A new method for the radiochemical purity measurement of 111In-pentetreotide

OBJECTIVES AND METHODSThe recommended method for the measurement of radiochemical purity (RCP) of In-labelled pentetreotide is thin-layer chromatography with a silica gel as the stationary phase and a 0.1 N sodium citrate solution (pH 5) as the mobile phase. According to the supplier’s instructions,...

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Veröffentlicht in:Nuclear medicine communications 2011-12, Vol.32 (12), p.1241-1244
Hauptverfasser: Salgado-Garcia, Carlos, Montoza-Aguado, Manuel, Luna-Alcaide, Ana B, Segovia-Gonzalez, Maria M, de Mora, Elena Sanchez, Lopez-Martin, Juana, Ramos-Font, Carlos, Jimenez-Heffernan, Amelia
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container_end_page 1244
container_issue 12
container_start_page 1241
container_title Nuclear medicine communications
container_volume 32
creator Salgado-Garcia, Carlos
Montoza-Aguado, Manuel
Luna-Alcaide, Ana B
Segovia-Gonzalez, Maria M
de Mora, Elena Sanchez
Lopez-Martin, Juana
Ramos-Font, Carlos
Jimenez-Heffernan, Amelia
description OBJECTIVES AND METHODSThe recommended method for the measurement of radiochemical purity (RCP) of In-labelled pentetreotide is thin-layer chromatography with a silica gel as the stationary phase and a 0.1 N sodium citrate solution (pH 5) as the mobile phase. According to the supplier’s instructions, the mobile phase must be prepared before the test is carried out, and the recommended stationary phase is off-market. We propose a new method for RCP measurement in which the mobile phase is acid citrate dextrose, solution A, which does not need to be prepared beforehand, and thin-layer chromatography is performed with a silica gel-impregnated glass fibre sheet as the stationary phase. We used both methods to measure the percentages of radiopharmaceutical and impurities. RESULTSThe range of RCP values obtained was 98.0–99.9% (mean=99.3%) by the standard method and 98.1–99.9% (mean=99.2%) by the new method. We observed no differences between the RCP values of both methods (P=0.070). CONCLUSIONThe proposed method is suitable for RCP testing because it yields results that are in good agreement with those of the standard method and because it is easier to perform as the mobile-phase solution need not be prepared in advance.
doi_str_mv 10.1097/MNM.0b013e32834a7003
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According to the supplier’s instructions, the mobile phase must be prepared before the test is carried out, and the recommended stationary phase is off-market. We propose a new method for RCP measurement in which the mobile phase is acid citrate dextrose, solution A, which does not need to be prepared beforehand, and thin-layer chromatography is performed with a silica gel-impregnated glass fibre sheet as the stationary phase. We used both methods to measure the percentages of radiopharmaceutical and impurities. RESULTSThe range of RCP values obtained was 98.0–99.9% (mean=99.3%) by the standard method and 98.1–99.9% (mean=99.2%) by the new method. We observed no differences between the RCP values of both methods (P=0.070). CONCLUSIONThe proposed method is suitable for RCP testing because it yields results that are in good agreement with those of the standard method and because it is easier to perform as the mobile-phase solution need not be prepared in advance.</description><identifier>ISSN: 0143-3636</identifier><identifier>EISSN: 1473-5628</identifier><identifier>DOI: 10.1097/MNM.0b013e32834a7003</identifier><identifier>PMID: 21946620</identifier><language>eng</language><publisher>England: Lippincott Williams &amp; Wilkins, Inc</publisher><subject>Chromatography, Thin Layer - methods ; Citric Acid ; Glass ; Glucose - analogs &amp; derivatives ; Humans ; Indium Radioisotopes ; Radiochemistry - methods ; Radiopharmaceuticals - analysis ; Radiopharmaceuticals - standards ; Reproducibility of Results ; Silica Gel ; Somatostatin - analogs &amp; derivatives ; Somatostatin - analysis ; Somatostatin - standards</subject><ispartof>Nuclear medicine communications, 2011-12, Vol.32 (12), p.1241-1244</ispartof><rights>2011 Lippincott Williams &amp; Wilkins, Inc.