Diflorasone Diacetate Ointment
»Diflorasone Diacetate Ointment contains not less than 90.0percent and not more than 110.0percent of the labeled amount of C26H32F2O7.
Packaging and storage— Preserve in collapsible tubes,preferably at controlled room temperature.
Identification— It responds to the Identificationtest under Diflorasone Diacetate Cream.
Microbial limits á61ñ— Proceed with Ointment as directed for Microbial limitsunder Diflorasone Diacetate Cream.
Minimum fill á755ñ: meets the requirements.
Assay—
Mobile phase,Internal standard solution,Standard preparation,andChromatographic system— Proceed as directed in the Assayunder Diflorasone Diacetate.
Assay preparation— Using Ointment instead of the Cream,proceed as directed for Assay preparationin the Assayunder Diflorasone Diacetate Cream.
Procedure— Proceed as directed for Procedurein the Assayunder Diflorasone Diacetate.Calculate the quantity,in mg,of diflorasone diacetate (C26H32F2O7)in the portion of Ointment taken by the formula:
0.03C(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 639
Phone Number:1-301-816-8139