Akademik Veri Yönetim Sistemi
JOURNAL OF RADIOANALYTICAL AND NUCLEAR CHEMISTRY, 2026 (SCI-Expanded, Scopus)
Lutetium-177 (Lu-177)-labeled radiopharmaceuticals are widely used in targeted radionuclide therapy, and radiochemical purity (RCP) is a critical quality parameter for clinical application. This study retrospectively evaluated the long-term quality control performance of Lu-177-labeled radiopharmaceuticals prepared using a fully manual labeling approach without automated synthesis modules between 2010 and 2026 at a single center. A total of 1815 productions, including [Lu-177]Lu-DOTATATE, [Lu-177]Lu-PSMA-617, [Lu-177]Lu-DOTANOC, [Lu-177]Lu-FAPI-04, and [Lu-177]Lu-EDTMP, were analyzed, corresponding to 3330 clinical administrations. Radiochemical purity was routinely assessed by high-performance liquid chromatography (HPLC) and instant thin-layer chromatography (ITLC). Detailed statistical evaluation was performed on randomly selected high-volume groups and all low-volume products. Across all productions, RCP values exceeded the clinical release criterion of 95%, and no batch failed quality requirements. No statistically significant differences were observed between radiopharmaceutical types, analytical methods, or production periods (p > 0.05), indicating long-term methodological stability. In addition, occupational radiation exposure of radiopharmacists remained within regulatory limits over a 7-year period. These findings demonstrate that manual preparation of Lu-177-labeled radiopharmaceuticals can provide consistently high quality, methodological reliability, and sustainable long-term performance in routine clinical practice.