USP Monographs: Fluorouracil Injection

Fluorouracil Injection

» Fluorouracil Injection is a sterile solution of Fluorouracil in Water for Injection, prepared with the aid of Sodium Hydroxide. It contains, in each mL, not less than 45 mg and not more than 55 mg of fluorouracil (C4H3FN2O2).

NOTE—If a precipitate is formed as a result of exposure to low temperatures, redissolve it by heating to 60

with vigorous shaking, and allow to cool to body temperature prior to use.

Packaging and storage— Preserve in single-dose containers, preferably of Type I glass, and store at controlled room temperature. Avoid freezing and exposure to light.

Labeling— Label it to indicate the expiration date, which is not more than 24 months after date of manufacture.

USP Reference standards

— USP Fluorouracil RS. USP Endotoxin RS.

Identification—

A: The retention time of the major peak in the chromatogram of the Assay preparation corresponds to that in the chromatogram of the Standard preparation as obtained in the Assay.

B: Carefully acidify a portion of Injection, equivalent to about 100 mg of fluorouracil, with glacial acetic acid. Stir and slightly chill the solution to precipitate the fluorouracil, collect the precipitate, wash with 1 mL of water, and then dry in vacuum over phosphorus pentoxide at 80

for 4 hours: the residue so obtained responds to Identification test A under Fluorouracil.

C: It responds to Identification test C under Fluorouracil.

Bacterial endotoxins

— It contains not more than 0.33 USP Endotoxin Unit per mg of fluorouracil.

791

: between 8.6 and 9.4.

Residual solvents

467

: meets the requirements.

(Official January 1, 2007)

Other requirements— It meets the requirements under Injections

Assay—

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

Assay preparation— Transfer a suitable volume of the Injection, equivalent to 50 mg of fluorouracil, to a 100-mL volumetric flask, dilute with water to volume, and mix. Dilute quantitatively a known volume of this solution with water to obtain a solution having 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 C4H3FN2O2 in the volume of Injection taken by the formula:

5(C / V)(rU / rS),

in which C is the concentration, in µg per mL, of USP Fluorouracil RS in the Standard preparation; V is the volume, in mL, of the Injection taken for the Assay preparation; and rU and rS are the fluorouracil peak 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 939

Phone Number : 1-301-816-8320


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