紫外线/Vis光谱作为平板电脑含量统一性的在线监测工具
René Brands1, Noah Tebart1, Markus Thommes1
1Laboratory of Solids Process Engineering, TU Dortmund University, Emil-Figge-Straße 68, Dortmund 44227, DE, Germany.
Journal of pharmaceutical and biomedical analysis
|September 28, 2023
概括
紫外线/Vis光谱学提供了一种简单的实时方法,用于在连续制造过程中监测药片中的活性药物成分 (API) 含量. 这个过程分析技术 (PAT) 工具提供了准确和精确的结果,证明了对其他光谱方法的可行替代方案.
科学领域:
- 制药制造业 制药制造业 制药制造业
- 过程分析技术 过程分析技术
- 频谱学是一种光谱学.
背景情况:
- 连续制造在制药行业中越来越重要.
- 使用过程分析技术 (PAT) 的实时质量监测对于连续的平板电脑制造至关重要.
- 紫外线/Vis光谱学为PAT中单变量数据分析提供了潜力.
研究的目的:
- 评估在线UV/Vis光谱法,用于监测药片中的活性药物成分 (API) 含量.
- 为了评估UV/Vis光谱在不同的药片生产速度的性能.
- 根据ICH Q2指南验证该方法.
主要方法:
- 实验是在旋转平板电压机上进行的,使用含有西奥菲林单酸盐作为API的平板电脑.
- 在线紫外线/Vis光谱探针安装在喷射位置,测量平板电脑的侧壁.
- 方法验证包括特异性,线性,精度,准确性和范围评估.
主要成果:
- 紫外线/紫外线方法证明了药片配方的特异性.
- 观察到足够的线性,确定系数>0.989.
- 可重复性和中间精度充足,变化系数≤6.46%.
结论:
- 紫外线/Vis光谱是一种有前途的PAT工具,用于在线监测持续制造的平板电脑中的API含量.
- 该方法在各种生产速度下提供准确和精确的测量.
- 在这种应用中,UV/Vis光谱为NIR和拉曼光谱提供了一个可行的,更简单的替代方案.
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