Validates an HPLC method for quality control of gallium-DOTATOC, suggesting improvements in patient care.
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.
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Crosio et al. (2026) studied this question.
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