ABSTRACT
During the early 1990s, crystallizations were considered more of an art than a science. During that time, process chemists would design a process that delivered an active pharmaceutical ingredient (API) with a certain particle size, and formulation chemists would use it to design a tablet or a capsule suitable for clinical trials or the marketplace. Since then, several events have changed that business model:
1. Concerns over the safety of tiny amounts of potential genotoxic impurities in APIs were driven by major advances in analytical instrumentation that allow detection of these impurities at parts per million levels.
