Packaging and storage— Preserve in well-closed containers.

USP Reference standards á11ñ— USP Hydrocortisone Acetate RS.

Identification— Transfer a quantity of Ointment,equivalent to about 5mg of hydrocortisone acetate,to a flask,add 5mLof methanol,and heat on a steam bath for 5minutes 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 á201ñ.Locate the spots by spraying the dried plate with a 70%methanolic sulfuric acid solution.Heat the plate for 20to 30minutes at 90,allow to cool,and view under long-wavelength UVlight:the RFvalue and fluorescence of the principal spot obtained from the test solution correspond to those obtained from the Standard solution.

Microbial limits á61ñ— It meets the requirements of the tests for absence of Staphylococcus aureusand Pseudomonas aeruginosa.

Minimum fill á755ñ: meets the requirements.

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

Expert Committee:(PA1)Pharmaceutical Analysis 1

USP28–NF23Page 964

Phone Number:1-301-816-8139