Accessed from 128.83.63.20 by nEwp0rt1 on Thu Dec 01 21:23:02 EST 2011
NF 30 Excipients 1673
Excipients
USP and NF Excipients, Listed by Category
In the following reference table, the grouping of excipi- Benzethonium Chloride ents by functional category is intended to summarize the Benzoic Acid most typically identified purpose that these excipients serve Benzyl Alcohol in drug product formulations. The list of substances in- Butylparaben cluded in each category is not comprehensive. The state- Calcium Propionate ment of category is intended neither to limit in any way the Cetrimonium Bromide choice or use of the substance nor to indicate that it has no Cetylpyridinium Chloride other utility. Chlorobutanol Acidifying Agent Chlorocresol Acetic Acid Cresol Acetic Acid, Glacial Dehydroacetic Acid Citric Acid, Anhydrous Erythorbic Acid Citric Acid Monohydrate Ethylparaben Fumaric Acid Methylparaben Hydrochloric Acid Methylparaben Sodium Hydrochloric Acid, Diluted Phenol Malic Acid Phenoxyethanol Nitric Acid Phenylethyl Alcohol Phosphoric Acid Phenylmercuric Acetate Phosphoric Acid, Diluted Phenylmercuric Nitrate Propionic Acid Potassium Benzoate Sulfuric Acid Potassium Sorbate Tartaric Acid Propylparaben Aerosol Propellant Propylparaben Sodium Butane Sodium Benzoate Dichlorodifluoromethane Sodium Dehydroacetate Dichlorotetrafluoroethane Sodium Propionate Isobutane Sorbic Acid Propane Thimerosal Trichloromonofluoromethane Thymol Air Displacement Antioxidant Carbon Dioxide Ascorbic Acid Nitrogen Ascorbyl Palmitate Butylated Hydroxyanisole Alcohol Denaturant Butylated Hydroxytoluene Denatonium Benzoate Erythorbic Acid Methyl Isobutyl Ketone Hypophosphorous Acid Sucrose Octaacetate Lactobionic Acid Alkalizing Agent Monothioglycerol Ammonia Solution, Strong Potassium Metabisulfite Ammonium Carbonate Propyl Gallate Diethanolamine Racemethionine Potassium Hydroxide Sodium Bisulfite Sodium Bicarbonate Sodium Formaldehyde Sulfoxylate Sodium Borate Sodium Metabisulfite Sodium Carbonate Sodium Sulfite Sodium Hydroxide Sodium Thiosulfate Trolamine Stannous Chloride Anticaking Agent (See Glidant) Sulfur Dioxide Antifoaming Agent Tocopherols Excipient Dimethicone Buffering Agent Myristic Acid Acetic Acid Palmitic Acid Adipic Acid Simethicone Ammonium Carbonate Antimicrobial Preservative Ammonium Phosphate Benzalkonium Chloride Boric Acid Benzalkonium Chloride Solution Citric Acid, Anhydrous
Official from May 1, 2012 Copyright (c) 2011 The United States Pharmacopeial Convention. All rights reserved. Accessed from 128.83.63.20 by nEwp0rt1 on Thu Dec 01 21:23:02 EST 2011
1674 Excipients NF 30
Citric Acid Monohydrate Methylcellulose Alpha-Lactalbumin Palm Kernel Oil Lactic Acid Palm Oil Phosphoric Acid Palm Oil, Hydrogenated Potassium Citrate Polydextrose, Hydrogenated Potassium Metaphosphate Polyethylene Glycol Potassium Phosphate, Dibasic Polyvinyl Acetate Potassium Phosphate, Monobasic Polyvinyl Acetate Dispersion Racemethionine Polyvinyl Acetate Phthalate Sodium Acetate Pullulan Sodium Citrate Rapeseed Oil, Fully Hydrogenated Sodium Lactate Solution Rapeseed Oil, Superglycerinated Fully Hydrogenated Sodium Phosphate, Dibasic Shellac Sodium Phosphate, Monobasic Starch, Pregelatinized Modified Succinic Acid Sucrose Bulking Agent for Freeze-Drying Titanium Dioxide Creatinine Wax, Carnauba Alpha-Lactalbumin Wax, Microcrystalline Mannitol Zein Polydextrose Color