Compound Degradation

The study of the compound degradation is mandatory for drug products and drug substances as it is stated in the FDA and ICH guidance state. These studies are done to understand their behavior over time under multiple environmental conditions. These properties are the key to decide about the formulation, packaging, storage conditions and expiration date of the potential new drugs.

There are two main levels to study compound degradation: long term stability studies (12 months) and accelerated stability analysis (6 month). Forced degradation can be used to get the degradation products in a few weeks that can be used later as standards in the long and accelerated studies. Therefore, forced degradation study goals are the study of the degradation pathway of the product distinguishing between the degradation products coming from the drug itself and from the combination of the drug and formulation components, elucidate the structure of the compounds formed and compute the stability in the formulation.

The information from these studies can then be used to understand the drug properties, to obtain a better formulation of the final product and to extract information that can be used in the long term and acceleration degradation studies that have to be introduced in the regulatory dossiers.