Module 3 Presentations

07/05/2024

Chemical modifications

Further chemical modifications – steric repositioning

– decarboxylation – polymerization

The Organisation for Professionals in Regulatory Affairs

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Routes/Causes of Degradation

• Excipient/drug interactions • Functional groups of excipients may react with the active pharmaceutical ingredient (API) • Or, there might be impurities, residues, or degradation products from the excipient itself which can react

The Organisation for Professionals in Regulatory Affairs

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