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