Neomycin and Polymyxin B Sulfates,Bacitracin Zinc,and Hydrocortisone Ointment
»Neomycin and Polymyxin B Sulfates,Bacitracin Zinc,and Hydrocortisone Ointment contains the equivalent of not less than 90.0percent and not more than 130.0percent of the labeled amounts of neomycin,polymyxin B,and bacitracin,and not less than 90.0percent and not more than 110.0percent of the labeled amount of hydrocortisone.
Packaging and storage— Preserve in well-closed containers,preferably at controlled room temperature.
Identification—
A: It meets the requirements under Thin-Layer Chromatographic Identification Test á201BNPñ.
B: The retention time of the major peak for hydrocortisone in the chromatogram of the Assay preparationcorresponds to that in the chromatogram of theStandard preparation,as obtained in theAssay for hydrocortisone.
Minimum fill á755ñ: meets the requirements.
Water,Method Iá921ñ: not more than 0.5%,20mLof a mixture of toluene and methanol (7:3)being used in place of methanol in the titration vessel.
Assay for neomycin,Assay for polymyxin B,and Assay for bacitracin— Proceed with Ointment as directed in theAssay for neomycin,in theAssay for polymyxin B,and in theAssay for bacitracin underNeomycin and Polymyxin B Sulfates and Bacitracin Zinc Ophthalmic Ointment.
Assay for hydrocortisone— Proceed with the Ointment 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 1355
Pharmacopeial Forum:Volume No.28(4)Page 1162
Phone Number:1-301-816-8335
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