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Breaking New Ground in Precise Composition Analysis of Nanomedicines
- Nanomedicine utilizes engineered nanoparticles for advanced healthcare applications, such as imaging and drug delivery, but faces challenges in precise analysis of elemental impurities and particle composition.
- Current pharmaceutical guidelines emphasize total elemental impurity concentration, lacking differentiation between free ions and nanoparticle forms, crucial for assessing safety and efficacy.
- A new analytical technique developed by Assistant Professor Yu-ki Tanaka's team at Chiba University enables the differentiation and quantification of metal ionic and nanoparticle states in nanomedicines.
- This breakthrough method utilizes asymmetrical flow field-flow fractionation (AF4) coupled with inductively coupled plasma mass spectrometry (ICP-MS) to assess elemental impurities and particle size distribution effectively.
- Validation using Resovist®, an iron-based contrast agent, showed minimal ionic iron content and optimal nanoparticle sizes for enhanced biological performance and safety.
- This innovative approach benefits various industries beyond healthcare, offering a comprehensive tool for analyzing metal-containing samples for safety assessments and quality control.
- The AF4-ICP-MS technique revolutionizes nanoparticle characterization by providing detailed insights into particle distribution and elemental content, crucial for regulatory compliance and patient health.
- By accurately quantifying particle aggregates and free ions, this method enhances nanomedicine quality control, ensuring consistency and safety in manufacturing processes.
- The method's applications extend to environmental assessments and food safety regulations, offering insights into metal contaminants and additives for public health protection.
- Assistant Professor Yu-ki Tanaka's expertise in heavy metal analysis and single-cell/particle techniques contributes significantly to advancing nanomedicine characterization and scientific research.
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