U.S. PHARMACOPEIA

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Pilocarpine Nitrate Ophthalmic Solution
» Pilocarpine Nitrate Ophthalmic Solution is a sterile, buffered, aqueous solution of Pilocarpine Nitrate. It contains not less than 90.0 percent and not more than 110.0 percent 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 preparation corresponds to that in the chromatogram of the Standard preparation obtained as directed in the Assay.
B: It responds to Identification test B under Pilocarpine Nitrate.
Sterility 71: meets the requirements.
pH 791: between 4.0 and 5.5.
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
Assay— Proceed with Ophthalmic Solution as directed in the Assay under Pilocarpine Hydrochloride Ophthalmic Solution, except to read pilocarpine nitrate instead of pilocarpine hydrochloride throughout and to calculate the quantity, in mg, of C11H16N2O2·HNO3 in each mL of the Ophthalmic Solution taken by the formula given therein.
Auxiliary Information— Staff Liaison : Feiwen Mao, M.S., Senior Scientific Associate
Expert Committee : (MDOOD05) Monograph Development-Ophthalmics Oncologics and Dermatologicals
USP29–NF24 Page 1735
Phone Number : 1-301-816-8320