Improved methods to determine radionuclidic purity of F-18 compounds

Current revisions of monographs for F-18 pharmaceuticals in the European Pharmacopoeia (Ph. Eur.) ( Ph. Eur., 2011) call for a radionuclidic purity (RNP) of or better than 99.9%. However, the current method is not sufficient nor effective for testing this required RNP level. We present a theoretical...

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Bibliographic Details
Published in:Applied radiation and isotopes 2012-03, Vol.70 (3), p.430-437
Main Authors: Jørgensen, Thomas, Ankerstjerne Micheelsen, Mille, Jensen, Mikael
Format: Article
Language:English
Subjects:
F-18
Half-life measurements
Radionuclidic purity
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Summary:Current revisions of monographs for F-18 pharmaceuticals in the European Pharmacopoeia (Ph. Eur.) ( Ph. Eur., 2011) call for a radionuclidic purity (RNP) of or better than 99.9%. However, the current method is not sufficient nor effective for testing this required RNP level. We present a theoretical model leading to a practical procedure for a simple test of RNP for F-18 compounds that tells whether or not the sample is pure with a statistical confidence of 97.5% ( P=0.975). ► We examine the method for testing Radionuclidic Purity (RNP) of F-18 compounds. ► The current method is not sufficient for testing the required RNP level. ► We present a simple test that can determine RNP for F-18 compounds. ► The test answer is given with a statistical confidence of 97.5%. ► Contaminations with half-lives shorter than ∼ 165 min cannot be found for RNP=99.9%.
ISSN:0969-8043
1872-9800
DOI:10.1016/j.apradiso.2011.10.012