Radiochemical purity of iodine-131 labelled metaiodobenzylguanidine infusion fluids: a report from clinical practice |
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Authors: | AR Wafelman R Suchi CA Hoefnagel JH Beijnen |
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Affiliation: | Department of Pharmacy, Slotervaart Hospital, Amsterdam, The Netherlands. |
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Abstract: | Iodine-131 labelled metaiodobenzylguanidine (131I]MIBG) has a diagnostic and therapeutic role in the management of neural crest tumours, particularly neuroblastoma, malignant phaeochromocytoma and paraganglioma. With therapeutic amounts of 131I]MIBG it is essential that the amount of free 131I]iodide, the most important impurity, is known. In clinical practice the percentage of free 131I]iodide seen in a 131I]MIBG infusion concentrate increased from 2.2% +/- 0.67% to 3.6% +/- 0.39% (mean +/- SD; n = 23) 1 day after production. At the time of use the percentage of free 131I]iodide was always below our upper limit of acceptance of 5%. Since 5% of free 131I]iodide is within practical reach in our environment, a higher percentage at the time of preadministration quality control is not accepted in the Netherlands Cancer Institute. |
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