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Quality control of radiopharmaceuticals

  • Azuwuike Owunwanne
  • Mohan Patel
  • Samy Sadek

Abstract

In hospitals, most radiopharmaceuticals are prepared by reconstituting ready-to-use kits with appropriate radionuclide. This reconstitution procedure results in the formation of a ‘new’ chemical compound. Therefore quality control tests must be performed after the final step of the preparation of the radiopharmaceutical in addition to those required for nonradioactive drugs. The quality control tests associated with the ‘kits’ formulation and production of radionuclides from primary sources are performed by manufacturers, while those associated with the final step of the preparation of the radiopharmaceutical are performed in the radiopharmacy. Broadly, two classes of quality control tests are performed: biologic and physicochemical.

Keywords

Radiochemical Purity United States Pharmacopeia Solvent Front Quality Control Test Radionuclidic Impurity 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

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Copyright information

© Azuwuike Owunwanne, Mohan Patel and Samy Sadek 1995

Authors and Affiliations

  • Azuwuike Owunwanne
    • 1
  • Mohan Patel
    • 2
  • Samy Sadek
    • 3
  1. 1.Department of Nuclear Medicine, Faculty of MedicineKuwait UniversityKuwait
  2. 2.Kuwait Central Radiopharmacy Kuwait Cancer Control CenterMinistry of Public HealthKuwait
  3. 3.Department of Nuclear Medicine Faculty of MedicineKuwait UniversityKuwait

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