Module 3 2019

Characterisation Studies ➢ Commence from early development through to clinical studies Investigate: − Evidence of structure − Physicochemical properties (solid & solution) − Explain/predict behavior under conditions not studied ➢

➢ Naturally divided into three areas: − Spectroscopic properties − Solid state properties − Solution properties

➢ Results are reflected in the control tests to ensure batch to batch uniformity

Nomenclature and Characterisationof the Active Ingredient

The Organisation for Professionals in Regulatory Affairs