A: Ultraviolet Absorption á197Uñ—

Solution: 25µg per mL.

Medium:pH6.8buffer prepared as directed in the Assayunder Cefmenoxime Hydrochloride.

B: The retention time of the cefmenoxime peak in the chromatogram of the Assay preparationcorresponds to that in the chromatogram of the Standard preparation,both relative to the internal standard,as obtained in the Assay.

pH6.8buffer,Mobile phase,Internal standard solution,Standard preparation,and Chromatographic system— Prepare as directed in the Assayunder Cefmenoxime Hydrochloride.

Assay preparation 1 (where it is represented as being in a single-dose container)—Constitute a container of Cefmenoxime for Injection in a volume of water,accurately measured,corresponding to the volume of diluent specified in the labeling.Withdraw all of the withdrawable contents,using a suitable hypodermic needle and syringe,and quantitatively dilute with water to obtain a solution containing the equivalent of about 1mg of cefmenoxime (C16H17N9O5S3)per mL.Transfer 4.0mLof this solution to a 50-mLvolumetric flask,add 20.0mLof Internal standard solution,dilute with Mobile phaseto volume,and mix.This solution contains the equivalent of about 80µg of cefmenoxime per mL.

Assay preparation 2 (where the label states the quantity of cefmenoxime in a given volume of constituted solution)—Constitute a container of Cefmenoxime for Injection in a volume of water,accurately measured,equivalent to the volume of diluent specified in the labeling.Quantitatively dilute an accurately measured volume of the constituted solution with water to obtain a solution containing about 1mg of cefmenoxime (C16H17N9O5S3)per mL.Transfer 4.0mLof this solution to a 50-mLvolumetric flask,add 20.0mLof Internal standard solution,dilute with Mobile phaseto volume,and mix.This solution contains the equivalent of about 80µg of cefmenoxime per mL.

Procedure— Proceed as directed for Procedurein the Assayunder Cefmenoxime Hydrochloride.Calculate the quantity,in mg,of cefmenoxime (C16H17N9O5S3)withdrawn from the container or in the portion of constituted solution taken by the formula: in which Lis the labeled quantity,in mg,of cefmenoxime (C16H17N9O5S3)in the container or in the volume of constituted solution taken,Dis the concentration,in µg of cefmenoxime per mL,of Assay preparation 1or Assay preparation 2,based on the labeled quantity in the container or in the volume of constituted solution taken,respectively,and the extent of dilution,WSis the weight,in mg,of USP Cefmenoxime Hydrochloride RStaken to prepare the Standard preparation,PSis the designated cefmenoxime (C16H17N9O5S3)content,in µg per mg,of USP Cefmenoxime Hydrochloride RS,and RUand RSare the response ratios of the cefmenoxime peak to the internal standard peak obtained from the Assay preparationand the Standard preparation,respectively.