A reliable method for the quality control of 99mTc-MIBI prepared using fractionated cardiolite kits

Full text: The reconstitution of fractionated Cardiolite kits with Na[99mTc]TcO4 eluted from a wet-column generator results in a preparation that contains elevated amounts of a polar radiochemical impurity, which is normally present in only trace amounts when such kits are reconstituted with eluate from a dry-column generator. We demonstrate, using HPLC, that this impurity causes a positive bias in several reported quality control methods (TLC, ITLC and SPE) for 99mTc-MIBI, including that recommended by the manufacturer (TLC). A rapid procedure, based on a C18 solid phase extraction (SPE) cartridge, for measuring the radiochemical purity (RCP) of 99mTc-MIBI samples was developed and compared with three other methods including HPLC. Over a RCP range of 49-98%, the values obtained using our SPE method deviated from those obtained using HPLC by 1.1+1.395 (n=26). In conclusion our SPE method is a rapid and reliable means of quality controlling 99mTc-MIBI