EFFECT OF HYDROLYSIS TIME ON RADIOCHEMICAL AND CHEMICAL PURITY OF 2- [18F] FLUORO-2-DEOXY-D-GLUCOSE.

The basis for the release of [¹⁸F]FDG for use is the results of quality control studies within the scope of the specification, based on the recommendations of the Pharmacopoeia (FP XI and Ph. Eur. IX). The object of this study is the influence of the [¹⁸F]FDG hydrolysis time on the quality parameters, with particular regard to radiochemical purity. The synthesis was performed at three different hydrolysis times: 8, 10, and 12 minutes. 21 syntheses were performed for each time. For the [¹⁸F]FDG solution, the radiochemical purity was assessed with the TLC method, the radiochemical and chemical purity with the HPLC method, and the pH value with the potentiometric method. Extending the hydrolysis time significantly increased the radiochemical purity of the final [¹⁸F]FDG product, improving its quality parameters (mainly reducing the amount of acetyl derivatives of [¹⁸F]FDG while maintaining chemical purity and pH value but with a slight loss of activity. A result at the accept/reject limit may negatively affect the stability test. Increasing the radiochemical purity allows us to avoid the invalidation of this test due to the influence of device measurement error and possible operator error (human). Minimizing contamination reduces impact GLUT independent tumor cell accumulation of [¹⁸F]FDG, which its detail of character is still unknown. The possibility of a false-positive result in an imaging examination and minimizes the impact of radiation from contaminants on the patient's tissues. Additional biological studies should be performed to investigate the metabolism of the acetyl derivative of [¹⁸F]FDG. [ABSTRACT FROM AUTHOR]