THE UNITED STATES PHARMACOPEIA
`
`THE NATIONAL FORMULARY
`
`By authority of the United States Pharmacopeia/
`Convention, Inc., meeting at Washington, D. C.,
`March 8-10, 1990. Prepared by the Committee of
`Revision and published by the Board of Trustees
`
`Official from January 1, 199 5
`
`UNITED STATES PHARMACOPEIAL CONVENTION, INC.
`12601 Twinbrook Parkway, Rockville, MD 20852
`
`LUYE1006
`IPR of Patent No. 6,667,061
`
`

`
`NOTICE AND WARNING
`Concerning U.S. Patent or Trademark Rights
`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
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`owner, and no other person may exercise the same without express permission, authority, or
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`
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`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.
`
`The United States Pharmacopeia! Convention, Inc.
`© 1994
`12601 Twinbrook Parkway, Rockville, MD 20852.
`All rights reserved
`ISSN 0195-7996
`ISBN 0-913595-76-4 (cloth)
`0-913595-81-0 (leather)
`
`Printed by Rand McNally, 1133 County Street, Taunton, MA 02780-3795
`
`LUYE1006
`IPR of Patent No. 6,667,061
`
`

`
`274
`
`Carboprost / Official Monographs
`
`1 in 50 solution of a-bromo-2'-acetonaphthone in acetonitrile. Swirl
`to wash down the sides of the vial. Add 50 ~L of a freshly
`prepared 1 in 100 solution of diisoptopylethylamine in acetoni-
`trile, swirl again, and place the vial in a suitable heating device
`maintained at a temperature of 30° to 35° for not less than 15
`minutes. Evaporate the acetonitrile from the vial with the aid of
`a stream of nitrogen, add 2.0 mL of .Internal standard prepa-
`ration, mix, and filter the resulting solution through a fine-po-
`rosity filter. Protect the filtered solution from light prior to in-
`jection to prevent degradation of the naphthacyl ester of
`carboprost.
`Assay preparation-Using Carboprost Tromethamine, pro-
`ceed as dtrected under Standard preparation.
`·
`Procedure-As a system suitability test, chromatograph dif-
`ferent volumes of the Standard preparation using a suitable mi-
`crosyringe or sampling valve to determine appropriate volume
`and other operating parameters. The retention times for guai-
`fenesin and the 2-naphthacyl ester of carboprost are about 7
`minutes and 11 minutes, respectiveLy. In a suitable chromato-
`gram, the resolution factor between these two peaks is not less
`than 4.0 and the relative standard deviation for four replicate
`injections of the Standard preparation show a relative standard
`deviation of not more than 2.0%. Use a suitable high-pressure
`liquid chromatograph of the general type (see· Chromatography
`(621)) capable of providing column pressure up to about 1500
`psig operated at room temperature and equipped with an ultra-
`violet detector capable of monitoring absorption. at 254 nm, a
`suitable recorder, and a 4-mm X 30-cm stainless steel column
`that contains 1 0-~m packing L3. · Chromatograph equal volumes
`of the Standard preparation and the Assay preparation. Cal-
`culate the quantity, in mg, of C25H47N08, in the portion of Car-
`boprost Tromethamine taken by the formula:
`Ws(Ru/Rs),
`in which Ws is the weight, in mg, of USP Carboprost Tro-
`methamine RS used in the Standard preparation,. and Rl/ and
`Rs are the ratios of the peak responses of the 2-naphthacyl ester
`of carboprost and the internal standard obt11ined from the Assay
`preparation and the Standard preparation, respectively.
`
`Carboprost Tromethamine Injection
`,, Carboprost Tromethamine Injection is a sterile so-
`lution of Carboprost Tromethamine in aqueous ·so-
`lution, which may contain also benzyl alcohol, sodium
`chloride, and tromethamine. It contains not less than
`90.0 percent and not more than 110.0 percent of the
`labeled amount of carboprost (C21H360s).
`.
`.
`Packaging and storage-Preserve in· single-dose or in multiple-
`dose containers, preferably of Type. I glass, in a refrigerator.
`USP Reference standards ( 11 )-USP Carboprost Trometh-
`amine RS. USP Endotoxin RS.
`Identification-Extract a volume of Injection equivalent to about
`2.5 mg of carboprost tromethamine with 1.5 to 2 times its volume
`of chloroform. Discard the chloroform layer, and acidify the
`aqueous layer with 3 to. 5 drops of hydrochloric acid. Extract
`the acidified solution with an equivalent volume of chloroform.
`Filter the chloroform layer through a ple4get of cotton, and con-
`centrate it to a volume of less than 1 mL. Combine the resulting
`solution with 150 to 180 mg· of potassium bromide. Dry the
`potassium bromide mix,ture in vacuum overnight, and prepare a
`potassium bromide pellet from the dried ·mixture: the infrared.
