Characterization and quality control analysis of 99mTc-bicisate

J Nucl Med Technol. 2005 Jun;33(2):89-93.

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.

Publication types

  • Evaluation Study

MeSH terms

  • Chromatography / methods*
  • Cysteine / analogs & derivatives*
  • Cysteine / analysis
  • Cysteine / standards
  • Organotechnetium Compounds / analysis*
  • Organotechnetium Compounds / standards
  • Quality Assurance, Health Care / methods*
  • Quality Control
  • Radiopharmaceuticals / analysis
  • Radiopharmaceuticals / standards

Substances

  • Organotechnetium Compounds
  • Radiopharmaceuticals
  • technetium Tc 99m bicisate
  • Cysteine