The purpose of stability testing is to provide evidence on how the quality of an active substance or medicinal product varies within time under the influence of a variety of environmental factors such as temperature and humidity. Furthermore, stability testing is used to establish a retest period for the drug substance or a shelf life for the drug product and recommended storage conditions. Stability studies are performed according to ICH-Guideline Q1A.
Stress testing provides evidence of the intrinsic stability of the molecule. e.g. buffer capacity, impurities and degradation pathways. Special emphasis is given on batch selection, testing frequency, storage conditions, specification setting and evaluation of results e.g. trend analysis, OOS/OOE-results and deviations.
For stability studies VelaLabs offers three climate chambers; two of which are set by default at 5°C and 25°C / 60% humidity, respectively.