{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,12]],"date-time":"2026-10-12T21:39:25Z","timestamp":1791841165362,"version":"4.3.4"},"reference-count":26,"publisher":"MDPI AG","issue":"11","license":[{"start":{"date-parts":[[2023,11,17]],"date-time":"2023-11-17T00:00:00Z","timestamp":1700179200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Pharmaceuticals"],"abstract":"<jats:p>A novel gas chromatography method was developed using automatic injections to identify and quantify the amount of residual solvents or analytes in samples of fluorine-18 and carbon-11 radiopharmaceuticals. This approach evaluates seven analytes in less than 5 versus 13 min of acquisition time. The method additionally includes a 3 min bakeout to aid in the removal and carry-over of higher-boiling impurities. Chromatographic parameters such as column temperature, hold time, column pressure, flow rate, and split ratios were adjusted and optimized to analyze radioactive drug samples containing analytes which include methanol, ethanol, acetone, acetonitrile, triethylamine, N,N-dimethylformamide, and dimethyl sulfoxide. The relative standard deviation for each solvent was determined to be no greater than 1.6%. The method limit of detection (LOD) and limit of quantification (LOQ) were between 0.053 and 0.163 and 0.000 (5.791 \u00d7 10\u22126) and 0.520 mg\/mL, respectively. This GC technique, using flame ionization detection (FID), was validated and is currently employed for the routine quality control of all approved IND and RDRC PET radiopharmaceuticals at our center.<\/jats:p>","DOI":"10.3390\/ph16111623","type":"journal-article","created":{"date-parts":[[2023,11,17]],"date-time":"2023-11-17T09:10:38Z","timestamp":1700212238000},"page":"1623","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["OMNI: Gas Chromatograph Captures Seven Common PET Radiotracer Analytes in under 5 Minutes"],"prefix":"10.3390","volume":"16","author":[{"given":"Camry Vonyae\u2019","family":"A\u2019Keen","sequence":"first","affiliation":[{"name":"Department of Radiology, New York University Grossman School of Medicine, 660 First Avenue, Room 240, New York, NY 10016, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jakub","family":"Mroz","sequence":"additional","affiliation":[{"name":"Department of Radiology, New York University Grossman School of Medicine, 660 First Avenue, Room 240, New York, NY 10016, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Simon Kunta","family":"Joseph","sequence":"additional","affiliation":[{"name":"Department of Radiology, New York University Grossman School of Medicine, 660 First Avenue, Room 240, New York, NY 10016, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jairo","family":"Baquero","sequence":"additional","affiliation":[{"name":"Department of Radiology, New York University Grossman School of Medicine, 660 First Avenue, Room 240, New York, NY 10016, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Melchor V.","family":"Cantorias","sequence":"additional","affiliation":[{"name":"Department of Radiology, New York University Grossman School of Medicine, 660 First Avenue, Room 240, New York, NY 10016, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7702-4674","authenticated-orcid":false,"given":"Patrick","family":"Carberry","sequence":"additional","affiliation":[{"name":"Department of Radiology, New York University Grossman School of Medicine, 660 First Avenue, Room 240, New York, NY 10016, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2023,11,17]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"1449","DOI":"10.1136\/bmj.326.7404.1449","article-title":"How does it work? Positron emission tomography","volume":"326","author":"Berger","year":"2003","journal-title":"BMJ"},{"key":"ref_2","doi-asserted-by":"crossref","first-page":"595","DOI":"10.1080\/01621459.2018.1497495","article-title":"Functional Data Analysis of Dynamic PET Data","volume":"114","author":"Chen","year":"2019","journal-title":"J. Am. Stat. Assoc."