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Quality Control of Radiopharmaceuticals

  • Gopal B. Saha
Chapter

Abstract

Since radiopharmaceuticals are intended for administration to humans, 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 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 products for human administration.

Keywords

Methyl Ethyl Ketone Limulus Amebocyte Lysate Quality Control Test Dose Calibrator Radionuclidic Purity 
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.

References and Suggested Reading

  1. Avis KE, Leuchuk JW. Parenteral preparations. In: Avis KE, Lieberman HA, and Lachman L, eds. Remington: The Science and Practice of Pharmacy. 21st ed. Baltimore, MD: Lippincott, Williams and Wilkins; 2005.Google Scholar
  2. Bobinet DD, Williams GC, Cohen MB. Comparison of commercial pyrogen testing laboratories. Am J Hosp Pharm. 1976; 33:801.PubMedGoogle Scholar
  3. Dewanjee MK. The chemistry of 99mTc-labeled radiopharmaceuticals. Semin Nucl Med 1990; 20:5.PubMedCrossRefGoogle Scholar
  4. Eckelman WC, Levenson SM, Johnston GS. Radiochemical purity of 99mTc-radiopharmaceuticals. Appl Radiol. 1977; 6:211.Google Scholar
  5. Centre for Drug Evaluation and Research (CDER). 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
  6. Krogsgaard OW. Radiochemical purity of various 99mTc-labelled bone-scanning agents. Eur J Nucl Med. 1976; 1:15.PubMedGoogle Scholar
  7. Pauwels EKJ, Feitsma RIJ. Radiochemical quality control of 99mTc-labeled radiopharmaceuticals. Eur J Nucl Med. 1977; 2:97.PubMedCrossRefGoogle Scholar
  8. Meyer GJ, Coenen HH, Waters SL, et al. Quality assurance and quality control of short-lived radioharmaceuticals for PET. In: Stöcklin G, Pike VW, eds. Radiopharmaceuticals for Positron Emission Tomography: Methodical Aspects. Dordrecht, Netherlands: Kluwer; 1993: 91.CrossRefGoogle Scholar
  9. Robbins PJ. Chromatography of technetium 99mTc-radiopharmaceuticals – a practical guide. New York: Society of Nuclear Medicine; 1984.Google Scholar
  10. United States Pharmacopeial Convention. U.S. Pharmacopeia 32 & National Formulary 27. Rockville, MD: The United States Pharmacopeial Convention; 2009.Google Scholar

Copyright information

© Springer Science+Business Media, LLC 2010

Authors and Affiliations

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

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