Neomycin and Polymyxin B Sulfates and Bacitracin Ointment

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Neomycin and Polymyxin B Sulfates and Bacitracin Ointment

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This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition

Issued and maintained by the United States Pharmacopeial Convention (USP)

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Neomycin and Polymyxin B Sulfates and Bacitracin 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 tight, light-resistant 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 DETERMINATION, Method 1921): 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 and Assay for polymyxin B-Proceed with Ointment as directed in the Assay for neomycin and in the Assay for polymyxin B under Neomycin and Polymyxin B Sulfates and Bacitracin Zinc Ophthalmic Ointment.

Assay for bacitracin-Proceed with Ointment as directed in the Assay under Bacitracin Ointment.

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