Polydextrose, Hydrogenated Caramel Pullulan Ferric Oxide, red, yellow, or blends Trehalose Coloring Agent Capsule Lubricant (See Tablet and/or Capsule Lubricant) Aluminum Oxide Chelating Agent Complexing Agent Edetate Calcium Disodium Edetate Calcium Disodium Edetate Disodium Edetate Disodium Edetic Acid Edetic Acid Alpha-Lactalbumin Oxyquinoline Sulfate Change to read: Desiccant Calcium Chloride Coating Agent Calcium Sulfate Amino Methacrylate Copolymer Polyvinyl Acetate Ammonio Methacrylate Copolymer Silicon Dioxide Ammonio Methacrylate Copolymer Dispersion Carboxymethylcellulose Sodium Emollient Carboxymethylcellulose Sodium, Enzymatically- Alkyl (C12-15) Benzoate Hydrolyzed Oleyl Oleate Cellaburate Polydecene, Hydrogenated Cellacefate (formerly Cellulose Acetate Phthalate) Soybean Oil, Hydrogenated Cellulose Acetate Cellulose Acetate Phthalate (see Cellacefate) Change to read: Chitosan Coconut Oil Emulsifying and/or Solubilizing Agent Coconut Oil, Hydrogenated Acacia Copovidone Carbomer Copolymer Corn Syrup Solids Carbomer Interpolymer Ethyl Acrylate and Methyl Methacrylate Copolymer Cholesterol Dispersion Coconut Oil Ethylcellulose Cyclodextrin, Gamma Ethylcellulose Aqueous Dispersion ▲ Desoxycholic Acid Ethylcellulose Dispersion Type B▲NF30 Diethanolamine (Adjunct) Ethylene Glycol and Vinyl Alcohol Graft Copolymer Diethylene Glycol Stearates Gelatin Ethylene Glycol Stearates Glaze, Pharmaceutical Glyceryl Distearate Hydroxypropyl Cellulose Glyceryl Monolinoleate Hydroxypropyl Methylcellulose (see Hypromellose) Glyceryl Monooleate Hydroxypropyl Methylcellulose Phthalate (see Hypro Glyceryl Monostearate mellose Phthalate) Alpha-Lactalbumin Hypromellose (formerly Hydroxypropyl Methylcellulose) Lanolin Alcohols Hypromellose Acetate Succinate Lecithin Hypromellose Phthalate (formerly Hydroxypropyl Mono- and Di-glycerides Methylcellulose Phthalate) Monoethanolamine (Adjunct) Alpha-Lactalbumin Oleic Acid (Adjunct) Maltodextrin Oleyl Alcohol (Stabilizer) Methacrylic Acid and Ethyl Acrylate Copolymer Oleyl Oleate Methacrylic Acid and Ethyl Acrylate Copolymer, Palm Kernel Oil Partially-Neutralized ▲ Palm Oil Methacrylic Acid and Ethyl Acrylate Copolymer Poloxamer Dispersion▲NF30 Polyglyceryl 3 Diisostearate Methacrylic Acid and Methyl Methacrylate Copolymer ▲ Polyglyceryl Dioleate▲NF30 Methacrylic Acid Copolymer Polyoxyethylene 50 Stearate Methacrylic Acid Copolymer Dispersion Polyoxyl 10 Oleyl Ether
Official from May 1, 2012 Copyright (c) 2011 The United States Pharmacopeial Convention. All rights reserved. Accessed from 128.83.63.20 by nEwp0rt1 on Thu Dec 01 21:23:02 EST 2011
NF 30 Excipients 1675
Polyoxyl 20 Cetostearyl Ether Change to read: Polyoxyl 35 Castor Oil Polyoxyl 40 Hydrogenated Castor Oil Humectant Polyoxyl 40 Stearate Corn Syrup Solids Polyoxyl Lauryl Ether Erythritol Polyoxyl Stearyl Ether Glycerin Polysorbate 20 Hexylene Glycol Polysorbate 40 Inositol Polysorbate 60 Maltitol Polysorbate 80 Polydextrose Propylene Glycol Dicaprylate/Dicaprate Polydextrose, Hydrogenated Propylene Glycol Monocaprylate Propylene Glycol Propylene Glycol Monostearate Sorbitol Rapeseed Oil, Superglycerinated Fully Hydrogenated Sorbitol Sorbitan Solution Sodium Cetostearyl Sulfate ▲ Hydrogenated Starch Hydrolysate▲NF30 Sodium Lauryl Sulfate Tagatose Sodium Stearate Sorbitan Monolaurate Ointment Base Sorbitan Monooleate Caprylocaproyl Polyoxylglycerides Sorbitan