Radiochemical purity of iodine-131 labelled metaiodobenzylguanidine infusion fluids: a report from clinical practice |
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Authors: | Amon R. Wafelman Rainer Suchi Cornelis A. Hoefnagel Jos H. Beijnen |
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Affiliation: | (1) Department of Pharmacy, Slotervaart Hospital, Louwesweg 6, NL-1066 EC Amsterdam, The Netherlands;(2) Department of Nuclear Medicine, Netherlands Cancer Institute, Amsterdam, The Netherlands;(3) Department of Pharmaceutical Quality Control, Amersham Buchler, Braunschweig, Germany |
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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 [1311]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 pre-administration quality control is not accepted in the Netherlands Cancer Institute.Correspondence to: A.R. Wafelman |
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Keywords: | Iodine-131 labelled iodide Iodine-131 labelled metaiodobenzylguanidine Infusion concentrates Radiochemical purity Therapy |
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