In case of drug substances, it is important to analyse its safety under various environmental conditions. Though the drug stability affects the potency and safety of the compound, any changes in its stability may result in formation of a toxic compound that adversely impacts the safety of the patient. It may also result in the formation of a compound that has diminished therapeutic effect, thus affecting the intended efficacy. It is therefore essential to assess the stability of the drug under various environmental conditions.
Purposeful degradation studies, also known as forced degradation studies are an important tool in predicting the stability of a drug, with effect on its purity, potency and safety under various stress conditions. Along with its role in formulation development, the studies are also helpful in selection of right packaging material for the drug substance.