Scale-Up and Development of a One-Step Process for the Synthesis of Succinylcholine
作者:Brijesh M. Sharma、Nakul Telang、Daniel W. Cook、Justina M. Burns、Rodger W. Stringham、Kai O. Donsbach、Tai-Yuen Yue
DOI:10.1021/acs.oprd.3c00322
日期:2024.1.19
describes a practical synthesis and scale-up of this active pharmaceutical ingredient (API) from readily available starting materials. Analytical methods were developed to identify and quantify impurities in the API. In addition, process development resulted in practical isolation and purification procedures, which avoid the need for a recrystallization step. The process has been scaled up to 25 g reproducibly
氯化琥珀胆碱是一种神经肌肉阻滞剂,被世界卫生组织确定为基本药物。本文描述了从现成的起始材料中实际合成和放大这种活性药物成分 (API)。开发了分析方法来识别和量化 API 中的杂质。此外,工艺开发导致了实用的分离和纯化程序,从而避免了重结晶步骤。该工艺已分三批重复放大至 25 g,平均总产率和纯度达到 89%,符合 API 品质琥珀胆碱的 USP 和 ICH 指导规范。