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Chemistry International Vol. 21, No. 3 May 1999 New Books and Publications New Books from the World Health Organization WHO Expert Committee on Biological Standardization, 47th Report, Technical Report Series No. 878 1998, vi + 101 pages (available in English; French and Spanish in preparation), ISBN 92 4 120878 3, CHF 20.-/USD 18.50; In developing countries: CHF 14, Order no. 1100878. WHO distribution and sales, CH-1211 Geneva 27, Switzerland. This report presents the recommendations of a WHO expert committee commissioned to coordinate a range of research and other activities needed to assure the purity, potency, safety, and stability of biological products used in medicine. Work includes the development and adoption of detailed requirements for the manufacturing, licensing, and control of vaccines and other biologicals. The committee also coordinates the establishment of international reference materials for measuring the potency and other characteristics of biological products. These reference materials are used worldwide and play a crucial role in ensuring the comparability of products on a global basis. The report has three parts. The first provides a brief discussion of general issues that shape the committee's work. Issues discussed include the implications of reverse transcriptase activity in avian cells, the need for reference preparations for evaluating hepatitis B, hepatitis C, and HIV diagnostic kits, and progress toward the standardization of gene-amplification methods for the viral safety testing of blood and blood products. The second part summarizes activities relating to the status of some 24 biological reference preparations categorized as antibiotics, antibodies, blood products and related substances, cytokines, endocrinological and related substances, toxins, and other substances. The third and most extensive part issues detailed requirements for the use of animal cells as in vitro substrates for the production of biologicals, guidelines for the production and control of the acellular pertussis component of monovalent or combined vaccines, and guidelines for assuring the quality of DNA vaccines. Basic Tests for Drugs, Pharmaceutical Substances, Medicinal Plant Materials, and Dosage Forms 1998, iii + 91 pages (available in English; French and Spanish in preparation) ISBN 92 4 154513 5 CHF 26.-/USD 23.40; In developing countries: CHF 18.20, Order no. 1150462 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 2 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. Quality Control Methods for Medicinal Plant Materials 1998, viii + 115 pages (available in English; French and Spanish in preparation), ISBN 92 4 154510 0, CHF 35.-/USD 31.50; In developing countries: CHF 24.50, Order no. 1150451. This manual provides a collection of recommended test procedures for assessing the identity, purity, and content of medicinal plant materials. Intended to assist national laboratories engaged in drug quality control, the manual responds to the growing use of medicinal plants, the special quality problems they pose, and the corresponding need for international guidance on reliable methods for quality control. Recommended procedures-whether involving visual inspection or the use of thin-layer chromatography for the qualitative determination of impurities-should also prove useful to the pharmaceutical industry and pharmacists working with medicinal plant materials. Test procedures are intended to support the development of national standards based on local market conditions, with due regard to existing national legislation and national and regional norms. The book also includes advice on general limits for pesticides and other contaminants commonly found in medicinal plant materials. The book opens with a brief discussion of general principles for the analysis of plant materials, including advice on the special handling procedures required during sampling, and guidance on macroscopic and microscopic examination as the first step toward establishing the identity and degree of purity of plant materials. Subsequent chapters describe procedures for the determination of foreign matter, ash, extractable matter, water and volatile matter, volatile oils, bitterness value, haemolytic activity, tannins, swelling index, and foaming index. Where relevant, suitable test apparatuses are illustrated and explained. Additional chapters set out test methods for the determination of such important contaminants as pesticide residues, arsenic and heavy metals, and microorganisms, including aflatoxins. The remaining chapters cover procedures for preparing culture media, strains of microorganisms suitable for use in tests, specifications for adsorbents for use in thin-layer chromatography, and detailed descriptions of the reagents, test solutions, and volumetric solutions used in the recommended tests.

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