BRIEFING

 Cefpodoxime Proxetil Tablets. This proposal is based on the version of the monograph official prior to 2013. On the basis of comments received, the proposal in PF 47(1) has been canceled and is being replaced with a new proposal. It is proposed to revise the monograph with the following changes:

1. Change the cefpodoxime proxetil R-epimer and cefpodoxime proxetil S-epimer peaks in Identification A to have them in elution order

2. Add Identification B which is based on UV spectra agreement as obtained in the Assay. Accordingly, revise the Detector in the Assay to support the proposed Identification B.

3. Clarify the preparation of Solution A in the Assay. Revise the Standard stock solution to provide flexibility. Revise the Standard solution to delete the filtration step since it's fully dissolved.

4. Revise the Assay to add a Run time based on supporting data.

5. Add a calculation equation in the Dissolution test for clarification.

6. Add a test for Organic Impurities based on a liquid chromatographic procedure which was validated using the Symmetry C18 brand of column with L1 packing. The typical retention times for cefpodoxime proxetil S-epimer and cefpodoxime proxetil R-epimer are about 29 and 33 min, respectively.

7. Delete the Water Determination test as it is formulation specific.

8. Revise the condition in the Packaging and Storage section in accordance with the available FDA-approved package insert.

 Additionally, minor editorial changes have been made to update the monograph to current USP style.

 (SM1: S. Shane)

 Case ID—SUB-1006