Phenylephrine Hydrochloride Ophthalmic Solution
»Phenylephrine Hydrochloride Ophthalmic Solution is a sterile,aqueous solution of Phenylephrine Hydrochloride.It contains not less than 90.0percent and not more than 115.0percent of the labeled amount of C9H13NO2·HCl.It may contain a suitable antimicrobial agent and buffer and may contain suitable antioxidants.
Packaging and storage— Preserve in tight,light-resistant containers of not more than 15-mLsize.
Identification— It responds to the Identificationtest under Phenylephrine Hydrochloride Injection.
Sterility á71ñ: meets the requirements.
pHá791ñ: between 4.0and 7.5for buffered Ophthalmic Solution;between 3.0and 4.5for unbuffered Ophthalmic Solution.
Assay—
Mobile phase,Dilution solvent,Standard preparation,Resolution solution,and Chromatographic system— Prepare as directed in the Assayunder Phenylephrine Hydrochloride Nasal Jelly.
Assay preparation— Transfer an accurately measured volume of Ophthalmic Solution,equivalent to about 10mg of phenylephrine hydrochloride,to a 100-mLvolumetric flask.Dilute with Dilution solventto volume,and mix.
Procedure— Separately inject equal volumes (about 20µL)of the Standard preparationand the Assay preparationinto the chromatograph,record the chromatograms,and measure the responses for the major peaks.Calculate the quantity,in mg,of C9H13NO2·HCl in each mLof Ophthalmic Solution taken by the formula:
100(C/V)(rU/rS),
in which Cis the concentration,in mg per mL,of USP Phenylephrine Hydrochloride RSin the Standard preparation,Vis the volume,in mL,of Ophthalmic Solution taken,and rUand rSare the peak responses obtained from the Assay preparationand the Standard preparation,respectively.
Auxiliary Information— Staff Liaison:Daniel K.Bempong,Ph.D.,Scientist
Expert Committee:(PA2)Pharmaceutical Analysis 2
USP28–NF23Page 1542
Phone Number:1-301-816-8143