Hydrocortisone Acetate Cream
» Hydrocortisone Acetate Cream is Hydrocortisone Acetate 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 acetate (C23H32O6).
Packaging and storage— Preserve in well-closed containers.
USP Reference standards 11
USP Hydrocortisone Acetate RS Click to View Structure
Identification— To 1 g of Cream add 40.0 mL of a 35% solution of acetonitrile in methanol, and shake until dissolved. To 20.0 mL of this solution add 10.0 mL of isooctane, and mix. Allow the layers to separate, discard the upper layer, and use the bottom layer as the test solution. Cream responds to the Thin-Layer Chromatographic Identification Test 201, a preparation containing 250 µg of USP Hydrocortisone Acetate RS per mL of methanol being used as the Standard solution, the prepared chromatographic plate being heated for 10 minutes at 105 and cooled, and the chromatogram being developed in a solvent system consisting of a mixture of ethyl acetate, toluene, and acetone (140:40:13) in a paper-lined chromatographic chamber equilibrated in an atmosphere of ammonia vapors.
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.
Minimum fill 755: meets the requirements.
Mobile phase , Chromatographic system, and Standard preparation—Proceed as directed in the Assay under Hydrocortisone Acetate.
Assay preparation— Transfer an accurately weighed quantity of Cream, equivalent to about 25 mg of hydrocortisone acetate, to a suitable container, add 100.0 mL of tetrahydrofuran, and shake until the cream dissolves. Transfer 10.0 mL of the resulting solution to another container, add 15.0 mL of Mobile phase, and mix.
Procedure— Separately inject equal volumes (about 10 µL) of the Standard preparation and the Assay preparation into the chromatograph, record the chromatograms, and measure the responses for the major peaks. Calculate the quantity, in mg, of hydrocortisone acetate (C23H32O6) in the portion of Cream taken by the formula:
250C(rU / rS)
in which C is the concentration, in mg per mL, of USP Hydrocortisone Acetate RS in the Standard preparation; and rU and rS are the hydrocortisone acetate peak responses obtained from the Assay preparation and the Standard preparation, respectively.
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Monograph Domenick Vicchio, Ph.D.
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(SM42010) Monographs - Small Molecules 4
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USP35–NF30 Page 3435