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UNIVERSITY OF BUCHAREST
FACULTY OF PHYSICS Guest
2024-11-22 1:46 |
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Conference: Bucharest University Faculty of Physics 2011 Meeting
Section: Nuclear and Elementary Particles Physics
Title:
Studies of the radionuclidic purity as an essential parameter in quality control of radiopharmaceuticals
Authors:
Beatris Neacsu, Aurelian Luca, Catalina Cimpeanu, Catalina Barna, Maria Sahagia
Affiliation:
Horia Hulubei National Institute for Physics and Nuclear Engineering (IFIN-HH)
E-mail
*) Corresponding author: beatris.neacsu@nipne.ro
Keywords:
(HPGe) gamma spectrometry system, detection efficiency, metrology, radionuclidic analysis, radiopharmaceuticals, radionuclidic purity.
Abstract:
In the production, deployment and use of the radiopharmaceutical products one essential parameter that needs to be controlled, studied and measured is the radionuclidic purity. There are specific requirements that need to be met in order to assure and comply with the current regulations quality and safety, according to the European Pharmacopoeia. The Laboratory for Testing and Certification of Compliance of Radiopharmaceuticals, Radiochemicals and Radioactive Sources (CPRLAB), accredited by the national body, RENAR, member of the European Accreditation (EA), in accordance with the prescriptions of the Standard SR EN ISO/IEC 17025: 2005 “General requirements for the competence of testing and calibration laboratories” assesses and certifies the compliance of radiopharmaceuticals, radiochemicals and radioactive sources, by appropriate nuclear testing methods. In this work, aspects regarding radionuclidic purity determinations for sodium iodide (131I) capsules for diagnostic use, sodium iodide (131I) solution and sodium pertechnectate (99mTc)) will be discussed . Specific methods will be presented for the sample measurements and evaluation with the high purity germanium detector (HPGe) gamma spectrometry system.
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