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.
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.
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— Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
Monograph Feiwen Mao, M.S.
(MDOOD05) Monograph Development-Ophthalmics Oncologics and Dermatologicals
Reference Standards Lili Wang, Technical Services Scientist
71 Radhakrishna S Tirumalai, Ph.D.
Senior Scientist
(MSA05) Microbiology and Sterility Assurance
USP32–NF27 Page 3307
Chromatographic Column—
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.