Module 3 2019

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 Characterisationof the Active Ingredient

The Organisation for Professionals in Regulatory Affairs