USP Monographs: Hydrocortisone Valerate Cream

Hydrocortisone Valerate Cream

» Hydrocortisone Valerate Cream is Hydrocortisone Valerate in a suitable cream base. It contains not less than 90.0 percent and not more than 110.0 percent of the labeled amount of hydrocortisone valerate (C26H38O6).

Packaging and storage— Preserve in well-closed containers.

USP Reference standards

— USP Hydrocortisone Valerate RS.

Identification— Using the Assay preparation and the Standard preparation obtained as directed in the Assay, proceed as directed under Thin-layer Chromatographic Identification Test

201

Minimum fill

755

: meets the requirements.

Residual solvents

467

: meets the requirements.

(Official January 1, 2007)

Assay—

Mobile phase , Internal standard preparation, Standard preparation, and Chromatographic system—Prepare as directed in the Assay under Hydrocortisone Valerate.

Assay preparation— Transfer an accurately weighed quantity of Cream, 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 at 80

for 1 minute, swirl again, and allow to cool to room temperature. Add 2.0 mL of Internal standard solution, and mix. Centrifuge for 5 minutes, and filter, if necessary, to obtain a clear supernatant.

Procedure— Proceed as directed for Procedure in the Assay under Hydrocortisone Valerate. Calculate the quantity, in mg, of hydrocortisone valerate (C26H38O6), in the portion of Cream 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

Phone Number : 1-301-816-8143


Search USP29