Specific activity determination and stability studies of therapeutic 131I-mIBG radiopharmaceutical

Board of Radiation and Isotope Technology, India is a manufacturer and supplier of therapeutic doses of the 131I-meta-iodobenzylguanidine to various nuclear medicine centers in India. The therapeutic dosage of radiopharmaceutical involves a single variable dose of >3.7 GBq activity. Since the radiopharmaceutical produced is mainly by isotope exchange, which yields a low specific activity product, the determination of its accurate mass is a critical parameter for its safe administration in patients. In view of this, a suitable high performance liquid chromatography (HPLC) method has been developed for the determination of specific activity with high precision. Also, quantification of stability in terms of the % radiochemical purity of the formulation >370 MBq/mL supplied, under different storage conditions over time was carried out using the developed HPLC method. (author)