| Article ID | Journal | Published Year | Pages | File Type |
|---|---|---|---|---|
| 1876296 | Applied Radiation and Isotopes | 2012 | 8 Pages |
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 ∼165min cannot be found for RNP=99.9%.
