Neomycin Sulfate and Flurandrenolide Lotion
»Neomycin Sulfate and Flurandrenolide Lotion contains the equivalent of not less than 90.0percent and not more than 130.0percent 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 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.
Microbial limits á61ñ— It meets the requirements of the tests for absence ofStaphylococcus aureus andPseudomonas aeruginosa.
Minimum fill á755ñ: meets the requirements.
Assay for neomycin— Proceed as directed for neomycin underAntibiotics—Microbial Assays á81ñ,using an accurately weighed portion of Lotion,equivalent to about 3.5mg of neomycin,blended for 3to 5minutes in a high-speed glass blender jar containing an accurately measured volume ofBuffer No.3sufficient to obtain a stock solution having a convenient concentration of neomycin.Dilute an accurately measured volume of this stock solution quantitatively withBuffer No.3to obtain aTest Dilution having a concentration of neomycin assumed to be equal to the median dose level of the Standard.
Assay for flurandrenolide— Proceed with Neomycin Sulfate and Flurandrenolide Lotion as directed in theAssay underFlurandrenolide Cream.Calculate the quantity,in mg,of C24H33FO6in the portion of Lotion 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.30(2)Page 516
Phone Number:1-301-816-8335