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The International Pharmacopoeia The International Pharmacopoeia THIRD EDITION Pharmacopoea internationalis Editio tertia Volume 4 Tests, methods, and general requirements Quality specifications for pharmaceutical substances, excipients, and dosage forms World Health Organization Geneva 1994 WHO Library Cataloguing in Publication Data The International Pharmacopoeia.- 3rd ed. Contents: v. 4. Tests, methods, and general requirements 1. Drugs -analysis 2. Drugs -standards ISBN 92 4 154462 7 (NLM Classification: QV 25) The World Health Organization welcomes requests for permission to reproduce or translate its publica- tions, in part or in full. Applications and enquiries should be addressed to the Of£ice of Publications, World Health Organization, Geneva, Switzerland, which will be glad to provide the latest information on any changes made to the text, plans for new editions, and reprints and translations already available. O World Health Organization, 1994 Publications of the World Health Organization enjoy copyright protection in accordance with the provi- sions 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 distin- guished by initial capital letters. Printed in Switzerland 9y9598-Atar-8MX) Contents Preface ix Acknowledgements xii General notices 1 Abbreviations and symbols 9 Tests, methods, and general requirements 13 Monographs for pharmaceutical substances 5 1 Monographs for excipients 105 Monographs for dosage forms 217 List of reagents, test solutions, and volumetric solutions 293 Amendments and corrigenda to Volumes 1,2, and 3 311 Index 319 Tests, methods, and general requirements 13 Test for sterility Methods of sterilization Atomic emission and absorption spectrometry General requirements for substances Hydroxyl value General requirements for dosage forms Tablets Capsules Parenteral preparations Disintegration test for tablets and capsules Topical semi-solid dosage forms Uniformity of content for single-dose preparations Uniformity of mass for single-dose preparations iii The International Pharmacopoeia Monographs for pharmaceutical substances (Latin names) Acidum iopanoicum Aluminii sulfas Calaminum Cisplatinum Dactinomycinum Homatropini methylbromidum Imipramini hydrochloridum Insulinum Iohexolum Ketamini hydrochloridum Magnesii sulfatis heptahydras Medroxyprogesteroni acetas Mercaptopurinum Natrii amidotrizoas Norethisteroni enantas Podophylli resina Propyliodonum Tamoxifeni citras Thiopentalum natricum Timololi maleas Vinblastini sulfas Substances undergoing chemical changes during formulation Acidum amidotrizoicum Acidum iotroxicum Megluminum Monographs for excipients (Latin names) Acidum aceticurn Acidum alginicum Acidum citricum Acidum hydrochloricum Acidum hydrochloricum dilutum Acidum lacticum Adeps lanae Adeps solidus Alcohol benzylicus Alcohol cetylicus Alcohol cetylstearylicus Alcoholum Aluminii magnesii silicas Amyla Aqua purificata Aqua pro injectione Aqua sterilisata pro injectione Bentoniturn Benzalkonii chloridum Benzylis hydroxybenzoas Butylhydroxyanisolum Butylhydroxytoluenum Calcii hydr~~enophosphas Calcii phosphas Calcii stearas Calcii sulfas Carbomerum Carmellosum natricum Cellacefatum Cellulosum microcrystallinum Cera carnauba Cera cetyla Cetomacrogolum 1000 Cetrimidum Chlorobutanolum Chlorocresolum Dinatrii edetas Ethanolum EthylceUulosum Ethylis hydroxybenzoas G elatina Glyceroli monostearas Glycerolum Glycerolum 85% m/m Gummi arabicum Hydroxyethylcellulosum Hydroxypropylcellulosum Hypromellosum Kaolinurn Lactosum Magnesii stearas Methylcellulosum The International Pharmacopoeia Methylis hydroxybenzoas Natrii hydroxydum Oleum arachidis Paraffinum album, Paraffinum flavum Paraffinum durum Phenylhydrargyri nitras Polysorbata 20,60, 80 Polyvidonum 2-Propanolum Propyleneglycolum Propylis hydroxybenzoas Saccharinum natricum Talcum Monographs for dosage forms (Latin names) 217 Oral Rehydration Salts Sales perorales ad rehydratationem Capsules Arnpicillini capsulae Cloxacillini natrici capsulae Tablets Acidi acetylsalicylici compressi Atropini sulfatis compressi Chloroquini phosphatis compressi Chloroquini sulfatis compressi Chlorphenamini hydrogenomaleatis compressi Dapsoni compressi Diethylcarbamazini dihydrogenocitratis compressi Ergometrini hydrogenomaleatis compressi Glycerylis trinitratis compressi Griseofulvini compressi Mebendazoli compressi Metronidazoli compressi Niclosamidi compressi Nitrofurantoini compressi Nystatini compressi Paracetamoli compressi