Neomycin and Polymyxin B Sulfates and Hydrocortisone Acetate Cream
»Neomycin and Polymyxin B Sulfates and Hydrocortisone Acetate Cream contains the equivalent of not less than 90.0percent and not more than 130.0percent of the labeled amounts of neomycin and polymyxin B,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 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 and Assay for polymyxin B— Proceed with Cream as directed in theAssay for neomycin and in theAssay for polymyxin BunderNeomycin and Polymyxin B Sulfates Cream.
Assay for hydrocortisone acetate— Proceed with Cream as directed in theAssayunderHydrocortisone Acetate Lotion.
Auxiliary Information— Staff Liaison:William W.Wright,Ph.D.,Scientific Fellow
Expert Committee:(PA7)Pharmaceutical Analysis 7
USP28–NF23Page 1359
Pharmacopeial Forum:Volume No.30(2)Page 520
Phone Number:1-301-816-8335