Quality Control of PET Radiopharmaceuticals

Abstract

PET radiopharmaceuticals are unique medicinal formulations administered to patients for diagnostic purposes in nuclear medicine. Quality control of these radiopharmaceuticals is important to assure the safety of the product before the release for clinical use. For this reason, efficient and quick tests have been adopted to check the quality of radiopharmaceutical preparations and specific procedures have been published in each country or regions such as found in the European Pharmacopoeia (EP), United States Pharmacopeia, and British Pharmacopoeia. In this chapter the parameters, the analytical techniques and the validation of analytical methods commonly employed in the quality control testing of PET radiopharmaceuticals are reported. Specific sections about the quality control of 18F, 11C, and 68Ga radiopharmaceuticals according to EP monographs are also provided as example for the routine testing of these preparations.