The International Pharmacopoeia [Vol 5] 3rd ed (WHO, 2003) WW.pdf

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The International
Pharmacopoeia
THIRD EDITION
Pharmacopoea internationalis
Editio tertia
Volume 5
Tests and general requirements for dosage forms
Quality specifications for pharmaceutical substances
and tablets
World Health Organization
Geneva
2003
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WHO Library Cataloguing-in-Publication Data
The International pharmacopoeia. Vol. 5, Tests and general requirements for dosage forms; Quality
specifications for pharmaceutical substances and dosage forms. – 3 rd ed.
1.Dosage forms – standards 2.Pharmaceutical preparations – analysis 3.Pharmaceutical prepa-
rations – standards 4.Antimalarials – standards 5.Tablets – standards I.World Health Organi-
zation II.Title: Tests and general requirements for dosage forms III.Title: Quality specifications
for pharmaceutical substances and dosage forms.
ISBN 92 4 154536 4
(NLM classification: QV 738 MW6)
© World Health Organization 2003
All rights reserved. Publications of the World Health Organization can be obtained from
Marketing and Dissemination, World Health Organization, 20 Avenue Appia, 1211 Geneva 27,
Switzerland (tel: +41 22 791 2476; fax: +41 22 791 4857; email: bookorders@who.int ). Requests for
permission to reproduce or tanslate WHO publication – whether for sale or for noncommercial dis-
tribution – should be addressed to Publications, at the above address (fax: +41 22 791 4806; email:
permissions@who.int).
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 World Health Organization concern-
ing the legal status of any country, territory, city or area or of its authorities, or concerning the
delimitation of its frontiers or boundaries. Dotted lines on maps represent approximate border lines
for which there may not yet be full agreement.
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.
The World Health Organization does not warrant that the information contained in this publica-
tion is complete and correct and shall not be liable for any damages incurred as a result of its use.
Typeset in Hong Kong
Printed in Spain
2000/13312 – SNP Best-set/Policrom – 6500
 
Contents
Preface
vii
History
xi
Acknowledgements
xiv
General notices
1
Abbreviations and symbols
2
Tests, methods, and general requirements
5
Monographs for pharmaceutical substances
37
Monographs for tablets
147
Monographs for antimalarial drugs
185
List of reagents, test solutions, and volumetric solutions
235
Amendments and corrigenda to Volumes 1, 2, 3, and 4
255
Supplementary information
315
Index
343
Tests, methods, and general requirements
5
General requirements for dosage forms
7
Ophthalmic preparations
7
Requirements for specific types of ophthalmic
preparations
Suppositories
11
Disintegration test for suppositories
14
Dissolution test for solid oral dosage forms
18
Test for extractable volume for parenteral preparations
27
Microbial purity of pharmaceutical preparations
28
Test for bacterial endotoxins
30
Test for sterility of non-injectable preparations
32
Visual inspection of particulate matter in injectable
preparations
33
iii
9
Tests for dosage forms
14
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The International Pharmacopoeia
Monographs for pharmaceutical substances (Latin names)
37
Albendazolum
39
Alcuronii chloridum
41
Amoxicillinum trihydricum
43
Atenololum
47
Benznidazolum
49
Benzoylis peroxidum cum aqua
51
Captoprilum
54
Chlorali hydras
57
Chloramphenicoli natrii succinas
58
Ciclosporinum
62
Ciprofloxacini hydrochloridum
65
Ciprofloxacinum
68
Clindamycini phosphas
71
Dacarbazinum
74
Diethyltoluamidum
77
Dinitrogenii oxidum
78
Dithranolum
86
Erythromycini lactobionas
90
Etoposidum
92
Heparinum calcicum
95
Heparinum natricum
99
Idoxuridinum
102
Isosorbidi dinitras dilutus
105
Ketoconazolum
108
Levamisoli hydrochloridum
110
DL -Methioninum
112
Methylrosanilinii chloridum
114
Metronidazoli benzoas
117
Nifedipinum
119
Nonoxinolum 9
122
Oxygenium
126
Prednisoloni natrii phosphas
132
Protamini sulfas
135
Retinolum densatum oleosum
138
Selenii disulfidum
140
Sulfadiazinum argentum
142
Tropicamidum
144
iv
 
Contents
Monographs for tablets (Latin names)
147
Allopurinoli compressi
149
Carbamazepini compressi
150
Codeini phosphatis compressi
152
Colchicini compressi
153
Dexamethasoni compressi
155
Diloxanidi furoatis compressi
157
Doxycyclini hyclatis compressi
159
Erythromycini ethylsuccinatis compressi
161
Erythromycini stearatis compressi
163
Ethambutoli hydrochloridi compressi
165
Ibuprofeni compressi
167
Indometacini compressi
168
Isoniazidi compressi
170
Morphini sulfatis compressi
171
Pethidini hydrochloridi compressi
172
Phenobarbitali compressi
174
Phenytoini natrici compressi
176
Praziquanteli compressi
177
Prednisoloni compressi
179
Pyranteli embonatis compressi
181
Monographs for antimalarial drugs (Latin names)
185
Artemetherum
187
Artemetheri capsulae
190
Artemetheri compressi
193
Artemetheri injectio
195
Artemisininum
198
Artemisinini capsulae
202
Artemisinini compressi
205
Artemotilum
209
Artemotili injectio
212
Artenimolum
215
Artenimoli compressi
218
Artesunatum
222
Artesunati compressi
225
Mefloquini hydrochloridum
228
Proguanili hydrochloridum
231
v
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