Neomycin and Polymyxin B Sulfates, Bacitracin Zinc, and Hydrocortisone Ointment

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, Bacitracin Zinc, and Hydrocortisone 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, and not less than 90.0 percent and not more than 110.0 percent of the labeled amount of hydrocortisone.

1 Packaging and storage

Preserve in well-closed containers, preferably at controlled room temperature.

1.1 USP Reference standards 〈11〉

USP Bacitracin Zinc RS

USP Hydrocortisone RS

USP Neomycin Sulfate RS

USP Polymyxin B Sulfate RS

2 Identification

A: It meets the requirements under Thin-Layer Chromatographic Identification Test 〈201BNP〉.

B: The retention time of the major peak for hydrocortisone in the chromatogram of the Assay preparation corresponds to that in the chromatogram of the Standard preparation, as obtained in the Assay for hydrocortisone.

Minimum fill 〈755〉: meets the requirements.

Water Determination, 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.

3 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.

4 Assay for hydrocortisone

Proceed with the Ointment as directed in the Assay for hydrocortisone under Neomycin and Polymyxin B Sulfates, Bacitracin Zinc, and Hydrocortisone Ophthalmic Ointment.