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Research Article Open Access

A Review on Impurity Profile in Pharmaceutical Substances

Abstract

Impurity is defined as any substance coexisting with the original drug, such as starting material or intermediates or that is formed, due to any side reactions. Impurity can be of three types: Impurities closely related to the product and coming from the chemical or from the biosynthetic route itself, Impurities formed due to spontaneous decomposition of the drug during the storage or on exposure to extreme conditions, or the precursors which may be present in the final product as impurities. Impurities present in excess of 0.1% should be identified and quantified by selective methods. The suggested structures of the impurities can be synthesized and will provide the final evidence for their structures, previously determined by spectroscopic methods. Therefore it is essential to know the structure of these impurities in the bulk drug in order to alter the reaction condition and to reduce the quantity of impurity to an acceptable level. Isolation, identification and quantification of impurities help us in various ways, to obtain a pure substance with less toxicity and, safety in drug therapy. This review covers the study of impurities present in new drug substances.

B Prathap, Akalanka Dey, G Srinivasa Rao, T Sundarrajan, and Shahul Hussain

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