Rui Chen | Authors

In recent years, improving productivity and cost-savings have become major initiatives in pharmaceutical discovery and development.

Chiral chromatography has become the preferred tool for enantiomer separations in the early stages of pharmaceutical development for the purpose of accurately identifying single pure enantiomers with pharmacologic, toxicological, and clinical information, as stipulated by the FDA.1

According to the FDA policy statement, developing stereoisomeric drugs, each enantiomer should be evaluated.

In the past decade, supercritical fluid chromatography (SFC) has been established as a cost-effective, sustainable, and green purification technology for pharmaceutical and related industries.

In the past decade, supercritical fluid chromatography (SFC) has experienced a steady growth in acceptance, particularly in pharmaceutical and chemical laboratories. In SFC, "supercritical" CO2 combined with one or more polar organic solvents, most commonly alcohols, are used as mobile phase. Preparative SFC is deemed by many to hold the greatest promise to attain mainstream acceptance. The reduction in solvent consumption and collection in relatively small volumes of volatile organic solvents, hence, a much less stringent post-purification endeavour, lead to significant savings on operation costs. For example, Ripka et al. calculated that 20000 samples purified by SFC instead of reverse phase liquid chromatography (RPLC) would realize a 48 times reduction in solvent consumption.1

In the past decade, supercritical fluid chromatography (SFC) has experienced a striking resurgence and exponential growth in acceptance, particularly in pharmaceutical and chemical laboratories. In SFC, "supercritical" CO2, in combination with one or more polar organic solvents, most commonly alcohols, are used as mobile phase. The polarity of CO2 is similar to that of hexane, and thereby making SFC a normal phase chromatographic technique. SFC has readily lent itself as an attractive complement to reversed phase HPLC (RPLC). For instance, in separating polar compounds that have little retention, and/or selectivity, even with special polar group embedded columns, SFC holds a unique advantage over RPLC due to its normal phase separation mechanism.