Stability studies

Stability studies

Medicago can provide stability studies to determine the quality and durability of products, for example how products are affected by time, temperature or humidity.

Climatic variation
We use climate chambers, refrigerators and freezers to assess the stability of samples under the influence of varied conditions, such as temperature and humidity. Besides full documentation of the execution of the study, we continuously log the performance and condition of our climate chambers, refrigerators and freezers. We can provide stability testing according to the following conditions:

• ICH Q1A (R2), controlled climate chambers
• 25°C +/-2°C, 60 +/- 5% RH
• 40°C +/-2°C, 75 +/- 5% RH
• 5°C +/- 3°C
• -20°C +/-5°C

Upon request, we can also assist customers with design and project management of more comprehensive stability studies, including quality controls. For these projects we work closely together with our network of accredited analysis labs to perform the analyzes we cannot provide in-house.