`absorption spectrum of the resulting pellet exhibits maxima at
`the same wavelengths as that of a similar preparation of USP
`Carboprost Tromethamine RS.
`Bacterial endotoxins {85)-lt contains not more than 714.3 USP
`Endotoxin Units per mg of carboprost tromethamine.
`pH (791): between 7.0 and 8.0.
`
`USP 23
`
`Other requirements-It meets the .requirements under Injections
`(1 ).
`Assay-
`Mobile solvent and Citrate buffer-Prepare as directed for
`Mobile solvent and Citrate buffer in the Assay under Carboprost
`Tromethamine.
`Internal standard preparation-Using the Mobile solvent, pre-
`pare a solution containing approximately 3 mg of guaifenesin per
`mL.
`Standard preparation-Using an accurately weighed quantity
`of the Reference Standard, prepare an aqueous Standard solution
`containing approximately 0.332 mg of USP Carboprost Trometh-
`amine RS and 9 mg of benzyl alcohol per mL. Pipet 2 mL of
`the resulting solution into a stoppered centrifuge tube. Add 20.0
`mL of methylene chloride and 1.0 mL of Citrate buffer, shake
`the stoppered tube for about 10 minutes, and centrifuge. Remove
`and discard the top (aqueous) layer, transfer an 8.0-mL aliquot
`of the lower (methylene .chloride) layer to a suitable vial, and
`evaporate the solution with the aid of a stream of nitrogen. (The
`residue does not evaporate to dryness-because of the presence of
`benzyl alcohol.) Add 100 ~L of a freshly prepared 1 in 50 solution
`of a-bromo-2'acetonaphthone in acetonitrile, and swirl to wash
`down the sides of the vial. Add 50 ~L of a freshly prepared 1
`in 100 solution of· diisopropylethylamine in acetonitrile. Swirl
`again, and place the vial in a suitable heating device maintained
`at a temperature of 30° to 35° for not less than 15 minutes.
`Evaporate the acetonitrile from the vial with the aid of a stream
`of nitrogen, add 1.0 mL of Internal standard solution, mix, and
`filter the resulting solution tbroug~ a fine-porosity filter. Protect
`the filtered solution from light prior to injection to prevent deg-
`radation of the naphthacyl ester .. of carboprost.
`Assay preparation-Pipet a volume of Injection, equivalent to
`about 500 ~g of carboprost, to a stoppered, 50-mL centrifuge
`t~be. Proceed as directed for Standar~ preparation, beginning
`wtth "Add 20.0 IIiL of methylene chlonde.'
`Procedure-Proceed as directed for Procedure in the Assay
`under Carboprost Tromethamine. Calculate the quantity, in /lg,
`of carboprost in each mL of the Injection taken by the formula:
`(368.51 I 489.65)( C)(Ru/ Rs),
`in which 368.51 and 489.65 are the molecular weights of car-
`boprost and carboprost tromethamine, respectively, Cis the con·
`centration, in ~g per mL, of USP Carboprost Tromethamine RS
`in the Standard solution used to prepare the naphthacyl ester,
`and Ru and Rs are the ratios. of the peak responses of the 2·
`naphthacyl ester of carboprost and the internal standard obtained
`from the Assay preparation and the Standard preparation, re-
`spectively.
`.
`
`Carboxymethylcellulose Calcium-see
`Carboxymethylcellulose Calcium NF
`
`Carboxymethylcellulose Sodium .
`Cellulose, carboxymethyl ether, sodium salt.
`Cellulose carboxymethyl ether sodium salt
`[9004-32-4].
`>> Carboxymethylcellulose Sodium is the sodium salt
`of a polycarboxymethyl ether of cellulose. It contains
`not less than 6.5 percent and ·not more than 9.5 per-
`cent of sodium (Na), ·calculated on the dried basis.
`Packaging and storage-Preserve in tight containers.
`LabeHng-Label it to indicate the viscosity in. solutions of stated
`concentrations.
`Identification-Add about 1 g of powdered Carboxymethylcel·
`lulose Sodium to 50 mL of water, while stirring to produce a
`
`LUYE1006
`IPR of Patent No. 6,667,061
`
`

`
`USP 23
`
`unifor~ dispersion. Continue· the stirring until a clear solution
`is produced, and use the solution for the following tests.
`.
`A: To 1 mL of the solution, diluted with an equal volume of
`water, in a small test tube, add 5 drops of !-naphthol TS . . Incline
`the test tube, and carefully introduce down the side of the tube
`2 mL of sulfuric acid so that it forms a lower layer: a red-purple
`color develops at the. interface.
`.
`B: To 5 mL of the solution add an equal volume of barium
`chloride TS: a fine, white precipitate is formed.
`·
`C: A portion of the solution responds to the tests for Sodium
`091).
