title: Characterization and quality control analysis of 99mTc-bicisate.
abstract: The aim of this study was to investigate the mini cartridge versus paper chromatography quality control methods for determining the radiochemical purity (RCP) of (99m)Tc-bicisate. The 4 methods that were compared with the manufacturer's method included Whatman 17 paper/ethyl acetate solvent, instant thin-layer chromatography (ITLC) silica gel paper/saline solvent, reverse-phase C18 mini cartridge/saline solvent, and strong anion exchange mini cartridge/water solvent. At 30 min after reconstitution, (99m)Tc-bicisate was formed at 97%-98% RCP as assayed by the paper and cartridge methods, and the strong anion exchange/water for injection (WFI) system slightly underestimated the percentage at 96%. A significantly lower RCP was obtained for the C18/saline method when a faster flow rate was used. The lipophilic complex moved with ethyl acetate on Whatman 17, was separated from origin impurities on ITLC silica gel/saline, and remained on the column with C18/saline. For strong anion exchange/WFI, components in the radioactive formulation are likely to have influenced the percentage of (99m)Tc-bicisate. The time disadvantage for ITLC silica gel/saline analysis made the method less than ideal. The C18 mini cartridge/saline method was found to be the simplest and fastest; a result was obtained in 2 min with use of a safe solvent of elution.
authors.affiliation: RAH Radiopharmacy, Nuclear Medicine Department, Royal Adelaide Hospital, North Terrace, Adelaide, Australia. ctsopela@mail.rah.sa.gov.au
authors.forename: Chris
authors.initials: C
authors.lastname: Tsopelas
authors.forename: Douglas
authors.initials: D
authors.lastname: Smyth
mesh_terms: D002845:Chromatography / Q000379:methods*; D003545:Cysteine / Q000031:analogs & derivatives* / Q000032:analysis / Q000592:standards; D015609:Organotechnetium Compounds / Q000032:analysis* / Q000592:standards; D011785:Quality Assurance, Health Care / Q000379:methods*; D011786:Quality Control; D019275:Radiopharmaceuticals / Q000032:analysis / Q000592:standards
chemical_list: D015609:Organotechnetium Compounds; D019275:Radiopharmaceuticals; C059659:technetium Tc 99m bicisate; D003545:Cysteine