德科维里马的不洁性研究
Emmanuel Mintah Bonku1,2, Hongjian Qin1,3, Abdullajon Odilov1,2
1State Key Laboratory of Drug Research, Shanghai Institute of Materia Medica, Chinese Academy of Sciences, 555 Zuchongzhi Road, Shanghai, 201203, PR China.
Heliyon
|May 14, 2024
概括
这项研究详细介绍了对tecovirimat的杂质控制,这是一种针对水的抗病毒药物. 有效的方法确保高质量的药物制造,符合全球制药标准.
科学领域:
- 制药制造业 制药制造业 制药制造业
- 分析化学 分析化学
- 抗病毒药物开发 抗病毒药物开发
背景情况:
- 德科维里马特是治疗水的关键抗病毒药物.
- 确保药物的纯度和安全性在制药生产中至关重要.
- 工艺和基因毒性杂质需要严格的识别和控制.
研究的目的:
- 在tecovirimat制造过程中系统地识别,合成和控制杂质.
- 建立符合ICH标准的tecovirimat药物质量标准.
- 为了评估商业样品和大规模生产的杂质控制.
主要方法:
- 关键杂质的合成.
- 使用核磁共振 (NMR) 分析进行结构确认.
- 染色学和质谱技术 (GC,HPLC-MS) 的使用.
主要成果:
- 建立了一种用于杂质识别和控制的综合方法.
- 证实了关键杂质的化学结构.
- 对于商业样品和高达60公斤的批量大小,有效的杂质控制被证明是有效的.
结论:
- 这项研究为tecovirimat生产中的杂质表征和控制提供了坚实的框架.
- 遵守ICH标准可以确保tecovirimat药物质量的质量和安全性.
- 这项工作是首次评估tecovirimat制造过程中的过程和基因毒性杂质.
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