The pharmaceutical impurities also known as API impurities are the unwanted chemical compounds that are found in drug substance or drug formulations. The impurities are formed due to stressful conditions and during the synthesis of API. These impurities are resposible for efficacy of the drug. The impurities also required for genotoxicity studies and reporing the impurity profile of API while regulatory submissions. Therefore the API impurities are essential in the process of drug development and manufacturing in the pharmaceutical industries.
Due to these reason the API impurities are synthezised perposely by using various chemical process. Amoung these methods Forced degredation of API is one of the most common method which is used by the researcher and pharmacetical organizations.