Tópicos

  • ICH Q3 Impurity Guidelines
  • ICH Q3A – Drug Substance Process-related Impurities
  • ICH Q3B – Drug Substance and Drug Product Degradation Impurities
  • ICH M7 – Genotoxic Impurities
  • ICH Q3C Guidelines
  • Residual Solvents
  • ICH Q3D Guidelines
  • Elemental Impurities



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