Green chemistry approaches for the purification of pharmaceuticals

To enable R&D of new drug products with a more green process emphasis, a full understanding of the impact of chromatography in the discovery phase of drug development is crucial. With large quantities of small scale (<1000 mg) separations typically evaluated and purified, a chromatographic technique needs to be easily integrated into workflows and readily robust. At Novartis, integration of supercritical fluid chromatography (SFC) has allowed for increases in productivity, decreases in toxic/hazardous solvent consumption and a more green approach to chromatography. The purpose of this review is to introduce the reader to new techniques available to organizations for the analysis and purification of mg-kg scale purifications that are routinely handled within discovery. Evaluation of a variety of techniques available to the industry has led to the implementation of SFC, with some of the pros of each technique noted below: An overview of enantiomeric purification methodologies is highlighted below in Table 1.