Pharmaceutical impurities: A Review

Abhimanyu Thakur, Bishal Mishra, Partha Pratim Mahata


A quality drug when marketed, has various factors associated with it one of the crucial factors being impurities identification at each stage of its development. Maintaing the quality, safety and efficacy of a drug indirectly protects the consumers’ right to health. A well accepted fact is that some impurities are unavoidable and will be present in trace amounts hence ICH comes into picture and through its guidelines and policies establishes the specification limits, evaluation and control of impurities. The regulatory bodies and drug development authorities look up to these guidelines for launching a quality drug into the market. Validation of analytical process for impurity identification is performed to establish the impurity profile of any drug substance. Hence the major focus of this review article is on characterisation of impurities, its sources, establishment of impurity profile and analytical approaches to establish its profile.


Impurities, International Conference on Harmonization, Formulation, Profiling, Isolation.

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