usp31nf26s1_m64170, USP Monographs: Phenylephrine Hydrochloride Injection
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`Select Pharmacopoeia USP31
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`Phenylephrine Hydrochloride Injection
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`» Phenylephrine Hydrochloride Injection is a sterile solution of Phenylephrine Hydrochloride in Water for Injection. It contains not less than
`90.0 percent and not more than 115.0 percent of the labeled amount of C9H13NO2·HCl.
`Packaging and storage— Preserve in single-dose or multiple-dose containers, preferably of Type I glass, protected from light.
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`USP Reference standards 11 —
`USP Phenylephrine Hydrochloride RS.
`USP Endotoxin RS.
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`Identification— Concentrate or dilute, if necessary, a suitable volume of Injection to a concentration of about 10 mg per mL. Apply 2 µL of this solution and of a
`Standard solution of USP Phenylephrine Hydrochloride RS, containing about 10 mg per mL, at points about 2.5 cm from the bottom edge of a suitable thin-layer
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`chromatographic plate (see Chromatography 621 ) coated with a 0.25-mm layer of chromatographic silica gel. Dry the spots in a current of warm air, and develop
`the chromatogram in a suitable chromatographic chamber with a mixture of methanol, water, and ammonium hydroxide (72:25:3) until the solvent front has moved about
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`12 cm. Dry the plate in warm air, and spray it with alcoholic potassium hydroxide TS. Dry at 60 for 15 minutes, and spray the plate with p-nitroaniline TS: the reddish
`orange spot obtained from the test solution corresponds in color, size, and intensity to that obtained from the Standard solution.
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`Bacterial endotoxins 85 — It contains not more than 25.0 USP Endotoxin Units per mg of phenylephrine hydrochloride.
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`pH 791 : between 3.0 and 6.5.
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`Other requirements— It meets the requirements under Injections 1 .
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`Assay—
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`Mobile phase— Prepare and filter a mixture of methanol and water (1:1) containing 1.1 g of sodium 1-octanesulfonate per liter, adjusted with 3 M phosphoric acid to a
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`pH of 3.0. Make adjustments if necessary (see System Suitability under Chromatography 621 ).
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`Dilution solvent— Prepare a mixture of methanol and water (1:1), adjusted with 3 M phosphoric acid to a pH of 3.0.
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`System suitability solution— Dissolve about 50 mg each of USP Phenylephrine Hydrochloride RS and USP Epinephrine Bitartrate RS in 5 mL of water, dilute with
`Dilution solvent to 25.0 mL, and mix. Further dilute 5.0 mL of the resulting solution with Dilution solvent to 25.0 mL, and mix to obtain a solution having a concentration
`of about 0.4 mg of phenylephrine hydrochloride and 0.4 mg of epinephrine bitartrate per mL.
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`Standard preparation— Dissolve about 50 mg of USP Phenylephrine Hydrochloride RS, accurately weighed, in 10 mL of water, dilute with Dilution solvent to 25.0 mL,
`and mix. Further dilute 5.0 mL of the resulting solution with Dilution solvent to 25.0 mL, and mix to obtain a solution having a known concentration of about 0.4 mg per
`mL.
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`Assay preparation— Transfer an accurately measured volume of Injection, equivalent to about 10 mg of phenylephrine hydrochloride, to a 25-mL volumetric flask. Dilute
`with Dilution solvent to volume, and mix.
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`Chromatographic system (see Chromatography 621 )—The liquid chromatograph is equipped with a 280-nm detector and a 4.6-mm × 25-cm column that contains
`packing L1. The flow rate is about 1 mL per minute. Chromatograph the System suitability solution, and record the responses for the major peaks: the resolution, R,
`between epinephrine and phenylephrine is not less than 1.0. Chromatograph replicate injections of the Standard preparation, and record the peak responses as directed
`for Procedure: the relative standard deviation is not more than 2.0%.
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`Procedure— Separately inject equal volumes (about 20 µL) of the Standard preparation and the Assay preparation into the chromatograph, record the chromatograms,
`and measure the responses for the major peaks. Calculate the quantity, in mg, of C9H13NO2·HCl in each mL of the Injection taken by the formula:
`(25C / V)(rU / rS)
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`in which C is the concentration, in mg per mL, of USP Phenylephrine Hydrochloride RS in the Standard preparation, V is the volume, in mL, of Injection taken, and rU
`and rS are the peak responses obtained from the Assay preparation and the Standard preparation, respectively.
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`Auxiliary Information— Staff Liaison : Clydewyn M. Anthony, Ph.D., Scientist
`Expert Committee : (MDCCA05) Monograph Development-Cough Cold and Analgesics
`USP31–NF26 Page 2986
`Phone Number : 1-301-816-8139
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`http://uspbpep.com/usp31/v31261/usp31nf26s1_m64170.asp#usp31nf26s1_m64170s3[8/11/2015 11:34:36 AM]
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`PARAGON - EXHIBIT 2008