The United States
`Pharmacopeia
`
`TWENTIETH REVISION
`
`Official from July 1, 1980
`
`The National
`Formulary
`
`FIFTEENTH EDITION
`
`Official from July 1, 1980
`
`l
`
`United States Pharmacopeial Convention, Inc.
`1260 I Twin brook Parkway, Rockvi lle, Md. 20852
`
`111/1 us------'P p
`
`1820
`
`EST.
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`
`MYLAN EXHIBIT 1027
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`

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`~ - -
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`Official coupon
`Do not remove
`
`NOTICE AND WARN ING
`Concerning U.S. Pa1ent or Trademark Rights
`The inclusion in t he Pharmacopeia or in the National Formulary of a monograph on any d rug
`in respect to which patent or trade mark rights may exist shall not be deemed, and is not
`intended as, a grant of, or aut hor ity to exercise, any right or privilege protected by such patent
`or trademark. A ll such rights and privileges a re vested in the patent or trademark owner, and
`no other person may exercise the same wit hout express per mission, authority, or license
`secured from such patent or trade mark owner.
`Concerning Use of USP or NF Text
`Attention is called to the fact that USP and NF text is ful ly copyr ighted. Authors a nd others
`wishing to use portions of the text should request permission to do so from the Secretary of the
`USPC Board of Trustees.
`
`Concerning Laws of Other Coumries
`In establishing t he Pharmacopeial and Nat ional Formulary standa rds, the USP Committee of
`Revision does not attempt to take into accoun t t he laws of countries other t han the United
`S ta tes of America desiring to enforce these standards wit hin their ju risdictions.
`
`© I 979 The United States P harmacopeial Convention, Inc.
`1260 I Twin brook Parkway, Rockville, Md. 20852
`
`/Ill rights reserved
`
`ISS N 0195-7996
`ISB N 0 -912734-30-2 (cloth)
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`0-912734-31-0 ( leather)
`
`Typeset a nd printed by Mack Printing Company, Easton, Pa . 18042
`
`Dist ribu ted by Mack Publishing Compa ny, Easton, Pa. 18042
`
`

`

`USP XX
`
`The United States
`Pharmacopeia
`
`TWENTIETH REVISION
`
`By authority of the United States Pharmacopeial Convention, Inc.,
`meeting at Washington, D. C., March 22, 1975. Prepared by
`the Committee of Revision and published by the Board of Trustees
`
`&15./113
`t),113
`
`Officialfrom July 1, 1980
`
`United States Pharmacopeial Convention, Inc.
`1260 I Twi n brook Parkway, Rockvi lle, Md. 20852
`
`

