2003
`
`‘I
`
`-
`
`3
`
`THE UNITED STATES PHARMACOPEIA
`
`NF 21
`THE NATIONAL FORMULARY
`
`Kl
`
`and
`
`By authority of the United States Pharmacopeial
`Convention, Inc., meeting at Washington, D.C.,
`April 12-16, 2000. Prepared by the Council of Experts
`and published by the Board of Trustees
`
`Oflicial from January I, 2003
`
`The designation on the cover of this publication, “USP NF
`2003,” is for ease of identification only. The publication
`contains two separate compendia: The Pharmacopeia of the
`United States Twenty—sixth Revision, and the National
`Formulary, Twenty—first Edition.
`
`xiv
`__
`
`XV
`
`13
`
`"—‘
`
`1963
`
`1963
`
`1994
`
`2002
`
`2016
`
`2051
`
`2105
`
`2235
`
`UNITED STATES PHARMACOPEIAL CONVENTION, INC.
`12601 Twinbrook Parkway, Rockville, MD 20852
`
`T
`
`Amgen Ex. 2011
`
`Complex Innovations v. Amgen
`
`IPRZO16-00085
`
`I
`
`Amgen Ex. 2011
`Complex Innovations v. Amgen
`IPR2016-00085
`
`

`
`
`
`The inclusion in the Pharmacopeia or in the National Formulary of a monograph on any drug in respect
`to which patent or trademark rights may exist shall not be deemed, and is not intended as, a grant of, or
`authority to exercise, any right or privilege protected by such patent or trademark. All such rights and
`privileges are vested in the patent or trademark owner, and no other person may exercise the same with-
`out express permission, authority, or license secured from such patent or trademark owner.
`
`NOTICE AND WARNING
`
`Concerning US. Patent or Trademark Rights
`
`Concerning Use of USP or NF Text
`
`Attention is called to the fact that USP and NF text is fully copyrighted. Authors and others wishing to
`use portions of the text should request permission to do so from the Secretary of the USPC Board of
`Trustees.
`
`Copyright © 2002 The United States Pharmacopeial Convention, Inc.
`12601 Twinbrook Parkway, Rockville, MD 20852
`All rights reserved.
`ISSN 0195-7996
`ISBN 1-889788-13-9
`Printed in Canada by Webcom Limited, Toronto, Ontario
`
`

`
`
`
`Excipients
`
`2679
`
`Excipients
`
`Phenylmercuric Acetate
`Phenylmercuric Nitrate
`Potassium Benzoate
`Potassium Sorbate
`Propylparaben
`Propylparaben Sodium
`Sodium Benzoate
`Sodium Dehydroacetate
`Sodium Propionate
`Sorbic Acid
`Thimerosal
`Thymol
`
`Antioxidant
`Ascorbic Acid
`Ascorbyl Palmitate
`Butylated Hydroxyanisole
`Butylated Hydroxytoluene
`Hypophosphorous Acid
`Monothioglycerol
`Potassium Metabisulfite
`Propyl Gallate
`Sodium Formaldehyde Sulfoxylate
`Sodium Metabisulfite
`Sodium Thiosulfate
`Sulfur Dioxide
`Tocopherol
`Tocopherols Excipient
`
`Buffering, Agent
`Acetic -Acid
`Ammonium Carbonate
`Ammonium Phosphate
`Boric Acid
`Citric Acid
`Lactic Acid
`Phosphoric Acid
`Potassium Citrate
`Potassium Metaphosphate
`Potassium Phosphate, Monobasic
`Sodium Acetate
`Sodium-Citrate
`Sodium Lactate Solution
