Diflorasone Diacetate Ointment
» Diflorasone Diacetate Ointment contains not less than 90.0 percent and not more than 110.0 percent of the labeled amount of C26H32F2O7.
Packaging and storage— Preserve in collapsible tubes, preferably at controlled room temperature.
Identification— It responds to the Identification test under Diflorasone Diacetate Cream.
Minimum fill 755: meets the requirements.
Assay—
Mobile phase, Internal standard solution, Standard preparation, and Chromatographic system— Proceed as directed in the Assay under Diflorasone Diacetate.
Assay preparation— Using Ointment instead of the Cream, proceed as directed for Assay preparation in the Assay under Diflorasone Diacetate Cream.
Procedure— Proceed as directed for Procedure in the Assay under 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— Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
Monograph Daniel K. Bempong, Ph.D.
Senior Scientist
1-301-816-8143		 (MDPS05) Monograph Development-Pulmonary and Steroids
Reference Standards Lili Wang, Technical Services Scientist
1-301-816-8129
RSTech@usp.org
61 Radhakrishna S Tirumalai, Ph.D.
Senior Scientist
1-301-816-8339		 (MSA05) Microbiology and Sterility Assurance
62 Radhakrishna S Tirumalai, Ph.D.
Senior Scientist
1-301-816-8339		 (MSA05) Microbiology and Sterility Assurance
USP32–NF27 Page 2142
Chromatographic Column—
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.