`.
`.
`Viscosity ( 911 )-Determine the viscosity in a water solution at
`the concentration stated on the label. Using undried Carboxy-
`methylcellulose Sodium, weigh accurately the amount which; on
`the dried basis, will provide 200 g of solution of the stated· con-
`centration. Add the substance in small amounts to ~bout 180
`mL of stirred water contained in a tared, wide-mouth bottle,
`continue stirring rapidly until the powder is well wetted, add
`sufficie11;t water t.o mak~ t~e mixt~re we~$h ~00 g, and allo~ to
`stand, wtth occastortal sttmng, until solut10p IS complete. AdJust
`the temperature to 25 ± 0.2°, and determine the viscosity, using
`a totational type of viscosimeter, making certain that the system
`reaches equilibrium before taking the final reading. The viscosity
`of solutions of 2% or higher concentration is not less than 80.0%
`and not more than 120.0% of that stated on the label; the viscosity
`of solutions of 1% concentration is not le~s than 75.0% and not
`more than 140.0% of that stated on the label.
`pH (791): between 6.5 and 8.5 in a solution (1 in 100).
`Loss ~n drying (731)-Dry it at 105~ for 3 hours: it loses not
`.
`.
`more than 10.0% of its weight.
`Heavy metals-Determine as directed in the test for Jleavy met-
`als under Methylcel/ulose, using a 500-mg specimen: the limit
`is 0.004%.
`Assay.,-Transfer to a beaker about 500 mg of Carboxymethyl-
`cellulose Sodium, accurately weighed, add 80 mL of glacial acetic
`acid, heat the mixture on a boiling water bath for 2 ·hours, cool
`to room temperature, and titrate with 0.1 N perchloric acid VS,
`determining the endpoint potentiometrically. Each mL of 0.1 N
`perchloric acid is equivalent to 2.299 mg of Na.
`
`.
`
`Carboxymethylcellulose· Sodium Paste
`,, Carboxymethylcellulose Sodium Paste contains not
`less than 16.0 percent and not more than 17.0 percent
`of carboxymethylcellulose sodium .
`.. ·
`.
`Packaging and stqrage-Preserve in well-closed obntainers, arid
`avoid prolonged exposure to temperatures exceeding 30°.
`Identification-Digest a quantity of Paste,. equivalent to about I
`g of carboxymethylcellulose sodium, with 50 mL of water until
`solution is virtually complete, and filter: the filtrate responds to
`~
`l
`the following tests.
`. ·
`.
`·
`~-: - To a.bout 30. n:tL ofYfie solution ado-3 mL ofliyorocliloric
`ac1d: a wh1te prec1p1tate IS formed.
`1
`B: To the remainder of the solution add an equal volume of
`barium chloride TS: a fine, white, precipitate is formed.
`C: The filtrate from Identification test A responds to the tests
`for Sodium (191).
`Consistency-Determine as directed in the test for Consistency
`under White Petrolatum: the final average of the trials is not
`less than 30.0 mm and not more than 36.0 mm, indicating a
`consistency value between· 300 and 360.
`Microbial limits ( 61 >~The total bacterial. count does not exceed
`1000 per g, and the tests for Salmonella species and Escherichia
`coli are negative.
`Loss on drying (731)-Dry it at 105° for 3 hours: it loses not
`more than 2.0% of its weight.
`Heavy inetais (231)-Determine as directed in the test for Heavy
`metals under Methylcellulose, using a 400-mg specimen: the
`limit is 0.005%.
`·
`
`275
`
`Official Monographs I Carisoprodol
`Assay-Transfer about 2 g of Paste, accurately weighed, to a
`. glass-stoppered, 250-mL conical flask. Add 7 5 mL of glacial
`acetic acid, attach a condenser, and reflux for 2 hours. Cool,
`transfer the mixture to a 250-mL beaker with the aid of small
`volumes of glacial acetic acid, and titrate with 0.1 N perchloric
`acid in dioxane VS, determining the endpoint potentiometrically.
`Each mL of 0.1 N perchloric acid is equivalent to 29.67 mg of
`carboxymethylcellulose sodium.
`
`Carboxymethylcellulose Sodium Tablets
`,, Carboxymethylcellulose Sodium Tablets contain
`an amount of sodium (Na) equivalent to not less than
`6.5 percent and not more than 9.5 percent of the
`labeled amount of carboxymethylcelhdose sodium.
`Packaging and .~torage-Preserve ·in tight containers.
`Identification.:-Digest a quantity of powdered Tablets, equivalent
`to about 1 g of carboxymethylcellulose sodium, with 50 mL of
`water until solution is · virtually complete, and filter: the .filtrate
`responds to the following tests.
`· .
`·
`·
`. A: To about 30 mL of the solution add 3 mL of hydrochloric
`acid: a white preCipitate is formed.
