Stability testing
QSI GmbH supports manufacturers with stability testing of bulk and finished products up to in-use stability, as well as ongoing stability monitoring of market batches.
Stability testing is necessary to determine and verify the chemical and physical durability of products under specified storage conditions, with respect to humidity and temperature.
Prior to clinical trials, stability tests ensure the durability of investigational medicinal products over the study duration. Long-term studies on the final finished product are mandatory to obtain approval or registration.
Furthermore, manufacturers are required to conduct regular ongoing stability testing to demonstrate that the medicinal product can be safely used throughout its entire shelf life.
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