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Anita Singh*, Sadaf Afreen, Dhirendra Pratap Singh and Rajeev Kumar


In drug discovery process, validation of safety and efficacy of drug are essential parameters and expectedly pharmaceutical companies lay stress upon these. However, every drug which is marketed is associated with several other determinate quality parameters from all of them some are identification, quantification and removal of impurities at each step of development. Recently, there has been an increased stress on impurity profiling of APIs and formulation. According to ICH guidelines, an impurity is any component of drug substance that is not a part of chemical entity and effects purity of active ingredients. from above definition, it becomes easy to realize that impurities are unavoidable and will be present in minor amounts and consequently various regulatory bodies follow workable guidelines to come up with
permissible limits of impurities, to launch a drug product into the market. Impurities are not always necessarily inferior from active ingredient and sometimes may have independent pharmacological or toxicological Properties. However in majority of the cases they are a nuisance and should be curtailed. In this review article, impurities, their types, their characterization and applications have been described.

Keywords: Impurity profile, Impurities, API, Characterization, ICH, Pharmacological, toxicological.

[Full Text Article]

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