`Sodium Phosphate, Dibasic
`Sodium Phosphate, Monobasic
`
`Bulking Agent for Freeze-Drying
`Creatinine
`Mannitol
`Capsule Lubricant (See Tablet and/or Capsule Lubricant)
`
`Chelating Agent
`Edetate Calcium Disodium
`Edetate Disodium
`Edetic Acid
`
`Coating Agent
`Carboxymethylcellulose, Sodium
`Cellacefate (formerly Cellulose Acetate Phthalate)
`Cellulose Acetate
`Cellulose Acetate Phthalate (see Cellacefate)
`Ethylcellulose
`Ethylcellulose Aqueous Dispersion
`Gelatin
`Glaze, Pharmaceutical
`Hydroxypropyl Cellulose
`Hydroxypropyl Methylcellulose
`
`
`
`USP and NF Excipients, Listed by Categories
`
`,,xcidify_ing Agent
`- Acetic Acid
`Acetic Acid, Glacial
`Citric Acid
`Fumaric Acid
`Hydrochloric Acid
`Hydrochloric Acid, Diluted
`Malic Acid
`Nitric Acid
`Phosphoric Acid
`Phosphoric Acid, Diluted
`Propionic Acid
`Sulfuric Acid
`Tartaric Acid
`
`Aerosol Propellant
`Butane
`Dichlorodifluoromethane
`Dichlorotetrafluoroethane
`Isobutane
`Propane
`Trichloromonofluoromethane
`
`led in
`
`Air Displacement
`Carbon Dioxide
`Nitrogen
`
`Alcohol Denaturant
`Denatonium Benzoate
`Methyl Isobutyl Ketone
`Sucrose Octaacetate
`
`Alkalizing Agent
`Ammonia Solution, Strong
`Ammonium Carbonate
`Diethanolamine
`Potassium Hydroxide
`Sodium Bicarbonate
`Sodium Borate
`Sodium Carbonate
`Sodium Hydroxide
`Trolamine
`
`Anticaking Agent (See Glidant)
`
`Antifoaming Agent
`Dimethicone
`Slmethicone
`
`Antimicrobial Preservative
`Benzalkonium Chloride
`Benzalkonium Chloride Solution
`Benzethonium Chloride
`Benzoic Acid
`Benzyl Alcohol
`Butylparaben
`Cetylpyridinium Chloride
`Chlorobutanol
`Chlorocresol
`Cresol
`Ethylparaben
`Methylparaben
`Methylparaben Sodium
`henol
`Phenylethyl Alcohol
`
`
`
`

`
`“Far '
`
`
`
`2680
`
`Excipients
`
`Hydroxypropyl Methylcellulose Phthalate (see Hypromellose
`Phthalate)
`Hypromellose Phthalate (formerly Hydroxypropyl
`Methylcellulose Phthalate)
`Methacrylic Acid Copolymer
`Methacrylic Acid Copolymer Dispersion
`Methylcellulose
`'
`Polyethylene Glycol
`Polyvinyl Acetate Phthalate
`Shellac
`Sucrose
`Titanium Dioxide
`Wax, Camauba
`Wax, Microcrystalline
`Zein
`
`Color
`Caramel
`Ferric Oxide, red yellow, black, or blends
`
`Complexing Agent
`Edetate Disodium
`Edetic Acid
`Oxyquinoline Sulfate
`
`Desiccant
`Calcium Chloride
`Calcium Sulfate
`Silicon Dioxide
`
`Emollient
`Alkyl (C12-15) Benzoate
`
`Emulsifying and/or Solubilizing Agent
`Acacia
`Cholesterol
`Diethanolamine (Adjunct)
`Glyceryl Monostearate
`Lanolin Alcohols
`Lecithin
`Mono- and Di—glycerides
`Monoethanolamine (Adjunct)
`Oleic Acid (Adjunct)
`Oleyl Alcohol (Stabilizer)
`Poloxamer
`Polyoxyethylene 50 Stearate
`Polyoxyl 35 Castor Oil
`Polyoxyl 40 Hydrogenated Castor Oil
`Polyoxyl 10 Oleyl Ether
`Polyoxyl 20 Cetostearyl Ether
`Polyoxyl 40 Stearate
`Polysorbate 20
`Polysorbate 40
`Polysorbate 60
`Polysorbate 80
`Propylene Glycol Monostearate.