`·
`- ' ·
`B: To the remainder of the solution add. an . equal volume of
`barium chloride TS: a fine, white pre~ipitate is formed.
`C: The filtrate from Identification test A responds to the tests
`for Sodium (191 ). ·
`·
`.
`·
`Disintegration (701): 2 hours.
`Uniformity of dosage units (905): meet the requirements.
`Assay-Weigh and finely powder not less than 20 Tablets. Weigh
`accurately a portion of the powder, · equivalent to about 500 mg
`of carboxymethylcellulose sodium, add 80 mL of glacial acetic
`acid, heat the mixture on a steam bath for 2 hours, cool to. room
`temperature, and titrate with 0.1 N perchloric acid VS, deter-
`mining.the. endpoint potentiometrically. Each mL of 0.1 N per-
`chloric acid is equivalent to 2.299 mg of Na.
`. ·
`
`·
`
`~arboxymethylcellulose Sodium, Microcrystalline
`Cellulose and-see Microcrystalline and
`.
`Carboxymethylcellulose Sodium NF ·
`Carboxymethylcellulose Sodium 12-see
`_· Carboxymethylcellulose Sodium 12 NF
`
`G-arisoprodol
`
`260.34
`C12H24N204
`( ± )-2-Methyl-2-propyl-1 ,3-propanediol carbamate
`isopropylcarbamate
`[78-44-4].
`,, Carisoprodol contains not less than 98.0 percent
`and not more than 102.0 percent of C 12H 24N 20 4, cal-
`culated on the dried basis.
`Packaging and storage-Preserve in tight containers.
`USP Reference standards (11 )-USP Carisoprodol RS. USP
`Meprobamate RS. ·
`·
`
`LUYE1006
`IPR of Patent No. 6,667,061
`
`

`
`1840
`
`(911) Viscosity l Physical Tests
`(911) VISCOSITY.
`Viscosity is a property of liquids that is closely related to the
`resistance to flow. It is defined in terms of the force required to
`move one plane surface continuously past another under specified
`steady-state conditions when the space between is filled by the
`liquid in question. It is defined as the shear stress divided by
`the rate of shear strain. The basic unit ·is the poise,· however,
`viscosities commonly encountered represent fractions of the poise,
`so that the centipoise {l poise ':"" 100 centipoises) proves to be
`the more convenient unit. The specifying of temperature is im-
`portant because viscosity changes with temperature; in general,
`viscosity decreases ·as temperature is raised. While on the ab-
`solute scale viscosity is , measured in poises or centipoise~, for
`convenience the kinematic scale, in which th~ units are stokes
`and centistokes (1 stoke.= 100 centistokes) commonly is used.
`To obtain the kinematic viscosity from the absolute viscosity, tht(
`latter is divided by the density of the liquid at the same tern~
`perature, i.e., kinematic viscosity =·(absolute viscosity)/(den-
`sity). The sizes of the units are such that viscosities in the or-
`dinary ranges are convt(niently expressed in centistokes. The .
`approximate viscosity in .. centistokes at. room temperature of ether:
`is 0.2; of water, 1; of kerosene, 2.5; of mineral oil, 20 to 70; and
`of honey, 10,000.
`Absolute viscosity cai} be measure<;~ directly if accu.rate di-:-
`mertsions of the measuring instruments are known, but it is. more
`col)lmon practice to calibrate .. the instrument ·with a liqujd of
`known viscosity and to determine the yisc()~ity of· the unknown
`fluid by comparison with that of the known.
`Many substances, such as.the gums employed in pharm,acy,
`have varbtble viscosity, and most of them are less re~istant to
`flow at higher flow rates. In such cases, a given set of condition,s
`is selected for measurement, and the measurement obtained is
`considered to be .. an apparent viscosity. Since a:· ch~nge 'in the
`conditions of measurement would yield a different vahie for the .
`apparent viscosity of s.uch substances, the instrument dimensions
`ana conditions for measurement must be closely adhered to by
`the ·operator.
`.
`·
`.
`Measur~inent of Viscosity--The usual method for measure':'
`ment of viscosity involves the 4etermination of the time required
`for !1 given volu.me <?f.liql:lid to flow throu~h a: capillary. Many
`captllary-tube vtscostmeters have been dev1seP:, but Ostwald and
`Ubbelo!'lde vjscosimeters are among the most frequently used.
`Several types are describe4, with directions. for their use, by the
`Ameti~an Society for Testing and Materials (ASTM, D-445).
`The viscosity of oils is expressed on arbitrary scales that vary
`from one cQuntry to another, th.ere, being several corresponding
`instruments. The most widely used are the Redwood No. I and
`No. Il, .the Engler, the SayboltUniversal~ an.d the Saybolt Furol. .
