(Official January 1, 2007)

pH 6.8 Buffer , Mobile phase, Resolution solution, Standard preparation, and Chromatographic system—Prepare as directed in the Assay under Cefpiramide.

Assay preparation 1 (where it is represented as being in a single-dose container)—Constitute a container of Cefpiramide 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 Mobile phase to obtain a solution containing the equivalent of about 0.25 mg of cefpiramide (C25H24N8O7S2) per mL.

Assay preparation 2 (where the label states the quantity of cefpiramide in a given volume of constituted solution)—Constitute a container of Cefpiramide 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 0.25 mg of cefpiramide (C25H24N8O7S2) per mL.

Procedure— Proceed as directed for Procedure in the Assay under Cefpiramide. Calculate the quantity, in mg, of cefpiramide (C25H24N8O7S2) withdrawn from the container, or in the portion of constituted solution taken by the formula: in which L is the labeled quantity, in mg, of cefpiramide (C25H24N8O7S2) in the container, or in the volume of constituted solution taken; D is the concentration, in mg of cefpiramide 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; C is the concentration, in mg per mL, of USP Cefpiramide RS in the Standard preparation; E is the designated cefpiramide (C25H24N8O7S2) content, in µg per mg, of USP Cefpiramide RS; and rU and rS are the cefpiramide peak responses obtained from the Assay preparation and the Standard preparation, respectively.