Impurity Profiling of Anti-Malarial Drugs

Impurities are the unwanted materials which can interact with the pharmaceutical product and affects the quality of the product or the formulation. According to ICH guidelines, impurity is the part of the drug substance which affects the quality and purity of the active ingredients. Therefore, its identification and control is the major issue in the formulation industries. For the control and the limits of the impurity in the pharmaceutical dosage form, International Conference on Harmonization (ICH) formulated the guidelines for the impurity control and management. In this review, list of the sources of the impurity with their possible causes and effects with their suitable examples are given. Also, the regulatory body and guidelines involved in the detection and identification of the impurity are discussed. The article further discusses about the comprehensive information of the compendial methods and work done on the anti-malarial drugs with their possible impurities along with their structural elucidation and also the detection methods for the determination of impurity.