Hydrocortisone Valerate Ointment
»Hydrocortisone Valerate Ointment contains not less than 90.0percent and not more than 110.0percent of the labeled amount of hydrocortisone valerate (C26H38O6)in a suitable ointment base.
Packaging and storage— Preserve in tight containers,and store at controlled room temperature.
Identification— Using theAssay preparation and theStandard preparation as directed in theAssay,proceed as directed underThin-Layer Chromatographic Identification Test á201ñ.
Microbial limits á61ñ— It meets the requirements of the tests for absence ofStaphylococcus aureus andPseudomonas aeruginosa.The total microbial count does not exceed 100cfu per g.
Minimum fill á755ñ: meets the requirements.
Assay—
Mobile phase,Internal standard solution,Standard preparation,and Chromatographic system— Prepare as directed in theAssay underHydrocortisone Valerate.
Assay preparation— Transfer an accurately weighed quantity of Ointment,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 in a steam bath until melted (about 30seconds),swirl again,and allow to cool at room temperature.Add 2.0mLofInternal standard solution,and mix.Centrifuge for 5minutes,and filter the supernatant,if necessary,to obtain a clear solution.
Procedure— Proceed as directed in theAssay underHydrocortisone Valerate.Calculate the quantity,in mg,of hydrocortisone valerate (C26H38O6)in the portion of Ointment 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
Pharmacopeial Forum:Volume No.27(2)Page 2165
Phone Number:1-301-816-8139
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