`

`USP XX
`
`Reference Tables / Description and Solubility
`
`1121
`
`DESCRIPTION AND SOLUBILITY
`
`The "description" and "solubility" statements pertaining to an
`article (formerly included in the individual monograph) are general
`in nature. The information is provided for those who use, prepare,
`and dispense drugs, solely to indicate descriptive and solubility
`properties of an article complying with monograph standards. The
`properties are not in themselves standards or tests for purity even
`though they may indirectly assist in the preliminary e.valuation of
`the integrity of an article.
`Only where a special, quantitative solubility test is given in the
`individual monograph, and is designated by a test heading, is it a
`lest for purity.
`The approximate solubilities of Pharmacopeial and National
`Formulary substances are indicated by the descriptive terms in the
`accompany table.
`
`Descriptive
`Term
`Very soluble
`Freely soluble
`Soluble
`Sparingly soluble
`Slightly soluble
`Very slightly soluble
`Practically insoluble,
`or Insoluble
`
`Parts of Solvent
`Required for
`I Part of Solute
`Less than I
`From I to 10
`From 10 to 30
`From 30 to I 00
`From 100 to 1000
`From 1000 to 10,000
`I 0,000 and over
`
`Description and Relative Solubility of USP and NF Articles
`Acetophenazine Maleate: Fine, yellow powder. Melts at about
`165° , with decomposition. Soluble in water; slightly soluble in
`acetone and in alcohol.
`Acetylcysteine: White, crystalline powder, having a slight acetic
`· odor. Freely soluble in water and in alcohol; practically insoluble
`in chloroform and in ether.
`Acrisorcin: Yellow, odorless powder. Melts at about 190°, with
`decomposition (see ( 7 41) ). Very slightly soluble in water and
`in ether; soluble in alcohol; slightly soluble in chloroform.
`Agar: Odorless or has a slight odor, and produces a mucilaginous
`sensation on the tongue.
`Insoluble in cold water; soluble in
`boiling water.
`Alanine: White, odorless crystals or crystalline powder, having
`a slightly sweet taste. Freely soluble in water; slightly soluble
`in 80% alcohol; insoluble in ether.
`Albumin Human: Practically odorless, moderately viscous, clear,
`brownish fluid .
`Alcohol: Clear, colorless, mobile, volatile liquid. Has a charac(cid:173)
`teristic odor and produces a burning sensation on the tongue. ls
`readily .volatilized even al low temperatures, and boils at about
`78°. Is flammable. Miscible with water and with practically
`all organic solvents.
`Dehydrated Alcohol: Clear, colorless, mobile, volatile liquid. Has
`a characteristic odor and produces a burning sensation on the
`tongue.
`Is readily volatilized even at low temperatures, and boils
`al about 78°.
`Is flammable. Miscible with waler and with
`practically all organic solvents.
`Diluted Alcohol: Clear, colorless, mobile liquid, having a char(cid:173)
`acteristic odor and producing a burning sensation on the
`tongue.
`Rubbing Alcohol: Transparent, colorless, or colored ~s desired,
`mobile, volatile liquid. Has an extremely bitter taste and, in the
`ls
`absence of added odorous constituents, a characteristic odor.
`flammable.
`Alginic Acid: White to yellowish white, fibrous powder.
`Is
`odorless, or practically odorless, and is tasteless. Insoluble in
`waler and in organic solvents; soluble in alkaline solutions.
`
`Soluble Pharmacopeial and National Formulary articles, when
`brought into· solution, may show traces of physical impurities, such
`as minute fragments of filter paper, fibers, and other particulate
`matter, unless limited or excluded by definite tests or other speci(cid:173)
`fications in the individual monographs.
`
`Acacia:
`ls practically odorless and produces a 111udlaginous
`sensation on the tongue. Insoluble in alcohol.
`Acetaminophen: White, odorless, crystalline powder, having a
`slightly bitter taste. Soluble in boiling water and in I N sodium
`hydroxide; freely soluble in alcohol.
`Acetazolamide: White to faintly yellowish white, crystalline,
`odorless powder. Very slightly soluble in water; sparingly soluble
`in practically boiling water; slightly soluble in alcohol.
`Sterile Acetazolamide Sodium: White solid, having the charac(cid:173)
`teristic appearance of freeze-dried products.
`Acetic Acid: Clear, colorless liquid, having a strong, characteristic
`odor, and a sharply acid taste. Specific gravity is about 1.045.
`Miscible with water, with alcohol, and with glycerin.
`Diluted Acetic Acid: Clear, colorless liquid, having a characteristic
`odor and a sharply acid taste. Specific gravity is about 1.008.
`Miscible with water, with alcohol, and with glycerin .
`Glacial Acetic Acid: Clear, colorless liquid, having a pungent,
`characteristic odor and, when well diluted with waler, an acid
`taste. Boils at about 118°. Specific gravity is about 1.05.
`Miscible with water, with alcohol, and with glycerin.
`Acetohexamide: White, crystalline, practically odorless powder.
`Practically insoluble in waler and in ether; soluble in pyridine and
`in dilute solutions of alkali hydroxides; slightly soluble in alcohol
`and in chloroform.
`Acetone: Transparent, colorless, mobile, volatile liquid, having
`a characteristic odor. A solution (I in 2) is neutral to litmus.
`Miscible with water, with alcohol, with ether, with chloroform,
`and with most volatile oils.
`
`Allopurinol: Fluffy white to off-white powder, having only a slight
`odor. Very slightly soluble in water and in alcohol; soluble in
`solutions of potassium and sodium hydroxides; practically in(cid:173)
`soluble in chloroform and in ether.
`Almond Oil: Clear, pale straw-colored or colorless, oily liquid,
`having a bland taste. Remains clear at -10°,'and does not
`congeal until cooled to almost -20°. Slightly soluble in alcohol;
`miscible with ether, with chloroform, with benzene, and with
`solvent hexane.
`Aloe: Has a characteristic, somewhat sour and disagreeable,
`odor.
`Alphaprodine Hydrochloride: White, crystalline powder, having
`a slight odor. Freely soluble in water, in alcohol, and in chloro(cid:173)
`form; insoluble in ether.
`
`Alum: Large, colorless crystals, crystalline fragments, or white
`powder. Is odorless, and has a sweetish, strongly astringent taste.
`Its solutions are acid to litmus. Freely soluble in water; very
`soluble in boiling water; freely but slowly soluble in glycerin;
`insoluble in alcohol.
`
`Aluminum Acetate Topical Solution: Clear, colorless liquid having
`a faint odor of acetic acid, and a sweetish, astringent taste.
`Specific gravity is about 1.02.
`
`t
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`11,
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`