`Sodium Lauryl Sulfate
`Sodium Stearate
`Sorbitan Monolaurate
`Sorbitan Monooleate
`Sorbitan Monopalmitate
`Sorbitan Monostearate
`Steafic Acid
`Trolamine
`Wax, Emulsifying
`
`Filtering Aid
`Cellulose, Powdered
`Siliceous Earth, Purified
`
`Flavors and Perfumes
`Anethole
`Benzaldehyde
`Ethyl Vanillin
`Menthol
`Methyl Salicylate
`Monosodium Glutamate
`Peppermint
`
`Peppermint Oil
`Peppermint Spirit
`Rose Oil
`Rose Water, Stronger
`Thymol
`Vanillin
`
`Glidant and/or Antieaking Agent
`Calcium Silicate
`Magnesium Silicate
`Silicon Dioxide, Colloidal
`Talc’
`.
`
`Humectant
`Glycerin
`Hexylene Glycol
`Propylene Glycol
`Sorbitol
`
`Ointment Base
`Diethylene Glycol Monoethyl Ether
`Lanolin
`Ointment, Hydrophilic
`Ointment, White
`Ointment, Yellow
`Polyethylene Glycol Ointment
`Petrolatum
`Petrolatum, Hydrophilic
`Petrolatum, White
`Rose Water Ointment
`Squalane
`Vegetable Oil, Hydrogenated, Type II
`
`Plasticizer
`Acetyltributyl Citrate
`Acetyltriethyl Citrate
`Castor Oil
`Diacetylated Monoglycerides
`Dibutyl Sebacate
`Diethyl Phthalate
`Glycerin
`“ Polyethylene Glycol
`. Propylene Glycol
`Triacetin
`Tributyl Citrate
`Triethyl Citrate
`
`Polymer Membrane
`Cellulose Acetate
`
`Sequestering Agent
`Beta Cyclodextrin (see Betadex)
`Betadex (formerly Beta Cyclodextrin)
`
`Solvent
`Acetone
`Alcohol
`Alcohol, Diluted
`Amylene Hydrate
`Benzyl Benzoate
`Butyl Alcohol
`Corn Oil
`Cottonseed Oil
`Diethylene Glycol Monoethyl Ether
`Ethyl Acetate
`Glycerin
`Hexylene Glycol
`Isopropyl Alcohol
`Methyl Alcohol
`Methylene Chloride
`Methyl Isobutyl Ketone .
`Mineral Oil
`Peanut Oil
`Polyethylene Glycol
`Propylene Glycol
`Sesame Oil
`Water for Injection
`Water for Injection, Sterile
`
`t
`
`
`
`

`
`Excipients
`
`2681
`
`A0321
`
`Water for Irrigation, Sterile
`Water, Purified
`
`sorbent
`Cellulose, Powdered
`Charcoal
`Siliceous Earth, Purified
`
`sorbent, Carbon Dioxide
`Barium Hydroxide Lime
`Soda Lime
`
`stiffening Agent
`Castor Oil, Hydrogenated
`Cetostearyl Alcohol
`Cetyl Alcohol
`Cetyl Esters Wax
`Cetyl Palmitate
`Hard Fat
`Paraffin
`Synthetic Paraffin
`Stearyl Alcohol
`Wax, Emulsifying
`Wax, White
`Wax, Yellow
`
`Suppository Base
`Cocoa Butter
`Hard Fat
`Polyethylene Glycol
`
`Suspending and/or Viscosity-increasing Agent
`Acacia
`Agar
`Alginic Acid
`Aluminum Monostearate
`Attapulgite, Activated
`Attapulgite, Colloidal Activated
`Bentonite
`Bentonite, Purified
`Bentonite Magma
`Carbomer 910
`Carbomer 934
`Carbomer 934P
`Carbomer 940
`Carbomer 941
`Carbomer 1342
`Carboxymethylcellulose Calcium
`Carboxymethylcellulose Sodium
`Carboxymethylcellulose Sodium 12
`Carrageenan
`Cellulose, Microcrystalline, and Carboxymethylcellulose
`Sodium
`Dextrin
`Gelatin
`Guar Gum
`Hydroxyethyl Cellulose
`Hydroxypropyl Cellulose
`Hydroxypropyl Methylcellulose
