Forced Degradation and Its Relation to Real Time Drug Product Stability

摘要: Forced degradation (stress testing) studies are fundamental to the developing stability-indicating analytical methods as part of overall control strategy. Stress testing conducted on both drug substance and product useful for gaining an understanding chemistry a drug. The products observed in such “potential” that may or not be formed under relevant storage conditions, but these reveal pathways available facilitate development methods. These can then used monitor stability during long-term determine which actually form room temperature accelerated conditions. In this presentation, foundational aspects forced their relationship Quality by Design principles will presented along with critical predicting “real time” profiles discussed.