Techniques & Tools Liquid Chromatography

Achiral-Chiral Heart-Cutting 2D-LC Analysis of Chiral Pharmaceutical Substances

Impurity analysis with simultaneous determination of enantiomeric composition using the Agilent 1290 Infinity 2D-LC Solution

07/01/2014

sponsored by Agilent Technologies

According to ICH guideline Q3A (R2), impurities in new drug substances at levels of 0.05 % or above must be reported, and impurities at 0.1 % or above must be identified. Enantiomers of chiral drugs often show differences in pharmacokinetic behavior and pharmacological activity. One enantiomer might be pharmacologically active, while the other might be inactive, or even toxic. Therefore, the FDA has released guidance on the development of new stereo-isomeric drugs, demanding that the stereo-isomeric composition of a drug with a chiral center is known, and that specifications for the final product include assurance of purity from a stereochemical viewpoint.

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