U.S. PHARMACOPEIA

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Suprofen Ophthalmic Solution
» Suprofen Ophthalmic Solution is a sterile, buffered, aqueous solution of Suprofen adjusted to a suitable tonicity. It contains a suitable antimicrobial preservative. It contains not less than 90.0 percent and not more than 115.0 percent of the labeled amount of C14H12O3S.
Packaging and storage— Preserve in tight containers.
Identification— The retention time of the major peak in the chromatogram of the Assay preparation corresponds to that in the chromatogram of the Standard preparation as obtained in the Assay.
Sterility 71: meets the requirements when tested as directed for Membrane Filtration under Test for Sterility of the Product to be Examined.
pH 791: between 6.5 and 8.0.
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
Assay—
Buffer solution, Mobile phase , Standard preparation, and Chromatographic system—Proceed as directed in the Assay under Suprofen.
Assay preparation— Transfer an accurately measured volume of Ophthalmic Solution, equivalent to about 20 mg of suprofen, to a 100-mL volumetric flask. Dilute with Buffer solution to volume, and mix. Transfer 2.0 mL of this solution to a 25-mL volumetric flask, dilute with Buffer solution to volume, and mix.
Procedure— Proceed as directed in the Assay under Suprofen. Calculate the quantity, in mg, of C14H12O3S in each mL of the Ophthalmic Solution taken by the formula:
1250(C / V)(rU / rS),
in which C is the concentration, in mg per mL, of USP Suprofen RS in the Standard preparation, V is the volume, in mL, of Ophthalmic Solution taken, and rU and rS are the peak responses obtained from the Assay preparation and the Standard preparation, respectively.
Auxiliary Information— Staff Liaison : Clydewyn M. Anthony, Ph.D., Scientist
Expert Committee : (MDCCA05) Monograph Development-Cough Cold and Analgesics
USP29–NF24 Page 2050
Phone Number : 1-301-816-8139