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.
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— Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
Monograph Clydewyn M. Anthony, Ph.D.
(MDCCA05) Monograph Development-Cough Cold and Analgesics
Reference Standards Lili Wang, Technical Services Scientist
71 Radhakrishna S Tirumalai, Ph.D.
Senior Scientist
(MSA05) Microbiology and Sterility Assurance
USP32–NF27 Page 3644
Chromatographic Column—
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.