Monopalmitate Diethylene Glycol Monoethyl Ether Sorbitan Monostearate Lanolin Sorbitan Sesquioleate Lauroyl Polyoxylglycerides Sorbitan Trioleate Linoleoyl Polyoxylglycerides Stannous Chloride Ointment, Hydrophilic Stearic Acid Ointment, White Sucrose Stearate Ointment, Yellow Trolamine Oleoyl Polyoxylglycerides Wax, Emulsifying Petrolatum Petrolatum, Hydrophilic Petrolatum, White Change to read: Polydecene, Hydrogenated Polyethylene Glycol Monomethyl Ether Film-Forming Agent Polyglyceryl 3 Diisostearate ▲ Rose Water Ointment Ammonio Methacrylate Copolymer▲NF30 Chitosan Squalane ▲ Stearoyl Polyoxylglycerides Ethylcellulose Dispersion Type B▲NF30 Methacrylic Acid and Ethyl Acrylate Copolymer Vegetable Oil, Hydrogenated, Type II Methacrylic Acid and Ethyl Acrylate Copolymer, Partially- Plasticizer Neutralized Acetyltributyl Citrate ▲Methacrylic Acid and Ethyl Acrylate Copolymer Acetyltriethyl Citrate Dispersion▲NF30 Castor Oil Methacrylic Acid and Methyl Methacrylate Copolymer Diacetylated Monoglycerides Filtering Aid Dibutyl Sebacate Cellulose, Powdered Diethyl Phthalate Siliceous Earth, Purified Glycerin Polyethylene Glycol Flavors and Perfumes Polyethylene Glycol Monomethyl Ether Almond Oil Propylene Glycol Anethole Pullulan Benzaldehyde Sorbitol Sorbitan Solution Ethyl Acetate Triacetin Ethyl Vanillin Tributyl Citrate L-Glutamic Acid, Hydrochloride Triethyl Citrate Lactitol Maltol Polymer Membrane Menthol Amino Methacrylate Copolymer Methyl Salicylate Ammonio Methacrylate Copolymer Monosodium Glutamate Ammonio Methacrylate Copolymer Dispersion Peppermint Cellaburate Peppermint Oil Cellulose Acetate Peppermint Spirit Ethyl Acrylate and Methyl Methacrylate Copolymer Racemethionine Dispersion Rose Oil Pullulan Rose Water, Stronger Sequestering Agent Thymol Betadex (formerly Beta Cyclodextrin) Vanillin Cyclodextrin, Beta (see Betadex) Glidant and/or Anticaking Agent Cyclodextrin, Gamma Calcium Silicate Hydroxypropyl Betadex Magnesium Silicate Pullulan Silica, Hydrophobic Colloidal Sodium Tartrate Silicon Dioxide, Colloidal Solvent Talc Acetone Alcohol Alcohol, Diluted Amylene Hydrate
Official from May 1, 2012 Copyright (c) 2011 The United States Pharmacopeial Convention. All rights reserved. Accessed from 128.83.63.20 by nEwp0rt1 on Thu Dec 01 21:23:02 EST 2011
1676 Excipients NF 30
Benzyl Benzoate Carbomer Copolymer Butyl Alcohol Carbomer Homopolymer Canola Oil Carbomer Interpolymer Caprylocaproyl Polyoxylglycerides Carboxymethylcellulose Calcium Corn Oil Carboxymethylcellulose Sodium Cottonseed Oil Carboxymethylcellulose Sodium 12 Diethylene Glycol Monoethyl Ether Carboxymethylcellulose Sodium, Enzymatically- Ethyl Acetate Hydrolyzed Glycerin Carmellose Hexylene Glycol Carrageenan Isopropyl Alcohol Cellulose, Microcrystalline, and Carboxymethylcellulose Lauroyl Polyoxylglycerides Sodium Linoleoyl Polyoxylglycerides Chitosan Methyl Alcohol Corn Syrup Methyl Isobutyl Ketone Corn Syrup Solids Methylene Chloride Dextrin Methylpyrrolidone Gelatin Mineral Oil Gellan Gum Oleoyl Polyoxylglycerides Guar Gum Peanut Oil Hydroxyethyl Cellulose Polydecene, Hydrogenated Hydroxypropyl Cellulose Polyethylene Glycol Hydroxypropyl Methylcellulose (see Hypromellose) Polyethylene Glycol Monomethyl Ether Hypromellose (formerly Hydroxypropyl Methylcellulose) Propylene Glycol Alpha-Lactalbumin Sesame Oil Magnesium Aluminum Silicate Stearoyl Polyoxylglycerides Maltodextrin