BRIEFING

 Eptifibatide. Because there is no existing USP monograph for this drug substance, a new monograph based on validated methods of analysis is being proposed. The proposal for this drug substance that appeared in PF 49(2) [Mar.–Apr. 2023] has been canceled and is being replaced with a new proposal. This new proposal contains modifications made on the basis of public comments as well as requested revisions from the Biologics Monographs 1—Peptides and Oligonucleotides Expert Committee. The liquid chromatographic procedures in the Assay and in the Eptifibatide-Related Impurities test are based on analyses performed with the Synergi Max-RP C12 brand of column with L87 packing. The typical retention time for eptifibatide is about 35 min.

 (BIO1: J. Zhang)

 Case ID—SUB-980