Application Note: Optimization of rivaroxaban USP monograph using superficially porous particle technology
18 July 2023

In this application note, Advanced Materials Technology presents experimental data on the optimization of rivaroxaban United States Pharmacopeia (USP) monograph using superficially porous particle technology. Rivaroxaban is a drug used to treat blood clots in the legs and the lungs. The associated USP method calls for a fully porous particle using a 3.0 mm ID column. The method as written requires a 45-minute run time for the separation of four impurities associated with Rivaroxaban. Following the approved USP <621> modernization guidelines, the method can be improved with the use of HALO® column technology, which is a superficially porous particle, and the use of a smaller column ID (2.1 mm) and length.