Neomycin Sulfate and Flurandrenolide Cream
»Neomycin Sulfate and Flurandrenolide Cream contains the equivalent of not less than 90.0percent and not more than 135.0percent of the labeled amount of neomycin,and not less than 90.0percent and not more than 110.0percent of the labeled amount of flurandrenolide (C24H33FO6).
Packaging and storage— Preserve in collapsible tubes or in tight containers,protected from light.
Identification—
A: It meets the requirements for neomycin underThin-Layer Chromatographic Identification Test á201BNPñ.
B: It meets the requirements for theIdentification test underFlurandrenolide Cream.
Minimum fill á755ñ: meets the requirements.
Assay for neomycin— Proceed with Cream as directed in theAssay underNeomycin Sulfate Ointment.
Assay for flurandrenolide— Proceed with Cream as directed in theAssay underFlurandrenolide Cream.Calculate the quantity,in mg,of C24H33FO6in the portion of Cream taken by the formula:
10C(rU/rS),
in whichCis the concentration,in mg per mL,of USP Flurandrenolide RSin theStandard preparation;andrUandrSare the peak responses obtained from theAssay preparation and theStandard preparation,respectively.
Auxiliary Information— Staff Liaison:William W.Wright,Ph.D.,Scientific Fellow
Expert Committee:(PA7)Pharmaceutical Analysis 7
USP28–NF23Page 1346
Pharmacopeial Forum:Volume No.28(4)Page 1155
Phone Number:1-301-816-8335
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