Packaging and storage— Preserve in well-closed containers.

USP Reference standards á11ñ— USP Hydrocortisone RS.

Identification— Transfer a quantity of Ointment,equivalent to about 5mg of hydrocortisone,to a flask,add 10mLof methanol,and heat on a steam bath for 5minutes with frequent shaking.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.

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 Cream,except to read Ointment instead of Cream,and to use alcohol instead of methanol.

Expert Committee:(PA1)Pharmaceutical Analysis 1

USP28–NF23Page 960

Phone Number:1-301-816-8139