Module 3 2019

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 Characterisationof the Active Ingredient

The Organisation for Professionals in Regulatory Affairs

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