Abstract
Fludeoxyglucose F 18 ([18F]FDG) is the most used radiopharmaceutical for positron emission tomography, especially on oncology. Organic solvents such as ether, ethanol and acetonitrile might be used in the synthesis of [18F]FDG; however, they might not be completely removed during purification steps. The determination of residual solvents in [18F]FDG is required in the European Pharmacopoeia (EP) and the United States Pharmacopeia (USP) monographs. While the procedure described in the EP is quite general, the one described in the USP requires a long runtime (about 13 minutes). In this work a simple and fast (4-minute) analytical procedure was developed and validated for determination of residual solvents in [18F]FDG. Analyses were carried out by gas chromatography – flame ionization detector (GC-FID). The separation was obtained on a 0.53-mm x 30 m fused-silica column. Validation included the evaluation of various parameters, such as: specificity, linearity and range, limits of detection and quantitation, precision (repeatability and intermediate precision), accuracy, and robustness. Results were found to be within acceptable limits, indicating the developed procedure is suitable for its intended application. Considering the short half-life of fluorine-18 (109.7 minutes), this new method could be a valuable alternative for routine quality control of [18F]FDG.
Highlights
Positron emission tomography (PET) is an important medical imaging technique that uses compounds labeled with positron-emitting radioisotopes as molecular probes to image and measure biological processes at the molecular or cellular level in vivo
Fludeoxyglucose F 18 ([18F]FDG) is the most commercially successful and widely employed tracer used for PET, especially on oncology [1,2]. [18F]FDG is a glucose analogue in which the hydroxyl group on the 2–carbon of a glucose molecule was replaced by a fluoride atom
After purification steps [18F]FDG is obtained as an injectable aqueous preparation [3]. Organic solvents such as ether, ethanol and acetonitrile might be used in the synthesis of [18F]FDG; they might not be completely removed during purification steps
Summary
Positron emission tomography (PET) is an important medical imaging technique that uses compounds labeled with positron-emitting radioisotopes as molecular probes to image and measure biological processes at the molecular or cellular level in vivo. After purification steps [18F]FDG is obtained as an injectable aqueous preparation [3] Organic solvents such as ether, ethanol and acetonitrile might be used in the synthesis of [18F]FDG; they might not be completely removed during purification steps. The amount of residual solvents in the final product has to be determined through quality control, since the permitted levels of some organic solvents are strictly limited [4]. The determination of residual solvents is required in [18F]FDG monographs of both pharmacopeias. The procedure described in the EP is quite general while the one described in the USP requires a long runtime, which takes about 13 minutes. The aim of this work was to validate a new and fast gas chromatographic procedure for analysis of residual solvents in [18F]FDG. Validation included the evaluation of the specificity, linearity and range, limits of detection (LOD) and quantitation (LOQ), precision (repeatability and intermediate precision), accuracy and robustness of the procedure in accordance with international guidelines
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