`Each of these instruments uses .arbitrary unit~ that bear t~e name ·
`of the instrument; Standard temperatures are adopted as a mat-
`ter of convenience with these instruments. For the Saybolt in-
`struments, in~asurements usually ar~ madt( at l00°F. and 210°F;
`Redwood instruments may be used. at sevei'altemperatures up to
`250°F; and values obtained on the Engler instrument usually are
`reported at 20°C and 50°C. A particularly conveni~nt and rap~d
`type of i~strU~ent is a r~tational vis.cosi~et~r, which utilizes a
`bob or spmdle tmmersed m the te~t spectmen and measures the
`resistance to movement of the rotating part. Different. spindles
`are available for given viscosity ranges, and several rotational
`speeds generally are available. Other rotational instruments niay
`have a stationary 'bob and a rotating cup. The Brookfield, Ro-
`touisco, and Stormer viscosimeters are examples of rotating-bob
`instruments, and the MacMichael is an exam:ple of the rotating-
`cup instrument. Numerous other rotational mstruments of ad-
`vanced design. with special devices for re~i.ding or recording, and
`with wide ranges of rotational:speed, have been devised.
`Where only a particular type of ~nstrument is suitable, the
`·
`individual monograph so indicates.
`For measurement of viscosity or apparent viscosity, the tem-
`perature of the ·substance being measured must be accurately
`controlled, since small temperature changes may lead to marked
`changes in·viscosity. For usual pharmaceutical purposes, the tem.~.
`peratD;re &hould be held to within ± 0.1°.
`.
`·:.
`.
`·Procedure for Cellulose Derivatives-Measurement of the vis-
`cosity of solutions· of the high-viscosity types of 1flethylc'ellulose
`is .a special case, since they are too viscous for the conimonly
`available viscosimeters. The Ubbelohde viscosimeter may be
`
`USP 23
`adapted (cf. ASTM, D-1347) to the-measurement of the ranges
`of viscosity encountered in methylcellulose solutions.
`Calibration of Capillary-Type Viscosimeters-:-Determine the
`v~scosimeter c<;msta.nt, k, for each viscosimeter by th~ use of an
`od of known vtscostty. *
`·
`· ·
`Ostwald-Type Viscosimeter-Fill the tube with. the exact
`amount of oil (adjusted to 20.0 ± 0.1 °) as specified by the manu-
`facturer. Adjust the meniscus of the column of liquid in the
`capillary tube to the ~evel of the top graduation. line. with the aid
`of either pressure or suction. Open both the filling and, capillary
`tubes in order to permit the liquid to flow into the reservoir against
`atmospheric pressure. [NOTE-Failure to open either of these
`tubes will yield f~lse values.) Record the time, in seconds, for
`liquid ·to flow from the upper mark to the lower mark in the
`capillary tube.
`Ubbelohde-: Type Viscosimeter-Place a quantity of the oil (ad-
`justed to 20.0. ± 0.1 °) in the filling tube, and transfer to the
`capillary tupe by gentle suction, ta,king care to prevent bubble
`formation in the liquid by keeping the air vent tube.closed. Adju.st
`the meniscu~ of the column of liquid in the capillary tube to the
`level of the top graduation line. Open both the vent a,nd capillary
`tubes in order to permit the liquiq to.flow into the reservoir against
`atmospheric pressure. [NOTE-Failure. to open the vent tube
`befor~ releasing the capillary tube will yielqfa,lse values.] Record
`the time, in seconds, for the liquid to flow from the upper mark
`to the lower mark in the capillary tube.
`.
`.
`·
`.
`Calculations-
`Calculate the viscosimeter constant, k, from the equation:
`k = vfdt,-
`in which v is the known viscosity ·of the liquid in centipoises, d
`is the specific gravity of the liquid tested at 20°/20°, and t is
`the time in seconds for the liquid to pass from the upper mark
`to the lower mark. .
`·
`.
`If a viscosimeter is repaired, it must be tecalibrated; since even
`minor repairs frequently cause significant changes in the value
`of its constant, k.
`* Oils of known viscosities may be obtained from the Cannon
`Instrument Co.;· Box 16, State College, P A 16801. · For meth-
`yl cellulose, choose an oil the viscosity ·of :which is as close as
`possible to that of the type of methylcellulose to be determined.
`
`(921) · WATER
`DETERMINATION ...
`Many Pharmacopeia} articles either are hydrates or contain
`water in adsorbed form. As a result, the deter.mimition of the
`water content is iniportant in.demonstrating compliance with the
`Pharmacopeia! standards. Generally one of the methods given
`below is called for in the individual monograph, depending upon
`the nature of the article. In rare cases, a choice is allowed be-
`tween two methods. When the article contains water of . hydra-
`tion, the Method I (Titrimetric ), the Method II (Azeotropic ), or
`the· Method III (Gravimetric) is employed, as directed in the
`individual monograph, and the requirement is given under the
`heading Water.
