usp31nf26s1_m64180, USP Monographs: Phenylephrine Hydrochloride Nasal Jelly
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`Select Pharmacopoeia USP31
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`Phenylephrine Hydrochloride Nasal Jelly
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`» Phenylephrine Hydrochloride Nasal Jelly contains not less than 90.0 percent and not more than 110.0 percent of the labeled amount of
`C9H13NO2·HCl.
`Packaging and storage— Preserve in tight containers.
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`USP Reference standards 11 —
`USP Phenylephrine Hydrochloride RS.
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`Identification— Dissolve a suitable quantity in water to obtain a solution having a concentration of about 60 µg per mL, and centrifuge, if necessary: the UV absorption
`spectrum of the solution so obtained exhibits maxima and minima at the same wavelengths as that of a similar solution of USP Phenylephrine Hydrochloride RS,
`concomitantly measured.
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`Minimum fill 755 : meets the requirements.
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`Assay—
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`Mobile phase— Prepare a mixture of methanol and water (1:1) containing 1.1 g of sodium 1-octanesulfonate per liter, adjust with phosphoric acid to a pH of 3.0, filter,
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`and degas. Make adjustments to the methanol and water ratio, if necessary (see System Suitability under Chromatography 621 ).
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`Dilution solvent— Prepare a mixture of methanol and water (1:1), and adjust with phosphoric acid to a pH of 3.0.
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`Standard preparation— Dissolve an accurately weighed quantity of USP Phenylephrine Hydrochloride RS in Dilution solvent to obtain a Stock standard solution having a
`known concentration of about 2 mg per mL. Dilute an accurately measured volume of this solution with Dilution solvent to obtain the Standard preparation having a
`known concentration of about 0.1 mg per mL.
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`Assay preparation— Transfer an accurately weighed amount of Nasal Jelly, equivalent to about 10 mg of phenylephrine hydrochloride, to a 100-mL volumetric flask.
`Dilute with Dilution solvent to volume, and mix.
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`Resolution solution— Transfer 5.0 mL of Stock standard solution to a 100-mL volumetric flask, add 10 mg of USP Epinephrine Bitartrate RS, 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 Resolution solution: the resolution, R, is not less than 1.5, and the tailing factor for the
`phenylephrine peak is not more than 2.0. Chromatograph replicate injections of the Standard preparation: 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 the portion of Nasal Jelly taken by the formula:
`100C(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, 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 2987
`Phone Number : 1-301-816-8139
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`http://uspbpep.com/usp31/v31261/usp31nf26s1_m64180.asp[8/11/2015 11:36:53 AM]
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`PARAGON - EXHIBIT 2009