 2011<br />

Date <strong>of</strong> Expiration : 19 January 2014


<strong>The</strong> <strong>Laboratory</strong> <strong>of</strong> <strong>Siam</strong> <strong>Bhe<strong>as</strong>ach</strong> <strong>Co</strong>., <strong>Ltd</strong>. <strong>h<strong>as</strong></strong> <strong>been</strong> <strong>accepted</strong> <strong>as</strong> an<br />

accredited laboratory in the field <strong>of</strong> drug testing for the following scopes.<br />

Type <strong>of</strong> Sample Test Method<br />

2. Ceftazidime pentahydrate - Loss on drying<br />

Buffer (sodium carbonate)<br />

Cef-4 500 mg Inj.<br />

Cef-4 1 g Inj.<br />

(<strong>Co</strong>ntinued)<br />

- Particulate matter<br />

- Pyridine content<br />

- Sterility<br />

- Bacterial endotoxin<br />

- <strong>Co</strong>nstituted solution<br />

- Identification<br />

- Sodium carbonate content<br />

USP 30 / NF 25 : 2007<br />

3. Cefotaxime sodium sterile - Appearance - In-house Method WI-QC-TM-01<br />

Claraxim 0.5 gm Inj.<br />

by visual technique<br />

Claraxim 1.0 gm Inj. - Average weight per unit - In-house Method WI-QC-TM-01<br />

by weight technique<br />

- Assay & Potency<br />

- Uniformity <strong>of</strong> dosage unit<br />

- pH<br />

- Loss on drying<br />

USP 30 / NF 25 : 2007<br />

- Particulate matter<br />

- Sterility<br />

- Bacterial endotoxin<br />

- <strong>Co</strong>nstituted solution<br />

- Identification<br />

- Chromatographic purity<br />

Bureau <strong>of</strong> <strong>Laboratory</strong> Quality Standards Page 2 <strong>of</strong> 8<br />

Accreditation Number 1012/45<br />

Date <strong>of</strong> Accreditation : 20 January 2011<br />

Date <strong>of</strong> Expiration : 19 January 2014


<strong>The</strong> <strong>Laboratory</strong> <strong>of</strong> <strong>Siam</strong> <strong>Bhe<strong>as</strong>ach</strong> <strong>Co</strong>., <strong>Ltd</strong>. <strong>h<strong>as</strong></strong> <strong>been</strong> <strong>accepted</strong> <strong>as</strong> an<br />

accredited laboratory in the field <strong>of</strong> drug testing for the following scopes.<br />

Type <strong>of</strong> Sample Test Method<br />

4. Acyclovir - Average weight per unit - In-house Method WI-QC-TM-01<br />

Vilerm 200 mg Tablet<br />

Vilerm 400 mg Tablet<br />

Vilerm 800 mg Tablet<br />

- Uniformity <strong>of</strong> dosage unit<br />

(Weight variation)<br />

- Assay<br />

- Friability<br />

- Disintegration<br />

- Dissolution<br />

- Related compounds<br />

* Guanine<br />

* Any other impurity<br />

- Identification<br />

by weight technique<br />

USP 32 / NF 27 : 2009<br />

5. Enalapril maleate - Average weight per unit - In-house Method WI-QC-TM-01<br />

Nalopril 5 mg Tablet by weighing technique<br />

Nalopril 10 mg Tablet<br />

Nalopril 20 mg Tablet<br />

- Uniformity <strong>of</strong> dosage unit<br />

(<strong>Co</strong>ntent Uniformity)<br />

- Assay<br />

- Disintegration<br />

USP 33 / NF 28 : 2010<br />

- Related compounds (Total)<br />

- Dissolution<br />

- Identification<br />

- Friability<br />

Bureau <strong>of</strong> <strong>Laboratory</strong> Quality Standards Page 3 <strong>of</strong> 8<br />

Accreditation Number 1012/45<br />

Date <strong>of</strong> Accreditation : 20 January 2011<br />

Date <strong>of</strong> Expiration : 19 January 2014


<strong>The</strong> <strong>Laboratory</strong> <strong>of</strong> <strong>Siam</strong> <strong>Bhe<strong>as</strong>ach</strong> <strong>Co</strong>., <strong>Ltd</strong>. <strong>h<strong>as</strong></strong> <strong>been</strong> <strong>accepted</strong> <strong>as</strong> an<br />

accredited laboratory in the field <strong>of</strong> drug testing for the following scopes.<br />

