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CC BY-NC-ND 4.0 · World J Nucl Med 2022; 21(04): 314-319
DOI: 10.1055/s-0042-1757381
Original Article

Evaluation of Tetrofosmin Cold Kit Fractionation Using Alternative New Method of Quality Control for Testing Radiochemical Purity

Autor*innen

  • Nisha Bhatia

    1   Department of Nuclear Medicine, Cancer Research Institute, Swami Rama Himalayan University, Dehradun, Uttarakhand, India
    2   Centre of Nuclear Medicine, Panjab University, Chandigarh, India

  • Rakhee Vatsa

    3   Department of Nuclear Medicine, Advanced Centre for Treatment Research and Education in Cancer (ACTREC), Tata Memorial Centre, Kharghar Navi Mumbai, Maharashtra, India

  • Vandana K. Dhingra

    4   Department of Nuclear Medicine, All India Institute of Medical Sciences, Rishikesh, Uttarakhand, India

  • Devinder Kumar Dhawan

    5   Department of Biophysics, Panjab University, Chandigarh, India

  • Vijayta Dani Chadha

    2   Centre of Nuclear Medicine, Panjab University, Chandigarh, India

Funding None.
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Abstract

Objective The aim of this study is to establish a method for the fractionation of tetrofosmin cold kit under different storage conditions and to optimize an alternate chromatography method from the reference method to test radiochemical purity (RCP).

Materials and Methods Tetrofosmin cold kit vial was fractionated aseptically in six equal fractions and stored in vials and syringes. To test the stability of the reconstituted solution for a longer duration, the mother vials and syringes were stored at two different temperatures, that is, at 4°C and at −20°C till further used. Radiolabeling of fractionated tetrofosmin was performed as per the standard labeling protocol. Radionuclide purity, radioassay, and pH were tested. Radiolabeling efficiency and RCP were determined by paper chromatography.

Results Radionuclide purity of eluate was greater than 99.9%. The pH of technetium-99m (Tc-99m) eluate and Tc-99m tetrofosmin was between 4.5–7.5 and 7.5–9.5, respectively. The deviation in the radioactivity during all measurements was less than 1%. The kits fractioned in glass vials resulted in higher radiolabeling yield and RCP as compared with kits fractionated in syringes. The RCP of glass vial versus syringe was observed to be greater than 95 versus 90% and 95 versus 80% at −20°C and 4°C, respectively.

Conclusion Tetrofosmin kit can be used in a cost-effective manner by fractionation. One tetrofosmin vial can be used in six fractions for up to 15 days when stored at −20°C and 4°C freezer temperature. The alternative method to check the RCP of Tc-99m tetrofosmin is safer and less time consuming as compared with the reference method.

Keywords

fractionation - radiochemical purity - radionuclide purity - Tc-99m tetrofosmin

Registration Number

Institutional Ethics committee (Ref No HIMS/RC/2015/1056, dated 27/07/2015).




Publikationsverlauf

Artikel online veröffentlicht:
14. September 2022

© 2022. World Association of Radiopharmaceutical and Molecular Therapy (WARMTH). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/)

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