Contents
Preface x
Arrangement xi
Acknowledgments xiii
Notice to Readers xiii
International Steering Committee xiv
Editorial Staff xv
Contributors xvi
About the Editors xx
New Monographs xxi
Related Substances xxii
Bibliography xxiv
Abbreviations xxv
Units of Measurement xxvii
Monographs
A
Acacia 1
Acesulfame Potassium 3
Acetic Acid, Glacial 5
Acetone 7
Acetyltributyl Citrate 8
Acetyltriethyl Citrate 10
Adipic Acid 11
Agar 13
Albumin 14
Alcohol 17
Alginic Acid 20
Aliphatic Polyesters 23
Alitame 28
Almond Oil 29
Alpha Tocopherol 31
Aluminum Hydroxide Adjuvant 34
Aluminum Monostearate 35
Aluminum Oxide 37
Aluminum Phosphate Adjuvant 38
Ammonia Solution 39
Ammonium Alginate 41
Ammonium Chloride 42
Ascorbic Acid 43
Ascorbyl Palmitate 46
Aspartame 48
Attapulgite 51
B
Bentonite 53
Benzalkonium Chloride 56
Benzethonium Chloride 59
Benzoic Acid 61
Benzyl Alcohol 64
Benzyl Benzoate 66
Boric Acid 68
Bronopol 70
Butylated Hydroxyanisole 73
Butylated Hydroxytoluene 75
Butylene Glycol 77
Butylparaben 78
C
Calcium Acetate 82
Calcium Alginate 83
Calcium Carbonate 86
Calcium Chloride 89
Calcium Hydroxide 91
Calcium Lactate 92
Calcium Phosphate, Dibasic Anhydrous 94
Calcium Phosphate, Dibasic Dihydrate 96
Calcium Phosphate, Tribasic 99
Calcium Silicate 101
Calcium Stearate 103
Calcium Sulfate 105
Canola Oil 108
Carbomer 110
Carbon Dioxide 115
Carboxymethylcellulose Calcium 117
Carboxymethylcellulose Sodium 118
Carrageenan 122
Castor Oil 126
Castor Oil, Hydrogenated 128
Cellulose, Microcrystalline 129
Cellulose, Microcrystalline and
Carboxymethylcellulose Sodium 134
Cellulose, Powdered 136
Cellulose, Silicified Microcrystalline 139
Cellulose Acetate 141
Cellulose Acetate Phthalate 143
Ceratonia 146
Ceresin 148
Cetostearyl Alcohol 150
Cetrimide 152
Cetyl Alcohol 155
Cetylpyridinium Chloride 157
Chitosan 159
Chlorhexidine 162
Chlorobutanol 166
Chlorocresol 168
Chlorodifluoroethane (HCFC) 171
Chlorofluorocarbons (CFC) 173
Chloroxylenol 176
Cholesterol 178
Citric Acid Monohydrate 181
Coconut Oil 184
Colloidal Silicon Dioxide 185
Coloring Agents 189
Copovidone 196
Corn Oil 199
Corn Starch and Pregelatinized Starch 200
Cottonseed Oil 202
Cresol 203
Croscarmellose Sodium 206
Crospovidone 208
Cyclodextrins 210
Cyclomethicone 215 D
Denatonium Benzoate 217
Dextrates 218
Dextrin 220
Dextrose 222
Dibutyl Phthalate 225
Dibutyl Sebacate 227
Diethanolamine 228
Diethyl Phthalate 230
Difluoroethane (HFC) 232
Dimethicone 233
Dimethyl Ether 235
Dimethyl Phthalate 236
Dimethyl Sulfoxide 238
Dimethylacetamide 241
Disodium Edetate 242
Docusate Sodium 244 E
Edetic Acid 247
Erythorbic Acid 250
Erythritol 251
Ethyl Acetate 253
Ethyl Lactate 256
Ethyl Maltol 257
Ethyl Oleate 259
Ethyl Vanillin 261
Ethylcellulose 262
Ethylene Glycol Stearates 267
Ethylene Vinyl Acetate 268
Ethylparaben 270 F
Fructose 273
Fumaric Acid 276 G
Gelatin 278
Glucose, Liquid 282
Glycerin 283
Glyceryl Behenate 286
Glyceryl Monooleate 288
Glyceryl Monostearate 290
Glyceryl Palmitostearate 293
Glycine 295
Glycofurol 297
Guar Gum 298 H
Hectorite 301
Heptafluoropropane (HFC) 303
Hexetidine 304
Hydrocarbons (HC) 306
Hydrochloric Acid 308
Hydrophobic Colloidal Silica 309
Hydroxyethyl Cellulose 311
Hydroxyethylmethyl Cellulose 314
Hydroxypropyl Betadex 315
Hydroxypropyl Cellulose 317
Hydroxypropyl Cellulose, Low-substituted 322
Hydroxypropyl Starch 325
Hypromellose 326
Hypromellose Acetate Succinate 330
Hypromellose Phthalate 333 I
Imidurea 337
Inulin 339
vi Contents
Iron Oxides 340
Isomalt 342
Isopropyl Alcohol 346
Isopropyl Myristate 348
Isopropyl Palmitate 350
K
Kaolin 352
L
Lactic Acid 355
Lactitol 357
Lactose, Anhydrous 359
Lactose, Inhalation 362
Lactose, Monohydrate 364
Lactose, Monohydrate and Corn Starch 370
Lactose, Monohydrate and Microcrystalline Cellulose 371
Lactose, Monohydrate and Povidone 373
Lactose, Monohydrate and Powdered Cellulose 374
Lactose, Spray-Dried 376
Lanolin 378
Lanolin, Hydrous 380
