Comparison of drug substance impurity profiles generated with extended length columns during packed-column SFC

Supercritical Fluid and Unified Chromatography

“…Blackwell et al took advantage of the normal-phase retention mechanisms and high flow rates of SFC to generate high-efficiency impurity profiles in far less time than required for RP-HPLC (126). Roston et al used the low viscosities of SFC mobile phases not only to increase flow rates but also to extend column length for impurity profiling (127). The extended column lengths provided higher chromatographic efficiencies and greater resolution of impurities.…”

Theory and Practice of UHPLC and UHPLC–MS

“…As discussed in Section 2.2, this was not possible with the old SFC platforms. Therefore, the first methods for impurity profiling were reported only in 2000 and 2001, with the focus on evaluation of impurity concentrations relative to the API, provided that the criterion of sensitivity was met (Roston et al, 2001;Gyllenhaal and Karlsson, 2000), but full validation was still missing. The studies focused on all aspects of impurity profiling, including quantitative aspects, and full method validations were published only recently (Plachká et al, 2016;Wang et al, 2011).…”