Identification, characterization and suppression of side-products formed during the synthesis of high dose 68Ga-DOTA-TATE

In the course of the establishment of 68Ga-DOTA-TATE production for clinical use a shoulder comprising presumably several impurities was observed in the chromatogram of the analytical radio-HPLC. LC–MS/MS results support the hypothesis that some of these radioimpurities are radiolytic oxidation by-products of 68Ga-DOTA-TATE. A new HPLC method was developed for quality control of 68Ga-DOTA-TATE. Significant improvement on the radiochemical purity of 68Ga-DOTA-TATE was achieved by the addition of ascorbic acid or ethanol to the reaction mixture.

► A new HPLC method was developed for quality control of 68Ga-DOTA-TATE.
► Radiolytic oxidation by-products of 68Ga-DOTA-TATE were formed at high dose of activity.
► It is necessary to add ascorbic acid or ethanol to the preparation for high dose of 68Ga-DOTA-TATE.