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用碎片离子过对DNA反应性杂质的衍生式非目标识别

Dongmei Zhang^1,2,3, Baojian Hang^1,2,3, Yiran Zhang⁴

¹Biological Products Research Division, Shandong Institute for Food and Drug Control, Xinluo Avenue No. 2749, Jinan 250101, China.

Molecules (Basel, Switzerland)

|October 16, 2025

概括

一种新方法使用衍生试剂选DNA直接反应杂质 (DDRIs),这可能导致突变. 这种方法提高了药品中这些有害化合物的检测.

科学领域:

制药化学制药化学制药化学
分析化学分析化学
毒理学毒理学毒理学

背景情况:

由于它们与DNA的反应性,DNA直接反应杂质 (DDRI) 构成突变的风险.
目前的控制策略依赖于已知的DDRI结构,限制了多样化或不稳定的化合物的检测.
对DDRI的非标查仍然是药物安全方面的重大挑战.

研究的目的:

为DNA直接反应杂质 (DDRI) 的非目标查开发一种新的衍生策略.
设计一种能够与DDRI反应并促进其检测的衍生试剂.
改善药品中未知DDRI的识别.

主要方法:

设计了一种衍生试剂,其中包含一个活性氨基群和一个报告群.
使用了两种特定的试剂,p-methoxyaniline和p-methoxybenzoyl-β-alaninamide,具有明显的染色学修饰.
使用超高性能液态色谱学与高分辨率质谱学 (UPLC-HRMS) 结合分析衍生产品.

主要成果:

通过报告组的产品离子过成功实现了DDRI的非目标选.
证明了设计的衍生试剂在检测DDRI中的实用性.
使用不同染色学修饰组在试剂中的缓解矩阵效应.

结论:

开发的衍生化方法可以有效地对DDRI进行非目标选.
这种方法提高了识别和控制药品中潜在的致变性杂质的能力.
该战略为改善药物安全和质量控制提供了一个有前途的工具.

关键词:

具有DNA反应性的杂质.衍生衍生是指指衍生衍生,它是指衍生衍生.碎片离子过器可以过.不针对目标的查.

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