BRIEFING

 Oseltamivir Phosphate for Oral Suspension. 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 Organic Impurities were validated using the Symmetry Shield RP-18 brand of column with L1 packing. The typical retention time for oseltamivir is about 25 min.

 (SM1: R. Fales)

 Case ID—SUB-1907