Type <strong>of</strong> Sample Test Method<br />

6. Sulcef Injection - Appearance - In-house Method WI-QC-TM-01<br />

Cefoperazone Sodium<br />

by visual technique<br />

Sulbactam Sodium - Average weight per unit - In-house Method WI-QC-TM-01<br />

by weighing technique<br />

- Uniformity <strong>of</strong> dosage unit<br />

(<strong>Co</strong>ntent Uniformity)<br />

- pH (25% solution)<br />

- Water content<br />

- <strong>Co</strong>nstituted solution USP 31 / NF 26 : 2008<br />

- Particulate matter<br />

- Sterility<br />

- Bacterial endotoxin<br />

- Identification<br />

- Chromatographic purity - In-house Method WI-QC-<br />

- Assay and Potency TM-01 by HPLC technique<br />

7. Isosorbide dinitrate - Average weight per unit - In-house Method WI-QC-TM-01<br />

Hartsorb 5 mg Tablet by weighing technique<br />

(Sublingual)<br />

Hartsorb 10 mg Tablet<br />

Hartsorb 30 mg Tablet<br />

Bureau <strong>of</strong> <strong>Laboratory</strong> Quality Standards Page 4 <strong>of</strong> 8<br />

Accreditation Number 1012/45<br />

Date <strong>of</strong> Accreditation : 20 January 2011<br />

Date <strong>of</strong> Expiration : 19 January 2014


<strong>The</strong> <strong>Laboratory</strong> <strong>of</strong> <strong>Siam</strong> <strong>Bhe<strong>as</strong>ach</strong> <strong>Co</strong>., <strong>Ltd</strong>. <strong>h<strong>as</strong></strong> <strong>been</strong> <strong>accepted</strong> <strong>as</strong> an<br />

accredited laboratory in the field <strong>of</strong> drug testing for the following scopes.<br />

Type <strong>of</strong> Sample Test Method<br />

7. Isosorbide dinitrate - Assay<br />

Hartsorb 5 mg Tablet - Uniformity <strong>of</strong> dosage unit<br />

(Sublingual)<br />

(<strong>Co</strong>ntent Uniformity)<br />

USP 33 / NF 28 : 2010<br />

Hartsorb 10 mg Tablet<br />

Hartsorb 30 mg Tablet<br />

(<strong>Co</strong>ntinued)<br />

- Friability<br />

- Disintegration<br />

- Dissolution<br />

- Identification<br />

8. Simv<strong>as</strong>tatin - Average weight per unit - In-house Method WI-QC-TM-01<br />

Lochol 10 mg Tablet<br />

Lochol 20 mg Tablet<br />

Lochol 40 mg Tablet<br />

Lochol 80 mg Tablet<br />

- Assay<br />

- Uniformity <strong>of</strong> dosage unit<br />

(<strong>Co</strong>ntent Uniformity)<br />

- Disintegration<br />

- Dissolution<br />

- Identification<br />

by weight technique<br />

USP 31 / NF 26 : 2008<br />

9. Sterile water for injection - Chloride<br />

- Sulfate<br />

- Calcium USP 30 / NF 25 : 2007<br />

- Carbondioxide<br />

- Oxidizable substance<br />

Bureau <strong>of</strong> <strong>Laboratory</strong> Quality Standards Page 5 <strong>of</strong> 8<br />

Accreditation Number 1012/45<br />

Date <strong>of</strong> Accreditation : 20 January 2011<br />

Date <strong>of</strong> Expiration : 19 January 2014


<strong>The</strong> <strong>Laboratory</strong> <strong>of</strong> <strong>Siam</strong> <strong>Bhe<strong>as</strong>ach</strong> <strong>Co</strong>., <strong>Ltd</strong>. <strong>h<strong>as</strong></strong> <strong>been</strong> <strong>accepted</strong> <strong>as</strong> an<br />

accredited laboratory in the field <strong>of</strong> drug testing for the following scopes.<br />

