Flurbiprofen Sodium Ophthalmic Solution
» Flurbiprofen Sodium Ophthalmic Solution contains not less than 90.0 percent and not more than 110.0 percent of the labeled amount of flurbiprofen sodium (C15H12FNaO2·2H2O).
Packaging and storage Preserve in tight containers.
USP Reference standards 11
USP Flurbiprofen Related Compound A RS
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.
pH 791: between 6.0 and 7.0.
Antimicrobial effectiveness 51: meets the requirements.
Sterility 71 It meets the requirements when tested as directed for Membrane Filtration under Test for Sterility of the Product to be Examined.
Diluent, Mobile phase, Standard flurbiprofen related compound A preparation, Standard preparation, and System suitability preparation Proceed as directed in the Assay under Flurbiprofen Sodium.
Assay preparation Use the undiluted Ophthalmic Solution.
Chromatographic system Proceed as directed in the Assay under Flurbiprofen Sodium, using a 4.0-mm × 5-cm guard column that contains 5-µm packing L1.
Procedure Separately inject equal volumes (about 15 µL) of the Standard preparation and the Assay preparation into the chromatograph, record the chromatograms, and measure the areas for the major peaks. Calculate the quantity of flurbiprofen sodium (C15H12FNaO2·2H2O) in each mL of the Ophthalmic Solution taken by the formula:
(302.27 / 244.27)C(rU / rS)in which 302.27 and 244.27 are the molecular weights of flurbiprofen sodium dihydrate and anhydrous flurbiprofen, respectively; C is the concentration, in mg per mL, of USP Flurbiprofen RS in the Standard preparation; and rU and rS are the peak responses obtained from the Assay preparation and the Standard preparation, respectively.
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USP35NF30 Page 3259