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探索高通量同步龙X射线粉末衍射,用于制药的结构分析.
M Reinle-Schmitt1, D Šišak Jung2, M Morin1
1Excelsus Structural Solutions (Swiss) AG, PARK INNOVAARE, 5234 Villigen, Switzerland.
International journal of pharmaceutics: X
|December 26, 2023
概括
高通量同步龙X射线粉末衍射 (s-XRPD) 提供快速,高质量的制药分析. 这项技术使复杂的同步仪测量更容易获得,并且在常规使用中具有成本效益.
科学领域:
- 材料科学 材料科学 材料科学
- 分析化学 分析化学
- 制药科学 制药科学
背景情况:
- 同步辐射提供优越的特性,如高亮度和连贯性比传统的来源.
- 从历史上看,同步机设备在可访问性和操作复杂性方面面临着挑战,限制了常规使用.
- 技术转让和高吞吐量系统的最新进展正在改善同步机可访问性.
研究的目的:
- 研究同步射线X射线粉末衍射 (s-XRPD) 在药物分析中的实际应用.
- 展示高吞吐量s-XRPD系统在制药分析革命中的潜力.
- 评估s-XRPD数据与基于实验室的XRPD数据的质量和可比性.
主要方法:
- 使用高通量同步龙X射线粉末衍射 (s-XRPD) 系统.
- 分析的药物活性成分 (API) 和辅助成分.
- 进行结构改进,并将单元格参数与文献数据进行比较.
主要成果:
- 高通量s-XRPD系统在不到5秒的时间内生成了与实验室XRPD相当或优于实验室XRPD质量的XRPD模式.
- 证明了对成熟的药物化合物的高通量分析的可行性.
- 通过与现有文献保持一致的结构性改进来确认数据质量.
结论:
- 高通量s-XRPD具有通过提供快速,高质量的数据来彻底改变药物分析的潜力.
- 同步机数据质量并不总是需要最先进的技术来与实验室XRPD竞争.
- 用户友好,可复制性,可访问性和成本效益是同步仪器仪表具有竞争力的关键.
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