},{"key":"ref_3","doi-asserted-by":"crossref","first-page":"385","DOI":"10.1146\/annurev-bioeng-071114-040723","article-title":"Positron Emission Tomography: Current Challenges and Opportunities for Technological Advances in Clinical and Preclinical Imaging Systems","volume":"17","author":"Vaquero","year":"2015","journal-title":"Annu. Rev. Biomed. Eng."},{"key":"ref_4","doi-asserted-by":"crossref","first-page":"382","DOI":"10.4329\/wjr.v7.i11.382","article-title":"Application of positron emission tomography\/computed tomography in radiation treatment planning for head and neck cancers","volume":"7","author":"Awan","year":"2015","journal-title":"World J. Radiol."},{"key":"ref_5","doi-asserted-by":"crossref","unstructured":"Hillman, E.M. (2007). Optical brain imaging in vivo: Techniques and applications from animal to man. J. Biomed. Opt., 12.","DOI":"10.1117\/1.2789693"},{"key":"ref_6","first-page":"53","article-title":"Gas chromatography-mass spectrometry","volume":"324","author":"Honour","year":"2006","journal-title":"Methods Mol. Biol."},{"key":"ref_7","doi-asserted-by":"crossref","first-page":"98","DOI":"10.1016\/j.clinbiochem.2019.08.007","article-title":"Rising above helium: A hydrogen carrier gas chromatography flame ionization detection (GC-FID) method for the simultaneous quantification of toxic alcohols and ethylene glycol in human plasma specimens","volume":"73","author":"Buse","year":"2019","journal-title":"Clin. Biochem."},{"key":"ref_8","doi-asserted-by":"crossref","first-page":"58","DOI":"10.1038\/scientificamerican1061-58","article-title":"Gas chromatography","volume":"205","author":"Keller","year":"1961","journal-title":"Sci. Am."},{"key":"ref_9","doi-asserted-by":"crossref","first-page":"70","DOI":"10.1016\/j.chroma.2017.08.048","article-title":"Generic gas chromatography-flame ionization detection method for quantitation of volatile amines in pharmaceutical drugs and synthetic intermediates","volume":"1518","author":"Graffius","year":"2017","journal-title":"J. Chromatogr. A"},{"key":"ref_10","doi-asserted-by":"crossref","first-page":"11","DOI":"10.1016\/j.jpba.2013.07.013","article-title":"Forced degradation and impurity profiling: Recent trends in analytical perspectives","volume":"86","author":"Jain","year":"2013","journal-title":"J. Pharm. Biomed. Anal."},{"key":"ref_11","unstructured":"Hinshaw, J.V. (2005). LC GC North America, Advanstar Communications MultiMedia Healthcare."},{"key":"ref_12","doi-asserted-by":"crossref","first-page":"137","DOI":"10.1016\/j.chroma.2015.02.061","article-title":"Ionization-based detectors for gas chromatography","volume":"1421","author":"Poole","year":"2015","journal-title":"J. Chromatogr. A"},{"key":"ref_13","doi-asserted-by":"crossref","unstructured":"Houck, M.M., and Siegel, J.A. (2010). Fundamentals of Forensic Science, Academic Press. [2nd ed.].","DOI":"10.1016\/B978-0-12-374989-5.00023-5"},{"key":"ref_14","doi-asserted-by":"crossref","first-page":"315","DOI":"10.1016\/S0021-9673(99)00227-7","article-title":"High-speed gas chromatography: An overview of various concepts","volume":"856","author":"Cramers","year":"1999","journal-title":"J. Chromatogr. A"},{"key":"ref_15","unstructured":"ICH (2023, November 13). International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use; ICH Guideline Q3C (R6) on Impurities: Guideline for Residual Solvents. Available online: https:\/\/www.ema.europa.eu\/en\/documents\/scientific-guideline\/ich-guideline-q2r2-validation-analytical-procedures-step-2b_en.pdf."},{"key":"ref_16","doi-asserted-by":"crossref","first-page":"875","DOI":"10.2174\/1568026614666140202205035","article-title":"Radiosyntheses using fluorine-18: The art and science of late stage fluorination","volume":"14","author":"Cole","year":"2014","journal-title":"Curr. Top. Med. Chem."