We’re (re)developing twin column “recycling” chromatography as a semi-preparative technology that separates and identifies trace impurities.
Fabrice Gritti |
The problem originates from the pharmaceutical industry: the need to unambiguously identify trace impurities that nearly co-elute with the main active pharmaceutical ingredient (API). The identification can be easily achieved by nuclear magnetic resonance (NMR) spectroscopy, but it requires that about 1 mg of the impurity be prepared at a purity level of at least 90 percent. Given the current state of instrumentation, the pharma industry could not find acceptable technologies capable of producing a (nearly) co-eluting trace impurity at this level within a reasonable timeframe – either because of a lack of resolution power (semi-prep instruments, see Figure 1) or a low production rate (analytical instruments). An alternative semi-prep technology is therefore desperately needed to solve this problem.
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