TY - JOUR T1 - Characterization and Quality Control Analysis of <sup>99m</sup>Tc-Bicisate JF - Journal of Nuclear Medicine Technology JO - J. Nucl. Med. Technol. SP - 89 LP - 93 VL - 33 IS - 2 AU - Chris Tsopelas AU - Douglas Smyth Y1 - 2005/06/01 UR - http://tech.snmjournals.org/content/33/2/89.abstract N2 - The aim of this study was to investigate the mini cartridge versus paper chromatography quality control methods for determining the radiochemical purity (RCP) of 99mTc-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, 99mTc-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 99mTc-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. ER -