Stability tests in accordance with the requirements of the ICH guidelines are a fundamental part of continuous quality control of pharmaceuticals. Results are used to draw conclusions about the shelf life and storage conditions of the finished drug product.
To check the storage and on-going stability, we have GMP-compliant climate cabinets with the following climatic conditions:
- 25°C/60% RH
- 30°C/65% RH
- 40°C/75% RH
After the finished medicinal products have been stored, we perform the analytical tests and/or coordinate tests with partner laboratories, if necessary. We give advice and support if storage plans must be prepared. Of course, we also simulate the opening of drugs to determine the in-use stability.