Chromatography

High-sensitivity quantitation of impurities using trap concentration, 2D separation, and an absorbance detector is another approach to achieving the quantitation of ultra-trace impurities required in the FDA draft guidance, "Genotoxic and Carcinogenic Impurities in Drug Substances and Products: Recommended Approaches." This method can fully exploit various separation conditions, such as phosphoric acid buffers and ion-pair reagents, to achieve separation and high-sensitivity quantitation of specific ultra-trace impurities. This can be achieved by the Shimadzu Co-Sense for Impurities system.

The Co-Sense for Impurities System, a combination of online-top concentration and 2D separation, achieves an approximately 20-fold increase in sensitivity over detection using only 1D separation. This enables ultra-high sensitivity analysis with superior stability and lower running costs, even when using conventional detectors such as an absorbance detector.
Ultra-trace impurities, which were not adequately separated in the 1st separation phase from either the main components or other impurities, are reliably separated and can be accurately quantified. This is achieved by using columns with different retention characteristics for each separation or, alternatively, by using different composition mobile phases.
Specialized software with a graphical user interface easily allows anyone to operate the system, from setting analytical parameters to system cleaning.