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ISSN: 2637-4706

Drug Designing & Intellectual Properties International Journal

Review Article(ISSN: 2637-4706)

Genotoxic Impurities and Its Risk Assessment in Drug Compounds

Volume 2 - Issue 4

Amit Gosar1, Hussain Sayyed2 and Tabrez Shaikh3*

  • Author Information Open or Close
    • 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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