Radiopharmaceutical analysis - Glossary

Radiopharmaceutical analysis is a mandatory panel of release tests for radioactive medicinal products used in diagnostic imaging or therapy. These drugs emit radiation and decay rapidly, so every test must be completed quickly - before the drug expires and can no longer be administered. This process ensures that the product is safe and effective at the time of use.

Radiopharmaceutical analysis checks identity, potency, and purity

Identity: Confirms the product is the correct radioactive medicinal product.
Potency: Measures how much active substance is present in the sample.
Radiochemical purity: Verifies that the radioactive tag is correctly attached to the drug molecule.
Chemical purity: Checks for non-radioactive contaminants, including toxic solvents.
Radionuclidic purity: Identifies unwanted radioactive isotopes in the product.

Radiopharmaceutical analysis matters for patient safety and valid reports

Radiopharmaceutical analysis is the essential testing that confirms patient safety. If radiochemical purity is low, unbound radiation can travel to unintended organs, causing misleading scans or harmful radiation exposure. A valid report must show that the batch met all release criteria using validated, multi-method approaches such as radio-HPLC, rather than relying on a single testing method.

A serious warning sign is the misuse of this term for ordinary, non-radioactive 'research chemicals' or peptides. These products contain no radioactive isotopes, making radiopharmaceutical analysis technically impossible. Standard chemical purity and radiochemical purity are also distinct measures: a sample can be chemically pure yet still highly dangerous if the radioactive tag has detached.

Radiopharmaceutical analysis checks identity, potency, and purity

Radiopharmaceutical analysis matters for patient safety and valid reports

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