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Shruti Kharidia

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Open access Sep 2026

Regulatory Trends and Challenges in Pharmaceutical Submissions: A Critical Analysis of Health Authority Requirements on Nitrosamine Impurities, Elemental Impurities, Forced Degradation and Genotoxicity

Comparing regulatory anticipations of impurity management within pharmaceutical submissions in terms of elements of nitrosamine impurities, genotoxic impurities, forced degradation, and elemental impurities shows that the compliance with harmonized ICH requirements and regulatory frameworks allows managing impurities r...

Darshan Mistry, Zuki Patel, Vinit Movaliya et al. · 0 citations

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