Chirality in drug molecules has been a major factor in drug development since the USA FDA issued a policy statement in 1992.Under this policy, the stereoisomeric composition of a drug with a chiral center needs to be understood and the quantitative isomeric composition of the molecules used in pharmacologic, toxicologic, and clinical studies need to be defined.Specifications for the final product should assure identity, strength, quality and purity from a stereochemical perspective.
In the last 10 years, approximately 80% of the small-molecule drugs approved by the FDA were chiral of which nearly 75% were approved as single enantiomer products. As the impact of chirality in the drug industry continues to grow, technologies to produce single enantiomer molecules are increasingly important not only to the clinical success of the drug but also to its commercial success as complex single enantiomer drugs are very expensive to manufacture.
Chiral molecules can be built by several methods that include starting with chiral building blocks from natural products to using asymmetric chemical catalysts and biocatalysts. However, when these synthesis tools are not effective, chiral HPLC is the technology of choice.
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