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 C
14H
12O
3S 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.
71
:
meets the requirements when tested as directed for Membrane Filtration under Test for Sterility of the Product to be Examined.