Phenylephrine Hydrochloride Injection
» 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.
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 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 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.
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 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.
Bacterial endotoxins 85—
It contains not more than 25.0 USP Endotoxin Units per mg of phenylephrine hydrochloride.
85—
It contains not more than 25.0 USP Endotoxin Units per mg of phenylephrine hydrochloride.
pH 791:
between 3.0 and 6.5.
791:
between 3.0 and 6.5.
Other requirements—
It meets the requirements under Injections 1.
1.
Assay—
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 pH of 3.0. Make adjustments if necessary (see System Suitability under Chromatography 621).
621).
Dilution solvent—
Prepare a mixture of methanol and water (1:1), adjusted with 3 M phosphoric acid to a pH of 3.0.
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.
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.
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.
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%.
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%.
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)
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.
Auxiliary Information—
Please check for your question in the FAQs before contacting USP.
Chromatographic Column—
| Topic/Question | Contact | Expert Committee |
| Monograph | Clydewyn M. Anthony, Ph.D.
Scientist 1-301-816-8139 |
(MDCCA05) Monograph Development-Cough Cold and Analgesics |
| Reference Standards | Lili Wang, Technical Services Scientist 1-301-816-8129 RSTech@usp.org |
|
| 85 |
Radhakrishna S Tirumalai, Ph.D.
Senior Scientist 1-301-816-8339 |
(MSA05) Microbiology and Sterility Assurance |
USP32–NF27 Page 3284
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.