Detection of Impurities Hidden Under the API Peak at Relevant Levels
The analysis of impurities in low concentrations relative to an active
pharmaceutical ingredient (API) is important for quality control of drug
substances. When impurities are structurally similar to the API and the
concentration difference is high, chromatographic separation and detection can
be challenging.
The Agilent 1290 Infinity II 2D-LC Solution offers the possibility to switch easily
between comprehensive (LCxLC), multiple heart-cutting (MHC), or high-resolution
sampling 2D-LC (HiRes 2D-LC). In this Application Note, HiRes 2D-LC is used to
achieve the separation of two closely eluting compounds, one of which is present
at very low concentration, and is hidden under the other more highly concentrated
compound peak. Chlorodifluorobenzoic acids and deamidated insulin were
analyzed as standard substances and a real sample, respectively
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