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 90.0percent and not more than 115.0percent 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 preparationcorresponds to that in the chromatogram of the Standard preparationas obtained in the Assay.
Sterility á71ñ: meets the requirements when tested as directed forMembrane Filtrationunder Test for Sterility of the Product to be Examined.
pHá791ñ: between 6.5and 8.0.
Assay—
Buffer solution,Mobile phase ,Standard preparation,and Chromatographic system—Proceed as directed in the Assayunder Suprofen.
Assay preparation— Transfer an accurately measured volume of Ophthalmic Solution,equivalent to about 20mg of suprofen,to a 100-mLvolumetric flask.Dilute with Buffer solutionto volume,and mix.Transfer 2.0mLof this solution to a 25-mLvolumetric flask,dilute with Buffer solutionto volume,and mix.
Procedure— Proceed as directed in the Assayunder Suprofen.Calculate the quantity,in mg,of C14H12O3Sin each mLof the Ophthalmic Solution taken by the formula:
1250(C/V)(rU/rS),
in which Cis the concentration,in mg per mL,of USP Suprofen RSin the Standard preparation,Vis the volume,in mL,of Ophthalmic Solution taken,and rUand rSare the peak responses obtained from the Assay preparationand the Standard preparation,respectively.
Auxiliary Information— Staff Liaison:Daniel K.Bempong,Ph.D.,Scientist
Expert Committee:(PA2)Pharmaceutical Analysis 2
USP28–NF23Page 1842
Phone Number:1-301-816-8143
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