Neomycin Sulfate 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 Sulfate and Hydrocortisone Acetate Ointment contains the equivalent of not less than 90.0 percent and not more than 135.0 percent of the labeled amount of neomycin, and not less than 90.0 percent and not more than 110.0 percent of the labeled amount of hydrocortisone acetate (C₂₃H₃₂O₆).

Packaging and storage-Preserve in collapsible tubes or in well-closed containers.

USP REFERENCE STANDARDS (11)

USP Hydrocortisone Acetate RS

USP Neomycin Sulfate RS

Identification

A: It meets the requirements for neomycin 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 | (921): not more than 1.0%, 20 mL of a mixture of toluene and methanol (7:3) being used in place of methanol in the titration vessel.

Assay for neomycin-Proceed with the Ointment as directed in the Assay under Neomycin Sulfate Ointment.

Assay for hydrocortisone acetate-Proceed with the Ointment as directed in the Assay under Hydrocortisone Acetate Lotion.