Validation of the analytical method of chemical purity of 18f radiopharmaceutical fludesoxyglucose (fdg) via thin layer chromatography

For the release of the 18F-Fludesoxyglucose radiopharmaceutical in humans, one of the tests required in its official monograph present in the American pharmacopeia is the determination of the chemical purity. This test consists of a process of quantification of the analyte Kryptofix 2.2.2, using the realization of a limiting assay, developed in thin layer chromatography. To prove the reliability of the results obtained, the centers producing radiopharmaceuticals should promote the validation of the analytical methods used in quality control by the relevant legislation in the country. Thus, the analytical validation developed in the present work had the objective of verifying the behavior of the analytical method about the parameters: specificity, limit of detection and robustness, based on the criteria established in Anvisa RE 899/2003. Specificity verification assays have demonstrated the ability of the method of detecting the analyte of interest even in the presence of the significant impurities reported for the radiopharmaceutical. For the limit of detection, it is estimated that minimum mass, capable of generating the expected analytical response is equal to 0.03 μg. Finally, the results obtained for the robustness test allow us to state that the method can withstand the modifications proposed for certain stages of the analysis; concluding, therefore, that the technique is duly validated according to the established criteria of RE 899/2003 ANVISA.