FOR SOLID PACKAGED IN SINGLE-UNIT CONTAINERS: meets the requirements.

(Official January 1, 2007)

Mobile phase, Diluent, and Chromatographic system— Prepare as directed in the Assay under Cefpodoxime Proxetil.

Standard preparation— Transfer about 30 mg of USP Cefpodoxime Proxetil RS, accurately weighed, to a 50-mL volumetric flask, dissolve in 5 mL of methanol, dilute with Diluent to volume, and mix. Transfer 5.0 mL of this solution to a 100-mL volumetric flask, dilute with Diluent to volume, and mix. Pass through a filter having a 0.45-µm or finer porosity.

Assay preparation— Constitute a container of Cefpodoxime Proxetil for Oral Suspension as directed in the labeling. Shake the resulting suspension thoroughly, and determine its density. Transfer an accurately weighed quantity of the suspension, equivalent to about 50 mg of cefpodoxime, to a 100-mL volumetric flask. Add 10 mL of water, and shake to disperse. Add 20 mL of acetonitrile, and sonicate for 15 minutes. Cool to room temperature, dilute with Diluent to volume, and mix. Transfer 5.0 mL of this solution to a 100-mL volumetric flask, dilute with Diluent to volume, mix, and pass through a filter having a 0.45-µm or finer porosity.

Procedure— Separately inject equal volumes (about 20 µL) of the Standard preparation and the Assay preparation into the chromatograph, record the chromatograms, and measure the responses for the major peaks. Calculate the quantity, in mg of cefpodoxime (C15H17N5O6S2) in the portion of Oral Suspension taken by the formula: in which C is the concentration, in mg per mL, of USP Cefpodoxime Proxetil RS in the Standard preparation; P is the designated potency, in µg per mg, of cefpodoxime (C15H17N5O6S2) in USP Cefpodoxime Proxetil RS; and rU and rS are the sums of the peak responses for cefpodoxime proxetil S-epimer and cefpodoxime proxetil R-epimer obtained from the Assay preparation and the Standard preparation, respectively.