U.S. PHARMACOPEIA

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Hydrocortisone Butyrate Cream
» Hydrocortisone Butyrate Cream is Hydrocortisone Butyrate 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 butyrate (C25H36O6).
Packaging and storage— Preserve in well-closed containers.
Identification— The retention time of the major peak in the chromatogram of the Assay preparation corresponds to that in the chromatogram of the Standard preparation, as obtained in the Assay.
Microbial limits 61— It meets the requirements of the tests for absence of Staphylococcus aureus and Pseudomonas aeruginosa.
Minimum fill 755: meets the requirements.
pH 791: between 3.5 and 4.5.
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
Assay—
Mobile phase, Solvent, Diluting solution, Standard preparation, System suitability solution and Chromatographic system— Proceed as directed in the Assay under Hydrocortisone Butyrate.
Assay preparation— Transfer an accurately weighed quantity of Cream, equivalent to about 1.0 mg of Hydrocortisone Butyrate, to a 50-mL volumetric flask, dissolve in 10 mL of Solvent, shake by mechanical means for 30 minutes, and dilute with Diluting solution to volume.
Procedure— Separately inject equal volumes (about 5 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 butyrate (C25H36O6) in the portion of Cream taken by the formula:
50C(rU / rS),
in which C is the concentration, in mg per mL, of USP Hydrocortisone Butyrate RS in the Standard preparation; and rU and rS are the peak responses obtained from the Assay preparation and the Standard preparation, respectively.
Auxiliary Information— Staff Liaison : Daniel K. Bempong, Ph.D., Scientist
Expert Committee : (MDPS05) Monograph Development-Pulmonary and Steroids
USP29–NF24 Page 1074
Phone Number : 1-301-816-8143