Identification, characterization and suppression of side-products formed during the synthesis of high dose 68Ga-DOTA-TATE
In the course of the establishment of 68Ga-DOTA-TATE production for clinical use a shoulder comprising presumably several impurities was observed in the chromatogram of the analytical radio-HPLC. LC–MS/MS results support the hypothesis that some of these radioimpurities are radiolytic oxidation by-p...
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| Veröffentlicht in: | Applied radiation and isotopes 2013-06, Vol.76, p.63-69 |
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| container_title | Applied radiation and isotopes |
| container_volume | 76 |
| creator | Mu, Linjing Hesselmann, Rolf Oezdemir, Ufuk Bertschi, Louis Blanc, Alain Dragic, Martina Löffler, Dirk Smuda, Christoph Johayem, Anass Schibli, Roger |
| description | In the course of the establishment of 68Ga-DOTA-TATE production for clinical use a shoulder comprising presumably several impurities was observed in the chromatogram of the analytical radio-HPLC. LC–MS/MS results support the hypothesis that some of these radioimpurities are radiolytic oxidation by-products of 68Ga-DOTA-TATE. A new HPLC method was developed for quality control of 68Ga-DOTA-TATE. Significant improvement on the radiochemical purity of 68Ga-DOTA-TATE was achieved by the addition of ascorbic acid or ethanol to the reaction mixture.
► A new HPLC method was developed for quality control of 68Ga-DOTA-TATE. ► Radiolytic oxidation by-products of 68Ga-DOTA-TATE were formed at high dose of activity. ► It is necessary to add ascorbic acid or ethanol to the preparation for high dose of 68Ga-DOTA-TATE. |
| doi_str_mv | 10.1016/j.apradiso.2012.07.022 |
| format | Article |
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► A new HPLC method was developed for quality control of 68Ga-DOTA-TATE. ► Radiolytic oxidation by-products of 68Ga-DOTA-TATE were formed at high dose of activity. ► It is necessary to add ascorbic acid or ethanol to the preparation for high dose of 68Ga-DOTA-TATE.</description><identifier>ISSN: 0969-8043</identifier><identifier>EISSN: 1872-9800</identifier><identifier>DOI: 10.1016/j.apradiso.2012.07.022</identifier><identifier>PMID: 22939572</identifier><language>eng</language><publisher>England: Elsevier Ltd</publisher><subject>68Ga-DOTA-TATE ; Ascorbic Acid - chemistry ; Chromatography, High Pressure Liquid - methods ; Ethanol - chemistry ; HPLC quality control ; Isotope Labeling - methods ; Organometallic Compounds - chemical synthesis ; Organometallic Compounds - isolation & purification ; Quality Control ; Radiochemical purity ; Radiopharmaceuticals - chemical synthesis ; Tandem Mass Spectrometry</subject><ispartof>Applied radiation and isotopes, 2013-06, Vol.76, p.63-69</ispartof><rights>2012 Elsevier Ltd</rights><rights>Copyright © 2012 Elsevier Ltd. All rights reserved.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c2132-c376e38235829e29400b3c8e19b1d461de0d51690a2711da7134f1fa119687d33</citedby><cites>FETCH-LOGICAL-c2132-c376e38235829e29400b3c8e19b1d461de0d51690a2711da7134f1fa119687d33</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.sciencedirect.com/science/article/pii/S0969804312004551$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>314,776,780,3537,27901,27902,65306</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/22939572$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Mu, Linjing</creatorcontrib><creatorcontrib>Hesselmann, Rolf</creatorcontrib><creatorcontrib>Oezdemir, Ufuk</creatorcontrib><creatorcontrib>Bertschi, Louis</creatorcontrib><creatorcontrib>Blanc, Alain</creatorcontrib><creatorcontrib>Dragic, Martina</creatorcontrib><creatorcontrib>Löffler, Dirk</creatorcontrib><creatorcontrib>Smuda, Christoph</creatorcontrib><creatorcontrib>Johayem, Anass</creatorcontrib><creatorcontrib>Schibli, Roger</creatorcontrib><title>Identification, characterization and suppression of side-products formed during the synthesis of high dose 68Ga-DOTA-TATE</title><title>Applied radiation and isotopes</title><addtitle>Appl Radiat Isot</addtitle><description>In the course of the establishment of 68Ga-DOTA-TATE production for clinical use a shoulder comprising presumably several impurities was observed in the chromatogram of the analytical radio-HPLC. LC–MS/MS results support the hypothesis that some of these radioimpurities are radiolytic oxidation by-products of 68Ga-DOTA-TATE. A new HPLC method was developed for quality control of 68Ga-DOTA-TATE. Significant improvement on the radiochemical purity of 68Ga-DOTA-TATE was achieved by the addition of ascorbic acid or ethanol to the reaction mixture.
