开发一种同时分析方法,用于对应10种典型的亚胺氨基的氨基
Shohei Fukuda1, Takehiro Hoshiyama1, Kanako Kondo2
1R&D Division, Analytical Technology Unit, API Analytical Development Department, Towa Pharmaceutical Co., Ltd., 7-1-3 Doi-cho, Amagasaki, Hyogo 660-0083, Japan.
ACS omega
|January 20, 2025
概括
这项研究提出了一种新的分析方法,用于检测API中的残留氨基,这对于评估药品中酸胺污染风险至关重要. 该方法有助于识别传统风险评估中遗漏的潜在污染源.
科学领域:
- 药品分析 药品分析
- 化学污染 化学污染
- 监管科学 监管科学
背景情况:
- 世界各地的监管机构正在强制要求对制药中的尼托拉胺污染进行风险评估.
- 目前的风险评估依赖于办公室调查,这些调查可能无法确定所有潜在的污染源.
- 亚胺由氨基和化剂形成;活性药物成分 (API) 中的残留氨基是潜在的来源.
研究的目的:
- 开发和验证用于检测API中的残留氨基的同时分析方法.
- 提供一种工具,用于识别未被办公室调查所覆盖的潜在的尼托胺污染风险.
主要方法:
- 为10种典型的小氨基胺开发同步分析方法.
- 验证该方法的线性,量化极限,检测极限,恢复和可重复性.
- 测试方法在各种API中的适用性.
主要成果:
- 该方法证明了不同氨基的特定范围内的良好的线性.
- 达到量测 (0.003微克/毫升) 和检测 (0.001-0.003微克/毫升) 的低极限.
- 显示了可接受的恢复率 (70-130%的121个API) 和良好的重复性 (%RSD<15%).
结论:
- 经过验证的分析方法有效量化了API中的残留氨基.
- 这种方法可以识别传统评估中遗漏的潜在的尼托胺污染风险.
- 该方法预计将对尼托胺污染的制药风险评估策略做出重大贡献.
相关概念视频
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