通过与225 Ac的同位素比,使用ICP-MS测量227 Ac
Jakob E Baumeister1, Benjamin W Puffer1, Cory A Hawkins1
1NorthStar Medical Radioisotopes, LLC, 1800 Gateway Blvd., Beloit, Wisconsin 53511, United States.
ACS omega
|December 1, 2025
概括
一种新方法使用ICP-MS.精确测量了actinium-227 (ac) 在actinium-225 (ac) 活性药物成分 (api) 中的作用. 这种快速,敏感的技术可以确保Ac API的质量测试和监管合规.
科学领域:
- 放射化学 放射化学是指辐射化学.
- 分析化学 分析化学
- 核医学是一种核医学.
背景情况:
- 动-225 (Ac) 是一种关键的治疗性放射性核酸.
- 确保225 Ac API的放射性同位素纯度对于患者的安全和治疗疗效至关重要.
- 在225 Ac API中量化Actinium-227 (227Ac) 杂质的现有方法是耗时的.
研究的目的:
- 开发和验证一种快速,准确和灵敏的方法来测量Ac在Ac API中.
- 提供一种适用于225 Ac API的常规质量控制测试的方法.
- 为了使227Ac内容的准确报告能够符合监管要求.
主要方法:
- 诱导合等离子体质谱学 (ICP-MS) 与同位素比分析相结合.
- 从ICP-MS计数速率数据直接测量了225 Ac/227 Ac同位素比.
- 使用核衰变方程将同位素比率转换为活性比率,加上直角225 Ac活性测量.
主要成果:
- 该方法证明了线性,准确性 (尖峰回收率为74-108%),精度 (中间精度为4.1%).
- 对227Ac的仪器检测极限低至23 Bq L-1.
- 分析时间在简单的样品制备 (在酸中稀释) 中只有2小时.
结论:
- 开发的ICP-MS方法提供了一个快速,准确和灵敏的方法来量化Ac在Ac API.
- 这种方法优于传统的放射测量技术,为质量测试提供更快的结果.
- 该方法的实施支持Ac API生产商和最终用户在确保产品质量和监管遵守方面.
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