EC kit production and quality control

This study describes a method developed at Radioisotopes Division laboratories, for preparation of L,L,Ethylenedicysteine kit for technetium-99m labeling. This kit is used in renography for renal tubular function studies. EC kit is prepared in two vials one contains kit ingredients and reducing agents while the other contains buffer solution to keep pH value of labeled kit about 8.5. This study also describes quality control procedures, and a summary of their results like physical properties and biological purity (sterility and pyrogenity), in addition to radiochemical purity, biodistribution, stability and the maximum activity can be used in kit labeling. This kit showed unique properties superior to that of similar kits like MAG3 and iodohupporane where it is cleared quickly with low retention in kidneys. (author)