What is the maximum allowable limit of Al 3+ in Tc-99m eluate set by?

The maximum allowable limit of Al 3+ in Tc-99m eluate is set by the US Pharmacopeia (USP). The USP establishes standards for the identity, strength, quality, and purity of medicines, including radiopharmaceuticals, ensuring that these products are safe and effective for patient use. Specifically, the USP outlines acceptable levels of metal contaminants in pharmaceuticals, including aluminum ions, which can be harmful if present in excessive amounts.

For Tc-99m, the standards defined by the USP guide manufacturers to ensure that their preparations meet the required safety and quality criteria before being used in clinical settings. This regulatory oversight is vital in maintaining the integrity of radiopharmaceuticals and optimizing patient care.

In contrast, the World Health Organization, National Institutes of Health, and Food and Drug Administration, while involved in various aspects of health and medication safety, do not specifically set the limits for aluminum content in radiopharmaceuticals like Tc-99m; those standards are strictly governed by the US Pharmacopeia.