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 90.0 percent and not more than 130.0 percent 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 11
USP Bacitracin Zinc RS.
USP Neomycin Sulfate RS.
USP Polymyxin B Sulfate RS.
Thin-layer chromatographic identification test 201BNP: meets the requirements.
Minimum fill 755: meets the requirements.
Water, Method I 921: not more than 0.5%, 20 mL of 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 the Assay for neomycin, in the Assay for polymyxin B, and in the Assay for bacitracin under Neomycin and Polymyxin B Sulfates and Bacitracin Zinc Ophthalmic Ointment.
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USP32NF27 Page 3058Pharmacopeial Forum: Volume No. 28(4) Page 1161