Neomycin Sulfate and Hydrocortisone 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)
Neomycin Sulfate and Hydrocortisone 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 (C21H30O5).
Packaging and storage—Preserve in collapsible tubes or in well-closed containers.
USP Reference standards 〈11〉
USP Hydrocortisone RS
USP Neomycin Sulfate RS
Identication
A: It meets the requirements for neomycin under Thin-Layer Chromatographic Identication 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 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 Ointment as directed in the Assay under Neomycin Sulfate Ointment.
Assay for hydrocortisone—Proceed with Ointment as directed in the Assay for hydrocortisone under Neomycin and Polymyxin B Sulfates, Bacitracin Zinc, and Hydrocortisone Ophthalmic Ointment.
