Analytical Method Lifecycle of SFC Methods from Development Use to Routine QC Implementation; Supporting Small Molecule R&D and Commercialization

Abstract

Selection of the correct analytical technique from the outset of method development is key in securing the optimal and most robust method to be used throughout a product’s development journey from R&D to commercialization. In this article, we review some key considerations for chromatographic technique selection and method development across the full drug process—from early-stage API synthesis to routine commercial release activities. We describe the implementation of supercritical fluid chromatography (SFC) in the pharmaceutical industry, especially for chiral, water sensitive analytes, and low to high LogP and LogD hydrophobic compounds, while demonstrating high levels of method robustness and support of “green” analytics.