Standardization of quality control methods for 99mTc radiopharmaceuticals

Physico-chemical characterization of 99mTc-radiopharmaceuticals is presented. Limiting pH values, iso-osmotic pressure and the apparent coefficient values between two immiscible phases are determined. A selection of radiochromatographic methods (stationary or mobile phase) for routine quality control of 99mTc radiopharmaceuticals for radiochemical purity was made. The methods chosen are simple, accurate, sufficiently sensitive and fast in operation. The mean values were determined for 99mTc radiopharmaceutical distribution per organs, characteristic for the tested preparates and for radiochemical purity. (author)