► A new HPLC method was developed for quality control of 68Ga-DOTA-TATE. ► Radiolytic oxidation by-products of 68Ga-DOTA-TATE were formed at high dose of activity. ► It is necessary to add ascorbic acid or ethanol to the preparation for high dose of 68Ga-DOTA-TATE.</description><subject>68Ga-DOTA-TATE</subject><subject>Ascorbic Acid - chemistry</subject><subject>Chromatography, High Pressure Liquid - methods</subject><subject>Ethanol - chemistry</subject><subject>HPLC quality control</subject><subject>Isotope Labeling - methods</subject><subject>Organometallic Compounds - chemical synthesis</subject><subject>Organometallic Compounds - isolation & purification</subject><subject>Quality Control</subject><subject>Radiochemical purity</subject><subject>Radiopharmaceuticals - chemical synthesis</subject><subject>Tandem Mass Spectrometry</subject><issn>0969-8043</issn><issn>1872-9800</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2013</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqFkD1v2zAQQImgReKm-QsBxw6VeiQlkdxqpGkSIEAWdyZo8hTTsCWFJxVwf33lOuma6XCHd1-PsWsBpQDRfNuWfsg-JupLCUKWoEuQ8owthNGysAbgA1uAbWxhoFIX7BPRFgAqY-U5u5DSKltruWCHh4jdmNoU_Jj67isPG599GDGnP_8q3HeR0zQMGYmOed9yShGLIfdxCiPxts97jDxOOXXPfNwgp0M3B0p0hDfpecNjT8gbc-eLH0-rZbFarm4_s4-t3xFevcZL9uvn7ermvnh8unu4WT4WQQoli6B0g8pIVRtpUdoKYK2CQWHXIlaNiAixFo0FL7UQ0Wuhqla0XgjbGB2VumRfTnPng18mpNHtEwXc7XyH_UROqLqutFVKzmhzQkPuiTK2bshp7_PBCXBH7W7r3rS7o3YH2s3a58br1x3Tenbxv-3N8wx8PwE4f_o7YXYUEnYBY8oYRhf79N6Ov-iAltI</recordid><startdate>201306</startdate><enddate>201306</enddate><creator>Mu, Linjing</creator><creator>Hesselmann, Rolf</creator><creator>Oezdemir, Ufuk</creator><creator>Bertschi, Louis</creator><creator>Blanc, Alain</creator><creator>Dragic, Martina</creator><creator>Löffler, Dirk</creator><creator>Smuda, Christoph</creator><creator>Johayem, Anass</creator><creator>Schibli, Roger</creator><general>Elsevier Ltd</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope></search><sort><creationdate>201306</creationdate><title>Identification, characterization and suppression of side-products formed during the synthesis of high dose 68Ga-DOTA-TATE</title><author>Mu, Linjing ; Hesselmann, Rolf ; Oezdemir, Ufuk ; Bertschi, Louis ; Blanc, Alain ; Dragic, Martina ; Löffler, Dirk ; Smuda, Christoph ; Johayem, Anass ; Schibli, Roger</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c2132-c376e38235829e29400b3c8e19b1d461de0d51690a2711da7134f1fa119687d33</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2013</creationdate><topic>68Ga-DOTA-TATE</topic><topic>Ascorbic Acid - chemistry</topic><topic>Chromatography, High Pressure Liquid - methods</topic><topic>Ethanol - chemistry</topic><topic>HPLC quality control</topic><topic>Isotope Labeling - methods</topic><topic>Organometallic Compounds - chemical synthesis</topic><topic>Organometallic Compounds - isolation & purification</topic><topic>Quality Control</topic><topic>Radiochemical purity</topic><topic>Radiopharmaceuticals - chemical synthesis</topic><topic>Tandem Mass