Diflorasone Diacetate Cream
» Diflorasone Diacetate Cream 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— The chromatogram of the Assay preparation exhibits a major peak for diflorasone diacetate at a retention time that corresponds to that exhibited in the chromatogram of the Standard preparation obtained in the Assay.
Microbial enumeration tests 61 and Tests for specified microorganisms 62 It meets the requirements of the tests for absence of Staphylococcus aureus and Pseudomonas aeruginosa.
Minimum fill 755 meets the requirements.
Mobile phase, Internal standard solution, Standard preparation, and Chromatographic system Proceed as directed in the Assay under Diflorasone Diacetate.
Assay preparation— Transfer an accurately weighed amount of Cream, equivalent to about 1 mg of diflorasone diacetate, to a suitable container. Add 30.0 mL of Internal standard solution, and shake for about 30 minutes. Centrifuge the solution, and remove and discard the top (excipient) layer. Use the lower, clear chloroform layer.
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 Cream 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
(MDPS05) Monograph Development-Pulmonary and Steroids
Reference Standards Lili Wang, Technical Services Scientist
61 Radhakrishna S Tirumalai, Ph.D.
Senior Scientist
(MSA05) Microbiology and Sterility Assurance
62 Radhakrishna S Tirumalai, Ph.D.
Senior Scientist
(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.