Stability Testing
Looking for advice or support on GMP stability studies for your product?
Investigating the stability and shelf-life of a finished product is an important area of expertise at Quercus Labo.
We can help you determine the best approach for investigating the stability of your product with:
- ICH stability testing (long-term, intermediate, and accelerated)
- Stress testing (light, pH, humidity, temperature, oxidation)
- In-use stability testing
- Development & Validation of stability-indicating methods
- Temperature cycle test, freeze-thaw, transportation
- Study management, protocols and reporting
Please do not hesitate to contact us for more information on our stability testing services.
Storage conditions
In accordance with ICH guidance
Storage conditions in accordance with ICH guidance are available on-site:
- 5°C (refrigerated storage)
- 25°C / 60%RH (long term stability storage)
- 30°C/ 65%RH (intermediate stability storage)
- 40°C/ 75%RH (accelerated stability storage)
All conditions are access-controlled, mapped, and continually monitored to ensure a secure and GMP-controlled environment is guaranteed at all times.
Independent study coordinator
Independent supervision and full documentation
All tests are performed in our laboratory under the supervision of an independent study coordinator who manages your project. You receive full documentation of the stability study and results.
Lastly, you can count on our consulting firm for regulatory support and application assistance.