1995 SP
`
`THE UNITED STATES PHARMACOPEIA
`
`NF 1 8
`
`THE NATIONAL FORMULARY
`
`By authority of the United States Pharmacopeial
`Convention, Ina, 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, I995
`
`IQD
`
`sINc£1a2o
`
`UNITED STATES PHARMACOPEIAL CONVENTION, INC.
`12601 Twinbrook Parkway, Rockville, MD 20852
`MYLAN ET AL. - EXHIBIT 1024
`
`0001
`
`MYLAN ET AL. - EXHIBIT 1024
`
`0001
`
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`
`NOTICE AND WARNING
`
`Concerning U.S. Parent 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
`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 without express permission, authority, or
`license secured from such patent or trademark owner.
`
`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.
`
`The United States Pharmacopeial 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
`
`
`
`
`
`
`
`0002
`
`0002
`
`

`

`.
`
`USP 23
`
`B: Evaporate the chloroform solution from Identification test
`A on a steam bath to dryness, dissolve the residue in 2 mL of 2
`N sulfuric acid, and add 1 mL of a freshly prepared solution of
`mercuric nitrate (prepared_by dissolving 700 mg of mercuric
`nitrate in 4 mL of water, adding 100 mg of sodium nitrate, mixing,
`and filtering): no red color is produced immediately, but after
`heating, a yellow to red color develops in about 15 minutes.
`Assay-
`Mobile phase and Standard preparation——Prepare as directed
`in the Assay under Dextromethorphan Hydrobromide.
`Assay preparation—Pipet, using a to-contain pipet, a volume
`of Syrup, equivalent to about 10 mg of dextromethorphan hy-
`drobromide, into a 100-mL volumetric flask, dilute with water to
`volume, and mix.
`Chromatographic system and Procedure (see Chromatogra-
`phy (621))—Proceed as directed in the Assay under Dextro-
`methorphan Hydrobromide. Calculate the quantity, in mg, of
`C1311-I25NO-HBr-H20 in the volume of Syrup taken by the for-
`mu a:
`
`(370.33/352.32)(l00C)(rU/rs),
`
`in which 370.33 and 352.32 are the molecular weights of dex-
`tromethorphan hydrobromide and anhydrous dextromethorphan
`hydrobromide, respectively, C is the concentration,
`in mg per
`mL, of USP Dextromethor han Hydrobromide RS, on the an-
`hydrous basis, in the Standrzzrd preparation, and ry and r5 are
`the peak responses obtained from the Assay preparation and the
`Standard preparation, respectively.
`
`Dextrose
`
`HO
`
`on
`
`o H,o
`
`on
`
`HO
`
`OH
`
`198.17
`C5H12O6-H20
`D-Glucose, monohydrate.
`D-Glucose monohydrate
`Anhydrous
`180.16
`
`[5996-I0-I].
`[50-99-7].
`
`» Dextrose is a sugar usually obtained by the hy-
`drolysis of Starch. It contains one molecule of water
`of hydration or is anhydrous.
`
`Packaging and storage—Preserve in well-closed containers.
`Labeling——Label it to indicate whether it is hydrous or anhydrous.
`Identification-—Add a few drops of a solution (1 in 20) to 5 mL
`of hot alkaline cupric tartrate TS: a copious red precipitate of
`cuprous oxide is formed.
`Color of solution—Disso1ve 25 g in water to make 50.0 mL of
`solution:
`the solution has no more color than a solution prepared
`by mixing 1.0 mL of cobaltous chloride CS, 3.0 mL of ferric
`chloride CS, and 2.0 mL of cupric sulfate CS with water to make
`10 mL, and diluting 3 mL of this solution with water to 50 mL.
`Make the comparison by viewing the solutions downward in
`matched color-comparison tubes against a white surface.
`Specific rotation (78lS): between +52.6° and +53.2°.
`Test solution: 100 mg per mL, in 0.012 N ammonium hy-
`droxide.
`
`Acidity—Dissolve 5.0 g in 50 m_L of carbon dioxide—fre_e water.
`Add phenolphthalein TS, and titrate with 0.020 N sodium hy-
`droxide to the production of a distinct pink color: not more than
`0.30 ml. is required for neutralization.
