Hydrocortisone Acetate Cream
»Hydrocortisone Acetate Cream is Hydrocortisone Acetate in a suitable cream base.It contains not less than 90.0percent and not more than 110.0percent of the labeled amount of hydrocortisone acetate (C23H32O6).
Packaging and storage— Preserve in well-closed containers.
Identification— To 1g of Cream add 40.0mLof a 35%solution of acetonitrile in methanol,and shake until dissolved.To 20.0mLof this solution add 10.0mLof 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 á201ñ,a preparation containing 250µg of USP Hydrocortisone Acetate RSper mLof methanol being used as the Standard solution,the prepared chromatographic plate being heated for 10minutes at 105and 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 limits á61ñ— It meets the requirements of the tests for absence of Staphylococcus aureusand Pseudomonas aeruginosa.
Minimum fill á755ñ: meets the requirements.
Assay—
Mobile phase ,Chromatographic system,and Standard preparation—Proceed as directed in the Assayunder Hydrocortisone Acetate.
Assay preparation— Transfer an accurately weighed quantity of Cream,equivalent to about 25mg of hydrocortisone acetate,to a suitable container,add 100.0mLof tetrahydrofuran,and shake until the cream dissolves.Transfer 10.0mLof the resulting solution to another container,add 15.0mLof Mobile phase,and mix.
Procedure— Separately inject equal volumes (about 10µL)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 acetate (C23H32O6)in the portion of Cream taken by the formula:
250C(rU/rS),
in which Cis the concentration,in mg per mL,of USP Hydrocortisone Acetate RSin the Standard preparation;and rUand rSare the hydrocortisone acetate 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 963
Phone Number:1-301-816-8139