Quality Control of Radiopharmaceuticals
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 on all in-house preparations before dispensing these agents for human administration.
KeywordsRadiochemical Purity Methyl Ethyl Ketone Limulus Amebocyte Lysate Quality Control Test Dose Calibrator
Unable to display preview. Download preview PDF.
- Avis KE. Parenteral preparations. In: Remington’s Pharmaceutical Sciences. 16th ed. Easton, PA: Mack; 1980:1463.Google Scholar
- Eckelman WC, Levenson SM, Johnston GS. Radiochemical purity of 99mTc-radiopharmaceuticals. Appl Radiol. 1977; 6:211.Google Scholar
- Guideline on validation of the Limulus Amebocyte Lysate test as an end-product endotoxin test for human and animal parenteral drugs, biological products, and medical devices. Rockville, MD; U.S. FDA; 1987.Google Scholar
- Robbins PJ. Chromatography of technetium 99mTc-radiopharmaceuticals—a practical guide. New York: Society of Nuclear Medicine; 1984.Google Scholar
- Tubis M. Quality control of radiopharmaceuticals. In: Rocha AFG, Harbert JC, eds. Textbook of Nuclear Medicine: Basic Science. Philadelphia: Lea & Febiger; 1978:234.Google Scholar
- U.S. Pharmacopeia XXVIII United States Pharmacopeial Convention, Rockville, MD: 1996.Google Scholar