Pilocarpine Nitrate Ophthalmic Solution
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This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition
Issued and maintained by the United States Pharmacopeial Convention (USP)
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.
USP Reference standards 〈11〉—
USP Pilocarpine Nitrate RS
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 Tests 〈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.
