Stability studies

Baccinex offers stability testing according to ICH guidelines in order to support the development program of clients: QC laboratory performs stability studies regularly for development or commercial batches manufactured at Baccinex.

Dedicated qualified chambers are installed to conduct stability studies in compliance with ICH requirements:

  • - 20°C ± 5°C
  • 5°C ± 3°C
  • 25°C ± 2°C / 60% HR ± 5% HR
  • 30°C ± 2°C / 65% HR ± 5% HR
  • 40°C ± 2°C / 75% RH ± 5% RH