Towards the full automation of QC release tests for [18]fluoride-labeled radiotracers

Current Organic Chemistry

Volumn 17, Issue 19, 2013, Pages 2153-2158

  Anzellotti, Atilio I ^a   McFarland, Aaron R ^a   Ferguson, Doug ^a   Olson, Ken F ^a  

^a ABT Molecular Imaging Inc ^*  (United States)

Author keywords

Automation; F 18; FDG; Fluoride; PET; QC; Radiochemistry; Release tests

Indexed keywords

FLUORINE COMPOUNDS; QUALITY ASSURANCE; QUALITY CONTROL; RADIOACTIVE TRACERS;

CONTROL METHODS; F-18; FDG; FLUORIDE; KEY RELEASE; QC; RADIOCHEMICAL PURITY; RADIOCHEMISTRY; RELEASE TEST; RESIDUAL SOLVENTS;

AUTOMATION;

EID: 84893198363     PISSN: 13852728     EISSN: None     Source Type: Journal    
DOI: 10.2174/13852728113179990107     Document Type: Article

References (20)

1. Hoh, C.K. Clinical use of FDG PET. Nucl Med Biol, 2007, 34(7), 737-742.
2. Thompson-Reuters Web of Science until April 2012, search criteria: FDG + all years.
3. 18F-FDG PET in the Evaluation of Dementia: A review of the recent Literature. J Nucl Med, 2012, 53, 59-71.
4. Rudd, J.H.F.; Narula, J.; Strauss, H.W.; Virmani, R.; Machac, J.; Klimas, M.; Tahara, N.; Fuster, V.; Warburton, E.A.; Fayad, Z.A.; Tawakol, A.A. Imaging Atherosclerotic Plaque Inflammation by Fluorodeoxyglucose With Positron Emission Tomography: Ready for Prime Time?. J Am Coll Cardiol. 2010, 55(23), 2527-2535.
5. Couturier, O.; Luxen, A.; Chatal, J-.F.; Vuillez, J-.P.; Rigo, P.; Hustinx, R. Fluorinated tracers for imaging cancer with positron emission tomography. Eur J Nucl Med Mol Imaging. 2004, 31, 1182-1206.
6. Hjelstuen, O.K.; Svadberg, A.; Olberg, D.E.; Rosser, M. Standardization of fluorine-18 manufacturing processes: New scientific challenges for PET. Eur J Pharm Biopharm, 2011, 78, 307-313.
7. Shao, X.; Hoareau, R.; Hockley, B.G.; Tluczek, L.J.; Henderson, B.D.; Padgett, H.C.; Scott, P.J. Highlighting the Versatility of the Tracerlab Synthesis Modules. Part 1: Fully Automated Production of [18F]Labelled Radiopharmaceuticals using a Tracerlab FX(FN). J Labelled Comp Radiopharm, 2011, 54 (6), 292-307.
8. 18F]FDG. Appl Radiat Isotopes, 2010, 68 (9), 1740-1742.
9. 18F]FDG preparation by highperformance liquid chromatography with UV detection. Nucl Med Biol, 2008, 35, 239-244.
10. Nakao, R.; Ito, T.; Yamaguchi, M.; Suzuki, K. Improved quality control of [18F]FDG by HPLC with UV detection. Nucl Med Biol, 2005, 32, 907-912.
11. FDA/ICH, (CDER and CBER), Process Validation: General Principles and Practices, 2011. http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm070336.pdf
12. th ed. Fluodeoxyglucose F18 Injection, Rockville MD: United States Pharmacopeial Convention, Inc. 2012. 2868-2869.
13. th ed.,Strasbourg: France European Directorate for the Quality of Medicine. 2011, 969-971.
14. th ed. General Chapter pH, Rockville MD: United States Pharmacopeial Convention, Inc. 2012.
15. FDA/ICH - Guidance for Industry: Q3C Impurities: Residual Solvents 2012 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm073395.pdf
16. 18F-FDG Injection. J Nucl Med, 2002, 43, 1495-1506.
17. 18F-FDG synthesis and quality control. Biomed Imaging Interv J, 2006, 2(4), e57
18. 18F]-fluoro-2-deoxy-D-glucose using aminopolyethersupported nucleophilic substitution. J Nucl Med, 1986, 27, 235-238.
19. http://www.millipore.com/publications.nsf/a73664f9f981af8c852569b9005b4eee/edd3a8cbd689305c85256bd8004acd49/$FILE/TB039.pdf
20. Antonsen, H.R.K; Awafo, V; Bender, J.L.; Carter, J.R.; Conway, R.S.; Egli, S.; Feeser, T.M.; Jornitz, M.W., Kearns, M.; Levy, R.V.; Madsen, R.E.; Martin, J.M.; McBurnie, L.D.; Meissner, L.S.; Meltzer, T.H.; Pawar, V.; Phelan, M.; Stinavage, P.S.; Sweeney, N.; Vega, H.; Witchey-Lakshmanan, L.C. Sterilizing Filtration of Liquids, Parenteral Drug Association: Tech Report # 26, 2008, 62(S-5).