Type <strong>of</strong> Sample Test Method<br />

9. Sterile water for injection - pH<br />

(<strong>Co</strong>ntinued)<br />

- Volume in container<br />

- Particulate matter<br />

- Sterility USP 30 / NF 25 : 2007<br />

- Bacterial endotoxin<br />

- Ammonia<br />

10. Meropenem injection - Assay Meropenem<br />

(Mapenem 0.5 g injection,<br />

Mapenem 1.0 g injection)<br />

- Uniformity <strong>of</strong> dosage unit<br />

- pH<br />

- Loss on drying<br />

- Particulate matter<br />

USP 32 / NF 27 : 2009<br />

- <strong>Co</strong>ntent <strong>of</strong> sodium<br />

- Chromatographic purity<br />

- <strong>Co</strong>nstituted solution<br />

- Sterility test<br />

- Bacterial endotoxin<br />

- Identification<br />

Bureau <strong>of</strong> <strong>Laboratory</strong> Quality Standards Page 6 <strong>of</strong> 8<br />

Accreditation Number 1012/45<br />

Date <strong>of</strong> Accreditation : 20 January 2011<br />

Date <strong>of</strong> Expiration : 19 January 2014


<strong>The</strong> <strong>Laboratory</strong> <strong>of</strong> <strong>Siam</strong> <strong>Bhe<strong>as</strong>ach</strong> <strong>Co</strong>., <strong>Ltd</strong>. <strong>h<strong>as</strong></strong> <strong>been</strong> <strong>accepted</strong> <strong>as</strong> an<br />

accredited laboratory in the field <strong>of</strong> drug testing for the following scopes.<br />

Type <strong>of</strong> Sample Test Method<br />

11. Powder injection<br />

- Cavumox 1.2 g<br />

(Amoxicillin sodium +<br />

Clavulanic acid)<br />

- Cavumox 0.6 g<br />

(Amoxicillin sodium +<br />

Clavulanic acid)<br />

- Fazolin<br />

(Cefazolin sodium)<br />

- Cefxitin<br />

(Cefoxitin sodium)<br />

Sterility test<br />

Bacterial endotoxin test<br />

USP 32 / NF 27 : 2009<br />

- Furoxime<br />

(Cefuroxime sodium)<br />

- Sulam<br />

(Cefoperazone sodium +<br />

Sulbactam sodium)<br />

- Vilerm<br />

(Acyclovir sodium)<br />

- O – sid<br />

(Omeprazole sodium)<br />

Bureau <strong>of</strong> <strong>Laboratory</strong> Quality Standards Page 7 <strong>of</strong> 8<br />

Accreditation Number 1012/45<br />

Date <strong>of</strong> Accreditation : 20 January 2011<br />

Date <strong>of</strong> Expiration : 19 January 2014


<strong>The</strong> <strong>Laboratory</strong> <strong>of</strong> <strong>Siam</strong> <strong>Bhe<strong>as</strong>ach</strong> <strong>Co</strong>., <strong>Ltd</strong>. <strong>h<strong>as</strong></strong> <strong>been</strong> <strong>accepted</strong> <strong>as</strong> an<br />

accredited laboratory in the field <strong>of</strong> drug testing for the following scopes.<br />

Type <strong>of</strong> Sample Test Method<br />

12. Small volume injection<br />

- Dosanac<br />

(Dicl<strong>of</strong>enac sodium)<br />

- Furetic – S<br />

(Furosemide sodium),<br />

- Inopin (Dopamine HCl),<br />

- Nausil (Metoclopramide HCl), Sterility test USP 32 / NF 27 : 2009<br />

- Onsia (Ondansetron HCl), Bacterial endotoxin test<br />

- Zantidon (Ranitidine HCl),<br />

- Lidocaine HCl 1%<br />

(Lidocaine HCl),<br />

- Solvent for O – Sid<br />

(Polyethylene Glycol 400),<br />

- Flucozole (Fluconazole)<br />

13. Large volume injection<br />

- Metrolex (Metronidazole), Sterility test USP 32 / NF 27 : 2009<br />

- Glyceol (Glycerine) Bacterial endotoxin test<br />

Bureau <strong>of</strong> <strong>Laboratory</strong> Quality Standards Page 8 <strong>of</strong> 8<br />

Accreditation Number 1012/45<br />

Date <strong>of</strong> Accreditation : 20 January 2011<br />

Date <strong>of</strong> Expiration : 19 January 2014

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