Neomycin Sulfate and Hydrocortisone Cream
»Neomycin Sulfate and Hydrocortisone 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 hydrocortisone (C21H30O5).
Packaging and storage— Preserve in collapsible tubes or 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 peaks for hydrocortisone in the chromatogram of theAssay preparationcorresponds to that in the chromatogram of theStandard preparation,as obtained in theAssay for hydrocortisone.
Minimum fill á755ñ: meets the requirements.
Assay for neomycin— Proceed with Cream as directed in theAssay underNeomycin Sulfate Ointment.
Assay for hydrocortisone— Proceed with Cream as directed in theAssay for hydrocortisone underNeomycin and Polymyxin B Sulfates,Bacitracin Zinc,and Hydrocortisone Ophthalmic Ointment.
Auxiliary Information— Staff Liaison:William W.Wright,Ph.D.,Scientific Fellow
Expert Committee:(PA7)Pharmaceutical Analysis 7
USP28–NF23Page 1347
Pharmacopeial Forum:Volume No.28(4)Page 1156
Phone Number:1-301-816-8335
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