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<p>Unexplained production issues with Ga-DOTATOC kits continue to cause economic losses and delays in patient care. This study aimed to adapt the European Pharmacopoeia method and validate a rapid UV/radiometric HPLC method to identify gallium-DOTATOC, free gallium, and unlabeled peptide, and to quantify free-gallium and DOTATOC in a single run. The method proved to be accurate, precise, and repeatable, providing a practical tool to investigate labeling failures. This work allows the optimization of quality control, the investigation of labeling failures, and the cut of associated costs.</p>

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Validation of a HPLC method for quality control of 68Ga-DOTATOC

  • 期刊论文

  • 出版模式：

    开放获取

  • 发表日期：

    2026年3月23日

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  • B. Crosio,
  • C. Subreville,
  • P. Stein,
  • Y. Fromage,
  • B. Lortal

摘要

Unexplained production issues with Ga-DOTATOC kits continue to cause economic losses and delays in patient care. This study aimed to adapt the European Pharmacopoeia method and validate a rapid UV/radiometric HPLC method to identify gallium-DOTATOC, free gallium, and unlabeled peptide, and to quantify free-gallium and DOTATOC in a single run. The method proved to be accurate, precise, and repeatable, providing a practical tool to investigate labeling failures. This work allows the optimization of quality control, the investigation of labeling failures, and the cut of associated costs.