BRIEFING

 Daptomycin for Injection. Because there is no existing USP monograph for this drug product, a new monograph based on validated methods of analysis is proposed. The UHPLC procedures in the Assay and in the test for Organic Impurities were validated using two columns connected in series, both the Acquity UPLC CSH C18 brand of column with L1 packing. The typical retention time for daptomycin is about 23 min.

 (SM1: S. Shane)

 Case ID—SUB-1277