Fission 99Mo/99mTc Generators--a study of their quality

Area of Science:

• Nuclear Medicine
• Radiopharmacy
• Analytical Chemistry

Background:

• The widespread use of 99mTc necessitates stringent quality control of its primary generator systems.
• Fission-produced molybdenum-99 (99Mo) is the parent radionuclide in the most common 99mTc generators.
• Ensuring the purity and performance of these generators is critical for safe and effective diagnostic imaging.

Purpose of the Study:

• To assess the quality of seven commercially available 99Mo/99mTc generators in Germany.
• To evaluate the radionuclidic and radiochemical purity of 99mTc eluates.
• To determine the 99Mo breakthrough, elution efficiency, pH, and aluminum content of the eluates, alongside generator usability.

Main Methods:

• Analysis of 99mTc eluates using gamma spectrometry and thin-layer chromatography.
• Measurement of 99Mo content in the aluminum oxide column.
• Quantification of aluminum in eluates via atomic absorption spectrometry.
• Assessment of elution yield, pH, and practical application of generator accessories.

Main Results:

• All 99mTc eluates exhibited high radionuclidic purity (except one) and excellent radiochemical purity.
• 99Mo breakthrough was not significant, and elution yields ranged from 85% to 122%.
• Eluates consistently met specifications with pH values between 5.0-6.5 and aluminum content below 1 µg/mL.

Conclusions:

• The tested 99Mo/99mTc generators generally performed well, providing a reliable source of 99mTc-pertechnetate.
• The quality control results indicate that these generators are suitable for medical applications, with safe and satisfactory performance.
• Minor exceptions in purity and application did not compromise the overall reliability of the generators.