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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Hydrocortisone Acetate Ointment is Hydrocortisone Acetate in a suitable ointment base. It contains not less than 90.0 percent and not more than 110.0 percent of the labeled amount of C₂₃H₃₂O₆. 

Packaging and storage—Preserve in well-closed containers. 

USP Reference standards 〈11〉— 

USP Hydrocortisone Acetate RS 

Identication—Transfer a quantity of Ointment, equivalent to about 5 mg of hydrocortisone acetate, to a flask, add 5 mL of methanol, and heat on a steam bath for 5 minutes with frequent mixing. Cool to solidify the ointment base, and filter. Using the filtrate as the test solution, proceed as directed under Thin-layer Chromatographic Identication Test 〈201〉. Locate the spots by spraying the dried plate with a 70% methanolic sulfuric acid solution. Heat the plate for 20 to 30 minutes at 90°, allow to cool, and view under long-wavelength UV light: the R value and F 

fluorescence of the principal spot obtained from the test solution correspond to those obtained from the Standard solution. Microbial enumeration tests 〈61〉 and Tests for specified microorganisms 〈62〉—It meets the requirements of the tests for absence of Staphylococcus aureus and Pseudomonas aeruginosa. 

Minimum fill 〈755〉: meets the requirements. 

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