Spectrometry</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Mu, Linjing</creatorcontrib><creatorcontrib>Hesselmann, Rolf</creatorcontrib><creatorcontrib>Oezdemir, Ufuk</creatorcontrib><creatorcontrib>Bertschi, Louis</creatorcontrib><creatorcontrib>Blanc, Alain</creatorcontrib><creatorcontrib>Dragic, Martina</creatorcontrib><creatorcontrib>Löffler, Dirk</creatorcontrib><creatorcontrib>Smuda, Christoph</creatorcontrib><creatorcontrib>Johayem, Anass</creatorcontrib><creatorcontrib>Schibli, Roger</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Applied radiation and isotopes</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Mu, Linjing</au><au>Hesselmann, Rolf</au><au>Oezdemir, Ufuk</au><au>Bertschi, Louis</au><au>Blanc, Alain</au><au>Dragic, Martina</au><au>Löffler, Dirk</au><au>Smuda, Christoph</au><au>Johayem, Anass</au><au>Schibli, Roger</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Identification, characterization and suppression of side-products formed during the synthesis of high dose 68Ga-DOTA-TATE</atitle><jtitle>Applied radiation and isotopes</jtitle><addtitle>Appl Radiat Isot</addtitle><date>2013-06</date><risdate>2013</risdate><volume>76</volume><spage>63</spage><epage>69</epage><pages>63-69</pages><issn>0969-8043</issn><eissn>1872-9800</eissn><abstract>In the course of the establishment of 68Ga-DOTA-TATE production for clinical use a shoulder comprising presumably several impurities was observed in the chromatogram of the analytical radio-HPLC. LC–MS/MS results support the hypothesis that some of these radioimpurities are radiolytic oxidation by-products of 68Ga-DOTA-TATE. A new HPLC method was developed for quality control of 68Ga-DOTA-TATE. Significant improvement on the radiochemical purity of 68Ga-DOTA-TATE was achieved by the addition of ascorbic acid or ethanol to the reaction mixture.
► A new HPLC method was developed for quality control of 68Ga-DOTA-TATE. ► Radiolytic oxidation by-products of 68Ga-DOTA-TATE were formed at high dose of activity. ► It is necessary to add ascorbic acid or ethanol to the preparation for high dose of 68Ga-DOTA-TATE.</abstract><cop>England</cop><pub>Elsevier Ltd</pub><pmid>22939572</pmid><doi>10.1016/j.apradiso.2012.07.022</doi><tpages>7</tpages></addata></record> |
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| ispartof | Applied radiation and isotopes, 2013-06, Vol.76, p.63-69 |
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| language | eng |
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| source | MEDLINE; Elsevier ScienceDirect Journals Collection |
| subjects | 68Ga-DOTA-TATE Ascorbic Acid - chemistry Chromatography, High Pressure Liquid - methods Ethanol - chemistry HPLC quality control Isotope Labeling - methods Organometallic Compounds - chemical synthesis Organometallic Compounds - isolation & purification Quality Control Radiochemical purity Radiopharmaceuticals - chemical synthesis Tandem Mass Spectrometry |
| title | Identification, characterization and suppression of side-products formed during the synthesis of high dose 68Ga-DOTA-TATE |
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