BRIEFING

 Apremilast Tablets. Because there is no existing USP monograph for this drug product, a new monograph based on validated methods of analysis is being proposed.

 The liquid chromatographic procedure in the Assay, Dissolution test, and the test for Organic Impurities was validated using the Acquity UPLC BEH C18 brand of column with L1 packing. The typical retention time for apremilast is about 1.7 min for the Assay and Organic Impurities test, and is about 0.8 min for the Dissolution test.

 (SM2: H. Ramanathan)

 Case ID—SUB-1897