Fundamental concepts of radiopharmaceuticals quality controls

Abstract

Quality control (QC) procedures should always be performed following radiopharmaceutical preparation and prior to patient administration. The main aim of QC is to ensure optimal radiopharmaceutical product properties except for some short half-life tracers such as some positron emission tomography (PET) imaging probs. by dispensing a radiopharmaceutical of the highest quality the risk of having to repeat a nuclear medicine study due to poorly performing radiopharmaceuticals will be reduced. The existence of radiochemical impurity or impurities in radiopharmaceutical cause unnecessary radiation burden to the patient or undesirable high background without adding to the diagnostic information or improving treatment. Therefore, radiopharmaceuticals quality control is crucial and involves two different aspects including pharmaceutical parameters (such as sterility, bacterial endotoxins/ pyrogens, bioaffinity and biodistribution studies) and radioactive parameters (such as radionuclide and radiochemical purity) and chemical impurity which will be focused on here.

Keywords

• radiopharmaceutical
• quality control
• radiochemical
• radionuclide
• purity