PRESENCE OF ORGANIC IMPURITIES INTO ACTIVE PHARMACEUTICAL INGREDIENTS: A REVIEW

The presence of an excess amount of pharmaceutical impurities in active pharmaceutical ingredients and control of these are a major issue for all pharmaceutical companies. It is essential to know the presence of impurities in the drug substances and control them up to a certain level to avoid adverse effects. Impurities in organic drug molecules can be developed during organic synthesis, formulation or upon aging of active pharmaceutical ingredients, which may affect the quality, safety, and efficacy of drugs. Impurity profile is defined as the description of identified and unidentified impurities present in new drugs as per ICH guidelines. The identification of the impurities of different drugs is done by a variety of available Chromatographic and Spectroscopic techniques. The different analytical methods are utilized for characterization and identification of impurities such as Capillary Electrophoresis (CE), Gas Chromatography (GC), Supercritical Fluid Chromatography (SFC), Thin Layer Chromatography (TLC), High Performance Thin Layer Chromatography (HPTLC), High Performance Liquid Chromatography (HPLC), UV-Visible, IR, Mass, NMR and Raman spectroscopy. In this review article, a study has been done on various well known marketed drugs for their organic impurities, those were reported by various researchers, and a list of few drugs is prepared, those were obtained from British Pharmacopeia 2007.