BRIEFING

 Regadenoson 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 in the Assay and Organic Impurities test were validated using the Alltima C18 brand of column with L1 packing. The typical retention time for regadenoson is about 27 min.

 (SM4: S. Dragan)

 Case ID—SUB-55, SUB-147