(Official January 1, 2007)

Solvent— Prepare a mixture of water, methanol, and acetonitrile (90:5:5).

Mobile phase, Solvent, Standard preparation, Resolution solution, and Chromatographic system— Proceed as directed in the Assay under Cefotetan.

Assay preparation 1 (where the package is represented as being in a single-dose container)—Constitute Cefotetan for Injection as directed in the labeling. Withdraw all of the withdrawable contents, and quantitatively dilute with Solvent to obtain a solution containing the equivalent of about 200 µg of cefotetan per mL.

Assay preparation 2 (where the label states the quantity of cefotetan in a given volume of constituted solution)—Constitute Cefotetan for Injection as directed in the labeling. Dilute an accurately measured volume of the constituted solution quantitatively with Solvent to obtain a solution containing the equivalent of about 200 µg of cefotetan per mL.

Procedure— Proceed as directed for Procedure in the Assay under Cefotetan. Calculate the quantity, in mg, of cefotetan (C17H17N7O8S4) withdrawn from the container, or in the portion of constituted solution taken by the formula: in which L is the labeled quantity, in mg, of cefotetan in the container, or in the volume of constituted solution taken, and D is the concentration, in µg of cefotetan per mL, of Assay preparation 1 or Assay preparation 2, based on the labeled quantity in the container or in the portion of constituted solution taken, respectively, and the extent of dilution, and the other terms are as defined therein.