A: Ultraviolet Absorption 197U—

Solution: 25 µg per mL.

Medium: pH 6.8 buffer prepared as directed in the Assay under Cefmenoxime Hydrochloride.

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

(Official January 1, 2007)

pH 6.8 buffer, Mobile phase, Internal standard solution, Standard preparation, and Chromatographic system— Prepare as directed in the Assay under 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 1 mg of cefmenoxime (C16H17N9O5S3) per mL. Transfer 4.0 mL of this solution to a 50-mL volumetric flask, add 20.0 mL of Internal standard solution, dilute with Mobile phase to volume, and mix. This solution contains the equivalent of about 80 µg 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 1 mg of cefmenoxime (C16H17N9O5S3) per mL. Transfer 4.0 mL of this solution to a 50-mL volumetric flask, add 20.0 mL of Internal standard solution, dilute with Mobile phase to volume, and mix. This solution contains the equivalent of about 80 µg of cefmenoxime per mL.

Procedure— Proceed as directed for Procedure in the Assay under 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 Calculate the quantity, in mg, of cefmenoxime (C16H17N9O5S3) withdrawn from the container or in the portion of constituted solution taken by the formula: in which L is the labeled quantity, in mg, of cefmenoxime (C16H17N9O5S3) in the container or in the volume of constituted solution taken; D is the concentration, in µg of cefmenoxime per mL, of Assay preparation 1 or 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; WS is the weight, in mg, of USP Cefmenoxime Hydrochloride RS taken to prepare the Standard preparation; PS is the designated cefmenoxime (C16H17N9O5S3) content, in µg per mg, of USP Cefmenoxime Hydrochloride RS; and RU and RS are the response ratios of the cefmenoxime peak to the internal standard peak obtained from the Assay preparation and the Standard preparation, respectively.