WHO Technical Report Series
885
World Health Organization
Geneva 1999
This report contains the collective views of an international group of experts and does not necessarily represent the decisions or the stated policy of the World Health Organization
The World Health Organization was established in 1948 as a specialized agency of the United Nations serving as the directing and coordinating authority for international health matters and public health. One of WHO's constitutional functions is to provide objective and reliable information and advice in the field of human health, a responsibility that it fulfils in part through its extensive programme of publications.
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The WHO Technical Report Series makes available the findings of various international groups of experts that provide WHO with the latest scientific and technical advice on a broad range of medical and public health subjects. Members of such expert groups serve without remuneration in their personal capacities rather than as representatives of governments or other bodies; their views do not necessarily reflect the decisions or the stated policy of WHO. An annual subscription to this series, comprising about 10 such reports, costs Sw. fr. 132.- (Sw. fr. 92.40 in developing countries).
WHO Library Cataloguing in Publication Data
WHO Expert Committee on Specifications for Pharmaceutical Preparations (1997: Geneva, Switzerland) WHO Expert Committee on Specifications for Pharmaceutical Preparations: thirty-fifth report.
(WHO technical report series: 885)
1. Pharmaceutical preparations - standards 2. Drug industry 3. Quality control
4. Reference standards 5. Legislation, Drug 6. Guidelines I. Title II. Series
ISBN 92 4 120885 6 (Classification NLM: QV 771)
ISSN 0512-3054
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© World Health Organization 1999
Publications of the World Health Organization enjoy copyright protection in accordance with the provisions of Protocol 2 of the Universal Copyright Convention, All rights reserved.
The designations employed and the presentation of the material in this publication do not imply the expression of any opinion whatsoever on the part of the Secretariat of the World Health Organization concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of Its frontiers or boundaries.
The mention of specific companies or of certain manufacturers' products does not imply that they are endorsed or recommended by the World Health Organization in preference to others of a similar nature that are not mentioned. Errors and omissions excepted, the names of proprietary products are distinguished by initial capital letters.
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Printed in Spain
98/12121 - Best-set/Fotojae - 6500
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