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相关概念视频

Ion-Exchange Chromatography01:09

Ion-Exchange Chromatography

Ion-exchange chromatography, or IEC, is a technique for separating ions based on their affinity for the stationary phase. The stationary phase is a cross-linked polymer resin with covalently attached ionic functional groups. The functional groups can be either positively charged (cation exchangers) or negatively charged (anion exchangers). A cation exchanger consists of a polymeric anion and active cations, while an anion exchanger is a polymeric cation with active anions. The choice of...

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An HS-MRM Assay for the Quantification of Host-cell Proteins in Protein Biopharmaceuticals by Liquid Chromatography Ion Mobility QTOF Mass Spectrometry
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使用IPRP-LC-HRMS与提取离子染色体处理方法开发托弗森的测试方法.

Anuradha A Hargude1, Vijay S Bhalekar1, Ravi P Shah1

  • 1Department of Pharmaceutical Analysis, National Institute of Pharmaceutical Education and Research, Ahmedabad (NIPER-A), India. ravi.shah@niperahm.res.in.

Analytical methods : advancing methods and applications
|July 2, 2025
PubMed
概括

这项研究开发了一种用于测量托弗森 (TSN) 的新分析方法,克服了类似杂质的挑战. 经过验证的试验确保了药物配方中托弗森的准确测量.

科学领域:

  • 分析化学 分析化学
  • 药品分析 药品分析

背景情况:

  • 由于共同排泄杂质,限制测定适用性和监管合规性,橄核酸质量控制具有挑战性.
  • 由于结构相似的杂质,对像托弗森 (TSN) 这样的活性药物成分的准确量化受到阻碍.

研究的目的:

  • 开发一种强大的分析试验,以准确量化传感器.
  • 为了应对在寡核酸分析中共同排泄杂质的挑战.
  • 确保对药品质量控制的监管标准的遵守.

主要方法:

  • 离子对逆相液态色谱与高分辨率质谱相结合.
  • 使用提取离子色谱处理用于杂质分辨率.
  • 采用Nusinersen (NSN) 作为信号稳定的内部标准.

主要成果:

  • 该方法证明了在3-10μg mL-1度范围内的线性反应和特异性.
  • 从配方矩阵中恢复是在可接受的80-120%范围内.
  • 该测试显示了关键色谱学和质谱学参数的精度和稳定性.

结论:

  • 开发的方法使得尽管存在共同排泄杂质,但能够准确量化托弗森.

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  • 这种验证的试验符合ICH Q2和USP监管要求.
  • 该方法为寡核酸质量控制和制药分析提供了可靠的工具.