`the
`Water, Method III (921)—Dry it at 105° for 16 hours:
`hydrous form loses between 7.5% and 9.5% of its weight, and the
`anhydrous form loses not more than 0.5% of its weight.
`Residue on ignition (281 )2 not more than 0.1%.~
`
`Ojficial Monographs / Dextrose
`
`483
`
`Chloride (221)—A 2.0-g portion shows no more chloride than
`corresponds to 0.50 mL of 0.020 N hydrochloric acid (0.018%).
`Sulfate (221 )—A 2.0-g portion shows no more sulfate than cor-
`responds to 0.50 mL of 0.020 N sulfuric acid (0.025%).
`Arsenic, Method I (211):
`1 ppm.
`Heavy metals (231)——Dissolve 4.0 g in water to make 25 mL of
`solution:
`the limit is 5 ppm.
`Dextrin—Reflux 1 g of finely powdered Dextrose with 20 mL of
`alcohol:
`it dissolves completely.
`Soluble starch,_sul_fites——To a solution of 1 g in 10 mL of water
`add 1 drop of iodine TS:
`the liquid is colored yellow.
`
`Dextrose Excipient—see Dextrose Excipient NF
`
`Dextrose Injection
`
`» Dextrose Injection is a sterile solution of Dextrose
`in Water for Injection. It contains not less than 95.0
`percent and not more than 105.0 percent of the la-
`beled amount of C5H12O6-H20. Dextrose Injection
`contains no antimicrobial agents.
`
`Packaging and storage—Preserve in single-dose glass or plastic
`containers. Glass containers are preferably of Type I or Type II
`glass.
`USP Reference standards (11)—USP Endotoxin RS.
`Bacterial endotoxins (85)—It contains not more than 0.5 USP
`Endotoxin Unit per mL for Injections containing less than 5% of
`dextrose and not more than 10.0 USP Endotoxin Units per mL
`for Injections containing between 5% and 70% of dextrose.
`[NOTE——Pri0r to analysis, dilute Injections containing more than
`10% of dextrose to a concentration of 10% of dextrose.]
`Labeling——The label states the total osmolar concentration in
`m0smol per liter. Where the contents are less than 100 mL, or
`where the label states that the Injection is not for direct injection
`but is to be diluted before use, the label alternatively may state
`the total osmolar concentration in m0smol per mL.
`Identification—It responds to the Identification test under Dex-
`trose.
`
`pH (791): between 3.2 and 6.5, determined on a portion to which
`0.30 mL of saturated potassium chloride solution has been added
`for each 100 mL and which previously has been diluted with
`5/ater, if necessary, to a concentration of not more than 5% of
`extrose.
`Particulate matter (788): meets the requirements under Small-
`volume Injections.
`Heavy metals (231 )—Transfer a volume of Injection, equivalent
`to 4.0 g of dextrose, to a suitable vessel, and adjust the volume
`to 25 mL by eva
`ration or addition of water, as necessary:
`the
`limit is 0.0005
`0, in which C is the labeled amount, in g, of
`C5H,2O6-H20 per mL of Injection.
`Limit of 5-h droxymethylfurfural and related substances—Dilute
`an accurate y measured volume of Injection, equivalent to 1.0 g
`of C6H12O6-H20, with water to 250.0 mL. Determine the ab-
`sorbance of this solution in a 1-cm cell at 284 nm, with a suitable
`spectrophotometer, using water as the blank:
`the absorbance is
`not more than 0.25.
`
`Other requirements——It meets the requirements under Injections
`(1).
`Assay—Transfer an accurately measured volume of Injection,
`containing 2 to 5 g of dextrose, to a 100-mL volumetric flask.
`Add 0.2 mL of 6 N ammonium hydroxide, dilute with water to
`volume, and mix. Determine the angular rotation in a suitable
`polarimeter tube at 25° (see Optical Rotation (781)). The ob-
`served rotation, in degrees, multiplied by 1.0425A, in which A
`
`0003
`
`0003
`
`

`

`484
`
`Dextrose / Official Monographs
`
`is the ratio 200 divided by the length, in mm, of the polarimeter
`tube employed, represents the weight, in g, of C51-11206-H20 in
`the volume of Injection taken.
