Neomycin Sulfate and Methylprednisolone Acetate Cream
»Neomycin Sulfate and Methylprednisolone Acetate 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 methylprednisolone acetate (C24H32O6).
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: In the thin-layer chromatogram prepared as directed in theAssay for methylprednisolone acetate,theRFvalue of the principal spot obtained from theAssay preparation corresponds to that obtained from theStandard preparation,prepared as directed in theAssay for methylprednisolone acetate.
Minimum fill á755ñ: meets the requirements.
Assay for neomycin— Proceed with Cream as directed in theAssay underNeomycin Sulfate Ointment.
Assay for methylprednisolone acetate— Proceed with Cream as directed in theAssay underMethylprednisolone Acetate Cream.
Auxiliary Information— Staff Liaison:William W.Wright,Ph.D.,Scientific Fellow
Expert Committee:(PA7)Pharmaceutical Analysis 7
USP28–NF23Page 1351
Pharmacopeial Forum:Volume No.28(4)Page 1158
Phone Number:1-301-816-8335
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