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Automated Radiochemical Synthesis of [18F]3F4AP: A Novel PET Tracer for Imaging Demyelinating Diseases
Published on: May 29, 2017
Improved methods to determine radionuclidic purity of F-18 compounds
Thomas Jørgensen1, Mille Ankerstjerne Micheelsen, Mikael Jensen
1Hevesy Lab, Technical University of Denmark, Roskilde, Denmark. sam_malone@me.com
Abstract:
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).
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