Green chemistry approaches for the purification of pharmaceuticals

Sustainable separations in pharmaceutical manufacturing

“…Nevertheless, the majority of comparative studies have reported on the superiority of SFC in terms of productivity and sustainability not simply over chiral preparative batch LC [78,79] but also in non-conventional achiral separations [80,81]. These advantages are exemplified by a recent case study [82] published by Novartis under section 4.3 of this chapter. Methanol as co-solvent can be efficiently substituted with azeotropic ethanol-water mixture in chiral SFC [83].…”

“…The use of normal phase (NP) separations in the discovery phase as flash methods and chiral techniques, have been reduced by supercritical techniques and innovative green approaches [40,91,92]. However, their widespread application in chiral API manufacturing is yet to be replaced with greener alternatives [78,79,82]. Reversed phase (RP) techniques still dominate the field of pharmaceutical analysis; however, with the advent of innovative sample preparation techniques, UHPLC, miniaturization, core-shell particles and multidimensional separations, the sustainability of RPLC has significantly improved [115].…”

“…Workflows Novartis researchers provided an insightful evaluation of preparative chromatographic techniques from an industrial perspective [82]. Normal phase HPLC even with steady state recycling is characterized by a large footprint and high costs.…”

A Green Chemistry Continuum for a Robust and Sustainable Active Pharmaceutical Ingredient Supply Chain

“…Separation science departments within the pharma industry are also eager to partner with CRO/CDMOs that have access to greener purification and separation techniques . In particular, research organizations are increasingly relying on supercritical fluid chromatography (SFC) as a means to separate compounds, especially racemic or diastereomeric mixtures . As this method utilizes supercritical CO 2 as opposed to toxic and hazardous solvents (e.g., hexanes, dichloromethane), it is an ideal technique for an enterprise seeking to maximize a green approach.…”

“…95 In particular, research organizations are increasingly relying on supercritical fluid chromatography (SFC) as a means to separate compounds, especially racemic or diastereomeric mixtures. 96 As this method utilizes supercritical CO 2 as opposed to toxic and hazardous solvents (e.g., hexanes, dichloromethane), it is an ideal technique for an enterprise seeking to maximize a green approach. Significantly less solvent waste is generated via this technology as opposed to traditional flash chromatography with disposable silica cartridges.…”