Wide-ranging tests for reliable results
The stability studies usually last between two and five years. During development, the studies are much more compressed to support landmark decisions. The stability samples are stored in so-called ‘stability rooms’ under different climatic conditions (temperature (° C) and relative air humidity (RH)). During storage of samples in these rooms, how the quality of a product changes over the specified storage period at different storage conditions by means of a complex inspection program are analyzed. For example, the content of the API, degradation products or the appearance of the solution can be affected. For example, does it stay clear or change color over time? Depending on the previously defined requirements, for example, the functionality of te injection system (gliding forces, integrity of the system etc.) is also checked. The tests are determined at different points in time (previously scheduled for the entire study period).
Samples are often stored under several storage conditions to accelerate results. Samples must be stored, transferred or retrieved at predetermined times for the respective analysis. In addition, it is essential to correctly interpret the results by statistical evaluation.