GENOTOXIC IMPURITIES IN PHARMACEUTICALS: THE CASE OF NITROSAMINES

Autores

  • Andrey da Silva Nique
  • Daniela Marques Dos Santos Pereira
  • Vera Lucia Eifler-Lima
  • Gustavo Machado das Neves
  • Gabriela Göethel

Palavras-chave:

genotoxic impurities, nitrosamines, ICH M7, in silico modeling, in vitro and in vivo assays

Resumo

Nitrosamines (NAs) are recognized genotoxic impurities frequently detected in pharmaceutical products, associated with significant mutagenic and carcinogenic risks in humans.

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Publicado

2026-01-05

Edição

v. 5 (2025)

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Artigos

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