Basic Tests for Drugs: Pharmaceutical Substances, Medicinal Plant Materials and Dosage forms
Publication hors sÚrie
World Health Organization
ISBN-13    9789241545136 ISBN-10    9241545135
Order Number    11500462   
Price    CHF    26.00 / US$    31.20 Developing countries:    CHF    18.20
English     1998        94   pages
Table of contents
Related Publications
Translation(s) available
This book provides a step-by-step guide to simple methods for verifying the identity of commonly used pharmaceutical substances and dosage forms. The basic tests described can also be used to detect mislabelled, substandard, or counterfeit products when the labelling or physical attributes give rise to doubt. Intended for use in developing countries, where resources and specialized skills may be scarce, all tests rely on a limited range of easily available reagents and equipment and need not be performed in a fully equipped laboratory or by persons with specialized training in pharmacy or chemistry.
The book describes tests for 23 pharmaceutical substances and 58 pharmaceutical dosage forms, most of which are included in the WHO Model List of Essential Drugs. Basic tests for confirming the identity of four commonly used medicinal plant materials are also included. As stressed in the text, these tests, which merely confirm identity, are intended for use as primary screening tools and may need to be followed, in cases of adverse test results, by a full pharmacopoeial analysis.
The book opens with a brief description of the importance of basic tests as one of the many steps needed to ensure a supply of safe and effective drugs. Chapter two describes several collections of more sophisticated tests, including volumetric or spectrophotometric analysis and thin-layer chromatography, that can be useful in the primary screening of imported pharmaceutical substances and dosage forms. Information on how to obtain and use these guides to tests, which have not been published by WHO, is also provided.
Against this background, the main part of the book sets out test procedures for verifying the identity of selected pharmaceutical substances, pharmaceutical dosage forms, and medicinal plant materials. The book concludes with a cumulative index of test procedures described here and in the related WHO publications, Basic Tests for Pharmaceutical Substances and Basic Tests for Pharmaceutical Dosage Forms.