Study of the automated synthesis influence factors and quality control of ¹¹C-acetate

Objective: To use Tracerlab FXC transformation to achieve a stable automated synthesis of ¹¹C-acetate, while performing necessary quality control and analysis of key factors of production yield. Methods: The devices that do not participate were short-circuited in the reaction of synthesis, adding external controllable valves or devices to control the external factors which may affect the synthesis yield. The active ¹¹C-CO₂ reacts with 500 μl of 0.5 mol/L methyl magnesium bromide and then quenched and diluted, and solid phase extraction was used to obtain ¹¹C-acetate. Quality control is applied to the final product according to Chinese Pharmacopoeia Fourth General. Results: The analysis of the key factors of yield was carried out to identify the major factors exerts the most considerable effect on the processing synthesis of ¹¹C-acetate. All results qualified after testing according to Chinese Pharmacopoeia quality control guidelines with five times of consecutive synthesis. Conclusions: Numerous factors affect the synthesis of ¹¹C-acetate, and production yield is highly unstable, as well. The modified Tracerlab FXC is able to produce ¹¹C-acetate in a faster, more stable, and secure approach, and the final product is also qualified according to the product standard. (authors)