Episode 1: Why Chirality Still Matters: Stereochemistry as a Critical Quality Attribute
The pharmaceutical meaning of chirality, the real impurity space, and where chiral HPLC fits The pharmaceutical meaning of chirality Chirality matters in drug development for a simple reason. Biological systems are chiral, so the body does not experience two stereoisomers as the same molecule. FDA stated this explicitly in its landmark 1992 stereoisomer guidance, noting …
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