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Preparation and Evaluation of 99mTc-labeled Tridentate Chelates for Pre-targeting Using Bioorthogonal Chemistry

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A rapid radiochemical purity testing method for 99mTc-tetrofosmin.

Laura A Eggert¹, Michael D Dick, Douglas W Mahoney

¹Division of Nuclear Medicine, Department of Radiology, Mayo Clinic, Rochester, Minnesota 55905-0001, USA.

Journal of Nuclear Medicine Technology

|May 21, 2010

Summary

This summary is machine-generated.

A new, faster radiochemical purity (RCP) testing method for technetium-99m-tetrofosmin (99mTc-tetrofosmin) has been developed. This alternative method is accurate, easier to perform, and uses readily available materials, offering a superior alternative to the current standard procedure.

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Area of Science:

Nuclear Medicine
Radiopharmaceutical Quality Control

Background:

The standard radiochemical purity (RCP) testing for 99mTc-tetrofosmin is time-consuming (20-30 min) and requires significant expertise.
The silica gel strips used in the standard method will soon be unavailable, necessitating an alternative.

Purpose of the Study:

To evaluate a laboratory-developed method for RCP testing of 99mTc-sestamibi as a potential alternative for 99mTc-tetrofosmin.
To establish a more efficient and accessible RCP assay for 99mTc-tetrofosmin.

Main Methods:

An alternative RCP testing system using precut paper strips as the stationary phase and a chloroform:tetrahydrofuran mobile phase was employed.
Radiochemical purity values from 17 kit preparations, including intentionally low-purity samples, were compared between the standard and alternative methods.

Main Results:

The alternative method demonstrated high overall agreement (94%) with the standard method.
It showed 86% sensitivity for detecting unacceptable RCP levels and 98% specificity for acceptable levels.
Replicated trials showed excellent agreement for the alternative method (99%) compared to the standard method (92%).

Conclusions:

The alternative method is significantly faster, easier to perform, and less dependent on operator technique than the standard method.
It utilizes readily available, moisture-insensitive materials, making it more practical for routine use.
This validated alternative method provides accurate RCP determination for 99mTc-tetrofosmin and is also suitable for 99mTc-sestamibi.