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Handbook of
Pharmaceutical
Excipients
Fifth Edition
Edited by
Raymond C Rowe, Paul J Sheskey
and Siân C OwenHandbook of
Pharmaceutical Excipients
London.Chicago
Handbook of
Pharmaceutical Excipients
FIFTH EDITION
Edited by
Raymond C Rowe
BPharm, PhD, DSc, FRPharmS, CChem,
FRSC, CPhys, MInstP
Chief Scientist
Intelligensys Ltd
Billingham, UK
Paul J Sheskey
BSc, RPh
Technical Services Leader
The Dow Chemical Company
Midland
MI, USA
Sian C Owen
BSc, MA
Development Editor
Royal Pharmaceutical Society of Great Britain
London, UK
Published by the Pharmaceutical Press
Publications division of the Royal Pharmaceutical Society of Great Britain1 Lambeth High Street, London SE1 7JN, UK
100 South Atkinson Road, Suite 206, Grayslake, IL 60030-7820, USA
and the American Pharmacists Association2215 Constitution Avenue, NW, Washington, DC 20037-2985, USA
#Pharmaceutical Press and American Pharmacists Association 2006 is a trademark of Pharmaceutical PressFirst published 1986
Second edition published 1994
Third edition published 2000
Fourth edition published 2003
Fifth edition published 2006
Printed in Great Britain by Butler & Tanner, Frome, SomersetTypeset by Data Standards Ltd, Frome, Somerset
ISBN 0 85369 618 7 (UK)
ISBN 1 58212 058 7 (USA)
All rights reserved. No part of this publication may be reproduced, stored in a retrieval system, or transmitted in any form or by any means, without the prior written permission of the copyright holder. The publisher makes no representation, express or implied, with regard to the accuracy of the information contained in this book and cannot accept any legal responsibility or liability for any errors or omissions that may be made. A catalogue record for this book is available from the British Library Library of Congress Cataloging-in-Publication Data Handbook of pharmaceutical excipients.-5th ed. / edited by Raymond C.Rowe, Paul J. Sheskey, Sia
n C. Owen.
p. ; cm.Includes bibliographical references and index.
ISBN 1-58212-058-7 (USA) - ISBN 0-85369-618-7 (UK)1. Excipients-Handbooks, manuals, etc.
[DNLM: 1. Excipients-Handbooks. 2. Technology, Pharmaceutical-Handbooks. QV 735 H236 2006] I. Rowe, Raymond C. II. Sheskey, Paul J. III. Owen, SianC.
IV. American Pharmacists Association.
RS201.E87H36 2006
6150 .19-dc22
2005028523
Contents
International Steering Committeeix
Editorial Staffix
Contributorsx
About the Editorsxii
New Monographsxiii
Related Substancesxiv
Prefacexvi
Arrangementxvii
Acknowledgmentsxix
Notice to Readersxix
Bibliographyxx
Abbreviationsxx
Units of Measurementxxii
Monographs
Acacia 1
Acesulfame Potassium 4
Acetic Acid, Glacial 6
Acetone 8
Acetyltributyl Citrate 10
Acetyltriethyl Citrate 12
Agar 14
Albumin 16
Alcohol 18
Alginic Acid 21
Aliphatic Polyesters 24
Alitame 28
Almond Oil 30
Alpha Tocopherol 32
Aluminum Hydroxide Adjuvant 36
Aluminum Oxide 38
Aluminum Phosphate Adjuvant 40
Aluminum Stearate 42
Ammonia Solution 44
Ammonium Alginate 46
Ascorbic Acid 48Ascorbyl Palmitate 51
Aspartame 53
Attapulgite 56
Bentonite 58
Benzalkonium Chloride 61
Benzethonium Chloride 64
Benzoic Acid 66
Benzyl Alcohol 69
Benzyl Benzoate 72
Boric Acid 74
Bronopol 76
Butylated Hydroxyanisole 79
Butylated Hydroxytoluene 81
Butylparaben 83
Calcium Alginate 86
Calcium Carbonate 89
Calcium Phosphate, Dibasic Anhydrous 93
Calcium Phosphate, Dibasic Dihydrate 96
Calcium Phosphate, Tribasic 100
Calcium Stearate 102
Calcium Sulfate 105
Canola Oil 108
Carbomer 111
Carbon Dioxide 116
Carboxymethylcellulose Calcium 118
Carboxymethylcellulose Sodium 120
Carrageenan 124
Castor Oil 128
Castor Oil, Hydrogenated 130
Cellulose, Microcrystalline 132
Cellulose, Powdered 136
Cellulose, Silicified Microcrystalline 139
Cellulose Acetate 142
Cellulose Acetate Phthalate 145
Ceratonia 148
Cetostearyl Alcohol 150
Cetrimide 152
Cetyl Alcohol 155
Cetylpyridinium Chloride 157
Chitosan 159
Chlorhexidine 163
Chlorobutanol 168
Chlorocresol 171
Chlorodifluoroethane (HCFC) 174
Chlorofluorocarbons (CFC) 176
Chloroxylenol 180
Cholesterol 182
Citric Acid Monohydrate 185
Colloidal Silicon Dioxide 188
Coloring Agents 192
Copovidone 201
Corn Oil 204
Cottonseed Oil 206
Cresol 208
Croscarmellose Sodium 211
Crospovidone 214
Cyclodextrins 217
Cyclomethicone 222
Denatonium Benzoate 224
Dextrates 226
Dextrin 228
Dextrose 231
Dibutyl Phthalate 234
Dibutyl Sebacate 236
Diethanolamine 238
Diethyl Phthalate 240
Difluoroethane (HFC) 242
Dimethicone 244
Dimethyl Ether 246
Dimethyl Phthalate 248
Dimethyl Sulfoxide 250
Dimethylacetamide 253
Disodium Edetate 255
Docusate Sodium 257
Edetic Acid 260
Erythorbic Acid 264
Erythritol 266
Ethyl Acetate 268
Ethyl Lactate 270
Ethyl Maltol 272Ethyl Oleate 274
Ethyl Vanillin 276
Ethylcellulose 278
Ethylene Glycol Palmitostearate 283
Ethylene Vinyl Acetate 285
Ethylparaben 287
Fructose 290
Fumaric Acid 293
Gelatin 295
Glucose, Liquid 299
Glycerin 301
Glyceryl Behenate 304
Glyceryl Monooleate 306
Glyceryl Monostearate 308
Glyceryl Palmitostearate 311
Glycofurol 313
Guar Gum 315
Hectorite 318
Heptafluoropropane (HFC) 321
Hexetidine 323
Hydrocarbons (HC) 325
Hydrochloric Acid 328
Hydroxyethyl Cellulose 330
Hydroxyethylmethyl Cellulose 334
Hydroxypropyl Cellulose 336
Hydroxypropyl Cellulose, Low-substituted 341
Hydroxypropyl Starch 344
Hypromellose 346
Hypromellose Acetate Succinate 350
Hypromellose Phthalate 354
Imidurea 359
Inulin 362
Iron Oxides 364
Isomalt 366
Isopropyl Alcohol 371
Isopropyl Myristate 374
Isopropyl Palmitate 376
Kaolin 378
Lactic Acid 381
Lactitol 383
Lactose, Anhydrous 385
Lactose, Monohydrate 389
Lactose, Spray-Dried 396
Lanolin 399viContents
Lanolin Alcohols 402
Lanolin, Hydrous 404
Lauric Acid 406
Lecithin 409
Leucine 412
Linoleic Acid 414
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