Neomycin and Polymyxin B Sulfates, Bacitracin, and Hydrocortisone Acetate 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, and Hydrocortisone Acetate 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 acetate in a suitable ointment base.

1 Packaging and storage

Preserve in collapsible tubes or in well-closed containers.

1.1 USP Reference standards 〈11〉

USP Bacitracin Zinc RS

USP Hydrocortisone Acetate 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 acetate in the chromatogram of the Assay preparation corresponds to that in the chromatogram of the Standard preparation, as obtained in the Assay for hydrocortisone acetate.

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 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.

4 Assay for bacitracin

Proceed with Ointment as directed in the Assay under Bacitracin Ointment.

5 Assay for hydrocortisone acetate

Proceed with Ointment as directed in the Assay under Hydrocortisone Acetate Lotion.