BRIEFING

 Dapagliflozin 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 Organic Impurities test are validated using the YMC-Pack Pro C18 brand of column with L1 packing. The typical retention time for dapagliflozin is about 19 min.

 (SM3: R. Fales)

 Case ID—SUB-964