Quality-based design and stability assessment of sodium [18F]fluoride radiopharmaceutical forpet imaging

This study presents the results of a 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, with quality control tests performed at two-hour intervals. All pre-release and post-release tests outlined in the sodium[18F]fluoride specification were conducted, including appearance, identification, pH, chemical, radiochemical, radionuclidic purity, bacterial endotoxins, and sterility. The results of pH, chemical, radiochemical, and radionuclidicpurity tests met acceptance criteria at all tested time points across the three batches, demonstrating physicochemical stability. Microbiological stability was confirmed through compliance with bacterial endotoxin and sterility requirements. Overall, the findings confirm that sodium [18F]fluoride remains stable for up to 10 hours after the end of synthesis, ensuring its suitability for clinical use