USP Monographs: Fluorouracil Topical Solution

Fluorouracil Topical Solution

» Fluorouracil Topical Solution contains not less than 90.0 percent and not more than 110.0 percent of the labeled amount of C4H3FN2O2.

Packaging and storage— Preserve in tight containers, and store at controlled room temperature.

USP Reference standards

— USP Fluorouracil RS.

Identification— It responds to the Identification test under Fluorouracil Cream.

Microbial limits

— It meets the requirements of the tests for absence of Staphylococcus aureus and Pseudomonas aeruginosa.

Residual solvents

467

: meets the requirements.

(Official January 1, 2007)

Assay—

Mobile phase, Standard preparation, and Chromatographic system— Proceed as directed in the Assay under Fluorouracil.

Assay preparation— Transfer an accurately weighed portion of Solution, equivalent to about 20 mg of fluorouracil, to a 100-mL volumetric flask, dilute with water to volume, and mix. Quantitatively dilute a volume of this solution with water to obtain a concentration of 10 µg per mL.

Procedure— Separately inject equal volumes (about 10 µL) of the Standard preparation and the Assay preparation into 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 C is the concentration, in µg per mL, of USP Fluorouracil RS in the Standard preparation; and rU and rS are the fluorouracil responses obtained from the Assay preparation and the Standard preparation, respectively.

Auxiliary Information— Staff Liaison : Feiwen Mao, M.S., Senior Scientific Associate

Expert Committee : (MDOOD05) Monograph Development-Ophthalmics Oncologics and Dermatologicals

USP29–NF24 Page 940

Phone Number : 1-301-816-8320


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