通过H固态NMR对制药冷溶液中的废水进行量化
1Analytical Research and Development, Merck & Co. Inc., Rahway, NJ 07065, USA.
Journal of pharmaceutical sciences
|April 21, 2024
概括
在冷的生物制品中量化未冷的水对于稳定性至关重要. 一种新的1H神奇角度旋转的NMR方法测量结点和流动水,帮助生物制药的发展.
科学领域:
- 生物制药科学 生物制药科学
- 分析化学是一种分析化学.
- 物理化学 物理化学
背景情况:
- 结对于生物制药的稳定性至关重要,但未结的水可以增加降解风险.
- 目前的方法缺乏在现场定量测量未结水的含量.
研究的目的:
- 开发和应用一种新的1H神奇角度旋转的NMR技术,用于在现场定量结生物制品中的移动水.
- 分析商用高度药物产品的冷行为.
主要方法:
- 利用1H魔角旋转的NMR光谱来确定结点 (Tice) 和量化移动水含量.
- 将该技术应用于商业药物产品 (Dupixent®),以研究冷动态.
主要成果:
- 证明水的结受缓冲盐,冷保护剂和蛋白质度的影响.
- 表明1H化学转移可以指示未冷阶段的pH值,预测微环境酸度.
- 在复杂的生物配方中成功量化移动水含量并确定结点.
结论:
- 开发的NMR方法为结缩溶液和生物制药稳定性提供了新的见解.
- 这种技术增强了对稳定的冷和冷化生物制药的理解和设计.
关键词:
(1) H NMR 的时间.生物制剂 生物制剂 生物制剂一个双重的Dupixent.结缩缩剂可以冷.在冷干燥过程中进行冷干燥.冷溶液的冷解决方案阶段变化 阶段变化废水 废水 废水 废水 废水 废水固态NMR是一种固态NMR.更多相关视频
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