`
`Dextrose Injection, Alcohol in—see Alcohol in
`Dextrose Injection
`Dextrose Injection, Bupivacaine in—see
`Bupivacaine in Dextrose Injection
`Dextrose Injection, Dopamine Hydrochloride and—-
`see Dopamine Hydrochloride and Dextrose
`Injection
`Dextrose Injection, Lidocaine Hydrochloride and-
`see Lidocaine Hydrochloride and Dextrose
`Injection
`Dextrose Injection, Potassium Chloride in-see
`Potassium Chloride in Dextrose Injection
`Dextrose Injection, Potassium Chloride in Lactated
`Ringer’s and—see Potassium Chloride in
`Lactated Ringer’s and Dextrose Injection
`Dextrose Injection, Ringer’s and—see Ringer’s and
`Dextrose Injection
`Dextrose Injection, Lactated Ringer’s and—see
`Lactated Ringer’s and Dextrose Injection
`Dextrose Injection, Half-strength Lactated Ringer’s
`and—see Half-strength Lactated Ringer’s and
`Dextrose Injection
`Dextrose Injection, Modified Lactated Ringer’s
`and—see Modified Lactated Ringer’s and
`Dextrose Injection
`Dextrose Injection, Tetracaine Hydrochloride in— ,
`see Tetracaine Hydrochloride in Dextrose
`Injection
`Dextrose Injection, Theophylline in—see
`Theophylline in Dextrose Injection
`Dextrose Injection Type 1, Multiple Electrolytes
`and—see Multiple Electrolytes and Dextrose
`Injection Type 1
`Dextrose Injection Type 2, Multiple Electrolytes
`and—see Multiple Electrolytes and Dextrose
`Injection Type 2
`Dextrose Injection Type 3, Multiple Electrolytes
`and—see Multiple Electrolytes and Dextrose
`Injection Type 3
`Dextrose Injection Type 4, Multiple Electrolytes
`and—see Multiple Electrolytes and Dextrose
`Injection Type 4
`
`Dextrose and Sodium Chloride Injection
`
`» Dextrose and Sodium Chloride Injection is a ster-
`ile solution of Dextrose and Sodium Chloride in Water
`for Injection. It contains not less than 95.0 percent
`and not more than 105.0 percent of the labeled amount
`of C5H,2O5-H20 and of NaCl. It contains no anti-
`microbial agents.
`
`USP 23
`
`Packaging and storage—Preserve in single-dose glass or plastic
`containers. Glass containers are preferably of Type I or Type II
`glass.
`USP Reference standards (11)—USP Endotoxin RS.
`Bacterial endotoxins (85)—It contains not more than 10.0 USP
`Endotoxin Units per g of dextrose.
`Labeling—The label states the total osmolar concentration in
`mOsmol per liter. Where the contents are less than 100 mL, or
`where the label states that the Injection is not for direct injection
`but is to be diluted before use, the label alternatively may state
`the total osmolar concentration in mOsmol per mL.
`Identification——It responds to the Identification test under Dex-
`trose, and to the tests for Sodium (191) and for Chloride (191).
`
`pl.-I (791): between 3.5 and 6.5, determined on a portion diluted
`with water, if necessary, to a concentration of not more than 5%
`of dextrose.
`
`Limit of 5-hydroxymethylfurfural and related substances-—Dilute
`an accurately measured volume of Injection, equivalent to 1.0 g
`of C6H,205-H20 with water to 500.0 mL. Determine the ab-
`sorbance of this solution in a 1-cm cell at 284 nm, with a suitable
`spectrophotometer, using water as the blank:
`the absorbance is
`not more than 0.25.
`
`?ther requirements—It meets the requirements under Injections
`1
`.
`Assay for dextrose—Transfer an accurately measured volume of
`Injection, containing from 2 to 5 g of dextrose, to a 100-mL
`volumetric flask. Add 0.2 mL of 6 N ammonium hydroxide,
`dilute with water to volume, and mix. Determine the angular
`rotation in a suitable polarimeter tube at 25° (see Optical Ro-
`tation (781)). The observed rotation, in degrees, multiplied by
`l.0425A, in which A is the ratio 200 divided by the length, in
`mm, of the polarimeter tube employed, represents the weight, in
`g, of C51-I12O6~H2O in the volume of Injection taken.
