Validation of a HPLC method for quality control of 68Ga-DOTATOC
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.
Authors
- Yeleen Fromage (ORCID: https://orcid.org/0009-0002-3356-557X)
- Ph. Stein
- Barbara Lortal (ORCID: https://orcid.org/0000-0003-1338-6857)
- C. Subreville
- B. Crosio
Institutions
- Inserm (FR)
- Institut Bergonié (FR)
- Hôpital Dupuytren (FR)
Publication Details
- Journal
- Journal of Radioanalytical and Nuclear Chemistry
- Published
- 2026-03-23
- DOI
- https://doi.org/10.1007/s10967-026-10815-1
- Primary Topic
- Radiopharmaceutical Chemistry and Applications
- Type
- article
- Field-Weighted Citation Impact
- 0.00