Flurandrenolide Lotion
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This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition
Issued and maintained by the United States Pharmacopeial Convention (USP)
Flurandrenolide Lotion contains not less than 90.0 percent and not more than 110.0 percent of the labeled amount of flurandrenolide (C24H33FO6).
Packaging and storage—Preserve in tight containers, protected from heat, light, and freezing.
USP Reference standards 〈11〉—
USP Flurandrenolide RS
Identication—It responds to the Identication test under Flurandrenolide Cream.
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.
pH 〈791〉: between 3.5 and 6.0, determined in a 1 in 10 dilution of the Lotion in water containing 0.30 mL of saturated potassium chloride solution per 100 mL.
Assay—
Methanolic sodium chloride, Mobile phase, Internal standard solution, Standard preparation, and Chromatographic system—Prepare as directed in the Assay under Flurandrenolide Cream.
Assay preparation—Transfer an accurately weighed portion of Lotion, calculated from the density to contain about 500 µg of flurandrenolide, to a separator. (Determine the density by taring a 100-mL volumetric ask containing 50.0 mL of water, adding approximately 25 g of well shaken Lotion, and again weighing, then carefully adjusting the contents of the volumetric ask with water from a buret to volume, and nally calculating the density taken by the formula:
A/B
in which A is the weight, in g, of the Lotion taken; and B is 50.0 mL minus the volume, in mL, of water necessary to adjust the contents of the volumetric ask to volume.) Proceed as directed for Assay preparation in the Assay under Flurandrenolide Cream, beginning with “Add 50 mL of hexane and 25 mL of Methanolic sodium chloride.”
Procedure—Proceed as directed in the Assay under Flurandrenolide Cream. Calculate the quantity, in mg, of flurandrenolide (C24H33FO6) in each mL of the Lotion taken by the formula:
10C(D/W)(RU /RS )
in which C is the concentration, in mg per mL, of USP Flurandrenolide RS in the Standard preparation; D is the density of the Lotion; W is the weight, in g, of Lotion taken; and RU and RS are the peak response ratios obtained from the Assay preparation and the Standard preparation, respectively.
