Neomycin Sulfate and Hydrocortisone Acetate Lotion
»Neomycin Sulfate and Hydrocortisone Acetate 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 hydrocortisone acetate (C23H32O6).
Packaging and storage— Preserve in well-closed containers.
Identification—
A: It meets the requirements for neomycin underThin-Layer Chromatographic Identification Test á201BNPñ.
B: The retention time of the major peak for hydrocortisone acetate in the chromatogram of theAssay preparationcorresponds to that in the chromatogram of theStandard preparation,as obtained in theAssay for hydrocortisone acetate.
Minimum fill á755ñ: meets the requirements.
Assay for neomycin— Proceed as directed for neomycin underAntibiotics—Microbial Assays á81ñ,blending an accurately measured volume of Lotion for 3to 5minutes in a high-speed glass blender jar containing an accurately measured volume ofBuffer No.3.Dilute an accurately measured volume of the solution so obtained quantitatively and stepwise 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 hydrocortisone acetate— Proceed with Lotion as directed in theAssay underHydrocortisone Acetate Lotion.
Auxiliary Information— Staff Liaison:William W.Wright,Ph.D.,Scientific Fellow
Expert Committee:(PA7)Pharmaceutical Analysis 7
USP28–NF23Page 1348
Pharmacopeial Forum:Volume No.30(2)Page 518
Phone Number:1-301-816-8335
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