Genotoxic Impurities and Its Risk Assessment in Drug
Compounds
Volume 2 - Issue 4
Amit Gosar1, Hussain Sayyed2 and Tabrez Shaikh3*
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- 1,3Indoco Research Centre, Navimumbai, Maharashtra, India
- 2,3Sir Sayyed College, Department of Chemistry, Aurangabad, India
*Corresponding author:
Tabrez Shaikh, Indoco Research Centre, Rabale, Navi Mumbai, Maharashtra, India
Received:October 17, 2018; Published: October 23, 2018
DOI: 10.32474/DDIPIJ.2018.02.000143
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Abstract
The present work is based on a assess analysis of the literature in order to define the genotoxic impurities present in the
drug substances and drug products. Starting from the definition of genotoxic impurities, sources of genotoxic impurities, their
generation and classification based on their toxicity. The article also explains the various regulatory guidelines to control the
genotoxic impurities in drug substances. Isolation, qualification of impurity and its identification along with quantification by the
various analytical methods is also described in this review article.
Keywords: Impurities; Genotoxic; Classification; Guidelines; Drug substances
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