Phenoxymethylpenicillinikalici compressi Piperazini adipatis compressi Piperazini citratis compressi Primaquini diphosphatis compressi Probenecidi compressi Pyrazinamidi compressi Injections Ephedrini sulfatis injectio Ergometrini hydrogenomaleatis injectio Melarsoproli injectio Metronidazoli injectio Prednisoloni et natrii phosphatis injectio Quinini dihydrochloridi injectio Powders for injections Amphotericini B pulvis ad injectionem Ampicillini natrici pulvis ad injectionem Benzylpenicillini kalici pulvis ad injectionem Cloxacillini natrici pulvis ad injectionem Pentamidini isetionatis pulvis ad injectionem Prednisoloni et natrii succinatis pulvis ad injectionem Procaini benzylpenicillini pulvis ad injectionem Streptomycini sulfatis pulvis ad injectionem vii Preface The International Pharmacopoeia1 comprises a collection of recommended procedures for the analysis and specifications for the determination of pharmaceutical sub- stances, excipients, and dosage forms that are intended to serve as source material for reference or adaptation by any WHO Member States wishing to establish pharmacopoeial requirements. They are meant to have legal status only if a national authority expressly introduces them into appropriate legislation. The policies and aims of the third edition of The International Pharmacopoeia, together with general notices and methods of analysis, are set out in detail in the prefaces to previous volume^.^ Increasingly, the selection of monographs is deter- mined by those substances included in the current WHO Model List of Essential drug^.^ Volumes 2 and 3 of this edition already contain monographs for the majority of substances included in the Model List and this policy will continue to be adhered to in the future. Pharmaceutical substances and dosage forms for human use, as described in a monograph of The International Pharmacopoeia, should be manufactured according to the requirements of Good Manufacturing Practices (GMP), whether those recom- mended by WHO or those laid down by the competent national (regional) author- ity in the country of manufacture. The processes; premises, and installations should also comply with the provisions of the product licence or marketing authorization, relevant regulations and, in the case of products destined for export, with any binding international norms that would affect their entry onto the market. In many cases this compliance cannot be verified by analysing a sample of the final product against a pharmacopoeial monograph. The national authority will need to ensure that these instructions have been followed by any means at its disposal, including inspection of the manufacturing site or testing of samples beyond specifications. Pharmaceutical preparations that are produced on a large scale and will be stored before use should undergo testing to show physical and chemical stability during storage over the claimed shelf-life. Published in accordance with World Health Assembly resoIution WHA3.10, WOHandbook ofResolu- tions and Decisions, Vol. 1, 1973, p. 127. The International Pharmacopoeia, 3rd ed. Geneva, World Health Organization. Volume 1: General methods ofanalysis, 1979. Volume 2: Quality specifications, 1981. Volume 3: Quality specifications, 1988. WHO Technical Report Series, No. 825, 1992. The International Pharmacopoeia The requirements of the monographs are not Eramed to detect all possible impurities. The present tests are designed to determine impurities on which attention should be focused, to fix the limits of those that are tolerable to a certain extent, and to indicate methods for ensuring the absence of those that are undesirable. It is therefore not to be presumed that animpurity can be tolerated because it has not been precluded by the prescribed tests. In some purity tests, limits are indicated addition- ally in brackets in percentage terms: such limits are given for information only. The degree of protection provided by compendia1 standards will depend not only on their technical content but also to a great extent on how they are utilized. Pharmacopoeias are general compilations of established specifications for pharma- ceutical substances and dosage forms to which all products are required to comply throughout their established shelf-life. The specified tolerances and limits allow for the inevitable variations that occur during production and packaging, as well as for subsequent degradation within normal limits and for any analytical
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