» 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
Identification It responds to the Identification 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.
Methanolic sodium chloride , Mobile phase, Internal standard solution, Standard preparation, and Chromatographic systemPrepare 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 flask 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 flask with water from a buret to volume, and finally calculating the density taken by the formula:
A / Bin 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 flask 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.
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USP35NF30 Page 3254Pharmacopeial Forum: Volume No. 30(2) Page 489