A: Ultraviolet Absorption 197U—

Solution: 20 µg per mL.

Medium: water.

B: The retention time of the cefotiam peak in the chromatogram of the Assay preparation corresponds to that in the chromatogram of the Standard preparation; as obtained in the Assay.

Mobile phase , Standard preparation, System suitability solution, and Chromatographic system—Prepare as directed in the Assay under Cefotiam Hydrochloride.

Assay preparation 1 (where it is represented as being in a single-dose container)—Constitute a container of Cefotiam 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 dilute quantitatively with water to obtain a solution containing the equivalent of about 1 mg of cefotiam (C18H23N9O4S3) per mL. Transfer 5.0 mL of this solution to a 100-mL volumetric flask, dilute with Mobile phase to volume, and mix. This solution contains the equivalent of about 50 µg of cefotiam per mL. Use this solution without delay.

Assay preparation 2 (where the label states the quantity of cefotiam in a given volume of constituted solution)—Constitute a container of Cefotiam for Injection in a volume of water, accurately measured, equivalent to the volume of diluent specified in the labeling. Dilute an accurately measured volume of the constituted solution quantitatively with water to obtain a solution containing about 1 mg of cefotiam (C18H23N9O4S3) per mL. Transfer 5.0 mL of this solution to a 100-mL volumetric flask, dilute with Mobile phase to volume, and mix. This solution contains the equivalent of about 50 µg of cefotiam per mL. Use this solution without delay.

Procedure— Proceed as directed for Procedure in the Assay under Cefotiam Hydrochloride. Calculate the quantity, in mg, of cefotiam (C18H23N9O4S3) withdrawn from the container, or in the portion of constituted solution taken by the formula: in which C is the concentration, in µg per mL, of cefotiam (C18H23N9O4S3) in the Standard preparation, based on the quantity of USP Cefotiam Hydrochloride RS taken to prepare the Standard preparation, the designated cefotiam (C18H23N9O4S3) content, in µg per mg, of USP Cefotiam Hydrochloride RS, and the extent of dilution; L is the labeled quantity, in mg, of cefotiam (C18H23N9O4S3) in the container, or in the volume of constituted solution taken; D is the concentration, in µg of cefotiam 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; and rU and rS are the cefotiam peak responses obtained from the Assay preparation and the Standard preparation, respectively.