Hydrocortisone Butyrate Cream
»Hydrocortisone Butyrate Cream is Hydrocortisone Butyrate in a suitable cream base.It contains not less than 90.0percent and not more than 110.0percent 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 preparationcorresponds to that in the chromatogram of the Standard preparation,as obtained in the Assay.
Microbial limits á61ñ— It meets the requirements of the tests for absence of Staphylococcus aureusand Pseudomonas aeruginosa.
Minimum fill á755ñ: meets the requirements.
pHá791ñ: between 3.5and 4.5.
Assay—
Mobile phase,Solvent,Diluting solution,Standard preparation,System suitability solution and Chromatographic system— Proceed as directed in the Assayunder Hydrocortisone Butyrate.
Assay preparation— Transfer an accurately weighed quantity of Cream,equivalent to about 1.0mg of Hydrocortisone Butyrate,to a 50-mLvolumetric flask,dissolve in 10mLof Solvent,shake by mechanical means for 30minutes,and dilute with Diluting solutionto volume.
Procedure— Separately inject equal volumes (about 5µL)of the Standard preparationand the Assay preparationinto 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 Cis the concentration,in mg per mL,of USP Hydrocortisone Butyrate RSin the Standard preparation;and rUand rSare the peak responses obtained from the Assay preparationand the Standard preparation,respectively.
Auxiliary Information— Staff Liaison:Clydewyn M.Anthony,Ph.D.,Scientist
Expert Committee:(PA1)Pharmaceutical Analysis 1
USP28–NF23Page 966
Phone Number:1-301-816-8139
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