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.
USP Reference standards 11
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 enumeration tests 61 and Tests for specified microorganisms 62 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.
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.
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USP35NF30 Page 3443Pharmacopeial Forum: Volume No. 27(2) Page 2165