Confirmation of Bosutinib Structure; Demonstration of Controls To Ensure Product Quality

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• 作者：Paul Bowles ; Frank R. Busch ; Kyle R. Leeman ; Andrew S. Palm ; Karen Sutherland
• 刊名：Organic Process Research & Development
• 出版年：2015
• 出版时间：December 18, 2015
• 年：2015
• 卷：19
• 期：12
• 页码：1997-2005
• 全文大小：386K
• ISSN：1520-586X

文摘

Nonbranded/unauthorized vendors had been manufacturing/selling what they described as bosutinib, while the material supplied was actually an isomer of bosutinib. This raised concerns within the worldwide research community around the established control strategies for bosutinib. This manuscript summarizes that the appropriate testing was in place to ensure product quality, along with additional experimentation that was performed to confirm that testing (methods) can differentiate the potential isomeric compounds. Testing includes the use of IR for identity confirmation of raw materials, material characterization by NMR, single crystal X-ray to confirm structure, and evaluation of several potential isomers by HPLC, melting point, and IR, thus demonstrating the control strategy needed to ensure the product controls.