Reaction screening and optimization by an automated workstation‐based system

Abstract

The shortening of drug development timelines has caused SmithKline Beecham ChemicalDevelopment to rethink its strategies for product development

An automated workstation for forced degradation of active pharmaceutical ingredients

“…Off‐ line kinetic studies of enzymatic reactions are a useful example of the utility of mass spectral detection combined with HPLC separations,5 although it is feasible to monitor reactions by infusing the sample solution directly into a mass spectrometer 6. Development chemists have recently started to automate the work of optimizing and understanding reactions,7–9 which has had the added benefit of involving the incorporation of analytical monitoring into systems designed for small scale chemistry. One chemical process that analytical chemists are involved in is the forced degradation of new drug substances to aid in the development of stability indicating analytical methods to meet the regulatory requirements for marketing approval 10.…”