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Impurity Control Strategy of TMS-Triol

有机合成与工艺文献分享 2025-04-21 06:48

文章摘要

本文研究了TMS-Triol作为关键起始材料在Islatravir商业化生产中的杂质控制策略。背景方面，文章指出TMS-Triol来源于二羟基丙酮(DHA)，在生产过程中发现了两种非挥发性杂质TMS-Hexol和TMS-Ketal。研究目的主要是通过机理研究和工艺优化来控制这些杂质的形成。结论表明，通过控制TFA用量、反应温度和时间可以最小化TMS-Ketal的形成；提高水解温度至70°C可完全水解残留的TMS-Ketal；在工艺中增加在线过滤步骤可确保最终API中不含有TMS-Ketal杂质。这些优化措施实现了严格的杂质控制。

Impurity Control Strategy of TMS-Triol

查看文献： Impurity Control Strategy of TMS-Triol in the Manufacture Development of Islatravir
查看期刊：Organic Process Research & Development

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