Work

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

Year: 2026

Type: article

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.

Source: Journal of Radioanalytical and Nuclear Chemistry

DOI: 10.1007/s10967-026-10815-1

Authors: B. Crosio, C. Subreville, P. Stein, Y. Fromage, B. Lortal

Institutions: Institut Bergonié, Inserm, Hôpital Universitaire Dupuytren, Université de Limoges

Language: English

Topic: Radiopharmaceutical Chemistry and Applications

Subfield: Radiology, Nuclear Medicine and Imaging

Field: Medicine

Domain: Health Sciences

Open Access status: hybrid

Estimated APC paid: $3,790

Funder: Institut Bergonié