An impurity is “any component of the product which is not the chemical entity defined as the active substance or an excipient in the product”.
Drug Impurities are unwanted chemicals that remain with the active pharmaceutical ingredients (APIs) or develop during formulation or upon aging of both API and formulation. The presence of these unwanted chemicals even in trace amount may influence the efficacy and safety of pharmaceutical product. The control of impurities is an important task pharmaceutical impurities as per the regulatory norms. High Pure and Well characterized impurity Standards are used for Related Substances, Organic impurities and Validation of Analytical Methods.