Water, Purified Methylcellulose Water for Injection Pectin Water for Injection, Sterile Polydextrose, Hydrogenated Water for Irrigation, Sterile Polyethylene Oxide Sorbent Polyvinyl Alcohol Cellulose, Powdered Povidone Charcoal, Activated Propylene Glycol Alginate Siliceous Earth, Purified Pullulan Sorbent, Carbon Dioxide Silica, Hydrophobic Colloidal Barium Hydroxide Lime Silicon Dioxide Soda Lime Silicon Dioxide, Colloidal Sodium Alginate Stiffening Agent Starch, Corn Castor Oil, Hydrogenated Starch, Hydroxypropyl Corn Cetostearyl Alcohol Starch, Hydroxypropyl Pea Cetyl Alcohol Starch, Hydroxypropyl Potato Cetyl Esters Wax Starch, Pea Cetyl Palmitate Starch, Potato Hard Fat Starch, Tapioca Alpha-Lactalbumin Starch, Wheat Paraffin Sucrose Palmitate Paraffin, Synthetic Tragacanth Rapeseed Oil, Fully Hydrogenated Xanthan Gum Rapeseed Oil, Superglycerinated Fully Hydrogenated Stearyl Alcohol Wax, Emulsifying Change to read: Wax, White Wax, Yellow Sweetening Agent Suppository Base Acesulfame Potassium Cocoa Butter Aspartame Hard Fat Aspartame Acesulfame Polyethylene Glycol Corn Syrup Suspending and/or Viscosity-Increasing Agent Corn Syrup, High Fructose Acacia Corn Syrup Solids Agar Dextrates Alamic Acid Dextrose Alginic Acid Dextrose Excipient Aluminum Monostearate Erythritol Attapulgite, Activated Fructose Attapulgite, Colloidal Activated Galactose Bentonite Maltitol Bentonite, Purified Maltose Bentonite Magma Mannitol Carbomer 910 Saccharin Carbomer 934 Saccharin Calcium Carbomer 934P Saccharin Sodium Carbomer 940 Sorbitol Carbomer 941 Sorbitol Solution ▲ Carbomer 1342 Hydrogenated Starch Hydrolysate▲NF30
Official from May 1, 2012 Copyright (c) 2011 The United States Pharmacopeial Convention. All rights reserved. Accessed from 128.83.63.20 by nEwp0rt1 on Thu Dec 01 21:23:02 EST 2011
NF 30 Excipients 1677
Sucralose Corn Syrup Solids Sucrose Dextrates Sugar, Compressible Dextrin Sugar, Confectioner’s Dextrose Excipient Syrup Fructose Tagatose Kaolin Trehalose Alpha-Lactalbumin Lactitol Lactose, Anhydrous Change to read: Lactose, Monohydrate Maltitol Tablet Binder Maltodextrin Acacia Maltose Alginic Acid Mannitol Amino Methacrylate Copolymer Propylene Glycol Monocaprylate Ammonio Methacrylate Copolymer Pullulan Ammonio Methacrylate Copolymer Dispersion Sorbitol Carbomer Copolymer Starch Carbomer Homopolymer Starch, Corn Carbomer Interpolymer Starch, Hydroxypropyl Corn Carboxymethylcellulose Sodium Starch, Hydroxypropyl Pea Cellulose, Microcrystalline Starch, Hydroxypropyl Potato Cellulose, Silicified Microcrystalline Starch, Pea Coconut Oil, Hydrogenated Starch, Potato Copovidone Starch, Pregelatinized Corn Syrup Starch, Pregelatinized Modified Corn Syrup Solids Starch, Tapioca Dextrin Starch, Wheat ▲ Ethyl Acrylate and Methyl Methacrylate Copolymer Hydrogenated Starch Hydrolysate▲NF30 Dispersion Sucrose Ethylcellulose Sugar, Compressible Ethylene Glycol and Vinyl Alcohol Graft Copolymer Sugar, Confectioner’s Gelatin Trehalose Glucose, Liquid Tablet and/or Capsule Lubricant Guar Gum Behenoyl Polyoxylglycerides Hydroxypropyl Cellulose, Low-Substituted Calcium Stearate Hydroxypropyl Methylcellulose (see Hypromellose) Coconut Oil, Hydrogenated Hypromellose (formerly Hydroxypropyl Methylcellulose) Glyceryl Behenate Hypromellose Acetate Succinate Magnesium Stearate Alpha-Lactalbumin Mineral Oil, Light Maltodextrin Palm Oil, Hydrogenated Maltose Polyethylene