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Development of Adagrasib’s Commercial Manufacturing Route (3)

有机合成与工艺文献分享 2025-10-20 07:10
文章摘要
本文主要介绍了抗癌药物Adagrasib商业化生产路线的开发过程。研究背景涉及药物合成中关键中间体24的制备与纯化挑战，包括反应效率限制、产物分解问题及结晶困难。研究目的旨在开发稳定高效的结晶工艺以提升产物纯度和回收率。通过系统筛选，发现24-对甲苯磺酸盐具有理想的结晶特性，并优化了2-MeTHF/丙酮溶剂体系的比例至50:50 v/v，在控制p-TSA与游离碱比例略低于1的条件下，实现了优异的杂质去除效果和可接受的回收率，为规模化生产奠定了基础。
Development of Adagrasib’s Commercial Manufacturing Route (3)
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