Lanolin Alcohols 382
Lauric Acid 383
Lecithin 385
Leucine 387
Linoleic Acid 389
M
Macrogol 15 Hydroxystearate 391
Magnesium Aluminum Silicate 393
Magnesium Carbonate 397
Magnesium Oxide 400
Magnesium Silicate 402
Magnesium Stearate 404
Magnesium Trisilicate 408
Maleic Acid 410
Malic Acid 411
Maltitol 414
Maltitol Solution 416
Maltodextrin 418
Maltol 421
Maltose 422
Mannitol 424
Medium-chain Triglycerides 429
Meglumine 431
Menthol 433
Methionine 436
Methylcellulose 438
Methylparaben 441
Mineral Oil 445
Mineral Oil, Light 447
Mineral Oil and Lanolin Alcohols 449
Monoethanolamine 450
Monosodium Glutamate 452
Monothioglycerol 454
Myristic Acid 455
Myristyl Alcohol 456
N
Neohesperidin Dihydrochalcone 458
Neotame 460
Nitrogen 461
Nitrous Oxide 463
O
Octyldodecanol 465
Oleic Acid 466
Oleyl Alcohol 468
Olive Oil 470
P
Palmitic Acid 473
Paraffin 474
Peanut Oil 476
Pectin 478
Pentetic Acid 480
Petrolatum 481
Petrolatum and Lanolin Alcohols 484
Phenol 485
Phenoxyethanol 488
Phenylethyl Alcohol 490
Phenylmercuric Acetate 492
Phenylmercuric Borate 494
Phenylmercuric Nitrate 496
Phospholipids 499
Phosphoric Acid 503
Polacrilin Potassium 504
Poloxamer 506
Polycarbophil 509
Polydextrose 513
Poly (DL-Lactic Acid) 515
Polyethylene Glycol 517
Polyethylene Oxide 522
Contents vii
Polymethacrylates 525
Poly(methyl vinyl ether/maleic anhydride) 534
Polyoxyethylene Alkyl Ethers 536
Polyoxyethylene Castor Oil Derivatives 542
Polyoxyethylene Sorbitan Fatty Acid Esters 549
Polyoxyethylene Stearates 554
Polyoxylglycerides 557
Polyvinyl Acetate Phthalate 562
Polyvinyl Alcohol 564
Potassium Alginate 566
Potassium Alum 567
Potassium Benzoate 569
Potassium Bicarbonate 570
Potassium Chloride 572
Potassium Citrate 574
Potassium Hydroxide 576
Potassium Metabisulfite 577
Potassium Sorbate 579
Povidone 581
Propionic Acid 586
Propyl Gallate 587
Propylene Carbonate 590
Propylene Glycol 592
Propylene Glycol Alginate 594
Propylparaben 596
Propylparaben Sodium 599
Pyrrolidone 600
R
Raffinose 603
S
Saccharin 605
Saccharin Sodium 608
Safflower Oil 610
Saponite 612
Sesame Oil 614
Shellac 616
Simethicone 619
Sodium Acetate 620
Sodium Alginate 622
Sodium Ascorbate 625
Sodium Benzoate 627
Sodium Bicarbonate 629
Sodium Borate 633
Sodium Carbonate 635
Sodium Chloride 637
Sodium Citrate Dihydrate 640
Sodium Cyclamate 643
Sodium Formaldehyde Sulfoxylate 645
Sodium Hyaluronate 646
Sodium Hydroxide 648
Sodium Lactate 650
Sodium Lauryl Sulfate 651
Sodium Metabisulfite 654
Sodium Phosphate, Dibasic 656
Sodium Phosphate, Monobasic 659
Sodium Propionate 661
Sodium Starch Glycolate 663
Sodium Stearyl Fumarate 667
Sodium Sulfite 669
Sodium Thiosulfate 671
Sorbic Acid 672
Sorbitan Esters (Sorbitan Fatty Acid Esters) 675
Sorbitol 679
Soybean Oil 682
Starch 685
Starch, Pregelatinized 691
Starch, Sterilizable Maize 695
Stearic Acid 697
Stearyl Alcohol 700
Sucralose 701
Sucrose 703
Sucrose Octaacetate 707
Sugar, Compressible 709
Sugar, Confectioner’s 710
Sugar Spheres 712
Sulfobutylether b-Cyclodextrin 714
Sulfur Dioxide 718
Sulfuric Acid 719
Sunflower Oil 721
Suppository Bases, Hard Fat 722
T
Tagatose 727
Talc 728
Tartaric Acid 731
Tetrafluoroethane (HFC) 733
Thaumatin 735
Thimerosal 736
Thymol 739
Titanium Dioxide 741
Tragacanth 744
viii Contents
Trehalose 746
Triacetin 748
Tributyl Citrate 749
Tricaprylin 751
Triethanolamine 754
Triethyl Citrate 756
Triolein 757
V
Vanillin 760
Vegetable Oil, Hydrogenated 762
Vitamin E Polyethylene Glycol Succinate 764
W
Water 766
Wax, Anionic Emulsifying 770
Wax, Carnauba 772
Wax, Cetyl Esters 774
Wax, Microcrystalline 775
Wax, Nonionic Emulsifying 777
Wax, White 779
Wax, Yellow 780
X
Xanthan Gum 782
Xylitol 786
Z
Zein 790
Zinc Acetate 791
Zinc Stearate 793
Appendix I: Suppliers Directory 795
Appendix II: List of Excipient ‘E’ Numbers 847
Appendix III: List of Excipient ‘EINECS’ Numbers 849
Appendix IV: List of Excipient Molecular Weights 852
Index 855