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

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.