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Journal of Nuclear Medicine Technology

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Radiopharmacy

Pitfalls in the Standard Radiochemical Purity Testing for Technetium-99m-Exametazime

Joseph C. Hung, Mark E. Wilson and Edward B. Silberstein
Journal of Nuclear Medicine Technology December 1994, 22 (4) 229-231;
Joseph C. Hung
Nuclear Medicine, Department of Diagnostic Radiology, Mayo Clinic, Rochester, Minnesota; and University of Cincinnati Medical Center, Cincinnati, Ohio
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Mark E. Wilson
Nuclear Medicine, Department of Diagnostic Radiology, Mayo Clinic, Rochester, Minnesota; and University of Cincinnati Medical Center, Cincinnati, Ohio
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Edward B. Silberstein
Nuclear Medicine, Department of Diagnostic Radiology, Mayo Clinic, Rochester, Minnesota; and University of Cincinnati Medical Center, Cincinnati, Ohio
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Abstract

Objective: The purpose of this study was to examine discrepancies in the standard method for determining the radiochemical purity (RCP) of 99mTc-exametazime. The package insert for 99mTc-exametazime indicates that the entire RCP testing procedure requires approximately 15 min to complete, although the solvent-developing time for the three-paper chromatography system is described to be ≤100 sec. According to the package insert, all solvent-migrated radiochemical components moved up to relative front (Rf) 0.8–1.0; however, the suggested cut lines for three paper strips are all well below the stated Rf value.

Methods: Radiochromatogram and autoradiography techniques were used to determine and evaluate the radioactivity distribution of different radiochemical species on the strips. The times for solvent migration and the entire RCP testing procedure were measured.

Results: The mean times to run the three standard paper chromatography systems, namely, ITLC-SG/MEK, ITLC-SG/saline and Whatman/50% CH3CN strips were 130.4 ± 9.0 sec, 86.7 ± 9.4 sec and 123.1 ± 6.1 sec, respectively (n = 55). Although our solvent-developing time was longer than the suggested ≤100 sec, the entire RCP analysis procedure (i.e., sample spotting, solvent migration, radioactivity measurement and RCP calculation) can be completed within 5–7 min. Both ITLC-SG/MEK and Whatman/50% CH3CN systems showed significant streaking of radioactivity on the strips (i.e., 0.5–1.0 and 0.6–1.0, respectively) which does not agree with the recommended Rf 0.8–1.0.

Conclusion: The quality control information for 99mTc-exametazime should be modified in order to provide accurate information for the time required to perform the entire RCP procedure, the solvent-developing times for three strips and the Rf values for three chromatography systems.

  • technetium-99m-exametazime
  • radiochemical purity
  • quality control
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Journal of Nuclear Medicine Technology: 22 (4)
Journal of Nuclear Medicine Technology
Vol. 22, Issue 4
December 1, 1994
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Pitfalls in the Standard Radiochemical Purity Testing for Technetium-99m-Exametazime
Joseph C. Hung, Mark E. Wilson, Edward B. Silberstein
Journal of Nuclear Medicine Technology Dec 1994, 22 (4) 229-231;

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Pitfalls in the Standard Radiochemical Purity Testing for Technetium-99m-Exametazime
Joseph C. Hung, Mark E. Wilson, Edward B. Silberstein
Journal of Nuclear Medicine Technology Dec 1994, 22 (4) 229-231;
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Keywords

  • technetium-99m-exametazime
  • radiochemical purity
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