Abstract 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.
Crosio et al. (Mon,) studied this question.