`Assay for sodium chloride-—-Transfer an accurately measured vol-
`ume of Injection, equivalent to about 90 mg of sodium chloride,
`into a porcelain casserole, and add 140 mL of water and 1 mL
`of dichlorofluorescein TS. Mix, and titrate with 0.1 N silver
`nitrate VS until the silver chloride flocculates and the mixture
`acquires a faint pink color. Each mL of 0.1 N silver nitrate is
`equivalent to 5.844 mg of NaCl.
`
`Dextrose and Sodium Chloride Injection, Potassium
`Chloride in—see Potassium Chloride in
`Dextrose and Sodium Chloride Injection
`Dextrose Tablets, Sodium Chloride and—see
`Sodium Chloride and Dextrose Tablets
`
`Diacetylated Monoglycerides—see Diacetylated
`Monoglycerides NF
`
`Diatrizoate Meglumine
`0
`OH
`
`I
`
`u
`
`1
`
`Hac
`
`I
`
`u
`
`JOL
`
`cu,
`
`HO H HO H
`‘.
`‘.
`H
`' ~.c’"Vk.(k.F°"
`Ho H H OH
`
`809.13
`C1,H9I3N2O4-C7H17NO5
`Benzoic acid, 3,5-bis(acetylamino)-2,4,6-triiodo-, compd. with
`1-deoxy- I -(methylamino)-D-glucitol (1:1).
`l-Deoxy-1-(methylamino)-D-glucitol 3,5—diacetamido-2,4,6-tri-
`iodobenzoate (salt)
`[131—49-7].
`
`0004
`
`0004
`
`

`

`USP 23
`
`Identification~—It responds to the tests for Sodium (191) and for
`Bicarbonate (191).
`Bacterial endotoxins (85)——It contains not more than 5.0 USP
`Endotoxin Units per mEq.
`pH (791): between 7.0 and 8.5.
`Particulate matter (788): meets the requirements under Small-
`volume Injections.
`Other requirements—lt meets the requirements under Injections
`<1).
`
`Assay—Measure accurately a volume of Injection, equivalent to
`about 3 g of sodium bicarbonate, add methyl red TS, and titrate
`with l N hydrochloric acid VS. Add the acid slowly, with con-
`stant stirring, until the solution becomes faintly pink. Heat the
`solution to boiling, cool, and continue the titration until the faint
`pinkcolor no longer fades after boiling. Each mL of 1 N hy-
`drochloric acid is equivalent to 84.01 mg of Nal-ICO3.
`1
`
`I
`
`Official Monographs / Sodium
`
`1417
`
`Sodium Bicarbonates and Citric Acid Effervescent
`Tablets for Oral Solution, Potassium and——see
`Potassium and Sodium Bicarbonates and Citric
`Acid Effervescent Tablets for Oral Solution
`
`Sodium Biphosphate——see Sodium Phosphate,
`Monobasic
`
`Sodium Biphosphate Tablets, Methenamine and-
`see Methenamine and Monobasic Sodium
`Phosphate Tablets
`Sodium Borate—see Sodium Borate NF
`
`Sodium Carbonate——see Sodium Carbonate NF
`
`Sodium Carbonate Irrigation, Citric Acid,
`Magnesium Oxide, and——see Citric Acid,
`Magnesium Oxide, and Sodium Carbonate
`Irrigation
`
`Sodium Bicarbonate Oral Powder
`
`» Sodium Bicarbonate Oral Powder contains So-
`dium Bicarbonate and suitable added substances. It
`
`contains not less than 98.5 percent and not more than
`100.5 percent of NaHCO3, calculated on the dried
`basis.
`
`Packaging and storage—Preserve in well-closed containers.
`Labeling——Label Oral Powder to indicate that it is for oral use
`only.
`Other requirements—It meets the requirements for Identification
`and Loss on drying, under Sodium Bicarbonate.
`Assay—Proceed with Oral Powder as directed in the Assay under
`Sodium Bicarbonate.
`
`Sodium Bicarbonate for Oral Suspension,
`Magnesium Carbonate and——see Magnesium
`Carbonate and Sodium Bicarbonate for Oral
`
`Suspension
`
`Sodium Bicarbonate Tablets
`
`D Sodium Bicarbonate Tablets contain not less than
`
`95.0 percent and not more than 105.0 percent of the
`labeled amount of NaHCO3.
`
`Packaging and storage—Preserve in well-closed containers.
`Identification—-A solution of Tablets responds to the tests for
`Sodium (191) and for Bicarbonate (191).
