Specific activity determination and stability studies of therapeutic 131I-mIBG radiopharmaceutical |
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Authors: | V V Murhekar Anupam Mathur G Prabhakar Barakha P Karkhanis Neelam S Pilkhwal B K Tiwari D Padmanabhan Grace Samuel S S Sachdev |
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Institution: | 1. Radiopharmaceuticals Program, Board of Radiation and Isotope Technology (BRIT), Sec. 20, Vashi, Navi Mumbai, 400703, India
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Abstract: | 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. |
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