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在药品中检测N-尼胺杂质的创新:分析和监管挑战

Yunes M M A Alsayadi¹, Raghav Dogra², Vimal Arora¹

¹University Institute of Pharma Sciences, Chandigarh University, Mohali, Punjab, India.

Critical reviews in analytical chemistry

|June 10, 2025

概括

酸胺杂质 (NAI) 是药物中发现的致癌污染物,需要先进的分析方法来检测. 这次审查评估了NAI起源,毒理学和药物安全监管策略.

科学领域:

药品分析药品分析
分析化学分析化学
药品安全药品安全

背景情况:

由于其致癌性和基因毒性,N-尼托拉胺杂质 (NAI) 在药品中是一个重大问题.
召回的药物,如甲胺和拉尼蒂丁突出了迫切需要有效的NAI检测和控制.
美国FDA和EMA等机构的严格监管指导方针强调了解决NAI的全球重要性.

研究的目的:

提供对NAI的起源,形成机制和毒理影响的批判性评估.
审查目前用于药品中NAI检测和量化的分析技术.
分析方法上的差距,并为强大,高通量和符合监管的NAI分析提出未来的战略.

主要方法:

综合文献搜索 (2018-2025) 使用PubMed,科学网,科学直播和Scopus.
专注于分析技术,包括液体染色学-质谱学 (LC-MS),气体染色学-质谱学 (GC-MS) 和高分辨率质谱学 (HRMS).
分析样本准备方法,方法验证和与NII相关的监管框架.

主要成果:

由于结构多样性和低值,在微量水平上检测和量化NAI仍然具有分析挑战性.
目前的分析方法有希望,但在样本准备和仪器特异性方面存在局限性.
随着监管审查的不断发展,需要不断改进NAI监测和缓解策略.

结论:

强大的分析方法对于确保药物安全和保护公众健康免受NAI污染至关重要.
解决样本准备和分析中的方法差距是协调NAI监测的关键.
本综述是专业人士的资源,旨在通过有效的NAI控制来提高药物安全.

关键词:

遗传毒性杂质是一种污染物.在 LC/GC-MS 中使用.N-尼胺氨基化合物的含量通过杂质分析,进行了杂质分析.痕迹分析痕迹分析

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