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Rajveer Bhaskar*, Monika Ola, Prakash H. Patil and Rushikesh D. Shinde


Impurity is nothing but the drug substance that containing any component, that is not the chemical matter it can define as a new drug or part of new drug. Impurity also can be any part of drug product or drug substance or excipients in the product. The process of adapting knowledge and evaluation of data that gives us safety from the particular impurity called the impurity profiling. To the pharmaceutical industries, it is a critical issue to supervise the impurities in the pharmaceutical substances and products. The regulatory authorities like US-FDA, ICH, MHRA, TGA etc, are mainly supervise and control the impurities in pharmaceutical products and API’s. In the impurity profile, the multiple methods like spectroscopic and chromatographic techniques are used to evaluate and quantities the impurity in the drug substance and drug product. This review covers the study of source of impurity and also covers the necessity and comprehensiveness of impurity profiling in pharmaceuticals.

Keywords: Impurity, New Drug, Impurity Profile, Pharmaceuticals, spectroscopic, Chromatographic techniques.

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