title: Identification, characterization and suppression of side-products formed during the synthesis of high dose ⁶⁸Ga-DOTA-TATE.
abstract: In the course of the establishment of (68)Ga-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 (68)Ga-DOTA-TATE. A new HPLC method was developed for quality control of (68)Ga-DOTA-TATE. Significant improvement on the radiochemical purity of (68)Ga-DOTA-TATE was achieved by the addition of ascorbic acid or ethanol to the reaction mixture.
authors.affiliation: Center for Radiopharmaceutical Sciences ETH-PSI-USZ, Department of Nuclear Medicine, University Hospital Zurich, Switzerland. linjing.mu@usz.ch
authors.forename: Linjing
authors.initials: L
authors.lastname: Mu
authors.forename: Rolf
authors.initials: R
authors.lastname: Hesselmann
authors.forename: Ufuk
authors.initials: U
authors.lastname: Oezdemir
authors.forename: Louis
authors.initials: L
authors.lastname: Bertschi
authors.forename: Alain
authors.initials: A
authors.lastname: Blanc
authors.forename: Martina
authors.initials: M
authors.lastname: Dragic
authors.forename: Dirk
authors.initials: D
authors.lastname: Löffler
authors.forename: Christoph
authors.initials: C
authors.lastname: Smuda
authors.forename: Anass
authors.initials: A
authors.lastname: Johayem
authors.forename: Roger
authors.initials: R
authors.lastname: Schibli
mesh_terms: D001205:Ascorbic Acid / Q000737:chemistry; D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D000431:Ethanol / Q000737:chemistry; D007553:Isotope Labeling / Q000379:methods; D009942:Organometallic Compounds / Q000138:chemical synthesis* / Q000302:isolation & purification; D011786:Quality Control; D019275:Radiopharmaceuticals / Q000138:chemical synthesis; D053719:Tandem Mass Spectrometry
chemical_list: D009942:Organometallic Compounds; D019275:Radiopharmaceuticals; D000431:Ethanol; C513399:gallium Ga 68 dotatate; D001205:Ascorbic Acid