Iranian Heart Journal

Iranian Heart Journal

Optimizing the Assessment of [99mTc]-SestaMIBI Radiochemical Purity: A Study on Stability in Syringe Storage

Document Type : Original Article

Authors
Haleh Hashemizadeh 1
Leila Hassanzadeh 2
Homa Azizian 1
Reza Paydar 3
Davoud Ahmadvand 4
1 Department of Medicinal Chemistry, School of Pharmacy, Iran University of Medical Sciences, Tehran, IR Iran.
2 Department of Nuclear Medicine, School of Medicine, Rajaie Cardiovascular, Medical & Research Center, Iran University of Medical Sciences, Tehran, IR Iran.
3 Radiation Science Department, Faculty of Allied Medicine, Iran University of Medical Sciences, Tehran, IR Iran.
4 Department of Molecular Imaging, School of Advanced Technologies in Medicine, Iran University of Medical Sciences, Tehran, IR Iran.
Abstract
Background: [99mTc]-SestaMIBI ([99mTc]Tc-MIBI), approved by the FDA in 1990, has become widely used for cardiac perfusion imaging. It is crucial to ensure this radiopharmaceutical’s radiochemical purity (RCP), as it directly impacts the accuracy of patient diagnoses. The FDA has established standards mandating the verification of RCP before administering the tracer to patients. Maintaining consistent and reliable assessments within nuclear medicine departments remains a persistent challenge despite its importance.
Methods: In this research, we initially focused on evaluating various methods for determining RCP using thin layer chromatography (TLC) with different stationary and mobile phases, as well as column cartridges (Sep-Pak_C18). We optimized the method and compared its efficacy against the standard technique. Subsequently, we assessed the stability of the radiopharmaceutical under 2 distinct storage conditions: syringes and vials.
Results: Our investigation of aluminum oxide (Al2O3), silica gel (SG), and Whatman paper TLCs yielded the most favorable results when ethanol, methyl ethyl ketone, and ethyl acetate were employed as solvents, respectively. For the Sep-Pak_C18 method, saline and ethanol solvents proved the most effective. Notably, RCP exceeded 90% up to 6 hours following radiopharmaceutical preparation, which aligns with pharmacopeial standards. These findings were consistent for both syringe and vial storage conditions.
Conclusions: In this research, we successfully developed and validated 3 unique methods for determining the RCP of [99mTc]Tc-MIBI. Among these, the Whatman FN1 method utilizing Ethyl Acetate as the solvent demonstrated the most promising results, offering a combination of speed, robustness, reproducibility, and cost-efficiency that renders it suitable for routine use in clinical settings. Furthermore, our findings indicate that provided no other quality control concerns are present, the radiopharmaceutical kit remains stable in terms of RCP, making it a viable option for patient injections. (Iranian Heart Journal 2025; 26(1): 67-80)
Keywords
Radiochemical purity
Quality control
[99mTc]Tc-SestaMIBI
Thin layer chromatography
Sep-Pak_C18
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Iranian Heart Journal
Volume 26, Issue 1
Winter 2025
Pages 67-80