Stability Testing

The purpose of stability testing is to provide evidence on how the quality of an active substance or medicinal product varies with time under the influence of a variety of environmental factors such as temperature and humidity and to establish a retest period for the drug substance or a shelf life for the drug product and recommended storage conditions. Stability testing is 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 made on batch selection, testing frequency, storage conditions, specification setting and evaluation of results (e.g. trend analysis, OOS-results and deviations).

For stability studies Vela offers three climate chambers; two are set by default at 4°C and 25°C / 60% humidity, respectively.