Neomycin and Polymyxin B Sulfates and Bacitracin Zinc Ointment, chemical structure, molecular formula, Reference Standards

Neomycin and Polymyxin B Sulfates and Bacitracin Zinc Ointment

»Neomycin and Polymyxin B Sulfates and Bacitracin Zinc 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.It may contain a suitable local anesthetic.

Packaging and storage— Preserve in well-closed containers,preferably at controlled room temperature.

USP Reference standards á11ñ— USP Bacitracin Zinc RS.USP Neomycin Sulfate RS.USP Polymyxin B Sulfate RS.

Thin-layer chromatographic identification test á201BNPñ: meets the requirements.

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.

Auxiliary Information— Staff Liaison:William W.Wright,Ph.D.,Scientific Fellow

Expert Committee:(PA7)Pharmaceutical Analysis 7

USP28–NF23Page 1354

Pharmacopeial Forum:Volume No.28(4)Page 1161

Phone Number:1-301-816-8335