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How to carry out ICH M7 assessments using in silico tools – A case study for degradation and process impurities

In this webinar, Lhasa Principal Application Scientists, Fernanda Waechter and Diego Zulkiewicz Gomes demonstrated how ICH M7 risk assessments can be performed for impurities in an API, including the following steps:

  • Identification of potential degradation impurities using Zeneth
  • Identification of process related impurities
  • Classification of impurities through Derek Nexus and Sarah Nexus plus expert review
  • Establishing safe limits
  • Evaluating exposure through purge calculations using Mirabilis
  • Establishing control strategies