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 45mg and not more than 55mg of fluorouracil (C4H3FN2O2).
NOTE—If a precipitate is formed as a result of exposure to low temperatures,redissolve it by heating to 60with vigorous shaking,and allow to cool to body temperature prior to use.
Packaging and storage— Preserve in single-dose containers,preferably of Type Iglass,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 24months after date of manufacture.
Identification—
A: The retention time of the major peak in the chromatogram of the Assay preparationcorresponds to that in the chromatogram of the Standard preparationas obtained in the Assay.
B: Carefully acidify a portion of Injection,equivalent to about 100mg of fluorouracil,with glacial acetic acid.Stir and slightly chill the solution to precipitate the fluorouracil,collect the precipitate,wash with 1mLof water,and then dry in vacuum over phosphorus pentoxide at 80for 4hours:the residue so obtained responds to Identificationtest Aunder Fluorouracil.
C: It responds to Identificationtest Cunder Fluorouracil.
Bacterial endotoxins á85ñ— It contains not more than 0.33USP Endotoxin Unit per mg of fluorouracil.
pHá791ñ: between 8.6and 9.4.
Other requirements— It meets the requirements under Injections á1ñ.
Assay—
Mobile phase ,Standard preparation,and Chromatographic system—Proceed as directed in the Assayunder Fluorouracil.
Assay preparation— Transfer a suitable volume of the Injection,equivalent to 50mg of fluorouracil,to a 100-mLvolumetric 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 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 C4H3FN2O2in the volume of Injection taken by the formula:
5(C/V)(rU/rS),
in which Cis the concentration,in µg per mL,of USP Fluorouracil RSin the Standard preparation;Vis the volume,in mL,of the Injection taken for the Assay preparation;and rUand rSare the fluorouracil peak 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