Rapid Quality Control of Technetium-99m-2-Methoxy Isobutyl Isonitrile (Technetium-99m-Sestamibi)

Journal of Nuclear Medicine Technology

Jerry I. Hirsch¹  Mark W. Watson¹ 

[1] Nuclear Medicine Division, Virginia Commonwealth University/Medical College of Virginia, Richmond, Virginia and DuPont Merck Pharmaceutical Co., North Billerica, Massachusetts Nuclear Medicine Division, Virginia Commonwealth University/Medical College of Virginia, Richmond, Virginia and DuPont Merck Pharmaceutical Co., North Billerica, Massachusetts Nuclear Medicine Division, Virginia Commonwealth University/Medical College of Virginia, Richmond, Virginia and DuPont Merck Pharmaceutical Co., North Billerica, Massachusetts

关键词: technetium-99m-sestamibi;    radiochemical purity;    quality control;   

DOI  :  

学科分类：医学（综合）

来源: Society of Nuclear Medicine

【 摘 要 】

Objective: Technetium-99m-sestamibi (99mTc-MIBI) is a radiopharmaceutical imaging agent useful for assessing myocardial perfusion. We present a simple, rapid and accurate SepPak® method to confirm the radiochemical purity of 99mTc-MIBI.Methods: Technetium-99m-MIBI preparations of high (>95%), intermediate (83–90%) and low (25–43%) radiochemical purity were evaluated by the recommended thinlayer chromatography (TLC) procedure. Radiochemical purities were simultaneously determined by Alumina-N and C-18 SepPak treatment using 95% ethanol and 0.9% sodium chloride injection, USP as eluents. Statistical analysis was used to determine concordance between TLC and corresponding SepPak values for the entire range of 99mTc-MIBI purity studied.Results: For all purity groups studied, a significant difference was found when 99mTc-MIBI radiochemical purity values by the C-18 SepPak method were compared to values obtained by the recommended TLC procedure. However, no statistical difference in 99mTc-MIBI radiochemical purity values were found when Alumina-N SepPaks, treated with sufficient eluent, were compared to values obtained by the recommended TLC procedure.Conclusion: This study demonstrates that an Alumina-N SepPak method can be routinely used as an alternative to the recommended TLC method for the radiochemical purity determination of 99mTc-MIBI.

【 授权许可】

Unknown