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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