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For the transformation of starting material into the product is needed API synthesis, which involves multiple reaction steps, including reagents, intermediates, catalysts, solvents and others. As a result, low levels of by-products may appear in API as impurities.
Obtain an overview of GTI guidelines, regulations, strategies, and challenges.
Explore the scale of potential nitrosamine risk associated with existing approved APIs and recent updates on nitrosamine impurities by EMA & FDA.
Know how Sanofi scientists streamlined in silico hazard assessment of potential genotoxic impurities. Also, hear case studies of Nitrosamines.
Hear sessions led by experts from Pfizer, Sandoz, Genentech, AstraZeneca, and others about the latest developments in nitrosamine impurities.
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