Flurandrenolide Lotion
»Flurandrenolide Lotion contains not less than 90.0percent and not more than 110.0percent of the labeled amount of flurandrenolide (C24H33FO6).
Packaging and storage— Preserve in tight containers,protected from heat,light,and freezing.
Identification— It responds to the Identificationtest under Flurandrenolide Cream.
Microbial limits á61ñ It meets the requirements of the tests for absence of Staphylococcus aureusand Pseudomonas aeruginosa.
Minimum fill á755ñ: meets the requirements.
pHá791ñ: between 3.5and 6.0,determined in a 1in 10dilution of the Lotion in water containing 0.30mLof saturated potassium chloride solution per 100mL.
Assay—
Methanolic sodium chloride ,Mobile phase,Internal standard solution,Standard preparation,and Chromatographic system—Prepare as directed in the Assayunder Flurandrenolide Cream.
Assay preparation— Transfer an accurately weighed portion of Lotion,calculated from the density to contain about 500µg of flurandrenolide,to a separator.(Determine the density by taring a 100-mLvolumetric flask containing 50.0mLof water,adding approximately 25g 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/B,
in which Ais the weight,in g,of the Lotion taken,and Bis 50.0mLminus the volume,in mL,of water necessary to adjust the contents of the volumetric flask to volume.)Proceed as directed for Assay preparationin the Assayunder Flurandrenolide Cream,beginning with “Add 50mLof hexane and 25mLof Methanolic sodium chloride.”
Procedure— Proceed as directed in the Assayunder Flurandrenolide Cream.Calculate the quantity,in mg,of flurandrenolide (C24H33FO6)in each mLof the Lotion taken by the formula:
10C(D/W)(RU/RS),
in which Cis the concentration,in mg per mL,of USP Flurandrenolide RSin the Standard preparation;Dis the density of the Lotion;Wis the weight,in g,of Lotion taken;and RUand RSare the peak response ratios obtained from the Assay preparationand the Standard preparation,respectively.
Auxiliary Information— Staff Liaison:Clydewyn M.Anthony,Ph.D.,Scientist
Expert Committee:(PA1)Pharmaceutical Analysis 1
USP28–NF23Page 863
Pharmacopeial Forum:Volume No.30(2)Page 489
Phone Number:1-301-816-8139