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 11
USP Hydrocortisone Valerate RS Click to View Structure
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.
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 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.
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Topic/Question Contact Expert Committee
Monograph Domenick Vicchio, Ph.D.
Senior Scientific Liaison
(SM42010) Monographs - Small Molecules 4
Reference Standards RS Technical Services
USP35–NF30 Page 3443