U.S. PHARMACOPEIA

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Hydrocortisone Ointment
» Hydrocortisone Ointment is Hydrocortisone 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 hydrocortisone (C21H30O5).
Packaging and storage— Preserve in well-closed containers.
Identification— Transfer a quantity of Ointment, equivalent to about 5 mg of hydrocortisone, to a flask, add 10 mL of methanol, and heat on a steam bath for 5 minutes 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 201.
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.
(Official January 1, 2007)
Assay— Proceed with Ointment as directed in the Assay under Hydrocortisone Cream, except to read Ointment instead of Cream, and to use alcohol instead of methanol.
Auxiliary Information— Staff Liaison : Daniel K. Bempong, Ph.D., Scientist
Expert Committee : (MDPS05) Monograph Development-Pulmonary and Steroids
USP29–NF24 Page 1068
Phone Number : 1-301-816-8143