Identification of Critical Process Impurities and Their Impact on Process Research and Development

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• 作者：Yande Huang ; Qingmei Ye ; Zhenrong Guo ; Venkatapuram A. Palaniswamy ; John A. Grosso
• 刊名：Organic Process Research & Development
• 出版年：2008
• 出版时间：July 2008
• 年：2008
• 卷：12
• 期：4
• 页码：632-636
• 全文大小：170K
• 年卷期：v.12,no.4(July 2008)
• ISSN：1520-586X

文摘

The identification of low-level critical process impurities and degradants encountered during pharmaceutical development is crucial to the process development, but can often be challenging and can negatively impact the timeline of the developmental program. This is demonstrated during the early stage of process research and development of a Factor Xa inhibitor, the caprolactam 1. Details focusing on rapid identification of impurities in the active pharmaceutical ingredient (API), recognition of their root causes of formation, and the impact on process development are described.