title: Quality control of iodine-131-labeled metaiodobenzylguanidine.
abstract: OBJECTIVE
  Iodine-131-m-iodobenzylguanidine ([(131)I]mIBG) is used worldwide for the diagnosis and therapy of neuroendocrine tumors, particularly adrenal medullae tumors. After the synthesis and preparation of a radioiodinated MIBG drug formulation, quality control testing to determine its radiochemical purity (RCP) should be performed. European Pharmacopoeia 8.0 requires that the quality control include a test for RCP for the determination of [(131)I]mIBG. Previously reported procedures using reversed-phase conditions require long retention times. Our system enables the separation of [(131)I]mIBG within a few minutes. The aim of this work was to carry out RCP testing for [(131)I]mIBG without any type of sample pretreatment.
  
  
  METHODS
  RCP testing for ([(131)I]mIBG has been carried out using high-performance liquid chromatography and thin-layer chromatography methods.
  
  
  RESULTS
  A simple and rapid reversed-phase isocratic system enables the HPLC investigation of RCP testing for [(131)I]mIBG used for therapy within a few minutes.
  
  
  CONCLUSIONS
  From the point of view of radiation protection, this method is safer, especially for therapeutic amounts of [(131)I]mIBG.
authors.affiliation: aDepartment of Radioactive Waste, Cekmece Nuclear Research and Training Center bMinister of Justice, Council of Forensic Medicine, Istanbul, Turkey.
authors.forename: Betül
authors.initials: B
authors.lastname: Taşdelen
authors.forename: Erol
authors.initials: E
authors.lastname: Kam
authors.forename: Hızır
authors.initials: H
authors.lastname: Asliyuksek
mesh_terms: D019797:3-Iodobenzylguanidine / Q000032:analysis* / Q000302:isolation & purification / Q000627:therapeutic use; D002851:Chromatography, High Pressure Liquid; D011786:Quality Control; D011835:Radiation Protection; D019275:Radiopharmaceuticals / Q000032:analysis* / Q000302:isolation & purification / Q000627:therapeutic use
chemical_list: D019275:Radiopharmaceuticals; D019797:3-Iodobenzylguanidine