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<p>Actinium-225-labeled DOTATATE is a promising candidate for targeted alpha therapy (TAT) of neuroendocrine tumors due to its favorable radionuclide properties and ease of synthesis. This study evaluates the feasibility of using standard QC methods, typically used for Tc-99&#xa0;m, for TAT with Ac-225. [225Ac][Ac-DOTATATE] was synthesized with &gt; 92 ± 2% radiochemical purity and the product remained stable for 24&#xa0;h. Gamma spectrometry showed &gt; 99.9% radionuclide purity. ITLC-SG paper in aqueous acetonitrile resolved radiochemical species effectively, with Rf values of 0.2 for free radiometal and 0.8–0.9 for the labeled peptide while opposite behavior was observed with sodium citrate as mobile phase. These results demonstrate that standard QC infrastructure in Pakistan is adequate for alpha therapy, facilitating routine clinical application.</p> Graphical abstract <p></p>

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Synthesis and quality control of [225Ac][Ac-DOTATATE]: feasibility of the targeted alpha therapy (TAT) in conventional clinical pharmacy equipped for Tc-99 m in Pakistan

  • 期刊论文

  • 发表日期：

    2025年8月30日

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  • Shakera Khatoon Rizvi,
  • Amna Javed,
  • Qaiser Khan

摘要

Actinium-225-labeled DOTATATE is a promising candidate for targeted alpha therapy (TAT) of neuroendocrine tumors due to its favorable radionuclide properties and ease of synthesis. This study evaluates the feasibility of using standard QC methods, typically used for Tc-99 m, for TAT with Ac-225. [225Ac][Ac-DOTATATE] was synthesized with > 92 ± 2% radiochemical purity and the product remained stable for 24 h. Gamma spectrometry showed > 99.9% radionuclide purity. ITLC-SG paper in aqueous acetonitrile resolved radiochemical species effectively, with Rf values of 0.2 for free radiometal and 0.8–0.9 for the labeled peptide while opposite behavior was observed with sodium citrate as mobile phase. These results demonstrate that standard QC infrastructure in Pakistan is adequate for alpha therapy, facilitating routine clinical application.

Graphical abstract