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<p>Increasing interest in <sup>67</sup>Cu for targeted radionuclide therapy necessitates development of robust and validated analytical methods to ensure compliance with regulatory standards for clinical translation. We validated methods based on inductively coupled plasma optical emission spectroscopy (ICP-OES) and high-purity germanium (HPGe) γ-spectrometry. For ICP-OES, criteria were met for most elements, with Al and Ca, suffering matrix effects. Apparent molar activity calculated by ICP-OES was congruent with DOTA-titration-based effective molar activity when Al and Ca were excluded. HPGe γ-spectrometry was shown to enable accurate discrimination and quantification of co-produced radionuclides (<sup>67</sup>Ga, <sup>66</sup>Ga, <sup>69m</sup>Zn) from <sup>67</sup>Cu at 99.5% radionuclidic purity.</p>

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Validation of ICP-OES and γ-spectrometry methodologies for quality assessment of 67Cu from cyclotron production via the 70Zn(p,α)67Cu nuclear reaction

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年7月31日

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  • Ursula Søndergaard,
  • Kolle E. Thomas,
  • Rune Sundset,
  • Claire Deville,
  • Mikael Jensen,
  • Kristina S. Pedersen,
  • Angel Moldes-Anaya

摘要

Increasing interest in 67Cu for targeted radionuclide therapy necessitates development of robust and validated analytical methods to ensure compliance with regulatory standards for clinical translation. We validated methods based on inductively coupled plasma optical emission spectroscopy (ICP-OES) and high-purity germanium (HPGe) γ-spectrometry. For ICP-OES, criteria were met for most elements, with Al and Ca, suffering matrix effects. Apparent molar activity calculated by ICP-OES was congruent with DOTA-titration-based effective molar activity when Al and Ca were excluded. HPGe γ-spectrometry was shown to enable accurate discrimination and quantification of co-produced radionuclides (67Ga, 66Ga, 69mZn) from 67Cu at 99.5% radionuclidic purity.