Packaging and storage— Preserve in well-closed containers.

USP Reference standards 11— USP Hydrocortisone Acetate RS.

Identification— 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 Identification 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 RF value and fluorescence of the principal spot obtained from the test solution correspond to those obtained from the Standard solution.

Microbial limits 61— It meets the requirements of the tests for absence of Staphylococcus aureus and Pseudomonas aeruginosa.

Minimum fill 755: meets the requirements.

Residual solvents 467: meets the requirements.

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

Expert Committee : (MDPS05) Monograph Development-Pulmonary and Steroids

USP29–NF24 Page 1071

Phone Number : 1-301-816-8143