应用风险评估指导评估来验证全面的二维气相色谱来分析复杂的药品
Lukas Schwalb1,2, Ole Tiemann1,3, Uwe Käfer1,2,4
1Joint Mass Spectrometry Centre (JMSC), Chair of Analytical Chemistry, University of Rostock, Rostock, Germany.
本研究引入了一种风险评估方法,用于验证药品成分使用全面的二维气体染色学高分辨率飞行时间质谱法 (GC×GC-HR-ToF-MS) 的定性非定向分析.
科学领域:
- 分析化学 分析化学
- 药品分析 药品分析
背景情况:
- 在受监管的制药环境中,分析结果的可靠性至关重要.
- 现有的验证准则往往不足以用于定性非定向分析方法.
研究的目的:
- 开发和展示一种风险评估方法,用于验证定性非定向GC×GC-HR-ToF-MS方法.
- 识别和评估影响二硫酸盐 (SBS) 分析定性结果的关键参数.
主要方法:
- 采用风险评估策略,重点关注样品制备,蒸发性和热稳定性.
- 利用在线衍生,热重力测量分析 (TGA) 和负电喷射电离的里埃转换离子循环电波共振质谱 (ESI) 作为一个直角的技术.
主要成果:
- 证明了高衍生效率和可重复性,没有诱导的副作用.
- 识别了不完全衍生SBS的潜在热不稳定性.
- 证实了对定性数据的风险评估方法的实际可行性和有效性.
结论:
- 风险评估方法对于验证复杂的定性非定向分析方法是可行的和有效的.
- 这种方法提高了药品质量控制中的分析结果的可靠性.
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