Module 3 2019

Physicochemical Characteristics

➢ Polymorphism

Evidence of structure

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− 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 Characterisationof the Active Ingredient

The Organisation for Professionals in Regulatory Affairs