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甲磺酸伊马替尼中致突变杂质研究

张 兰平, 姚 彤, 刘 梦婷
连云港杰瑞药业有限公司

摘要


参照ICHM7(R1)制定了甲磺酸伊马替尼中致突变杂质甲磺酸甲酯(MMS)、甲磺酸乙酯(EMS)和甲磺酸异丙酯(IMS)的控制策略,研究确定采用GC-MS方法对其进行检测,采用6%氰丙基苯基和94%二甲基聚硅氧烷为固定相的毛细管柱,进样口温度为240℃;流速为每分钟1.5mL;进样量为1μL;分流比为20:1;载气为氮气;检测器为质谱,离子源为EI,MMS选择离子为79/80/95,EMS和IMS选择离子为79/97/109/123,线性关系、准确度等指标良好,符合ICHQ2(R1)要求。

关键词


致突变性杂质;甲磺酸甲酯(MMS);甲磺酸乙酯(EMS);甲磺酸异丙酯(IMS);GC-MS

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参考


[1]TheInternationalCouncilforHarmonisationofTechnicalRe-quirementsforPharmaceuticalsforHumanUse(ICH).Assess-mentandcontrolofDNAreactive(Mutagenic)inPharmaceuticalstolimitpotentialcarcinogenicrisk.[EB/OL].[2020-05-15].https://database.ich.org/sites/default/files/M7_R1_Guideline.pdf.

[2]TheInternationalCouncilforHarmonisationofTechnicalRequirementsforPharmaceuticalsforHumanUse(ICH).Val-idationofAnalyticalProcedures:Textandmethodology[EB/OL].[2020-05-15].https://database.ich.org/sites/default/files/Q2%28R1%29%20Guideline.pdf.

[3]CarcinogenicPotencyDatabase[EB/OL].[2020-05-15].https://files.toxplanet.com/cpdb/chempages/METHYL%20METHANESUL-FONATE.html.

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DOI: http://dx.doi.org/10.18686/xdhg.v2i4.31290

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