Quality Control of Radiopharmaceuticals

Abstract

Since radiopharmaceuticals are intended for human administration, it is imperative that they undergo strict quality control measures. Basically, quality control involves several specific tests and measurements that ensure the purity, potency, product identity, biologic safety, and efficacy of radiopharmaceuticals. All quality control procedures that are applied to nonradioactive pharmaceuticals are equally applicable to radiopharmaceuticals; in addition, tests for radionuclidic and radiochemical purity have to be carried out. Often these quality control tests are carried out by the manufacturers from the beginning of production all the way up to the finished product. However, the introduction of kits, the increasing use of short-lived radionuclides such as ^99mTc and ^113mIn, and the on-site preparation of many radiopharmaceuticals require that most, if not all, quality control tests be performed prior to dispensing these agents for human administration.