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-p...

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Bibliographic Details
Published in:Applied radiation and isotopes 2013-06, Vol.76, p.63-69
Main Authors: Mu, Linjing, Hesselmann, Rolf, Oezdemir, Ufuk, Bertschi, Louis, Blanc, Alain, Dragic, Martina, Löffler, Dirk, Smuda, Christoph, Johayem, Anass, Schibli, Roger
Format: Article
Language:English
Subjects:
68Ga-DOTA-TATE
Ascorbic Acid - chemistry
Chromatography, High Pressure Liquid - methods
Ethanol - chemistry
HPLC quality control
Isotope Labeling - methods
Organometallic Compounds - chemical synthesis
Organometallic Compounds - isolation & purification
Quality Control
Radiochemical purity
Radiopharmaceuticals - chemical synthesis
Tandem Mass Spectrometry
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Summary: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.
ISSN:0969-8043
1872-9800
DOI:10.1016/j.apradiso.2012.07.022