Module 3 Presentations

07/05/2024

Evidence of Chemical Structure (1)  Synthetic route – Comprehensive, Unequivocal, Resolution of isomers  Key intermediates

– Contribution to stereochemistry – Retention of stereochemistry – Evidence of structure  Spectroscopic evidence (with correct interpretation!) – UV-visible − IR – NMR: 1H, 13C, 15N, 31P − Mass –Other: Fluorescence, Raman

Nomenclature and Characterisation of the Active Ingredient

The Organisation for Professionals in Regulatory Affairs

21

Evidence of Chemical Structure (2)  Diagnostic characteristic chemical reactions  Optical rotation (for chiral molecules including racemates)  Crystallography  Definitive, Polymorphism  Elemental Analysis (with theoretical values)

… strengthened by orthogonal approaches

Nomenclature and Characterisation of the Active Ingredient

The Organisation for Professionals in Regulatory Affairs

22