Pathways for N-Nitroso Compound Formation: Secondary Amines and Beyond,Organic Process Research & Development

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Pathways for N-Nitroso Compound Formation: Secondary Amines and Beyond
Organic Process Research & Development ( IF 3.1 ) Pub Date : 2020-07-28 , DOI: 10.1021/acs.oprd.0c00323
Rocío López-Rodríguez ₁ , James A. McManus ₁ , Natasha S. Murphy ₁ , Martin A. Ott ₁ , Michael J. Burns ₁

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Recent drug recalls (e.g., valsartan and ranitidine) linked to the discovery of nitrosamine impurities have led to increased regulatory scrutiny in the manufacturing process of marketed medicines, notably for determining any sources of risk for nitrosamine (or related N-nitroso compound) formation within the manufacturing process. This review seeks to aid the risk assessment process through identifying known conditions and reactants through which N-nitroso compounds can be formed.

中文翻译：

N-亚硝基化合物形成的途径：仲胺及以后

与亚硝胺杂质的发现有关的近期药物召回（例如缬沙坦和雷尼替丁）已导致市场上生产药物的过程中的监管审查日益严格，特别是用于确定内部亚硝胺（或相关的N-亚硝基化合物）形成的任何风险来源制造过程。这项审查旨在通过确定可形成N-亚硝基化合物的已知条件和反应物，来协助风险评估过程。

更新日期：2020-09-20

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