Quality-based design and stability assessment of sodium 18F-fluoride radiopharmaceutical for PET imaging

This study presents the results of the stability assessment conducted on three production batches of sodium 18F-fluoride radiopharmaceutical intended for intravenous injection. The objective was to evaluate the physicochemical and microbiological stability, establish an appropriate shelf life, and confirm the overall quality of this radiopharmaceutical over a defined period under controlled storage conditions. The stability study was designed to assess the quality of in-house produced sodium 18F-fluoride radiopharmaceutical, with quality control tests performed at two-hour intervals. All pre-release and post-release tests established in the [18F]NaF specification were examined, including appearance, identification, pH, chemical, radiochemical, radionuclide purity, bacterial endotoxins, and sterility. The results of pH, chemical, radiochemical, and radionuclide purity met the acceptance criteria for all tested points across the three batches, demonstrating the physicochemical stability of the preparation. Microbiological stability was also proved through compliance with bacterial endotoxins and sterility requirements. Overall, the obtained results confirmed that sodium 18F-fluoride is stable for up to 10 hours after the end of synthesis, ensuring its suitability for clinical use.