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Identification of a Novel Process of Nevirapine API

有机合成与工艺文献分享 2025-01-24 08:46
文章摘要
本文报道了在Nevirapine原料药的高效液相色谱测试中发现的一种新型杂质8-n-propyl nevirapine，该杂质在现有生产工艺中难以去除，因其与原料药结构相似。通过结合LC-PDA/UV-MSn和NMR研究，确定了该杂质的结构，并提出了其可能的形成机制。研究过程中检测到了两个关键前体(E)-和(Z)-N-propylidenecyclopropanamine，并基于此优化了Nevirapine的生产工艺参数，成功将杂质水平降低至0.02%以下，同时提高了Nevirapine的产率16%。
Identification of a Novel Process of Nevirapine API
查看文献： Identification of a Novel Process Impurity, Root Cause Investigation, and Its Control Strategy in Process Chemistry of Nevirapine API
查看期刊：Organic Process Research & Development
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