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Stability studies

Stability studies take place complying with the ICH regulations. Each chamber operates independently with its own temperature-regulation and is under the supervision of a validated, continuous monitoring system. Each stability chamber has a secondary power source as well.

ICH stability chambers

  • 25°C/60%RH
  • 30°C/65%RH
  • 40°C/75%RH
  • Settings as required

ExtractumPharma carries out migration and stability analyses for both investigational medicinal products and generic drugs. The tests are carried out with the determination and documentation of adequate sampling procedures and methods. Our analytical services contain a stability programme as well:

  • Preparation of stability indicating methods
  • Stress studies (forced degradation studies)
  • Long term stability analyses
  • Quick migration analyses
  • Comparison migration analyses