在线拉曼光谱用于在连续结晶过程中的多态监测
Sreya Sarkar1, Andreas Stumpf1, Zhenqi Shi1
1Genentech Inc., Synthetic Molecule Pharmaceutical Sciences, 1 DNA Way, South San Francisco, California 94080 USA.
Applied spectroscopy
|June 18, 2025
概括
在线拉曼光谱监测连续结晶多态. 这个过程分析技术 (PAT) 工具可以实时进行定量分析,以更好地控制和理解过程.
科学领域:
- 化学工程是化学工程的重要组成部分.
- 结晶科学 结晶科学
- 频谱学是一种光谱学.
背景情况:
- 持续结晶提供了对产品属性的增强控制.
- 对多态构成的实时监测对于过程理解和优化至关重要.
- 在连续过程中的多态转换需要先进的分析技术.
研究的目的:
- 展示在线拉曼光谱作为一个过程分析技术 (PAT) 工具.
- 在流量诱导的连续结晶过程中对复杂的多态过渡进行定量监测.
- 了解过程设计空间,避免不必要的多态.
主要方法:
- 利用直线拉曼光谱法进行快速,现场,非破坏性测量.
- 应用第二导数拉曼光谱用于对多态变化的定性监测.
- 开发了一种高斯曲线适配方法,用于对多态化合物的定量确定.
主要成果:
- 在实时中成功监控微妙的多态过渡.
- 在各种连续结晶条件下的量化多态成分.
- 在过程中说明了多态过渡的动态性质.
结论:
- 在线拉曼光谱对于持续结晶的定性和定量监测是有效的.
- 这种PAT方法增强了对结晶动力学和工艺设计空间的理解.
- 能够避免过程条件导致不必要的多态.
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