Automatic Synthesis and Quality Control of 11C-Raclopride for Clinical Use
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Abstract
Automatic synthesis of 11C-Raclopride was used for routinely clinical imaging with home-made C-11 synthesized module. METHODS: 11C-Triflate-CH3 was bubbled through a vial at room temperature, containing a acetone solution of precursor and NaOH. The reaction solution was transferred to Semi-HPLC for purification. The crude production was purified by C-18 Solid-Extraction-Purification (SEP). The injection solution was formatted by 1mL alcohol eluated from the SEP-C-18, the eluated soluation was diluted with saline to less 10% of alcohol. RESULTE: The amount of base leaded to increase the yields of by production of C-N methlyation. The synthesis yield was (55.1±8.4)% (n=40) with precursor of 0.1 to 0.4 mg, and had no relationship with NaOH in 1 μmol to 50 μmol. It took 28 min from 11CO2 to obtain 11C-Raclopride injection solution. The radiochemical purity was over 99%. The radiochemical concentration was 370 to 550 MBq/mL at specific activity of 1.73×1014 Bq/g. The injection solution was proved to be sterile and pyrogen free. CONCLUSION: 11C-Raclopride was automatic synthesized from 11CH3-Triflate with home-made C-11 synthesizer module. The quality and quantity of 11C-Raclopride injection solution was confirmed to be suitable for clinical PET imaging.
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