Quality control and stability study of the [131I]I-rutin produced in acidic condition

Quality control of Radiopharmaceutical or labeled compound is performed to ensure the optimal quality of radiopharmaceutical or labeled compound. The existence of chemical/radiochemical impurities cause false diagnosis or inefficient therapy due to unnecessary radiation or undesirable high background. The quality control of labeled compound involves two different aspects including pharmaceutical and radioactive parameters. The objective of this study is to test the radiochemical stability of [131I]I-Rutin produced under acidic conditions under different storage conditions as evidenced by the quality of its radiochemical purity. The radiochemical purity of 131I-Rutin carried out by thin-layer chromatography method (TLC-SG F254 as stationary phase and methanol as mobile phase). This study investigated the quality of routine in time under the influence of environmental factors. The results showed that [131I]I-Rutin was stable for up to 4 hours at 37° C with radiochemical purity of [131I]I-Rutin 93.90% ± 2.57%.