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Open AccessArticle

Development and Successful Validation of Simple and Fast TLC Spot Tests for Determination of Kryptofix® 2.2.2 and Tetrabutylammonium in 18F-Labeled Radiopharmaceuticals

1
Department of Preclinical Imaging and Radiopharmacy, Eberhard Karls University Tübingen, Röntgenweg 15, Tübingen D-72076, Germany
2
Department of Radiochemistry, ABX GmbH, Heinrich-Gläser-Straße 10, Radeberg D-01454, Germany
*
Author to whom correspondence should be addressed.
Pharmaceuticals 2014, 7(5), 621-633; https://doi.org/10.3390/ph7050621
Received: 12 February 2014 / Revised: 1 May 2014 / Accepted: 7 May 2014 / Published: 14 May 2014
(This article belongs to the Special Issue Radiopharmaceutical Chemistry between Imaging and Radioendotherapy)
Kryptofix® 2.2.2 (Kry) or tetrabutylammonium (TBA) are commonly used as phase transfer catalysts in 18F-radiopharmaceutical productions for positron emission tomography (PET). Due to their toxicity, quality control has to be performed before administration of the tracer to assure that limit concentration of residual reagent is not reached. Here, we describe the successful development and pharmaceutical validation (for specificity, accuracy and detection limit) of a simplified color spot test on TLC plates. We were able to prove its applicability as a general, time and resources saving, easy to handle and reliable method in daily routine analyzing 18F-tracer formulations for Kry (in [18F]FDG or [18F]FECh) or TBA contaminations (in [18F]FLT) with special regard to complex matrix compositions. View Full-Text
Keywords: Kryptofix® 2.2.2; tetrabutylammonium; fluorine-18; quality control; thin layer chromatography (TLC) spot test Kryptofix® 2.2.2; tetrabutylammonium; fluorine-18; quality control; thin layer chromatography (TLC) spot test
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Kuntzsch, M.; Lamparter, D.; Brüggener, N.; Müller, M.; Kienzle, G.J.; Reischl, G. Development and Successful Validation of Simple and Fast TLC Spot Tests for Determination of Kryptofix® 2.2.2 and Tetrabutylammonium in 18F-Labeled Radiopharmaceuticals. Pharmaceuticals 2014, 7, 621-633.

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