`Disintegration (701): 30 minutes, simulated gastric fluid TS
`being substituted for water in the test.
`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 2 g of
`sodium bicarbonate, dissolve in 100 mL of water, add methyl red
`TS, and titrate with 1 N hydrochloric acid VS. Add the acid
`slowly, with constant stirring, until the solution becomes faintly
`pink. Heat the solution to boiling, cool, and continue the titration
`until the pink color no longer fades after boiling. Each mL of 1
`N hydrochloric acid is equivalent to 84.01 mg of Nal~lCO3.
`
`Sodium Chloride
`
`58.44
`NaCl
`Sodium chloride.
`Sodium chloride
`
`[7647-14-5].
`
`» Sodium Chloride contains not less than 99.0 per-
`cent and not more than 101.0 percent of NaCl, cal-
`culated on the dried basis. It contains no added sub-
`stance.
`
`Packaging and storage~Preserve in well-closed containers.
`Ia1beling——Where Sodium Chloride is intended for use in he-
`modialysis, it is so labeled.
`Identification—A solution (1 in 20) responds to the tests for So-
`dium (l9l) and for Chloride (191).
`Acidity or alkalinity——Dissolve 50.0 g in 200 mL of carbon diox-
`ide—free water, and add 10 drops of bromothymol blue pH in-
`dicator. If the solution is yellow, it requires not more than 1.0
`mL of 0.020 N sodium hydroxide to produce a blue color. If the
`solution is blue or green, it requires not more than 3.12 mL of
`0.020 N hydrochloric acid to produce a yellow color.
`Loss on dryin
`(731 )-Dry it at 105° for 2 hours:
`it loses not
`more than 0.5 o of its weight.
`Iodide or bromide—Digest 2.0 g of finely powdered Sodium Chlo-
`ride with 25 mL of warm alcohol for 3 hours, cool the mixture,
`and remove the undissolved salt by filtration. Evaporate the fil-
`trate to dryness, dissolve the residue in 5 mL of water, add 1 mL
`of chloroform, and cautiously introduce, dropwise, with constant
`agitation, 5 drops of dilute chlorine TS (1 in 3):
`the chloroform
`does not acquire a violet, yellow, or orange color.
`Aluminum (where it is labeled as intended for use in hemodi-
`alysis)——[NOTE—The Standard preparations and the Test
`rep-
`aration may be modified, if necessary, to obtain solutions 0 suit-
`able concentrations adaptable to the linear or working range of
`the instrument.]
`Nitric acid diluent and Standard preparations—Prepare as
`directed in the test for Aluminum under Sodium Bicarbonate.
`Test preparation~—Transfer 10.0 g of Sodium Chloride to a
`100-mL plastic volumetric flask, add 50 mL of water, and son-
`icate for 30 minutes. Add 4 mL of nitric acid, dilute with water
`to volume, and mix.
`Procedure—Proceed as directed for Procedure in the test for
`Aluminum under Sodium Bicarbonate. Calculate the ppm of Al
`in the specimen taken by multiplying by 10 the quantity, in ug,
`of aluminum found in each mL of the Test preparation: the limit
`is 0.2 ppm.
`Calcium and magnesium—Dissolve 20 g in 200 mL of water, and
`add 0.1 mL of hydrochloric acid, 5 mL of ammonia—ammonium
`chloride buffer TS, and 5 drops of eriochrome black TS. Titrate
`with 0.005 M disodium ethylenediaminetetraacetate VS to a pure
`
`0005
`
`0005
`
`

`

`—.-~
`
`~"— ~'
`
`-v—* —"
`\
`
`1418
`
`Sodium / Official Monographs
`
`blue endpoint. Each mL of 0.005 M disodium ethylenediamine-
`tetraacetate is equivalent to 0.2004 mg of Ca. Not more than
`0.005% of calcium and magnesium (as Ca) is found.
`Arsenic, Method I (211): 3 ppm.
`Iron (241)—Dissolve 5.0 g in 45 mL of water and 2 mL of
`hydrochloric acid:
`the limit is 2 ppm.
`Barium——Dissolve 4.0 g in 20 mL of water, filter if necessary,
`and divide the solution into two portions. To one portion add 2
`mL of 2 N sulfuric acid, and to the other add 2 mL of water:
`the solutions are equally clear after standing for 2 hours.
