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New AF4-ICP-MS method quantifies ionic and nanoparticle metals in nanomedicines

Validation on the MRI contrast agent Resovist® revealed just 0.022% of iron in ionic form, addressing a crucial blind spot in current pharmaceutical impurity guidelines

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Overview

  • Researchers from Chiba University pioneered a workflow that integrates asymmetric flow field-flow fractionation with inductively coupled plasma mass spectrometry for detailed compositional analysis of metal-based nanomedicines.
  • Testing on Resovist® showed that free ionic iron constituted only 0.022% of total iron content, underscoring the contrast agent’s stability and low toxicity risk.
  • The method exploits AF4’s initial focus step to filter out dissolved ions before size-based separation of nanoparticles and subsequent ICP-MS quantification of elemental content across particle fractions.
  • By distinguishing chemical species of elemental impurities, the assay addresses limitations in current International Council for Harmonization guidelines and enables more precise safety and quality assessments.
  • Demonstrated versatility with silicon and iron samples, the technique offers applications beyond pharmaceuticals, including cosmetics and environmental metal monitoring.