Degradation product

The term 'Degradation product' refers to a chemical entity that results from a change in the drug substance or drug product over time, often due to factors such as light, temperature, pH, or oxidation. In pharmaceutical science, these products are classified as impurities and are strictly regulated by organizations like the FDA and the International Council for Harmonisation (ICH) to ensure drug safety and stability. Because the term is a generic descriptor for the result of chemical decomposition rather than a specific biological molecule, it is not considered a therapeutic target. While specific degradation products (such as Amyloid-beta in Alzheimer's disease) may be targeted, the general category of 'Degradation product' serves as a parameter for quality control and shelf-life assessment. Consequently, it lacks the specific biological function or disease-modifying role associated with receptors, enzymes, or transporters.

Other names

Breakdown productDecomposition productDrug impurityMetabolite (in certain contexts)