Accelerated Stability Tests

The accelerated stability studies are designed to increase the rate of chemical degradation or physical change of a drug substance (DS)/Active pharmaceutical ingredient (API) or drug product (DP) using exaggerated storage conditions. The purpose of the study is to monitor any degradation reactions which than will help to predict the shelf life of a drug substance (API) or drug product (DP) under the defined (ICH) storage conditions.

Accelerated stability tests are testing, a product is stored at elevated stress conditions. Degradation at recommended storage conditions could be predicted based on the degradation at each stress condition at each stress condition and known relationships between the acceleration factor and the degradation rate. A product may be released based on accelerated stability data, but the real-time testing must be done in parallel to confirm the shelf-life prediction.