Hydrocortisone Valerate Cream
»Hydrocortisone Valerate Cream is Hydrocortisone Valerate in a suitable cream base.It contains not less than 90.0percent and not more than 110.0percent of the labeled amount of hydrocortisone valerate (C26H38O6).
Packaging and storage—
Preserve in well-closed containers.
Identification—
Using the Assay preparationand the Standard preparationobtained as directed in the Assay,proceed as directed under Thin-layer Chromatographic Identification Test á201ñ.
Minimum fill á755ñ:
meets the requirements.
Assay—
Mobile phase
,Internal standard preparation,Standard preparation,and Chromatographic system—Prepare as directed in the Assayunder Hydrocortisone Valerate.
Assay preparation—
Transfer an accurately weighed quantity of Cream,equivalent to about 1mg of hydrocortisone valerate,to a screw-capped tube.Add 8.0mLof a mixture of methanol and water (3:1),and swirl to disperse.Heat at 80
for 1minute,swirl again,and allow to cool to room temperature.Add 2.0mLof Internal standard solution,and mix.Centrifuge for 5minutes,and filter,if necessary,to obtain a clear supernatant.
for 1minute,swirl again,and allow to cool to room temperature.Add 2.0mLof Internal standard solution,and mix.Centrifuge for 5minutes,and filter,if necessary,to obtain a clear supernatant.
Procedure—
Proceed as directed for Procedurein the Assayunder Hydrocortisone Valerate.Calculate the quantity,in mg,of hydrocortisone valerate (C26H38O6),in the portion of Cream taken by the formula:
0.01C(RU/RS),
in which the terms are as defined therein.
Auxiliary Information—
Staff Liaison:Clydewyn M.Anthony,Ph.D.,Scientist
Expert Committee:(PA1)Pharmaceutical Analysis 1
USP28–NF23Page 970
Phone Number:1-301-816-8139