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Quality control of 223Ra eluate


Authors: Anna Bajzíková;  Ján Kozempel;  Martin Vlk;  Ekaterina Kukleva;  Petra Mičolová
Authors‘ workplace: Fakulta jaderná a fyzikálně inženýrská, Katedra jaderné chemie, ČVUT v Praze, ČR
Published in: NuklMed 2016;5:22-26
Category: Original Article

Overview

Introduction:
The use of radionuclides plays an irreplaceable role in medicine. Their usage is under the control of Law on Pharmaceuticals and other regulations including standardized operational procedures. The quality control of the radionuclides always includes the radionuclidic purity test. For 223Ra (T1/2 = 11,435 days), it may be carried out by alpha and gamma spectrometry. Particular care have to be taken of long half-life nuclides, e.g. the 227Ac (T1/2 = 21,773 years) or the 227Th (T1/2 = 18,72 days).

Methods:
The 223Ra was eluted from 227Ac/227Th/223Ra generator (227Ac on an ion exchanger Dowex-1). The elution was carried out in optimal conditions (0,7M HNO3 and 80% MeOH) and in conditions that simulated the presence of radionuclidic impurities. Generator eluates were analyzed by alpha and gamma spectrometry and an alternative control method employing the 223Ra analysis by paper chromatography was tested. Measurement on NaI(Tl) crystal was performed with developed paper strips (TODGA impregnated paper Whatman-1, mobile phase 1M HNO3).

Results:
The purity of eluates was cross-checked by alpha and gamma spectrometry and by paper chromatography. The mixture of 227Ac/227Th/223Ra was successfully separated and measured on TLC scanner. In optimal elution conditions the 223Ra and its daughter nuclides (219Rn, 215Po, 211Pb) were detected. In the radionuclidic impurities simulated elution the 227Th was also detected. In both cases the levels of radionuclidic impurities did not exceed 3,5 %.

Conclusion:
The purity of 223Ra radionuclide in both types of conditions was higher than 96 %. These results were confirmed by all selected methods of analysis. The paper chromatography is suitable alternative method for 227Ac/227Th/223Ra mixtures separation and analysis. This method can be used for the determination of 223Ra radionuclidic purity after a simple validation.

Key Words:
223Ra, radionuclidic purity, spectrometry, paper chromatography, quality control


Sources

1. WWW Table of Radioactive Isotopes: Nuclide search [online]. 1999. [cit. 2015-09-09]. Dostupné na: http://nucleardata.nuclear.lu.se/toi/nucSearch.asp

2. Státní úřad pro kontrolu léčiv: XOFIGO [online]. 2013. [cit. 2015-09-09]. Dostupné na: http://www.sukl.cz/modules/medication/detail.php?code=0194562&tab=info

3. FDA: Radium Ra 223 dichloride [online]. 2013. [cit. 2015-09-09]. Dostupné na: http://www.fda.gov/drugs/informationondrugs/approveddrugs/ucm352393.htm

4. EMA: Xofigo (radium Ra-223 dichloride) [online]. 2013. [cit. 2015-09-09]. Dostupné na: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/002653/human_med_001692.jsp&mid=WC0b01ac058001d124

5. Carrasquillo JA, O´Donoghue JA, Pandit-Taskar N et al. Phase I pharmacokinetic and biodistribution study with escalating doses of 223Ra-dichloride in men with castration-resistant metastatic prostate cancer. Eur J Nucl Med Mol Imaging. 2013;40:1384-1393

6. Shishkin DN, Krupitskii SV, Kuynetsov SA. Extraction Generator of 223Ra for Nuclear Medicine. Radiochemistry. 2011;53:404-406

7. Guseva LI, Tikhomirova GS, Dogadkin NN. An 277Ac-211Pb generator for test experiments of solution chemistry of element 114. J Radioanal Nucl Chem. 2004;260:167-172

8. Předpis č. 378/2007 Sb.: Zákon o léčivech a o změnách některých souvisejících zákonů (zákon o léčivech) [online]. 2007. [cit. 2015-09-09]. Dostupné na: http://www.zakonyprolidi.cz/cs/2007-378

9. Státní ústav pro kontrolu léčiv: Principy monitorování shody se zásadami správné laboratorní praxe [online]. 2015. [cit. 2015-09-09]. Dostupné na: http://www.sukl.cz/leciva/slp-6-verze-4

10. Státní ústav pro kontrolu léčiv: Informace o novém formátu povolení k výrobě a certifikátu správné výrobní praxe [online]. 2013. [cit. 2015-09-09]. Dostupné na: http://www.sukl.cz/leciva/vyr-40

11. Vyhláška Státního úřadu pro jadernou bezpečnost o radiační ochraně [online]. 2002. [cit. 2015-09-09]. Dostupné na: https://www.sujb.cz/fileadmin/sujb/docs/legislativa/vyhlasky/307_po_novele.pdf

12. Česko, Ministerstvo zdravotnictví, Český lékopis 2009 – doplňky 2010-2014. Grada. 2010

13. Kozempel J, Vlk M, Mičolová P, Bajzíková A. UV27591.Česká republika. 2014

Labels
Nuclear medicine Radiodiagnostics Radiotherapy
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