Supercritical Fluid Chromatography in the Pharmaceutical Industry: Implementation in Development and Quality Control
Supercritical fluid chromatography (SFC) is a well-established analytical technique used in the pharmaceutical industry for decades. However, it is still considered a new technique in some areas, for example, implementing the technique for purity profiling in late-stage development and production. In pharmaceutical analytical departments, SFC serves a wide variety of purposes, including compound purification, purity profile, and chiral analysis. Depending on the phase of drug development, the analytical performance requirements, such as speed of analysis, efficiency, and sensitivity, may vary considerably. The end goal is to provide robust, reliable and transferable analytical SFC methods. The challenges for future development and widespread implementation of SFC and the implementation of SFC in quality control (QC) laboratories using modern instrumentation are also discussed.