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Quench-Crystallization Operation in Drug Substance Manufacturing

有机合成与工艺文献分享 2025-10-15 08:49
文章摘要
本文针对药物生产中的淬灭结晶工艺展开研究。背景是原有甲醇共溶剂会导致哌嗪片段甲醇解产生杂质，且晶体粒径小、分布宽导致过滤效率低。研究目的通过溶剂筛选和过程分析技术优化结晶工艺，发现TFA-6盐在DCM中溶解度高而游离态6难溶的特性。结论表明采用NMP作为共溶剂可消除甲醇解问题，形成更大晶体提高过滤效率，并通过优化溶剂配比、加料速率和搅拌条件，成功在三个生产基地实现400公斤级规模应用。
Quench-Crystallization Operation in Drug Substance Manufacturing
查看文献： Developing and Optimizing a Quench-Crystallization Operation in Drug Substance Manufacturing
查看期刊： Organic Process Research & Development
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