This article describes the application of liquid chromatography combined with mass-spectrometry (LC-MS) as a new quality control tool for PET-radiopharmaceuticals.
The final step in the production of 2-[Vjfluoro-2deoxy-o-glucose ( 18F-FDG) is a purification by HPLC. This procedure was validated by liquid chromatography combined with mass-spectrometry (LC-MS) using the same separation conditions. o-Glucose, mannose and FDG were separated, identified and quantified. The specific activity of '*F-FDG was >37,OOOGBq .mmol-I. The concentration of D-ghCQSe was 0.5-l .O mg * mL-' and the concentration of mannose was c. 10 pg. mL-' . In addition, mass-spectrometry did not reveal other potential reaction products, like furfural or polymerized sugar derivatives in the final product. Consequently, the HPLC-purified FDG meets the USP requirements. Furthermore, LC-MS was applied to verify the identity of thymidine in [2-"Cjthymidine batches. In conclusion, LC-MS is a valuable tool for the identification of side-reaction-products and the validation of HPLC purification procedures in the preparation of PET-radiopharmaceuticals and thereby may help to assure safe and well-characterized PET-radiopharmaceuticals.