Basic Tests for Drugs: Pharmaceutical Substances, Medicinal Plant Materials and Dosage Forms
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 mislabeled, substandard, or counterfeit products when the labeling 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".
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above-calculated equivalent amount add 1 drop add 1 ml add an excess allow to stand ammonia ammonia 100 amount equivalent barium chloride Basic tests beclometasone dipropionate calculate the amount chloride 25 g/1 colour is produced cool cromoglicate curdy precipitate dichloromethane ethanol ethanol 750 ethyl acetate ferric chloride filtrate add heat hydrochloric acid hydrochloric acid 70 hydrochloride hydroxide 80 g/1 Identity tests Colour Identity tests Description INJECTION Description METHYLROSANILINIUM CHLORIDE minutes ml of ethanol ml of hydrochloric ml of nitric ml of silver ml of sodium ml of sulfuric ml of water nichrome nitrate 40 g/1 nitric acid nitric acid 130 nystatin Pool the contents precipitate dissolves precipitate is produced reactions sample silver nitrate silver nitrate 40 sodium hydroxide sodium hydroxide 80 sodium nitrite sodium nitroprusside solution is produced solution usually containing suitable vehicle sulfate sulfuric acid sulfuric acid 1760 test solution add test substance add water and add water-bath white precipitate