Module 3 Presentations

07/05/2024

Potential Isomerism  Effect on synthesis  Influence of reaction conditions  Scale  Resolved and unresolved center, mixtures of racemates  Effect on other data  Physical and chemical properties  Pharmacology and toxicology, Bioavailability, Biopharmaceutics  Implications  What is theoretically possible?  What is actually produced?  Is isomeric composition adequately demonstrated and controlled?  Has the composition changed?

Nomenclature and Characterisation of the Active Ingredient

The Organisation for Professionals in Regulatory Affairs

27

Physicochemical Characteristics  Polymorphism  Evidence of structure  Existence or absence of polymorphism:  Amorphous, polymorph or pseudo-polymorph  Techniques: DSC, XRD, IR (solid state), NMR (solid state)  Consequences of polymorphism  Effect on physical properties  Consistency of production  Control on polymorphic form  Partition coefficient – information for development pharmaceutics  Hygroscopicity

Nomenclature and Characterisation of the Active Ingredient

The Organisation for Professionals in Regulatory Affairs

28