Handbook of Pharmaceutical Excipients Fifth Edition Edited by Raymond C Rowe, Paul J Sheskey and Siân C Owen Handbook 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 Siaˆn 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 Britain 1 Lambeth High Street, London SE1 7JN, UK 100 South Atkinson Road, Suite 206, Grayslake, IL 60030-7820, USA and the American Pharmacists Association 2215 Constitution Avenue, NW, Washington, DC 20037-2985, USA # Pharmaceutical Press and American Pharmacists Association 2006 is a trademark of Pharmaceutical Press First 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, Somerset Typeset 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, Siaˆn 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, Siaˆn C. IV. American Pharmacists Association. RS201.E87H36 2006 6150 .19–dc22 2005028523 Contents International Steering Committee ix Editorial Staff ix Contributors x About the Editors xii New Monographs xiii Related Substances xiv Preface xvi Arrangement xvii Acknowledgments xix Notice to Readers xix Bibliography xx Abbreviations xx Units of Measurement xxii 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 48 Ascorbyl 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 272 Ethyl 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 399 vi Contents Lanolin Alcohols 402 Lanolin, Hydrous 404 Lauric Acid 406 Lecithin 409 Leucine 412 Linoleic Acid 414 Macrogol 15 Hydroxystearate 416 Magnesium Aluminum Silicate 418 Magnesium Carbonate 422 Magnesium Oxide 426 Magnesium Silicate 428 Magnesium Stearate 430 Magnesium Trisilicate 434 Malic Acid 436 Maltitol 438 Maltitol Solution 440 Maltodextrin 442 Maltol 445 Maltose 447 Mannitol 449 Medium-chain Triglycerides 454 Meglumine 457 Menthol 459 Methylcellulose 462 Methylparaben 466 Mineral Oil 471 Mineral Oil, Light 474 Mineral Oil and Lanolin Alcohols 476 Monoethanolamine 478 Monosodium Glutamate 480 Monothioglycerol 482 Myristic Acid 484 Neohesperidin Dihydrochalcone 486 Nitrogen 488 Nitrous Oxide 490 Octyldodecanol 492 Oleic Acid 494 Oleyl Alcohol 496 Olive Oil 498 Palmitic Acid 501 Paraffin 503 Peanut Oil 505 Pectin 507 Petrolatum 509 Petrolatum and Lanolin Alcohols 512 Phenol 514 Phenoxyethanol 517 Phenylethyl Alcohol 519 Phenylmercuric Acetate 521 Phenylmercuric Borate 524 Phenylmercuric Nitrate 526 Phosphoric Acid 530 Polacrilin Potassium 532 Poloxamer 535 Polycarbophil 539 Polydextrose 542 Polyethylene Glycol 545 Polyethylene Oxide 551 Polymethacrylates 553 Poly(methyl vinyl ether/maleic anhydride) 561 Polyoxyethylene Alkyl Ethers 564 Polyoxyethylene Castor Oil Derivatives 572 Polyoxyethylene Sorbitan Fatty Acid Esters 580 Polyoxyethylene Stearates 585 Polyvinyl Acetate Phthalate 589 Polyvinyl Alcohol 592 Potassium Alginate 594 Potassium Benzoate 596 Potassium Bicarbonate 598 Potassium Chloride 600 Potassium Citrate 603 Potassium Hydroxide 605 Potassium Metabisulfite 607 Potassium Sorbate 609 Povidone 611 Propionic Acid 617 Propyl Gallate 619 Propylene Carbonate 622 Propylene Glycol 624 Propylene Glycol Alginate 627 Propylparaben 629 2-Pyrrolidone 633 Raffinose 635 Saccharin 638 Saccharin Sodium 641 Saponite 644 Sesame Oil 646 Shellac 649