What Is Forced Degradation?

Forced degradation refers to a testing process for new drug substances or products that accelerates the conditions under which they degrade to determine what the effects are on those substances or products.

This process needs to be carried out to show specifically how their stability is affected under certain conditions. It shows the method of degradation and provides an insight into degradation pathways and the degradation of products to show the structure of the products after degradation. Degradation studies are intended to reveal the chemical behavior of the molecule under certain conditions which is used when developing the formulation and packaging for the product. Regulatory guidance is very general and does not have specific requirements for the performance of degradation studies. These studies are, nonetheless, considered a vital aspect of drug development and is most commonly known as stress testing, to determine the effective shelf life of a given pharmaceutical product.