U.S. PHARMACOPEIA

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Hydrocortisone Valerate Ointment
» Hydrocortisone Valerate Ointment contains not less than 90.0 percent and not more than 110.0 percent of the labeled amount of hydrocortisone valerate (C26H38O6) in a suitable ointment base.
Packaging and storage— Preserve in tight containers, and store at controlled room temperature.
Identification— Using the Assay preparation and the Standard preparation as directed in the Assay, 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. The total microbial count does not exceed 100 cfu per g.
Minimum fill 755: meets the requirements.
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
Assay—
Mobile phase, Internal standard solution, Standard preparation, and Chromatographic system— Prepare as directed in the Assay under Hydrocortisone Valerate.
Assay preparation— Transfer an accurately weighed quantity of Ointment, equivalent to about 1 mg of hydrocortisone valerate, to a screw-capped tube. Add 8.0 mL of a mixture of methanol and water (3:1), and swirl to disperse. Heat in a steam bath until melted (about 30 seconds), swirl again, and allow to cool at room temperature. Add 2.0 mL of Internal standard solution, and mix. Centrifuge for 5 minutes, and filter the supernatant, if necessary, to obtain a clear solution.
Procedure— Proceed as directed in the Assay under Hydrocortisone Valerate. Calculate the quantity, in mg, of hydrocortisone valerate (C26H38O6) in the portion of Ointment taken by the formula:
0.01C(RU / RS),
in which the terms are as defined therein.
Auxiliary Information— Staff Liaison : Daniel K. Bempong, Ph.D., Scientist
Expert Committee : (MDPS05) Monograph Development-Pulmonary and Steroids
USP29–NF24 Page 1078
Pharmacopeial Forum : Volume No. 27(2) Page 2165
Phone Number : 1-301-816-8143