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


Mu, Linjing; Hesselmann, Rolf; Oezdemir, Ufuk; Bertschi, Louis; Blanc, Alain; Dragic, Martina; Löffler, Dirk; Smuda, Christoph; Johayem, Anass; Schibli, Roger (2013). Identification, characterization and suppression of side-products formed during the synthesis of high dose (68)Ga-DOTA-TATE. Applied Radiation and Isotopes, 76:63-69.

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.

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.

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12 citations in Web of Science®
12 citations in Scopus®
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Additional indexing

Item Type:Journal Article, refereed, original work
Communities & Collections:04 Faculty of Medicine > University Hospital Zurich > Clinic for Nuclear Medicine
Dewey Decimal Classification:610 Medicine & health
Language:English
Date:2013
Deposited On:04 Feb 2013 12:13
Last Modified:05 Apr 2016 16:22
Publisher:Pergamon
ISSN:0969-8043
Publisher DOI:https://doi.org/10.1016/j.apradiso.2012.07.022
PubMed ID:22939572

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