The stability test provides evidence of how an active pharmaceutical ingredient (API), medicinal product, or medical device quality changes over time. This approach also accounts for the impact of various environmental factors such as temperature, humidity and light.
Stability testing also evaluates the potential interaction of a medicinal substance with other active ingredients or excipients, as well as contact with the container closure system and packaging materials. Mérieux NutriSciences performs accelerated, intermediate and long-term stability studies and photostability studies to ensure the regulatory compliance of active ingredients, medicinal products and medical devices.
We offer the following stability conditions for pharmaceutical stability storage:
- 25°C ± 2°C / 60% RH ± 5% RH
- 30°C ± 2°C / 65% RH ± 5% RH
- 30°C ± 2°C / 75% RH ± 5% RH
- 40°C ± 2°C / 75% RH ± 5% RH
All climatic conditions are continuously monitored using BMX eviSENSE LabguardTM software, ensuring a totally secure and controlled environment.