Febuxostat is a novel, non-purine, selective inhibitor of xanthine oxidase for hyperuricemia in patients with gout. It is the first promising substitute for allopurinol in 40 years. Various synthetic routes to febuxostat, as well as polymorphic forms and impurities of the drug, are reported in the literature. The authors have also identified several impurities that result from the synthesis of febuxostat. This article describes the identification and control of all isomeric, carryover, and byproduct impurities of febuxostat and its intermediates.
The quality-by-design principles used to control process variability are equally important to measurement systems because process variability includes contributions from measurement system variability. The authors use real-life examples from drug development projects to outline how an understanding of chromatographic measurement system variability might be achieved.
The Waters Xevo G2-XS mass spectrometer is a new high-performance benchtop quadrupole time-of-flight (QTof) mass spectrometer that combines the new XS Collision Cell with the technologies of Tof-MRM, StepWave and QuanTof for sensitivity and selectivity that allows detection of low-level compounds.
Thermo Fisher Scientific's Vanquish ultra-high performance liquid chromatography (UHPLC) system is a new design for improved productivity and usability when used as a standalone system or with the latest mass spectrometers.
Flexibility, which involves the ability to quickly change product capacity or even product type to meet market demand, is increasingly important. In new construction or renovation, modular process skids and modular buildings create this flexibility. Experts discuss trends and challenges.