`Sodium ferrocyanide——Dissolve 25 g in 80 mL of water in a glass-
`stoppered, 100-mL graduated cylinder or flask. Add 2 mL of
`ferrous sulfate TS and 1 mL of 2 N sulfuric acid, dilute with
`water to 100 mL, and mix. For a control, place 80 mL of water
`in a glass-stoppered, 100-mL graduated cylinder or flask, add 2
`mL of ferrous sulfate TS and 1 mL of 2 N sulfuric acid, dilute
`with water to 100 mL, and mix. Transfer 50-mL portions of the
`respective solutions to matched color-comparison tubes:
`the test
`solution shows no more blue color than the control, indicating the
`absence of sodium ferrocyanide.
`Sulfate (221 )—A l.0—g portion shows no more sulfate than cor-
`responds to 0.15 mL of 0.020 N sulfuric acid (0.0l5%).
`Heavy metals, Method I (231): 5 ppm.
`Organic volatile impurities, Method IV (467): meets the require-
`ments.
`
`Assay——Transfer about 250 mg of Sodium Chloride, accurately
`weighed, to a porcelain casserole, and add 140 mL of water and
`1 mL of dichlorofluorescein TS. Mix, and titrate with 0.1 N
`silver nitrate VS until the silver chloride flocculates and the mix-
`ture acquires a faint pink color. Each mL of 0.1 N silver nitrate
`is equivalent to 5.844 mg of NaCl.
`
`Sodium Chloride Inhalation—see Sodium Chloride
`Inhalation Solution
`
`Sodium Chloride Injection
`
`» Sodium Chloride Injection is a sterile solution of
`Sodium Chloride in Water for Injection. It contains
`no antimicrobial agents. It contains not less than 95.0
`percent and not more than 105.0 percent of the la-
`beled amount of NaCl.
`
`Packaging and storage-—Preserve in single-dose glass or plastic
`containers. Glass containers are preferably of Type I or Type II
`glass.
`Labeling—The label states the total osmolar concentration in
`mOsmol per liter. Where the contents are less than 100 mL, or
`where the label states that the Injection is not for direct injection
`but is to be diluted before use, the label alternatively may state
`the total osmolar concentration in mOsmol per mL.
`USP Reference standards (ll)—USP Endotoxin RS.
`ldentil'ication—lt responds to the tests for Sodium (191) and for
`Chloride (191).
`Bacterial endotoxins (85)~It contains not more than 0.5 USP
`Endotoxin Unit per mL where the labeled amount of sodium
`chloride in the Injection is between 0.5% and 0.9%, and not more
`than 3.6 USP Endotoxin Units per mL where the labeled amount
`of sodium chloride in the Injection is between 3.0% and 24.3%.
`pH (791): between 4.5 and 7.0.
`
`Particulate matter (788): meets the requirements under Small-
`volume Injections.
`
`USP 23
`
`Iron (241)—Dilute 5.0 mL of Injection with water to 45 mL,
`and add 2 mL of hydrochloric acid:
`the limit is 2 ppm.
`Heavy metals, Method 1 (231)——Place a volume of Injection,
`equivalent to 1.0 g of sodium chloride, in a suitable vessel, if
`necessary evaporate to a volume of about 20 mL, add 2 mL of
`1 N acetic acid, then dilute with water to 25 mL. Proceed as
`directed, except to use 1 mL of Standard Lead Solution (10 ug
`of Pb) in the Standard Preparation and in the Monitor Pre a-
`ration: the limit is 0.001%, based on the amount of sodium c 10-
`ride.
`
`?tl)ier requirements—It meets the requirements under Injections
`1
`.
`Assay—Pipet a volume of Injection, equivalent to about 90 mg
`of sodium chloride, into a porcelain casserole, and add 140 mL
`of water and 1 mL of dichlorofluorescein TS. Mix, and titrate
`with 0.1 N silver nitrate VS until the silver chloride flocculates
`and the mixture acquires a faint pink color. Each mL of 0.1 N
`silver nitrate is equivalent to 5.844 mg of NaCl.
`
`Bacteriostatic Sodium Chloride Injection
`
`» Bacteriostatic Sodium Chloride Injection is a ster-
`ile, isotonic solution of Sodium Chloride in Water for
`Injection, and it contains one or more suitable anti-
`microbial agents. It contains not less than 0.85 per-
`cent and not more than 0.95 percent of NaCl.
