Fluorouracil Topical Solution
»Fluorouracil Topical Solution contains not less than 90.0percent and not more than 110.0percent of the labeled amount of C4H3FN2O2.
Packaging and storage— Preserve in tight containers,and store at controlled room temperature.
Identification— It responds to the Identificationtest under Fluorouracil Cream.
Microbial limits á61ñ— It meets the requirements of the tests for absence of Staphylococcus aureusand Pseudomonas aeruginosa.
Assay—
Mobile phase ,Standard preparation,and Chromatographic system—Proceed as directed in the Assayunder Fluorouracil.
Assay preparation— Transfer an accurately weighed portion of Solution,equivalent to about 20mg of fluorouracil,to a 100-mLvolumetric flask,dilute with water to volume,and mix.Quantitatively dilute a volume of this solution with water to obtain a concentration of 10µg per mL.
Procedure— Separately inject equal volumes (about 10µL)of the Standard preparationand the Assay preparationinto the chromatograph,record the chromatograms,and measure the peak responses for the major peaks.Calculate the quantity,in mg,of fluorouracil (C4H3FN2O2)in the portion of Solution taken by the formula:
2C(rU/rS),
in which Cis the concentration,in µg per mL,of USP Fluorouracil RSin the Standard preparation;and rUand rSare the fluorouracil responses obtained from the Assay preparationand the Standard preparation,respectively.
Auxiliary Information— Staff Liaison:Lawrence Evans,III,Ph.D.,Scientist
Expert Committee:(PA6)Pharmaceutical Analysis 6
USP28–NF23Page 852
Phone Number:1-301-816-8389
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