`Magnesium Aluminum Silicate
`Methylcellulose
`Pectin
`Polyethylene Oxide
`Polyvinyl Alcohol
`Povidone
`Propylene Glycol Alginate
`Silicon Dioxide
`Silicon Dioxide, Colloidal
`Sodium Alginate
`Tragacanth
`Xanthan Gum
`
`sweetening Agent
`Aspartame
`Dextrates
`Dextrose
`Dextrose Excipient
`Fructose
`
`Mannitol
`Saccharin
`Saccharin Calcium
`Saccharin Sodium
`Sorbitol
`Sorbitol Solution
`Sucralose
`Sucrose
`Sugar, Compressible
`Sugar, Confectioner’s
`Synm
`
`Tablet Binder
`Acacia
`Alginic Acid
`Carboxymethylcellulose, Sodium
`Cellulose, Microcrystalline
`Dextrin
`Ethylcellulose
`Gelatin
`Glucose, Liquid
`Guar Gum
`Hydroxypropyl Methylcellulose
`Methylcellulose
`Polyethylene Oxide
`Povidone
`Starch, Pregelatinized
`Syrup
`
`Tablet and/or Capsule Diluent
`Calcium Carbonate
`Calcium Phosphate, Dibasic
`Calcium Phosphate, Tribasic
`Calcium Sulfate
`Cellulose, Microcrystalline
`Cellulose, Powdered
`Dextrates
`Dextrin
`Dextrose Excipient
`Fructose
`Kaolin
`Lactitol
`Lactose
`Mannitol
`Sorbitol
`Starch
`Starch, Pregelatinized
`Sucrose
`Sugar, Compressible
`Sugar, Confectioner’s
`
`Tablet Disintegrant
`Alginic Acid
`Cellulose, Microcrystalline
`Croscarmellose Sodium
`Crospovidone
`Polacrilin Potassium
`Sodium Starch Glycolate
`Starch
`Starch, Pregelatinized
`
`Tablet and/or Capsule Lubricant
`Calcium Stearate
`Glyceryl Behenate
`Magnesium Stearate
`Mineral Oil, Light
`Polyethylene Glycol
`Sodium Stearyl Fumarate
`Stearic Acid
`Stearic Acid, Purified
`Talc
`Vegetable Oil, Hydrogenated, Type 1
`Zinc Stearate
`
`Tonicity Agent
`Dextrose
`Glycerin
`Mannitol
`
`
`
`...n..-_—-.._
`
`

`
` ——
`
`2682
`
`Excipients
`
`Potassium Chloride
`Sodium Chloride
`
`Vehicle
`
`FLAVORED AND/OR SWEETENED
`Aromatic Elixir
`Benzaldehyde Elixir, Compound
`peppermint water
`sorbito1 somtion
`syrup
`OLEAGINOUS
`Alkyl (C12-15) Benzoate
`Almond on
`Com on
`-
`g31t;(;nCS)T§SteO11
`Isopmpyl Myfistate
`Isopropyl Palmitate
`Mineral Oil
`Mineral Oil, Light
`Octyldodecanol
`Olive
`Peanut Oil
`Safflower Oil
`Sesame Oil
`Soybean Oil
`Squalane
`SSOL“; CAWRIER
`“gar
`1’ ems
`STERILE
`Sodium Chloride Injection, Bacteriostatic
`
`~
`
`Water for Injection, Bacteriostatic
`Viscosity-Increasing (See Suspending Agent)
`
`Water Repelling Agent
`Cyclomethicone
`13_imetl{iC0n6
`S1m6th1C011e
`.
`_ _
`_
`Wetting and(or Solubihzmg Agent
`Benzalkonium Chloride
`Benzethonium Chloride
`Cetylpyridinium Chloride
`D°°“5a"= S°d1“m
`N°“°XYn°1 9
`§°f°XY“°1 9
`o oxamer
`Polyoxyl 35 Castor Oil
`Polyoxyl 40 Hydrogenated Castor Oil
`Polyoxyl 10 Oleyl Ether
`Polyoxyl 20 Cetostearyl Ether
`Po1yoxyl40 Stearate
`Polysorbate 20
`Polysorbate
`Polysorbate 60
`Polysorbate 80
`Sodium Lauryl Sulfate
`Sorbitan Monolaurate
`Sorbitan Monooleate
`Sorbitan Monopalmitatc
`Sorbitan Monostearate
`Tyloxapol