BRIEFING

 Foscarnet Sodium Injection. Because there is no existing USP monograph for this drug product, a new monograph based on validated methods of analysis is proposed. The liquid chromatographic procedures used in the Assay and the test for Limit of Phosphate and Phosphite are based on analysis performed with the IC-PAK Anion brand of column with L23 packing. The typical retention time for foscarnet is about 10.6 min.

 (SM1: P. Pabba)

 Case ID—SUB-1127