Characterization and quality control analysis of 99mTc-bicisate

Chris Tsopelas, Douglas Smyth

Research output: Contribution to journalArticlepeer-review

7 Citations (Scopus)

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 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.

Original languageEnglish
Pages (from-to)89-93
Number of pages5
JournalJournal of Nuclear Medicine Technology
Volume33
Issue number2
Publication statusPublished or Issued - 1 Dec 2005
Externally publishedYes

Keywords

  • Cartridge
  • Quality control
  • Radiopharmaceutical
  • Tc-ECD
  • Tc-bicisate

ASJC Scopus subject areas

  • Radiological and Ultrasound Technology
  • Radiology Nuclear Medicine and imaging

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