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Abstract

IMPURITY PROFILING IN PHARMACEUTICALS: A REVIEW

Dr. Sayyed Hussain, Dr. Amit Gosar and Tabrez Shaikh*

ABSTRACT

Impurities in the drug are the components which are responsible for the change in the quality of drug with respect to the safety and efficacy. Regulatory authorities such as the International Conference on Harmonization (ICH), the United States Food and Drug Administration (FDA), and the European Directorate for the quality of Medicines (EDQM) emphasis on the requirements of the pure drugs and identification of their impurities. There are various sources of impurity in pharmaceutical products such as starting material, reagent, catalyst, intermediate, solvent and degradation product formed during storage of the drug. Impurities are classified into various categories depending upon their origin, composition type, and biological safety. There are different isolation technique of impurities from the drug. The various analytical methods are used to qualify and characterize the impurities. This reveals that there is always needs and the scope for the impurity profiling of drugs in drug development.

Keywords: Impurities, definition, classification, regulatory and profiling.


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