在氧化中含有高水平的 - 一个样本制备工件?
Nhung Dang1, Johan Mattsson1, Adam Lanebjer1
1Research and development analytical department, Cambrex, Karlskoga, Sweden.
Journal of pharmaceutical and biomedical analysis
|May 14, 2025
概括
是一种致癌物质,可以从氧化 (BPO) 的降解中形成. 使用KOH将BPO降解为酸的新方法准确地测量了BPO中的低含量,与标准USP方法不同.
科学领域:
- 分析化学 分析化学
- 药品分析 药品分析
- 有机化学 有机化学
背景情况:
- 过氧化 (BPO) 的降解可以产生,一种已知的致癌物.
- 现有的活性药物成分 (API) 的分析方法可能会高估,这是由于BPO在溶液中的激进降解.
- 准确量化在BPO中的含量对于药品安全至关重要.
研究的目的:
- 开发和验证一种可靠的分析方法,用于准确量化在过氧化 (BPO) 中的.
- 调查BPO的新型降解途径,以减轻人工高读数.
- 将拟议的方法与目前的USP方法对BPO中的烯分析进行比较.
主要方法:
- 提出了一种使用氧化 (KOH) 的降解方法,将BPO转化为酸.
- 使用高性能液体染色学 (HPLC) 来确认BPO降解.
- 在BPO中使用Headspace气体染色学-质谱学 (HS-GC-MS) 分析.
- 验证了该方法的线性,准确性和精度在0.1-4.1ppm范围内.
主要成果:
- KOH辅助的降解有效地将BPO转化为酸,而酸不会产生.
- 拟议的方法检测出明显较低的含量 (约. 0.20 ppm) 与USP方法相比 (大约. 20 ppm) 的时间.
- 在不同年份的BPO批量中发现了持续的低含量,这表明来源是激进降解,而不是老化.
结论:
- 开发的分析方法通过消除BPO降解的工件来准确量化BPO中的.
- 使用强无机基 (KOH) 是有效的BPO样品预处理,促进准确的分析.
- 强大的分析方法的开发是必要的可靠的在药品成分的检测.
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