`The heading Loss on drying (see Loss on Drying (731)) is used
`in those cases where the loss sustained on heating may be not
`entirely water.
`
`METHOD I (TITRIMETRIC)
`Determine the water by Method Ia, unless otherwise specified
`in the individual monograph.
`
`Method Ia (Direct Titration)
`Principle-The titrimetric determination of water is based upon
`the quantitative reaction of water with an anhydrous solution of
`sulfur dioxide and iodine in the presence of a buffer that reacts
`with hydrogen ions.
`
`LUYE1006
`IPR of Patent No. 6,667,061
`
`

`
`Combined Index to USP 23 and NF 18
`
`Carba-Cepha
`
`2333
`
`1-[N-[ (S)~ 1-Carboxy-3-phenylpropyl]-L-alanyl]- ·
`L-proline 1'-ethyl ester, maleate (1: 1),
`586 .
`1-[NJ.-[ (S)-1-Carboxy-3-phenylpropyl]-L-lysyl]-
`L-proline dihydrate, 895
`Carboxymethylcellulose
`calcium, 2228
`sodium, 274
`sodium and microcrystalline cellulose, 2231
`sodium 12, 2228
`sodium paste, 27 5
`sodium tablets, 275
`( Carboxymethyl)trimethylammonium chloride,
`186
`Card-20(22)-enolide
`· 3-[ ( 0-2,6-dideoxy-P-D-ribo-hexopyranosyl-
`(1-4)-0-2,6-dideoxy-P-D-ribo-hexopyrano-
`syl-( 1-4 )-2,6-dideoxy-P-D-ribo-hexopyra-
`itosyloxy]-12,14-dihydroxy-, (3P,5P,12P)-.
`514
`3-[ ( 0-2,6-dideoxy-P-D-ribo-hexopyranosyl-
`( 1-;+4 )-0-2,6-dideoxy-p-o-ribp-hexopyrano-
`syl-( 1-4)-2,6-dideoxy-P-D-ribq-hexopyra-
`nosyl)oxy]-14-hydroxy, (3{3,5Ph 512
`3-[ ( 0-P-D-glucopyranosyl-( 1-4)-0-2,6-di-
`deoxy-P-D-ribo-hexopyranosyl-( 1-4 )-0-
`2,6-dideoxy-P-D-ribo-hexopyranosyl-
`( 1-4)-2,6-dideoxy-P-D-ribo-hexopyran-
`osyl)oxy]-12, 14-dihydroxy-, (3P,5P, 12{3)-,
`464
`Cardiovascular and renal drugs, panel on, ix
`Carisoprodol, 275
`aspirin, and codeine phosphate tablets, 278
`and aspirin tablets, 277
`tablets, 276
`• Carnauba wax, 2317
`Carotene
`beta, 185
`beta, capsules, 185
`p,p-Carotene, 185
`al/-trans-P-Carotene, 185
`Carrageenan, 2229
`Carrier gases, chromatographic solvents and,
`1987
`CAS registry numbers, lviii
`Casanthrol, 278
`Cascara
`fluidextract, aromatic, 282
`sagrada, 280
`sagrada extract, 281
`sagrada fluidextract, 282
`tablets, 281
`Casein, 2002
`pancreatic digest of, 2025
`Castor
`oil,282
`oil, aromatic, 283
`oil capsules, 283
`oil emulsion, 283
`oil, hydrogenated, 2230
`oil, hydrogenated, polyoxyl 40, 2288
`oil, polyoxyl 35, 2288
`Catalyst
`nickel-aluminum, 2022
`palladium, 2025
`Catechol, 2002
`Categories, USP and NF pharmaceutic ingre-
`dients listed by, 2205
`Cation-exchange
`resin, 2002
`resin, carboxylate (sodium form) SO- to 100-
`mesh), 2002
`resin, polystyrene, 2002
`resin, styrene-divinylbenzene, 2002
`resin, styrene-divinylbenzene, strongly
`acidic, 2003
`resin, sulfonic acid, 2003
`Cedar oil, 2003
`Cefaclor, 284
`capsules, 284
`for oral suspension, 284
`Cefadroxil, 28.5
`capsules, 286
`for oral suspension, 286
`tablets, 286
`Cefamandole
`nafate for injection, 287
`
`nafate, sterile, 287
`sodium for injection, 28&
`sodium, sterile, 289
`Cefazolin, 289
`sodium injection, 289
`sodium, sterile, 290
`Cefixime, 291
`for oral suspension, 291
`tablets, 292
`Cefmenoxime
`hydrochloride, sterile, 293
`for injection, 292
`Cefmetazole sodium, sterile, 294
`Cefonicid sodium, sterile, 295
`Cefoperazone
`sodium, 296
`sodium injection, 296
`sodium sterile, 297
`Ceforanide
`for injection, 297
`sterile, 298
`Cefotaxime
`sodium, 299
`sodium injection, 299
`sodium, sterile, 300
`Cefotetan disodium, sterile, 300
`Cefotiam
`hydrochloride, sterile, 302
`for injection, 301
`Cefoxitin
`sodium, 303
`sodium injection, 304
`sodium, sterile, 304
`Cefpiramide, 305
`for injection, 306
`Cefprozil, 307
`for oral suspension, 307
`tablets, 308
`Ceftazidime, 308
`injection, 309
`for injection, 310
`sterile, 311
`Ceftizoxime
`sodium, 312
`sodium injection, 312
`sodium, sterile, 313
`Ceftriaxone
`sodium, 314
`sodium injection, 314
`sodium, sterile, 315
`Cefuroxime
`axetil, 315
`axetil tablets, 316
`sodium, 316
`sodium injection, 317
`sodium, sterile, 317
`Cellulose, 2231
`acetate, 2232
`acetate, 1,2-benzenedicarboxylate, 223 3
`acetate phthalate, 2233
`.
