Full service provides
for your stability studies

QSI offers a comprehensive service for the storage, execution, and documentation of your stability studies:

  • Storage according to ICH Q1A conditions
  • Efficient planning and execution of on-going and in-use stability testing
  • Coordination, analysis, evaluation, and reporting
  • Assessment of OOx results (OOS, OOT, OOE)
  • Narcotics license according to § 3 of the German Narcotics Act (BtMG)
  • License for the storage of medical cannabis according to § 4 of the German Medical Cannabis Act (MedCanG)
  • State-of-the-art climate chambers with electronic real-time monitoring and alarm systems

 

Standard Conditions:

  • 25 °C/60 % RH, Long-term condition (Climate Zone II)
  • 30 °C/65 % RH, Intermediate condition (Climate Zone IVa)
  • 40 °C/75 % RH, Accelerated condition

 

Cold and Freezer Storage:

  • 2 °C to 8 °C
  • -20 °C
If interested, we would be happy to evaluate the feasibility of alternative climatic zones for you.
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