Which radionuclidic impurity must be monitored for every Tc99m eluate according to regulation?

The radionuclidic impurity that must be monitored for every Tc-99m eluate is molybdenum-99 (Mo-99). This is essential because Mo-99 is the parent isotope of Tc-99m, and it can be present in the final Tc-99m preparation due to incomplete separation during the elution process. The presence of Mo-99 is a concern because it has a longer half-life compared to Tc-99m and can contribute to unwanted radiation exposure and adverse effects for patients if not adequately controlled.

Regulations require that dosage forms of Tc-99m exhibit minimal levels of Mo-99 to ensure safety and efficacy in nuclear medicine procedures. Monitoring the levels of Mo-99 in every Tc-99m eluate confirms compliance with safety standards, particularly regarding patient safety and the effective use of radiopharmaceuticals in diagnostic imaging. Ensuring that Mo-99 levels are within regulatory limits is crucial for maintaining the integrity of nuclear medicine practices.