Abstract

Objective: The purpose of this study was to evaluate the radiochemical yield at the end of synthesis and the quality of synthesized [¹⁸F]FDG according to the acceptance criteria mentioned in different Pharmacopeia (USP, EP) and Korea Food and Drug Administration (KFDA) to reduce the hazards of the patients and obtain the best quality of image for proper diagnosis.

Method: Upon bombardment with a 16.5MeV cyclotron, Oxygen-18 enriched water is transformed into [¹⁸F]-fluoride ion. [¹⁸F]FDG was prepared by nucleophilic fluorination of Mannose triflate followed by basic hydrolysis. The entire synthesis was performed forty-six times using the chemistry module FASTlab2. The quality of produced [¹⁸F] FDG in the SNUH, South Korea was evaluated in a standard quality control laboratory. Radiochemical purity, radionuclide purity, chemical purity, pH, endotoxin tests were performed to ensure the quality of [¹⁸F] FDG before release. Sterility tests (FTM and TSB) and residual solvents (Acetonitrile and Ethanol) were analyzed after the release of the radiotracer.

Result: The average decay corrected yield was (81.52 ± 8.33) % more than the average non-decay corrected yield (71.20 % ± 8.02 %). The TLC result of [¹⁸F] FDG showed more than 95% radiochemical purity. Gamma emission spectrum shown more than 99.5% of the gamma emissions correspond to 511KeV photons. The results of the other quality control parameters were in the desired range. The total produced [¹⁸F] FDG in forty-six batches had been used for the treatment of around 2100 patients and found no immediate or afterward hazards to any patients.

Conclusion: The quality of synthesized [¹⁸F] FDG fulfilled all the requirements of USP, EP & KFDA and the radiochemical yield were in an acceptable range.

Keywords: Synthesis yield, Quality control