},{"key":"ref_17","first-page":"1215","article-title":"Tumor location with 1-aminocyclopentane [11C] carboxylic acid: Preliminary clinical trials with single-photon detection","volume":"18","author":"Hubner","year":"1977","journal-title":"J. Nucl. Med."},{"key":"ref_18","doi-asserted-by":"crossref","first-page":"65","DOI":"10.1002\/jlcr.3037","article-title":"Carbon-11 and fluorine-18 chemistry devoted to molecular probes for imaging the brain with positron emission tomography","volume":"56","author":"Dolle","year":"2013","journal-title":"J. Label. Comp. Radiopharm."},{"key":"ref_19","doi-asserted-by":"crossref","unstructured":"Joszai, I., Vekei, N., Bajnai, D., Kertesz, I., and Trencsenyi, G. (2022). A generic gas chromatography method for determination of residual solvents in PET radiopharmaceuticals. J. Pharm. Biomed. Anal., 207.","DOI":"10.1016\/j.jpba.2021.114425"},{"key":"ref_20","doi-asserted-by":"crossref","first-page":"6413","DOI":"10.1016\/j.chroma.2010.08.016","article-title":"A generic static headspace gas chromatography method for determination of residual solvents in drug substance","volume":"1217","author":"Cheng","year":"2010","journal-title":"J. Chromatogr. A"},{"key":"ref_21","doi-asserted-by":"crossref","first-page":"292","DOI":"10.1002\/jlcr.1865","article-title":"Highlighting the Versatility of the Tracerlab Synthesis Modules. Part 1: Fully Automated Production of [F]Labelled Radiopharmaceuticals using a Tracerlab FX(FN)","volume":"54","author":"Shao","year":"2011","journal-title":"J. Label. Comp. Radiopharm."},{"key":"ref_22","doi-asserted-by":"crossref","first-page":"110736","DOI":"10.1016\/j.apradiso.2023.110736","article-title":"Chromatographic method development using multivariate approaches for organic solvents optimized analysis in [(18)F]fluorocholine","volume":"195","author":"Costa","year":"2023","journal-title":"Appl. Radiat. Isot."},{"key":"ref_23","doi-asserted-by":"crossref","first-page":"677","DOI":"10.1093\/chromsci\/bmx035","article-title":"Gas Chromatography-Mass Spectrometry Method to Quantify Benzo[a]Pyrene in Tobacco Products","volume":"55","author":"Wagner","year":"2017","journal-title":"J. Chromatogr. Sci."},{"key":"ref_24","unstructured":"ICH (2023, November 13). International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use; ICH Guideline Q2(R2) on Validation of Analytical Procedures. Available online: https:\/\/www.ema.europa.eu\/en\/documents\/scientific-guideline\/international-conference-harmonisation-technical-requirements-registration-pharmaceuticals-human-use_en-33.pdf."},{"key":"ref_25","doi-asserted-by":"crossref","first-page":"465","DOI":"10.1002\/bmc.1313","article-title":"Determination of dimethyl sulfoxide and dimethyl sulfone in urine by gas chromatography-mass spectrometry after preparation using 2,2-dimethoxypropane","volume":"24","author":"Takeuchi","year":"2010","journal-title":"Biomed. Chromatogr."},{"key":"ref_26","doi-asserted-by":"crossref","first-page":"935","DOI":"10.1016\/j.nucmedbio.2006.07.003","article-title":"Residual solvent analysis by gas chromatography in radiopharmaceutical formulations containing up to 12% ethanol","volume":"33","author":"Klok","year":"2006","journal-title":"Nucl. Med. Biol."}],"container-title":["Pharmaceuticals"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.mdpi.com\/1424-8247\/16\/11\/1623\/pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,10]],"date-time":"2025-10-10T21:24:45Z","timestamp":1760131485000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.mdpi.com\/1424-8247\/16\/11\/1623"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2023,11,17]]},"references-count":26,"journal-issue":{"issue":"11","published-online":{"date-parts":[[2023,11]]}},"alternative-id":["ph16111623"],"URL":"https:\/\/doi.org\/10.3390\/ph16111623","relation":{},"ISSN":["1424-8247"],"issn-type":[{"value":"1424-8247","type":"electronic"}],"subject":[],"published":{"date-parts":[[2023,11,17]]}}}