Phenylephrine Hydrochloride Nasal Solution
» Phenylephrine Hydrochloride Nasal Solution 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 tight, light-resistant containers.
Identification— It responds to the Identification test under Phenylephrine Hydrochloride Injection.
Mobile phase, Dilution solvent, Standard preparation, Resolution solution, and Chromatographic system— Prepare as directed in the Assay under Phenylephrine Hydrochloride Nasal Jelly.
Assay preparation— Transfer an accurately measured volume of Nasal Solution, equivalent to about 10 mg of phenylephrine hydrochloride, to a 100-mL volumetric flask. Dilute with Dilution solvent to volume, and mix.
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 Nasal Solution taken by the formula:
100(C / 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 Nasal Solution 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.
Topic/Question Contact Expert Committee
Monograph Clydewyn M. Anthony, Ph.D.
(MDCCA05) Monograph Development-Cough Cold and Analgesics
Reference Standards Lili Wang, Technical Services Scientist
USP32–NF27 Page 3285
Chromatographic Column—
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.