Quality Control of Radiopharmaceuticals

  • Gopal B. Saha


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.


Radiochemical Purity Methyl Ethyl Ketone Limulus Amebocyte Lysate Quality Control Test Dose Calibrator 
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Copyright information

© Springer Science+Business Media New York 1998

Authors and Affiliations

  • Gopal B. Saha
    • 1
  1. 1.Department of Nuclear MedicineThe Cleveland Clinic FoundationClevelandUSA

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