Glycol Methylcellulose Polyoxyl 10 Oleyl Ether Palm Oil, Hydrogenated Polyoxyl 15 Hydroxystearate Polydextrose, Hydrogenated Polyoxyl 20 Cetostearyl Ether Polyethylene Oxide Polyoxyl 35 Castor Oil Polyvinyl Acetate Polyoxyl 40 Hydrogenated Castor Oil Povidone Polyoxyl 40 Stearate Pullulan Polysorbate 20 Starch, Corn Polysorbate 40 Starch, Hydroxypropyl Corn Polysorbate 60 Starch, Hydroxypropyl Pea Polysorbate 80 Starch, Hydroxypropyl Potato Sodium Lauryl Sulfate Starch, Pea Sodium Stearyl Fumarate Starch, Potato Sorbitan Monolaurate Starch, Pregelatinized Sorbitan Monooleate Starch, Pregelatinized Modified Sorbitan Monopalmitate Starch, Tapioca Sorbitan Monostearate Starch, Wheat ▲ Sorbitan Sesquioleate Hydrogenated Starch Hydrolysate▲NF30 Sorbitan Trioleate Syrup Starch Trehalose Stearic Acid Stearic Acid, Purified Change to read: Sucrose Stearate Talc Vegetable Oil, Hydrogenated, Type I Tablet and/or Capsule Diluent Zinc Stearate Calcium Carbonate Calcium Phosphate, Dibasic Tablet Disintegrant Calcium Phosphate, Tribasic Alginic Acid Calcium Sulfate Cellulose, Microcrystalline Cellulose, Microcrystalline Cellulose, Silicified Microcrystalline Cellulose, Silicified Microcrystalline Croscarmellose Sodium Cellulose, Powdered Crospovidone Corn Syrup Hydroxypropyl Cellulose, Low-Substituted
Official from May 1, 2012 Copyright (c) 2011 The United States Pharmacopeial Convention. All rights reserved. Accessed from 128.83.63.20 by nEwp0rt1 on Thu Dec 01 21:23:02 EST 2011
1678 Excipients NF 30
Maltose Polyoxyl 15 Hydroxystearate Polacrilin Potassium Safflower Oil Pullulan Sesame Oil Sodium Starch Glycolate Soybean Oil Starch Squalane Starch, Corn SOLID CARRIER Starch, Hydroxypropyl Corn Chitosan Starch, Hydroxypropyl Pea Corn Syrup Solids Starch, Hydroxypropyl Potato Alpha-Lactalbumin Starch, Pea Propylene Glycol Dicaprylate/Dicaprate Starch, Potato Propylene Glycol Monocaprylate Starch, Pregelatinized Sugar Spheres Starch, Pregelatinized Modified STERILE Starch, Tapioca rAlbumin Human Starch, Wheat Sodium Chloride Injection, Bacteriostatic Trehalose Water for Injection, Bacteriostatic Tonicity Agent Viscosity-Increasing Agent (See Suspending and/or Corn Syrup Viscosity-Increasing Agent) Corn Syrup Solids Dextrose Water-Repelling Agent Glycerin Cyclomethicone Mannitol Dimethicone Potassium Chloride Simethicone Sodium Chloride Wetting and/or Solubilizing Agent Vehicle Benzalkonium Chloride Benzethonium Chloride FLAVORED AND/OR SWEETENED Cetylpyridinium Chloride Aromatic Elixir Docusate Sodium Benzaldehyde Elixir, Compound Nonoxynol 9 Corn Syrup Solids Octoxynol 9 Dextrose Poloxamer Ethyl Maltol Polyoxyl 10 Oleyl Ether Peppermint Water Polyoxyl 15 Hydroxystearate Sorbitol Solution Polyoxyl 20 Cetostearyl Ether Syrup Polyoxyl 35 Castor Oil Trehalose Polyoxyl 40 Hydrogenated Castor Oil OLEAGINOUS Polyoxyl 40 Stearate Alkyl (C12-15) Benzoate Polysorbate 20 Almond Oil Polysorbate 40 Canola Oil Polysorbate 60 Corn Oil Polysorbate 80 Cottonseed Oil Pullulan Ethyl Oleate Sodium Lauryl Sulfate Isopropyl Myristate Sorbitan Monolaurate Isopropyl Palmitate Sorbitan Monooleate Mineral Oil Sorbitan Monopalmitate Mineral Oil, Light Sorbitan Monostearate Octyldodecanol Sorbitan Sesquioleate Olive Oil Sorbitan Trioleate Peanut Oil Tyloxapol Polydecene, Hydrogenated
Official from May 1, 2012 Copyright (c) 2011 The United States Pharmacopeial Convention. All rights reserved.