BRIEFING

 Ulipristal Acetate Tablets. Because there is no existing USP monograph for this drug product, a new monograph based on validated methods of analysis is proposed. The proposal for this monograph which appeared in PF 46(5) [Sep.–Oct. 2020] was canceled and is replaced with a new proposal. On the basis of comments received, applicable sonication steps have been added to the analytical solution preparations in the Assay and Organic Impurities test. The liquid chromatographic procedure used in both the proposed Assay and test for Organic Impurities is based on analyses performed with the Zorbax Eclipse XDB-C18 brand of column with L1 packing. The typical retention time for ulipristal acetate is about 10 min.

 (SM5: M. Tiedje)

 Correspondence Number—C317443