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A new 68Ga anionic concentration and purification method for automated synthesis of [68Ga]‐DOTA or NODAGA conjugated peptides in high radiochemical purity
Authors:Rana Ben Azzouna  Faisal Alshoukr  Sébastien Leygnac  Alexandre Guez  Walter Gonzalez  Olivier Rousseaux  Denis Guilloteau  Dominique Le Guludec
Affiliation:1. Nuclear Medicine Department and DHU FIRE, Bichat‐Claude Bernard University Hospital, AP‐HP, Paris, France;2. UMR 1148 Inserm, Paris, France;3. Federation de Recherche en Imagerie Multimodale, Paris 7 University, Paris, France;4. Pharmacy Department, Bichat Claude Bernard University Hospital, APHP, Paris, France;5. Pierre et Marie Curie University, Paris, France;6. Guerbet, Research Center, Aulnay‐sous‐Bois, France;7. Inserm, U930, Fran?ois Rabelais University, CHRU, Tours, France
Abstract:
The 68Ge/68Ga generator is of increasing interest for clinical PET. For successful labelling, the eluate has to be purified. The aim of our approach is to improve the existing anionic methods which have a number of advantages compared to other methods but which use high concentrated HCl, and require an additional anionizing step. A new 68Ga‐eluate anionic purification method that enables rapid and high efficiency labelling of DOTA and NODAGA conjugated peptides in high radiochemical purity is described. The new method uses NaCl as an alternative Cl? source to the corrosive HCl and combines the three standard steps in a single step. The recovery yield was ≥90%, and the 68Ge breakthrough was in conformity with the European Pharmacopeia limit. An automated labelling of DOTA and NODAGA‐conjugated peptides was performed with the new method, using acetate sodium buffer, with a total duration of 13 min and a radiochemical yield >85%. The labelled peptides have a radiochemical purity exceeding 99% and can be used directly without any further purification step and without the quality control by gas chromatography. Furthermore, the new method has an economic advantage: it offers the possibility to use generator until 20 months after the calibration date.
Keywords:gallium 68  anionic purification  NaCl  peptides  DOTA  NODAGA
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