Validation of alternative methods of preparing 99mTc-MAG3.

Parameters in the preparation of 99mTc-mertiatide (99mTc-MAG3) were investigated to determine the importance of total activity, activity concentration, boiling time, and delay before boiling for the radiochemical purity (RCP) and stability of the product. Satisfactory RCP results (>90%) were obtained over a range of concentrations including a dilute preparation for paediatric use. RCP was not affected by the time between the addition of pertechnetate and boiling, but low RCP (<60%) resulted when the kit was boiled for less than 10 min.

Simplified method for determining the radiochemical purity of 99mTc-MAG3.

Unlabelled: 99mTc-Mercaptoacetyltriglycine is used for dynamic renal imaging, and the summary of product characteristics (SPC) for the European formulation specifies a shelf life of 1 or 4 h, depending on the reconstitution volume of the kit. To minimize the time required to test the radiochemical purity, a simplified quality control method was developed.

Methods: To satisfy the recommendations of the International Commission on Harmonisation, results obtained with the methods described in the European and American SPCs were compared with those obtained with the simplified method.