Procedure for content uniformity— Perform the Assayon individual containers using Assay preparation 1or Assay preparation 2,or both,as appropriate.

pH3.4Acetate buffer,Mobile phase,Internal standard solution,Standard preparation,and Chromatographic system— Proceed as directed in the Assayunder Cefuroxime Sodium.

Assay preparation 1 (where it is represented as being in a single-dose container)—Constitute Cefuroxime for Injection in a volume of water,accurately measured,corresponding to the volume of solvent specified in the labeling.Withdraw all of the withdrawable contents,using a suitable hypodermic needle and syringe,and dilute quantitatively with water to obtain a solution containing about 1mg of cefuroxime per mL.Immediately transfer 5.0mLof the resulting solution to a 100-mLvolumetric flask,add 20.0mLof Internal standard solution,dilute with water to volume,and mix.

Assay preparation 2 (where the label states the quantity of cefuroxime in a given volume of constituted solution or suspension)—Constitute Cefuroxime for Injection in a volume of water,accurately measured,corresponding to the volume of solvent specified in the labeling.Dilute an accurately measured volume of the constituted solution or suspension quantitatively with water to obtain a solution containing about 1mg of cefuroxime per mL.Immediately transfer 5.0mLof the resulting solution to a 100-mLvolumetric flask,add 20.0mLof Internal standard solution,dilute with water to volume,and mix.

Procedure— Proceed as directed for Procedurein the Assayunder Cefuroxime Sodium.Calculate the quantity,in mg,of cefuroxime (C16H16N4O8S)withdrawn from the container,or in the portion of constituted solution or suspension taken by the formula: in which Lis the labeled quantity,in mg of cefuroxime (C16H16N4O8S),in the container,or in the volume of constituted solution or suspension taken;Dis the concentration,in mg of cefuroxime (C16H16N4O8S)per mL,of Assay preparation 1or Assay preparation 2,based on the labeled quantity in the container or in the portion of constituted solution or suspension taken,respectively,and the extent of dilution;Cis the concentration,in mg of cefuroxime (C16H16N4O8S)per mL,of the Standard preparation;and RUand RSare the peak response ratios of cefuroxime to the internal standard obtained from the Assay preparationand the Standard preparation,respectively.Where the test for Uniformity of dosage unitshas been performed using the Procedure for content uniformity,use the average of these determinations as the Assayvalue.