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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.

Summary3′[

The dependence of the radiochemical yield of [lSF]fluoromisonidazole (1) on different reaction parameters such as reaction time, temperature and amount of precursor was investigated for the nucleophilic substitution of tosylate by [lSF]fluoride and subsequent hydrolysis of the protecting group on l-(2'-nitro-l'-imidazolyl)-2-O-tetrahydropyranyl-3-O-toluenesulfonylpropanediol as the precursor molecule (2). Highest yields (86%+6%) were obtained using 10 mg (2) at 100 ~ for 10 minutes, whereas both at 80 and 120 ~ the yields were lower (46%_+11% and 29~ respectively). A rapid decrease of the yield was observed when the reaction time exceeded 15 minutes, i.e., at 100 ~ using 5 mg (2) the radiochemical yield decreased from 61%_+8% at 15 minutes to 18~ at 60 minutes.

No abstract