Abstract

LNMRI has sought to develop a methodology for the identification and accurate detection of impurities emitting gamma radiation at the metrological level, aiming to meet the recommendations not only of the international pharmacopoeia, but also of CNEN and ANVISA regarding quality control that can ensure patients That the doses received by the practices are as low as practicable. As an initial goal, it was possible to obtain an efficiency curve with uncertainty around 1% necessary to start future measurements of interest applied to nuclear medicine and to begin the development of the impurities analysis technique.

Highlights

  • Radiopharmaceuticals are preparations consisting of one or more radionuclides and a pharmacological moiety

  • It is important that purity checks be continued over time for the entire working life of a reference source or even a radiopharmaceutical administered to the patient, since the impurities of long half-lives have a longer life and their Percentage of the radionuclides with short half-lives, as is the case with radiopharmaceuticals

  • The radiopharmaceutical is characterized by a short half-life, but in this mode of production the presence of radionuclide impurities, usually of larger half-lives in relation to the main one, is common

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Summary

Introduction

Radiopharmaceuticals are preparations consisting of one or more radionuclides and a pharmacological moiety. Would it be a secondary standardization laboratory that would be assigned to measure or verify more than activity and impurity, and would normally be measured with calibrated equipment using activity standards provided by national laboratories via gamma spectrometry methods; Purity (chemical and radionuclide) should be the responsibility of the producing center and nuclear data are generally produced by specialized national metrology laboratories with their decay parameters related to radionuclides published in updated tables of nuclear data Thinking in this light, the LNMRI has sought to develop a methodology for analyzing these impurities in order to have as an end product an internal document where concepts for approaching the subject are well delineated. It is necessary to develop a procedure using gamma spectrometry techniques to ensure that these limits set by the pharmacopoeia are not exceeded [4..10]

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