Identification, control strategies, and analytical approaches for the determination of potential genotoxic impurities in pharmaceuticals: a comprehensive review
Potential genotoxic impurities in pharmaceuticals at trace levels are of increasing concern to both pharmaceutical industries and regulatory agencies due to their possibility for human carcinogenesis. Molecular functional groups that render starting materials and synthetic intermediates as reactive...
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my.utm.556492017-02-15T03:27:38Z http://eprints.utm.my/id/eprint/55649/ Identification, control strategies, and analytical approaches for the determination of potential genotoxic impurities in pharmaceuticals: a comprehensive review Reddy, Ambavaram Vijaya Bhaskar Jaffar, Jafariah Umar, Khalid Abdul Majid, Zaiton Aris, Azmi Talib, Juhaizah Madhavi, Gajulapalle QD Chemistry Potential genotoxic impurities in pharmaceuticals at trace levels are of increasing concern to both pharmaceutical industries and regulatory agencies due to their possibility for human carcinogenesis. Molecular functional groups that render starting materials and synthetic intermediates as reactive building blocks for small molecules may also be responsible for their genotoxicity.Determination of these genotoxic impurities at trace levels requires highly sensitive and selective analytical methodologies, which poses tremendous challenges on analytical communities in pharmaceutical research and development. Experimental guidance for the analytical determination of some important classes of genotoxic impurities is still unavailable in the literature. Therefore, the present review explores the structural alerts of commonly encountered potential genotoxic impurities, draft guidance of various regulatory authorities in order to control the level of impurities in drug substances and to assess their toxicity. This review also describes the analytical considerations for the determination of potential genotoxic impurities at trace levels and finally few case studies are also discussed for the determination of some important classes of potential genotoxic impurities. It is the authors' intention to provide a complete strategy that helps analytical scientists for the analysis of such potential genotoxic impurities in pharmaceuticals Wiley 2015-03 Article PeerReviewed Reddy, Ambavaram Vijaya Bhaskar and Jaffar, Jafariah and Umar, Khalid and Abdul Majid, Zaiton and Aris, Azmi and Talib, Juhaizah and Madhavi, Gajulapalle (2015) Identification, control strategies, and analytical approaches for the determination of potential genotoxic impurities in pharmaceuticals: a comprehensive review. Journal of Separation Science, 38 (5). pp. 764-779. ISSN 1615-9306 http://dx.doi.org/10.1002/jssc.201401143 DOI:10.1002/jssc.201401143 |
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QD Chemistry Reddy, Ambavaram Vijaya Bhaskar Jaffar, Jafariah Umar, Khalid Abdul Majid, Zaiton Aris, Azmi Talib, Juhaizah Madhavi, Gajulapalle Identification, control strategies, and analytical approaches for the determination of potential genotoxic impurities in pharmaceuticals: a comprehensive review |
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Potential genotoxic impurities in pharmaceuticals at trace levels are of increasing concern to both pharmaceutical industries and regulatory agencies due to their possibility for human carcinogenesis. Molecular functional groups that render starting materials and synthetic intermediates as reactive building blocks for small molecules may also be responsible for their genotoxicity.Determination of these genotoxic impurities at trace levels requires highly sensitive and selective analytical methodologies, which poses tremendous challenges on analytical communities in pharmaceutical research and development. Experimental guidance for the analytical determination of some important classes of genotoxic impurities is still unavailable in the literature. Therefore, the present review explores the structural alerts of commonly encountered potential genotoxic impurities, draft guidance of various regulatory authorities in order to control the level of impurities in drug substances and to assess their toxicity. This review also describes the analytical considerations for the determination of potential genotoxic impurities at trace levels and finally few case studies are also discussed for the determination of some important classes of potential genotoxic impurities. It is the authors' intention to provide a complete strategy that helps analytical scientists for the analysis of such potential genotoxic impurities in pharmaceuticals |
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Article |
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Reddy, Ambavaram Vijaya Bhaskar Jaffar, Jafariah Umar, Khalid Abdul Majid, Zaiton Aris, Azmi Talib, Juhaizah Madhavi, Gajulapalle |
author_facet |
Reddy, Ambavaram Vijaya Bhaskar Jaffar, Jafariah Umar, Khalid Abdul Majid, Zaiton Aris, Azmi Talib, Juhaizah Madhavi, Gajulapalle |
author_sort |
Reddy, Ambavaram Vijaya Bhaskar |
title |
Identification, control strategies, and analytical approaches for the determination of potential genotoxic impurities in pharmaceuticals: a comprehensive review |
title_short |
Identification, control strategies, and analytical approaches for the determination of potential genotoxic impurities in pharmaceuticals: a comprehensive review |
title_full |
Identification, control strategies, and analytical approaches for the determination of potential genotoxic impurities in pharmaceuticals: a comprehensive review |
title_fullStr |
Identification, control strategies, and analytical approaches for the determination of potential genotoxic impurities in pharmaceuticals: a comprehensive review |
title_full_unstemmed |
Identification, control strategies, and analytical approaches for the determination of potential genotoxic impurities in pharmaceuticals: a comprehensive review |
title_sort |
identification, control strategies, and analytical approaches for the determination of potential genotoxic impurities in pharmaceuticals: a comprehensive review |
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Wiley |
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2015 |
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http://eprints.utm.my/id/eprint/55649/ http://dx.doi.org/10.1002/jssc.201401143 |
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