Module 3 Presentations

07/05/2024

S.1 General Information  S.1.2 Structure  Structural formula including relative and absolute stereochemistry  Molecular formula  Relative molecular mass

 S.1.3 General Properties  Physicochemical properties  Properties affecting pharmacological efficacy

Nomenclature and Characterisation of the Active Ingredient

The Organisation for Professionals in Regulatory Affairs

19

S.3.1 Elucidation of Structure and other Characteristics  Full elucidation or with reference to a pharmacopoeial standard  Evidence of Chemical Structure  Synthetic route  Key intermediates  Spectroscopic evidence  Crystallography  Elemental analysis  Potential Isomerism  Asymmetric carbons  Other isomers  Physicochemical properties  Solubility  Physical characteristics  Polymorphism  Partition coefficient  Hygroscopicity

Nomenclature and Characterisation of the Active Ingredient

The Organisation for Professionals in Regulatory Affairs

20