What is the biological test that establishes a radiopharmaceutical's pyrogenicity?

The biological test that establishes the pyrogenicity of a radiopharmaceutical is known as apyrogenicity testing. Pyrogens are substances that can cause fever, and it is crucial for radiopharmaceuticals to be free from these agents to ensure patient safety. Apyrogenicity involves assessing whether the radiopharmaceutical elicits a pyrogenic response when administered, typically evaluated through testing methods such as the Limulus Amebocyte Lysate (LAL) test or the Rabbit Pyrogen Test.

These tests focus on identifying any substances present that may induce a fever response in humans, which is vital for regulatory compliance and patient health. Ensuring that a radiopharmaceutical is apyrogenic is an essential part of the development and quality control process for any medical imaging agent used in positron emission tomography (PET).