Monitoring and control of genotoxic impurity acetamide in the synthesis of zaurategrast sulfate

…, M Palacio, J Stofferis, JP Delatinne…

文献索引：Schuele, Arnaud; Ates, Celal; Palacio, Magali; Stofferis, Jimmy; Delatinne, Jean-Pierre; Martin, Bruno; Lloyd, Steven Organic Process Research and Development, 2010 , vol. 14, # 4 p. 1008 - 1014

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被引用次数: 11

摘要

In this article we describe the strategy adopted to minimize the risk of acetamide presence in zaurategrast sulfate drug candidate. A risk of acetamide formation (a potential genotoxic impurity) was identified in the API formation step of the process during the early development phase. In order to keep the project development timelines unchanged and without having the appropriate analytical method ready developed, we chose to minimize ...