`NOTE—Use Bacteriostatic Sodium Chloride In-
`jection with due regard for the compatibility of the
`antimicrobial agent or agents it contains with the
`particular medicinal substance that is to be dissolved
`or diluted.
`
`Packaging and storage-—Preserve in single-dose or in multiple-
`dose containers, of not larger than 30-mL size, preferably of Type
`I or Type II glass.
`Labeling——Label it to indicate the name(s) and proportion(s) of
`the added antimicrobial agent(s). Label it also to include the
`statement “NOT FOR use IN NEWBORNS,” in boldface capital
`letters, on the label immediately under the official name, printed
`in a contrasting color, preferably red. Alternatively, the state-
`ment may be placed prominently elsewhere on the label if the
`statement is enclosed within a box.
`
`USP Reference standards (1 1 )—USP Methylparaben RS. USP
`Propylparaben RS. USP Endotoxin RS.
`
`Antimicrobial agent(s)—It meets the requirements under Anti-
`microbial Preservatives—Eflectiveness (51), and meets the la-
`beled claim for content of the antimicrobial agent(s) as deter-
`mined by the method set forth under Antimicrobial Agents-
`Content (341), except to use the following procedure when meth-
`ylparaben and propylparaben are used as the antimicrobial agents.
`Mobile phase—Prepare a mixture of filtered methanol and
`water (about 70: 30)_, such that capacity factors (k’) of about 0.52
`and 1.05 are established for methylparaben and propylparaben,
`respectively, with a minimum separation factor (oz) of about 2.0.
`Standard pre_paration——Accurately weigh 30 mg of USP Pro-
`pylparaben RS into a 25-mL volumetric flask, dilute with meth-
`anol to volume (Solution I ), and mix. Accurately weigh 30 mg
`of USP Methylparaben RS into a 25-mL volumetric flask, pipet
`2.5 mL of Solution 1 into the flask, and dilute with methanol to
`volume (Solution 2). Pipe_t 5 mL of Solution 2 into a 50-mL
`volumetric flask, add by pipet 30 mL of methanol, dilute with
`water to volume, and mix.
`Test preparation—Pipet 1 mL of Injection into a 10-mL vol-
`umetric flask, add by pipet 7 mL of methanol, dilute with water
`to volume, and mix.
`Procedure——Introduce equal volumes (about 12 ;.iL) of the Test
`preparation and the Standard preparation into a high-perfor-
`mance liquid chromatograph (see Chromatography (621)) by
`
`0006
`
`0006
`
`

`

`,,________gf——IIIIIIIIIIIIIIIIIIIIIIIII
`
`USP 23
`
`means of a suitable microsyringe or sampling valve, adjusting the
`specimen size and other operating parameters such that the peak
`obtained with the Standard preparation is about 0.7 full scale.
`Typically, the apparatus is fitted with a 4-mm X 30-cm column
`containing packing L1, and is equipped with an ultraviolet de-
`tector capable of monitoring absorbance at 254 nm and a suitable
`recorder. Measure the height of the peaks, at identical retention
`times, obtained with the Test preparation and the Standard prep-
`aration, and calculate the concentration of methylparaben or pro-
`pylparaben, in mg per mL, taken by the formula:
`
`C(HU/HS).
`
`in which C is the concentration, in mg per mL. of USP Meth-
`ylparaben RS or USP Propylparaben RS in the Standard prep-
`aration, and Hg and H5 are the peak heights obtained from the
`Test preparation and the Standard preparation, respectively.
`Bacterial endotoxins (85)—It contains not more than 1.0 USP
`Endotoxin Unit per mL.
`Particulate matter (788): meets the requirements under Small-
`volume Injections.
`Other requirements—It responds to the Identification test and
`meets the requirements for pH, Iron, Heavy metals, and Assay
`under Sodium Chloride Injection. It meets also the requirements
`under Injections (1).