`carboxymethyl ether, calcium salt, 2228
`carboxymethyl ether, sodium salt, 274
`chromatographic, 2003
`derivatives, viscosity procedure for, 1840
`diacetate, 2232
`ethyl ether, 2245
`hydroxyethyl, 2253
`2-hydroxyethyl ether, 2253
`hydroxypropyl, 2253
`2-hydroxypropyl ether, 2253
`hydroxypropyl, 2253
`hydroxypropyl, low-substituted, 2253
`hydroxypropyl methyl ether, 774
`2-hydroxypropyl methyl ether, 774
`hydroxypropyl, ocular system, 774
`methyl ether, 774, 992
`microcrystalline, 2003, 2231
`microcrystalline, and carboxymethylcellulose
`sodium, 2231
`mixture, chromatographic, 2003
`nitrate, 1350
`oxidized, 318
`oxidized regenerated, 319
`powdered, 2232
`sodium phosphate, 319
`triacetate, 2232
`Cephalexin, 320
`capsules, 322
`
`Carbamic
`acid, (5-benzoyl-1H-benzimidazol-2-yl),
`methyl ester, 934
`acid, [ S-(propylthio )-1H-benzimidazol-2-yl]-,
`methyl ester, 37
`Carbamide, 1617
`peroxide, 267
`peroxide topical solution, 268
`Carbamothoic acid, methyl(3-methylphenyl)-,
`0-2-naphthalenyl ester, 1568
`( 6R, 7 S)-7 -L 4-(Carbamoylcarboxymethylene )-
`1 ,3-dithietane-2-carboxamido ]-7 -methoxy-
`3-[[(1-methyl-1H-tetrazol-5-
`yl)thio ]methyl]-8-oxo-5-thia-1-azabicy-
`clo[4.2.0]oct-2-ene-2-carboxylic acid, diso-
`dium salt, 300
`(3-Carbamoyl-3,3-diphenylproP,yl)diisopro-
`pylmethylammonium 10d1de, 84 7
`Carbenicillin
`disodium, sterile, 268
`indanyl sodium, 268
`indanyl sodium tablets, 269
`Carbidopa, 269
`.
`and levodopa tablets, 270
`Carbinoxamine
`maleate, 271
`maleate tablets, 271
`Carbol-fuchsin topical solution, 272
`Carbomer
`910, 2226
`934, 2226
`934P, 2226
`940, 2227
`941, 2227
`1342, 2227
`Carbon
`dioxide, 272
`dioxide detector tube, 2002
`disulfide, 2002
`disulfide, chromatographic, 2002
`, monoxide C 11, 273
`j monoxide detector tube, 2002
`tetrachloride, 2002 ·
`·
`l Carbonate identification, 1721
`l Carbonic
`acid, calcium salt (1: 1), 246
`acid, dilithium salt, 896
`acid, disodium·salt, 2301
`acid, dipotassium salt, 1252
`acid, magnesium salt, basic, 916
`acid, magnesium salt (1 :1), hydrate, 916
`acid, monoammonium salt, mixt. with am-
`monium carbamate, 2213
`acid, monopotassium salt, 1250
`\ acid monosodium salt, 1414
`l Carbonizable substances test, readily, 1731
`j Carboprost
`tromethamine, 273
`1
`.
