Chiral Fidelity
Definition: The degree to which stereochemical integrity is preserved throughout molecular design, synthesis, analysis, formulation, storage, and biological evaluation.
Context: Chiral fidelity reflects how well a system maintains the intended configuration or enantiomeric composition without racemization, epimerization, or atropisomer interconversion. In pharmaceutical development, high chiral fidelity is essential for reproducibility, safety, and regulatory compliance across the product lifecycle.
Example: Demonstrating that an enantiopure API retains ?99% enantiomeric excess during scale-up, formulation, and shelf-life stability studies.
Related Terms: Enantiopure; Racemization; Stereomutation; Chiral Control; Stereochemical Stability
Reference: ICH Q6A. Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and Products (1999).
Ariens, E. J., Stereochemistry, a basis for sophisticated nonsense in pharmacokinetics and clinical pharmacology, European Journal of Clinical Pharmacology, 26, 663-668 (1984).
DOI: 10.1007/BF00541922
Demonstrates how maintaining or improving enantiomeric integrity alters clinical outcomes - a practical expression of chiral fidelity.