经验证的GC-MS和LC-MS/MS方法用于ICH M7基的药物制品中基酸和亚基因毒性杂质的量化

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Updated: Jan 20, 2026

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Neşet Neşetoğlu^1,2, Durişehvar Özer Ünal^1,2

¹Department of Analytical Chemistry, Faculty of Pharmacy, Istanbul University, Istanbul, Turkey.

Biomedical chromatography : BMC

|January 19, 2026

概括

开发了分析方法来控制药品中的基因毒性杂质 (GTIs). 这些杂质特定技术通过检测药品中的微量有害物质来确保患者的安全.

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:

基因毒性杂质 (GTIs) 即使在低度下,也会带来重大风险,包括致病性和致癌性.
监管机构 (EMA,FDA,ICH) 要求制药品制定基于风险的,针对杂质的特定控制策略 (ICH M7).
由于GTIs的多样性,因此需要量身定制的分析方法,而不是单一的通用方法.

研究的目的:

开发和验证药品中基因毒性杂质的杂质特定分析方法.
展示GTI控制监管指南在不同制药矩阵中的实际应用.
确保分析方法适用于常规质量控制和有效的GTI风险管理.

主要方法:

气相色谱-质谱 (GC-MS) 优化了伊马替尼 mesylate API 中的挥发性化剂 (甲基,乙基,异甲硫酸盐).
液态染色学-并联质谱学 (LC-MS/MS) 已为瓦尔沙坦配方中的极性,热可溶性酸杂质建立.
方法验证是根据ICH Q2 ((R1) 准则进行的,评估了特异性,线性,准确性和精度.

主要成果:

优化的GC-MS和LC-MS/MS方法显示出出色的特异性,线性 (R2>0.999),准确性和精度.
达到的检测极限足以满足对基因毒性杂质控制的严格监管要求.
验证证实了开发的方法在药品质量控制中的实际应用中的稳定性.

结论:

杂质特定的分析方法对于药品中有效的基因毒性杂质控制至关重要.
开发的GC-MS和LC-MS/MS方法适用于例行质量控制,支持监管合规和患者安全.
对商业产品的成功应用验证了量身定制的GTI风险管理战略的实际实施.

关键词:

这是AZBT和AZBT.在GCMS中使用.在 LCMS/MS 中使用.基甲基甲基酸盐是什么遗传毒性杂质杂质遗传毒性杂质药品安全药品安全药品安全

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