`
`Sodium Chloride Injection, Dextrose and—see
`Dextrose and Sodium Chloride Injection
`Sodium Chloride Injection, Fructose and——see
`Fructose and Sodium Chloride Injection
`Sodium Chloride Injection, Inulin in—see Inulin in
`Sodium Chloride Injection
`Sodium Chloride Injection, Mannitol in—see
`Mannitol in Sodium Chloride Injection
`Sodium Chloride Injection, Potassium Chloride in-
`see Potassium Chloride in Sodium Chloride
`Injection
`Sodium Chloride Injection, Potassium Chloride in
`Dextrose and—see Potassium Chloride in
`Dextrose and Sodium Chloride Injection
`Sodium Chloride Injection, Ranitidine in—see
`Ranitidine in Sodium Chloride Injection
`
`Sodium Chloride Irrigation
`
`» Sodium Chloride Irrigation is Sodium Chloride
`Injection that has been suitably packaged, and it con-
`tains no antimicrobial agents.
`It contains not less
`than 95.0 percent and not more than 105.0 percent
`of the labeled amount of NaCl.
`
`Packaging and storage—Preserve in single-dose glass or plastic
`containers. Glass containers are preferably of Type] or Type II
`glass. The container may be designed to empty rapidly and may
`contain a volume of more than 1 liter.
`
`Labeling—The designation “not for injection” appears promi-
`nently on the label.
`USP Reference standards (11)—USP Endotoxin RS.
`Identification—It responds to the tests for Sodium (191) and for
`Chloride (191 ).
`
`Official Monographs / Sodium
`
`1419
`
`Bacterial endotoxins (85)—It contains not more than 0.5 USP
`Endotoxin Unit per mL.
`Sterility—lt meets the requirements under Sterility Tests (71).
`Other requirements——It meets the requirements for pH, Iron,
`Heavy metals, and Assay under Sodium Chloride Injection.
`
`Sodium Chloride Ophthalmic Ointment
`
`» Sodium Chloride Ophthalmic Ointment is Sodium
`Chloride in a suitable ophthalmic ointment base. It
`contains not less than 90.0 percent and not more than
`110.0 percent of the labeled amount of NaCl.
`It is
`sterile.
`
`Packaging and storage-—Preserve in collapsible ophthalmic oint-
`ment tubes.
`
`Identification———Transfer a quantity of Ophthalmic Ointment,
`equivalent to about 200 mg of sodium chloride, to a separator
`containing about 25 mL of ether, and extract with 5 mL of water:
`the aqueous extract so obtained responds to the tests for Sodium
`(191), and for Chloride (191).
`Sterility—lt meets the requirements for Ophthalmic Ointments
`under Sterility Tests (71).
`Minimum fill (755): meets the requirements.
`Particulate matter—-It meets the requirements of the test for
`Metal Particles in Ophthalmic Ointments (751).
`Assay—Transfer an accurately weighed quantity of Ophthalmic
`Ointment, equivalent to about 100 mg of sodium chloride, to a
`separator containing about 50 mL of ether, and extract with four
`20-mL portions of water. Combine the aqueous extracts in a
`porcelain casserole, and add 140 mL of water and 1 mL of di-
`chlorofluorescein TS. Mix, and titrate with 0.1 N silver nitrate
`VS until the silver chloride flocculates and the mixture acquires
`a faint pink color. Each mL of 0.1 N silver nitrate is equivalent
`to 5.844 mg of NaCl.
`
`Sodium Chloride Inhalation Solution
`
`D Sodium Chloride Inhalation Solution is a sterile
`
`solution of Sodium Chloride in water purified by dis-
`tillation or by reverse osmosis and rendered sterile.
`It contains not less than 90.0 percent and not more
`than 110.0 percent of the labeled amount of NaCl.
`It contains no antimicrobial agents or other added
`substances.
`
`Packaging and storage—Preserve in single-dose containers.
`Identification——It responds to the test for Sodium (191) and for
`Chloride (191).
`Sterility——It meets the requirements under Sterility Tests (71).
`pH (791): between 4.5 and 7.0.
`Assay—Pipet a volume of Inhalation Solution, equivalent to about
`90 mg of sodium chloride, into a porcelain casserole, and add
`140 mL of water and 1 mL of dichlorofluorescein TS. Mix, and
`titrate with 0.1 N silver nitrate VS until the silver chloride floc-
`culates and the mixture acquires a faint pink color. Each mL of
`0.1 N silver nitrate is equivalent to 5.844 mg of NaCl.
`
`_ OOO7_
`
`0007
`
`