BRIEFING

 Ulipristal Acetate. Because there is no existing USP monograph for this drug substance, 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, the limit for desmethyl ulipristal acetate in the test for Organic Impurities is revised to be consistent with the FDA-approved specification. Additionally, applicable sonication steps have been added to the analytical solution preparations in the Assay and Organic Impurities test. The liquid chromatographic procedure used in the proposed Assay and the 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.

 Description and solubility information: White to yellow crystalline powder. It is freely soluble in methylene chloride, methanol, acetone, and ethanol; insoluble in water.

 (SM5: M. Tiedje)

 Correspondence Number—C204664