Quality Control Procedures for Newer Radiopharmaceutical&

Because radiopharmaceuticals are intended for human administration, quality control procedures are essential in ensuring the safety of these preparations. Although extensive quality control procedures are performed by the manufacturer, many radiopharmaceutical preparations are prepared in nuclear medicine departments using kits and short-lived radionuclides including technetium-99m CmTc) and indiumIll e 11 ln). As a result, the ultimate responsibility for quality assurance of radiopharmaceuticals lies with the nuclear medicine department, usually with the radiopharmacist or the nuclear medicine technologist responsible for the nuclear pharmacy. Radiopharmaceuticals, whether commercial or in-house preparations, must be subjected to physicochemical and biological testing. Physicochemical testing includes the examination and determination of the physical state, osmolality, pH, chemical purity, radionuclidic purity, and radiochemical purity of the radiopharmaceutical. Biological testing of radiopharmaceutical preparations includes sterility and pyrogenicily testing. Radiochemical purity is defined as the proportion of the total radioactivity that is present in the specified chemical form. Numerous methodologies can be employed to assess the radiochemical purity of radiopharmaceuticals including thin layer chromatography, paper chromatography, gel permeation chromatography, high performance liquid chromatography (HPLC), and gel electrophoresis. Since time is critical in a nuclear medicine department, radiochemical quality control procedures must be rapid and relatively easy, in order to gain the maximum amount of information in the minimum amount of time. Thus, this review is written with an emphasis on rapid radiochemical quality control procedures for newer radiopharmaceuticals. The quality control procedures outlined in the text are fairly easy to use and have proved reliable in clinical nuclear medicine.