Automated Radiosynthesis of [18F]ML-10, a PET Radiotracer Dedicated to Apoptosis Imaging, on a TRACERLab FX-FN Module

[F-18]ML-10 is the most advanced radiopharmaceutical for the clinical imaging of the apoptosis phenomenon by PET. The preparation of this radiopharmaceutical on a commercial radiosynthesis module and the requested quality controls for its release are presented herein. ML-10 as reference and its mesyloxy derivative as precursor for labelling with fluorine-18 were prepared. [F-18]ML-10 was synthesized via a [F-18]fluorine-de-mesyloxy aliphatic nucleophilic substitution via a GE TRACERLabA (R) FX-FN module. Quality controls were performed. The labelling precursor was obtained in a four step synthesis in 28 % overall yield affording ML-10 in two steps (88 % yield). Pure [F-18]ML-10 was obtained with a decay corrected yield of 39.8 % +/- 8.4 % (n = 7) in 70 min and a specific activity of 235 +/- 85 GBq/mu mol at the end of synthesis. [F-18]ML-10 was prepared on a widely available automated module and passed the quality control. A LC/MS method was developed to measure specific radioactivity.