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Bari S. B, Jain P.S, Shirkhedkar A. A, Sonawane L. V, Mhaske A. J, Gawad J. B*


The pharmaceutical industry is required by the Food, Drug and Cosmetic Act to establish the identity and purity of all marketed drug products. The United States Food and Drug Administration (FDA) and other regulatory bodies around the world require that impurities in drug substance and drug product when present at threshold levels recommended by the International Conference on Harmonization (ICH) to be isolated and characterized. The identification of processrelated impurities and degradation products is tedious, it provides an understanding of various sources of impurities and degradation products, the process and methodologies involved in separation, isolation, and characterization of impurities. Chiral impurities are also discussed from the standpoint of their origin, analytical methodology and regulatory perspective for controlling them.

Keywords: Isolation, Characterization of impurities, analytical techniques.

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