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Sponsored Artificial Intelligence: A Modern Approach, Global Edition Artificial Intelligence: A Modern Approach, Global Edition

Author

Philippe Hubert

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1 paper indexed here

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Review Aug 2026

An analytical quality by design-guided method development for the quantification of N-nitroso-fluoxetine to support mitigation strategies for a fluoxetine drug product.

This work focused on N-nitroso-fluoxetine, a N-nitrosamine drug substance-related impurity (NDSRI) formed in fluoxetine-containing products via nitrosation pathways. N-nitroso-fluoxetine was previously detected above the established safety threshold of 100 ng/day, leading to temporary withdrawal of a marketed product i...

Yue Zhang, P. Sacré, B. Streel et al. · 1 citation · ⚡1

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