Development of a Pyrogallol-Formaldehyde Resin Column for One-Step Pre-Purification Of68ge/68Ga Generator Eluates: Enhanced [68Ga]Ga-Dota-Tate Radiolabeling Yield by Selective Removal of Tetravalent Cationic Impurities Publisher Pubmed



Ebrahimi F ; Ghiamaty Z ; Roustaei S ; Mokhtari Kheirabadi A ; Beiki D ; Rezanejad Bardeji Z ; Nikkholgh B ; Kaviani H ; Akhlaghi M
Source: Nuclear Medicine and Biology Published:2026

Abstract

A pyrogallol-formaldehyde resin (PGR) column was developed for one-step pre-purification of 68Ge/68Ga generator eluates. The resin selectively adsorbs tetravalent cations (Ge4+, Sn4+, Ti4+) with efficiencies of 81.8%, 42.4%, and 29.8% in standards, reducing Sn4+ and Ti4+ to undetectable levels in generator eluates. Formaldehyde leaching was negligible, and cell viability remained 98% ± 1.7%, confirming biocompatibility. 68Ge breakthrough decreased >20-fold (0.0008 ± 0.0001% to 0.00003 ± 0.00002%). Manual [68Ga]Ga-DOTA-TATE labeling yield increased from 58.9 ± 6% to 75.9 ± 1.8% (n = 10). The column is reusable for ≥10 runs. PGR enables high-purity, high-yield 68Ga radiopharmaceutical synthesis without additional processing time, resolving pH-dependent tetravalent cation interference via colloid mitigation. © 2026 Elsevier Inc. All rights are reserved, including those for text and data mining, AI training, and similar technologies.