Statistical evaluation of the quality control results of Tc-99m(Sn)-DPD
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The results of the quality control of Tc-99m-DPD produced during five consequtive years are statistically evaluated. Radiochemical purity of the kit determined in 75 batches was 98.3+/-1.3%. TLC on silica gel with the mixture of acetone and methanole (1:1, v/v) was used to determine the content of free pertechnetate. The labeled complex and Tc-99m-hydrolyzate was separated by using ascending paper (Schleicher and Schull) chromatography and 1N NaCl as the mobile phase. Reliable results were obtained showing that the content of the impurities Tc-99m-pertechnetate and Tc-99m-hydrolyzate is 1.7+/-1.3% and 3.4+/-2.1%, respectively. The biodistribution depends on the quantity of DPD. For the animal experiments its content should be 70-80 mu g/kg b.w. The experiments revealed that the mean value of bone distribution was 8.8+/-1.9%/g and in muscles 0.043+/-0.042%/g. The uptake in liver and kidneys was below 3%, i.e., 0.65+/-0.29 and 1.71+/-0.68%/organ, respectively. The bone/muscle ratio shoul...d be at least 160. The analysis shows that the obtained values are arranged around their, statistically allowed, mean values.