Studies designed to increase the rate of chemical degradation and physical change of an active pharmaceutical ingredient or finished pharmaceutical product by using exaggerated storage conditions as part of the stability testing programme.
The data thus obtained, in addition to those derived from long-term stability studies, may be used to assess longer- term chemical effects under non-accelerated conditions and to evaluate the impact of short-term excursions outside the label storage conditions, as might occur during shipping.
The results of accelerated testing studies are not always predictive of physical changes.
Related Topics: