Speaker
Summary
This work presents the validation of a simplified method to detect aminopolyether (RCA) in ¹⁸F-FDG samples as part of radiopharmaceutical quality control. The method uses a colorimetric assay with silica gel TLC plates and iodine chamber visualization instead of aluminum oxide plates, which are difficult to obtain in Costa Rica. The procedure was optimized to detect RCA at the pharmacopeial limit of 50 μg/mL, and validation included specificity, detection limit (0.006 mg/mL), and robustness (triplicate testing).
Results demonstrate that the method is selective, sensitive, and reproducible, providing a cost-effective and practical alternative for Latin American radiopharmaceutical laboratories, reducing reliance on imported supplies and optimizing analytical processes in ¹⁸F-FDG quality control.
Keywords: Quality control, aminopolyether, TLC, validation.