supplement ii to the japanese pharmacopoeia fifteenth edition - NIHS

ii Preface Supplement II, JP XVnational Harmonization (3); and Panel on PharmaceuticalWater (8).It should be noted that in the preparation of thedrafts for the supplement, generous cooperation wasgiven by the Technical Committee of the PharmaceuticalManufacturer’s Association of Osaka and of Tokyo,the Tokyo Crude Drugs Association, the JapanPharmaceutical Excipients Council, the Home MedicineAssociation of Japan, the Japan Kampo MedicineManufacturers’ Association, the Japan Flavor and FragranceMaterials Association, the Japan Medical PlantsFederation, the Japan Parental Drug Association, theJapan Reagent Association, the Japan Oilseeds ProcessorsAssociation, and the Association of MembraneSeparation Technology of Japan.In consequence of this revision, the JP 15th Editioncarries 1673 articles, owing to the addition of 106 articlesand the deletion of 1 article.The principles of description and the salient pointsof the revision in this Supplement are as follows:1. The Supplement II to JP 15th Edition comprisesthe following items, in order: Notification of MHLW;Contents; Preface; General Rules for Crude Drugs;General Tests, Official Monographs; Infrared ReferenceSpectra; and Ultraviolet-visible Reference Spectra;then followed by General Information; and as anappendix a Cumulative Index containing references tothe main volume and the Supplements I and II.2. The articles in General Rules for Preparations,Official Monographs, Infrared Reference Spectra andUltraviolet-visible Reference Spectra are respectivelyplaced in alphabetical order.3. The following items in each monograph are putin the order shown below, except that unnecessaryitems are omitted depending on the nature of the drug:(1) English title(2) Commonly used name(s)(3) Latin title (only for crude drugs)(4) Title in Japanese(5) Structural formula or empirical formula(6) Molecular formula and molecular mass(7) Chemical name(8) Origin(9) Limits of the content of the ingredient(s) and/orthe unit of potency(10) Labeling requirements(11) Method of preparation(12) Description/Description of crude drugs(13) Identification tests(14) Specific physical and/or chemical values(15) Purity tests(16) Loss on drying or ignition, or water(17) Residue on ignition, total ash or acid-insolubleash(18) Tests being required for pharmaceutical preparationsand other special tests(19) Isomer ratio(20) Assay or the content of the ingredient(s)(21) Containers and storage(22) Expiration date(23) Others4. In each monograph, the following physical andchemical values representing the properties and qualityof the drug are given in the order indicated below, exceptthat unnecessary items are omitted depending onthe nature of the drug:(1) Alcohol number(2) Absorbance(3) Congealing point(4) Refractive index(5) Osmolarity(6) Optical rotation(7) Viscosity(8) pH(9) Specific gravity(10) Boiling point(11) Melting point(12) Acid value(13) Saponification value(14) Ester value(15) Hydroxyl value(16) Iodine value5. Identification tests comprise the following items,which are generally put in the order given below:(1) Coloration reactions(2) Precipitation reactions(3) Decomposition reactions(4) Derivatives(5) Infrared and/or ultraviolet-visible absorptionspectrometry(6) Special reactions(7) Cations(8) Anions6. Purity tests comprise the following items, whichare generally put in the order given below, except thatunnecessary items are omitted depending on the natureof the drug:(1) Color(2) Odor(3) Clarity and/or color of solution(4) Acidity or alkalinity(5) Acidity