Real-Time Monitoring and Control of Critical Process Impurities during the Manufacture of Fostamatinib Disodium

摘要

Process analytical technology (PAT) was used to probe, monitor, and control the formation of process impurities during the synthesis of a pharmaceutical intermediate at 600 kg input scale. An accurate determination of end of reaction (EoR) was vital in limiting side-products, and a novel inline UV/vis-based approach was used where more traditional EoR techniques had failed.