Enantiomeric impurity determination

Abstract Chiral compounds that are supposed to exist as single enantiomers may contain a minor enantiomeric impurity. In pharmaceuticals, the demands on the enantiomeric purity of such a chiral compound or drug product are very stringent and the quantitation of the enantiomeric impurity in such drug substances and drug products, respectively, is an important analytical task. This holds likewise for chiral catalysts and chiral synthons. Yet, the precise and accurate determination of enantiomeric impurities becomes more and more challenging the lower the content of the enantiomeric impurity. Hence, some peculiarities and guidelines, respectively, are outlined in this chapter.


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