Module 3 Presentations

07/05/2024

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 Characterisation of the Active Ingredient

The Organisation for Professionals in Regulatory Affairs

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Spectroscopic Properties  Major objective to elucidate the structure of the chemical compound  Typically methods - all highly specific:  NMR ( 1 H, 13 C plus others)  MS  IR  UV-Visible

 Used often during early development, only require small quantities of samples

Nomenclature and Characterisation of the Active Ingredient

The Organisation for Professionals in Regulatory Affairs

12