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

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

 

Monographs Butylparaben 83    

Calcium Alginate 86    

Acacia 1 Calcium Carbonate 89    

Acesulfame Potassium 4 Calcium Phosphate, Dibasic Anhydrous 93    

Acetic Acid, Glacial 6 Calcium Phosphate, Dibasic Dihydrate 96    

Acetone 8 Calcium Phosphate, Tribasic 100    

Acetyltributyl Citrate 10 Calcium Stearate 102    

Acetyltriethyl Citrate 12 Calcium Sulfate 105    

Agar 14 Canola Oil 108    

Albumin 16 Carbomer 111    

Alcohol 18 Carbon Dioxide 116    

Alginic Acid 21 Carboxymethylcellulose Calcium 118    

Aliphatic Polyesters 24 Carboxymethylcellulose Sodium 120    

Alitame 28 Carrageenan 124    

Almond Oil 30 Castor Oil 128    

Alpha Tocopherol 32 Castor Oil, Hydrogenated 130    

Aluminum Hydroxide Adjuvant 36 Cellulose, Microcrystalline 132    

Aluminum Oxide 38 Cellulose, Powdered 136    

Aluminum Phosphate Adjuvant 40 Cellulose, Silicified Microcrystalline 139    

Aluminum Stearate 42 Cellulose Acetate 142    

Ammonia Solution 44 Cellulose Acetate Phthalate 145    

Ammonium Alginate 46 Ceratonia 148    

Ascorbic Acid 48 Cetostearyl Alcohol 150  

vi Contents

 

Cetrimide 152 Ethyl Oleate 274    

Cetyl Alcohol 155 Ethyl Vanillin 276    

Cetylpyridinium Chloride 157 Ethylcellulose 278    

Chitosan 159 Ethylene Glycol Palmitostearate 283    

Chlorhexidine 163 Ethylene Vinyl Acetate 285    

Chlorobutanol 168 Ethylparaben 287    

Chlorocresol 171 Fructose 290    

Chlorodifluoroethane (HCFC) 174 Fumaric Acid 293    

Chlorofluorocarbons (CFC) 176 Gelatin 295    

Chloroxylenol 180 Glucose, Liquid 299    

Cholesterol 182 Glycerin 301    

Citric Acid Monohydrate 185 Glyceryl Behenate 304    

Colloidal Silicon Dioxide 188 Glyceryl Monooleate 306    

Coloring Agents 192 Glyceryl Monostearate 308    

Copovidone 201 Glyceryl Palmitostearate 311    

Corn Oil 204 Glycofurol 313    

Cottonseed Oil 206 Guar Gum 315    

Cresol 208 Hectorite 318    

Croscarmellose Sodium 211 Heptafluoropropane (HFC) 321    

Crospovidone 214 Hexetidine 323    

Cyclodextrins 217 Hydrocarbons (HC) 325    

Cyclomethicone 222 Hydrochloric Acid 328    

Denatonium Benzoate 224 Hydroxyethyl Cellulose 330    

Dextrates 226 Hydroxyethylmethyl Cellulose 334    

Dextrin 228 Hydroxypropyl Cellulose 336    

Dextrose 231 Hydroxypropyl Cellulose, Low-substituted 341    

Dibutyl Phthalate 234 Hydroxypropyl Starch 344    

Dibutyl Sebacate 236 Hypromellose 346    

Diethanolamine 238 Hypromellose Acetate Succinate 350    

Diethyl Phthalate 240 Hypromellose Phthalate 354    

Difluoroethane (HFC) 242 Imidurea 359    

Dimethicone 244 Inulin 362    

Dimethyl Ether 246 Iron Oxides 364    

Dimethyl Phthalate 248 Isomalt 366    

Dimethyl Sulfoxide 250 Isopropyl Alcohol 371    

Dimethylacetamide 253 Isopropyl Myristate 374    

Disodium Edetate 255 Isopropyl Palmitate 376    

Docusate Sodium 257 Kaolin 378    

Edetic Acid 260 Lactic Acid 381    

Erythorbic Acid 264 Lactitol 383    

Erythritol 266 Lactose, Anhydrous 385    

Ethyl Acetate 268 Lactose, Monohydrate 389    

Ethyl Lactate 270 Lactose, Spray-Dried 396    

Ethyl Maltol 272 Lanolin 399  

Contents vii 

 

Lanolin Alcohols 402 Petrolatum and Lanolin Alcohols 512    

Lanolin, Hydrous 404 Phenol 514    

Lauric Acid 406 Phenoxyethanol 517    

Lecithin 409 Phenylethyl Alcohol 519    

Leucine 412 Phenylmercuric Acetate 521    

Linoleic Acid 414 Phenylmercuric Borate 524    

Macrogol 15 Hydroxystearate 416 Phenylmercuric Nitrate 526    

Magnesium Aluminum Silicate 418 Phosphoric Acid 530    

Magnesium Carbonate 422 Polacrilin Potassium 532    

Magnesium Oxide 426 Poloxamer 535    

Magnesium Silicate 428 Polycarbophil 539    

Magnesium Stearate 430 Polydextrose 542    

Magnesium Trisilicate 434 Polyethylene Glycol 545    

Malic Acid 436 Polyethylene Oxide 551    

Maltitol 438 Polymethacrylates 553    

Maltitol Solution 440 Poly(methyl vinyl ether/maleic anhydride) 561    

Maltodextrin 442 Polyoxyethylene Alkyl Ethers 564    

Maltol 445 Polyoxyethylene Castor Oil Derivatives 572    

Maltose 447 Polyoxyethylene Sorbitan Fatty Acid Esters 580    

Mannitol 449 Polyoxyethylene Stearates 585    

Medium-chain Triglycerides 454 Polyvinyl Acetate Phthalate 589    

Meglumine 457 Polyvinyl Alcohol 592    

Menthol 459 Potassium Alginate 594    

Methylcellulose 462 Potassium Benzoate 596    

Methylparaben 466 Potassium Bicarbonate 598    

Mineral Oil 471 Potassium Chloride 600    

Mineral Oil, Light 474 Potassium Citrate 603    

Mineral Oil and Lanolin Alcohols 476 Potassium Hydroxide 605    

Monoethanolamine 478 Potassium Metabisulfite 607    

Monosodium Glutamate 480 Potassium Sorbate 609    

Monothioglycerol 482 Povidone 611    

Myristic Acid 484 Propionic Acid 617    

Neohesperidin Dihydrochalcone 486 Propyl Gallate 619    

Nitrogen 488 Propylene Carbonate 622    

Nitrous Oxide 490 Propylene Glycol 624    

Octyldodecanol 492 Propylene Glycol Alginate 627    

Oleic Acid 494 Propylparaben 629    

Oleyl Alcohol 496 2-Pyrrolidone 633    

Olive Oil 498 Raffinose 635    

Palmitic Acid 501 Saccharin 638    

Paraffin 503 Saccharin Sodium 641    

Peanut Oil 505 Saponite 644    

Pectin 507 Sesame Oil 646    

Petrolatum 509 Shellac 649