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The presented method describes the use of the RCX-10 column for ananalysis of [18F]FDG. Applied conditions provided good chromatographic performance and elution of analytes of interest within 15 min. Described HPLC method fulfills both US Pharmacopoeia (USP) and European Pharmacopoeia (EP) requirements, and can be used for the routine analysis of [18F]FDG.

Introduction

[18F]FDG (2-[18F]fluoro-2-deoxy-D-glucose), represents the most clinically used radiotracer for positron emission tomography (PET). Its imaging properties rely on so-called Warburg effect of increased glucose uptake in tumor or inflamed tissue. [18F]FDG has found vast applications in the diagnosis, staging, and restaging of several clinical conditions, including lung cancer, colorectal cancer, lymphoma, melanoma, head and neck cancer, brain and breast cancer. In addition to its extensive use in oncology, [18F]FDG is also employed for metabolic studies in healthy tissue of the heart, lungs, and the brain.

Due to the short half-life (109.8 min) of the 18F radionuclide, radiotracers like for example [18F]FDG are preferably produced locally or only transported on a short distance. Increasing clinical demand for [18F]FDG, has led many hospitals to establish their own cyclotrons and facilities for synthesis of radiotracers. Quick and reliable on-site methods for quality control of [18F]FDG are also required. Before the release of the product for clinical use, each batch of [18F]FDG needs to be analyzed for its chemical and radiochemical purity, in accordance to Pharmacopeial regulations.

Compendial methods use High Performance Anion-Exchange Chromatography (HPAEC) with Pulsed Amperometric Detection (PAD) and a radioactivity detector for this purpose. Chromatographic runs are performed using isocratic conditions in combination with suitable anion exchange resin for the separation of the carbohydrates and impurities of interest. The strongly basic mobile phase used during analyses, leads weakly acidic sugars to form anions which are retained on the positively-charged resin (quaternary ammonium salt) in the column.

Author: Adam Tillo, Department of Medical Physics, Örebro University Hospital, Örebro, Sweden

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