Pilocarpine Nitrate Ophthalmic Solution
»Pilocarpine Nitrate Ophthalmic Solution is a sterile,buffered,aqueous solution of Pilocarpine Nitrate.It contains not less than 90.0percent and not more than 110.0percent of the labeled amount of C11H16N2O2·HNO3.It may contain suitable antimicrobial agents and stabilizers,and suitable additives to increase its viscosity.
Packaging and storage— Preserve in tight,light-resistant containers.
Identification—
A: The retention time of the major peak in the chromatogram of the Assay preparationcorresponds to that in the chromatogram of the Standard preparationobtained as directed in the Assay.
B: It responds to Identificationtest Bunder Pilocarpine Nitrate.
Sterility á71ñ: meets the requirements.
pHá791ñ: between 4.0and 5.5.
Assay— Proceed with Ophthalmic Solution as directed in the Assayunder Pilocarpine Hydrochloride Ophthalmic Solution,except to read pilocarpine nitrate instead of pilocarpine hydrochloride throughout and to calculate the quantity,in mg,of C11H16N2O2·HNO3in each mLof the Ophthalmic Solution taken by the formula given therein.
Auxiliary Information— Staff Liaison:Lawrence Evans,III,Ph.D.,Scientist
Expert Committee:(PA6)Pharmaceutical Analysis 6
USP28–NF23Page 1562
Phone Number:1-301-816-8389
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