The latest edition of The International Pharmacopoeia: Tests and General Requirements for Dosage Forms. Quality Specifications for Pharmaceutical Substances and Tablets describes methods and procedures for the quality control of pharmaceutical substances and dosage forms, including a special section on quality control of anti-malarials, with monographs on most artemisinin derivatives known to date. The International Pharmacopoeia gives priority to medicines for illnesses affecting developing country populations and those listed on the WHO Model List of Essential Medicines.
The monographs can be used in any country or setting. For this purpose, they are designed to cater for both high-technology methods of testing or, when these are not available, for alternative methods which are less technically demanding. Publication of The International Pharmacopoeia is aimed to help regulatory authorities, health services and manufacturers assure the quality of medicines and eliminate substandard products.
The following topics are also included: Tests, methods, and general requirements; Monographs for pharmaceutical substances; Monographs for tablets; Monographs for antimalarial drugs; List of reagents, test solutions, and volumetric solutions; General requirements for dosage forms; Ophthalmic preparations; Suppositories; Tests for dosage forms; Disintegration test for suppositories; Dissolution test for solid oral dosage forms; Test for extractable volume for parenteral preparations; Microbial purity of pharmaceutical preparations; Test for bacterial endotoxins; Test for sterility of non-injectable preparations; Visual inspection of particulate matter injectable preparations.
The International Pharmacopoeia: Tests and General Requirements for Dosage Forms. Quality Specifications for Pharmaceutical Substances and tablets 2003, ISBN 92 4 154536 4 US $85.50 available from WHO, Marketing and Dissemination, 1211 Geneva 27, Switzerland Tel: +4122 791 24 76 - Fax: +41 22 791 48 57 http://bookorders.who.int or firstname.lastname@example.org