BRIEFING

 Saxagliptin Tablets. 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 Dissolution test are based on validation performed with the Sunfire C18 brand of column with L1 packing. The typical retention time for saxagliptin is about 3.7 min for both the Assay and Dissolution test. The test for Organic Impurities is based on validation performed with the Zorbax Eclipse AAA brand of column with L1 packing. The typical retention time for saxagliptin is about 19 min.

 (SM3: P. Pabba)

 Case ID—SUB-777