International Pharmacopoeia Tests, Methods, and General Requirements Quality Specifications for Pharmaceutical Substances, Excipients, and Dosa

This volume in the third edition of THE INTERNATIONAL PHARMACOPOEIA provides a collection of recommended quality specifications & methods of analysis for selected pharmaceutical products, excipients, & dosage forms. Recommended procedures are intended to serve as source material for reference or adaptation by any WHO Member State wishing to establish pharmacopoeial requirements. Tests described in the volume are designed to determine impurities on which attention should be focused, to fix the limits of those that are tolerable to a certain extent, & to indicate methods for ensuring the absence of those that are undesirable. In most cases, recommended tests rely on simple, classical chemical techniques suitable for use in developing countries. The volume has two parts. The first offers guidance on the correct performance & application of certain general tests & other methods used in quality control, followed by general requirements pertaining to the testing of different dosage forms. The second & most extensive part presents monographs for 24 substances included in the WHO Model List of Essential Drugs. Each monograph provides exact instructions concerning which tests are required & which method should be used.WHO Staff is the author of 'International Pharmacopoeia Tests, Methods, and General Requirements Quality Specifications for Pharmaceutical Substances, Excipients, and Dosa', published 1994 under ISBN 9789241544627 and ISBN 9241544627.