`1 tromethamine inj~ction, 27 4
`l N-(2-Carboxy-3,3-dimethyl-7-oxo-4-thia-1-aza-
`l
`bicyclo[3.2.0]hept-6-yl)-2-phenylmalon-
`l
`amic acid disodium salt, 268
`j N-(2-Carboxy-3,3-dimethyl-7 -oxo-4-thia-1-aza-
`bicyclo[3.2.0]hept-6-yl)-3-thiophenemalon-
`amic acid disodium salt, 1550
`1
`I (R)-N-[(2S,5R,6R)-2-Carbo:Jty-3,4-dimethyl-7-
`1
`oxo-4-thia-1-azabicyclo[3.2.0]hept-6-yl]-3-
`l
`thiophenemalonamic acid monosodium
`salt, 1552
`1
` (R)-(3-Carboxy-2-hydroxypropyl)trimethyl-
`ammonium hydroxide, inner salt, 877
`!
`l (R)-3-Carboxy-2-hydroxy-N ,N,N-trimethyl-1-
`l
`propanaminium hydroxide, inner salt, 877
`l Carboxylate (sodium form) cation-exchange
`i
`resin, (50- to 100-mesh), 2002
`:j N-[ ( 6R, 7 R)-2-Carboxy-7-methoxy-3-[[ (1-
`methyl-1H-tetrazol-5-yl)thio ]methyl]-8-
`1
`l
`oxo-5-oxa-1-a. zabicyclo[4.2.0]oct-2-en-7-
`!
`yl]-2-(p-hydroxy.phenyl)malonamic acid di-
`!
`I (6R, 7 S)-4-[ [2-Carboxy-7 -methoxy-3-[[ ( 1-
`sodium salt, 1040
`·
`
`methyl-lH-tetr. azol-5-yl)thio.]methylj-8-
`oxo-5-thia-1-azabicyclo[4.2.0]oct-2-en-7-
`1
`yl] carbamoylJ-1 ,3-dithietane-82,«-malon-
`,
`j
`amic acid, disodium. salt, 300
`j l·[N-[(S)-1-Carboxy-3-phenylpropyl]-L-alanyl]-
`
`J L·pi'Qiine dihydrate, 587
`
`1
`
`.j
`
`LUYE1006
`IPR of Patent No. 6,667,061
`
`

`
`2390
`
`Vanco-Wool
`
`Combined Index to USP 23 and NF 18
`
`Vaccine
`adsorbed diphtheria and tetanus toxoids and
`pertussis, 538
`·
`adsorbed pertussis, 1195
`BCG, 166
`cholera, 366
`diphtheria and tetanus toxoids and pertussis
`adsorbed, 538
`diphtheria and tetanus toxoids and pertussis,
`538
`.
`group A, meningococcal polysaccharide, 948
`group c, meningococcal polysaccharide, 949
`groups A and C combined, meningococcal ·
`polysaccharide, 949
`hepatitis B, inactivated, virus, 738
`inactivated poliovirus, 1239
`influenza virus, 806
`live measles, mumps, and rubella virus, 933
`live measles and mumps virus, 933
`live measles and rubella virus, 934
`live measles virus, 933
`live mumps virus, 1041
`live poliovirus, oral, 1240
`live rubella and mumps virus, 1391
`live rubella virus, 1391
`.
`.
`measles virus, live, 933
`measles and mumps virus, live, 933
`measles, mumps, and rubella virus, live, 933
`measles and rubella virus, live, 934
`mumps, measles, and rubella virus, live, 933
`mumps virus, live, 1041
`pertussis, 1195
`pertussis, adsorbed, 1195
`pertussis, diphtheria and tetanus toxoids, ad-
`sorbed, 538
`plague, 1235
`poliovirus, inactivated, 1239
`.
`polivirus live, oral, 1240
`polysaccharide group A, meningococcal, 948
`polysaccharide group C, meningococcal, 949
`rabies, 1358
`rubella virus, live, 1391
`rubella and measles virus, live, 934
`rubella and mumps virus, live, 1391
`smallpox, 1412
`.
`tetanus and diphtheria toxoids and pertussis
`adsorbed, 538
`typhoid, 1614
`virus, influenza, 806
`yellow fever, 1641
`
`.
`Vancomycin
`hydrochloride, 1620
`hydrochloride capsules, 1621
`.
`hydrochloride inJection, 1621
`hydrochloride for oral solution, 1622
`hydrochloride, sterile, 1622
`monohydrochloride, 1620
`Vanillin, 2316
`ethyl, 2245
`.
`Variation, weight
`·
`in dosage units, 1838
`weight, of nutritional supplements, 2185
`Varicella-Zoster immune globulin, 1622
`Vasopressin
`8-L-arginine-, 1622
`injection, 1622
`8-L-lysine-, 1622
`Vegetable
`and animal substances, 13
`drugs-sampling. and methods of analysis,
`1754
`oil, hydrogenated, 2317
`Vehicles
`aqueous, for parenterals, 1650
`flavored and{or sweetened, 2206
`oleaginous, 2206
`solid carrier, 2206
`sterile, 220.6
`Verapa