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c2003-bba7aae3eae437ade3570a9165b098219c9e95826508f9992496ca6af1da65b23</citedby></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,778,782,27907,27908</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/21946620$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Salgado-Garcia, Carlos</creatorcontrib><creatorcontrib>Montoza-Aguado, Manuel</creatorcontrib><creatorcontrib>Luna-Alcaide, Ana B</creatorcontrib><creatorcontrib>Segovia-Gonzalez, Maria M</creatorcontrib><creatorcontrib>de Mora, Elena Sanchez</creatorcontrib><creatorcontrib>Lopez-Martin, Juana</creatorcontrib><creatorcontrib>Ramos-Font, Carlos</creatorcontrib><creatorcontrib>Jimenez-Heffernan, Amelia</creatorcontrib><title>A new method for the radiochemical purity measurement of 111In-pentetreotide</title><title>Nuclear medicine communications</title><addtitle>Nucl Med Commun</addtitle><description>OBJECTIVES AND METHODSThe recommended method for the measurement of radiochemical purity (RCP) of In-labelled pentetreotide is thin-layer chromatography with a silica gel as the stationary phase and a 0.1 N sodium citrate solution (pH 5) as the mobile phase. According to the supplier’s instructions, the mobile phase must be prepared before the test is carried out, and the recommended stationary phase is off-market. We propose a new method for RCP measurement in which the mobile phase is acid citrate dextrose, solution A, which does not need to be prepared beforehand, and thin-layer chromatography is performed with a silica gel-impregnated glass fibre sheet as the stationary phase. We used both methods to measure the percentages of radiopharmaceutical and impurities. RESULTSThe range of RCP values obtained was 98.0–99.9% (mean=99.3%) by the standard method and 98.1–99.9% (mean=99.2%) by the new method. We observed no differences between the RCP values of both methods (P=0.070). CONCLUSIONThe proposed method is suitable for RCP testing because it yields results that are in good agreement with those of the standard method and because it is easier to perform as the mobile-phase solution need not be prepared in advance.</description><subject>Chromatography, Thin Layer - methods</subject><subject>Citric Acid</subject><subject>Glass</subject><subject>Glucose - analogs &amp; derivatives</subject><subject>Humans</subject><subject>Indium Radioisotopes</subject><subject>Radiochemistry - methods</subject><subject>Radiopharmaceuticals - analysis</subject><subject>Radiopharmaceuticals - standards</subject><subject>Reproducibility of Results</subject><subject>Silica Gel</subject><subject>Somatostatin - analogs &amp; derivatives</subject><subject>Somatostatin - analysis</subject><subject>Somatostatin - standards</subject><issn>0143-3636</issn><issn>1473-5628</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2011</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp9kD1PwzAQhi0EglL4BwhlYwqc7cSJx6rio1ILC8zRJbkogaQutqOq_x6jFgYGptNJz_ve6WHsisMtB53drZ5Xt1AClyRFLhPMAOQRm_Akk3GqRH7MJsATGUsl1Rk7d-4dAHKpslN2JrhOlBIwYctZtKZtNJBvTR01xka-pchi3ZmqpaGrsI82o-38LjDoRksDrX1kmohzvljHm7CRt2R8V9MFO2mwd3R5mFP29nD_On-Kly-Pi_lsGVciPBmXJWaIJAkpkRnWJNMMUHOVlqDz8FulSae5UCnkjdZaJFpVqLDhNQZGyCm72fdurPkcyfli6FxFfY9rMqMrNAjI00zyQCZ7srLGOUtNsbHdgHZXcCi-NRZBY_FXY4hdHw6M5UD1b-jHWwDyPbA1vSfrPvpxS7ZoCXvf_t_9Benhf9Q</recordid><startdate>201112</startdate><enddate>201112</enddate><creator>Salgado-Garcia, Carlos</creator><creator>Montoza-Aguado, Manuel</creator><creator>Luna-Alcaide, Ana B</creator><creator>Segovia-Gonzalez, Maria M</creator><creator>de Mora, Elena Sanchez</creator><creator>Lopez-Martin, Juana</creator><creator>Ramos-Font, Carlos</creator><creator>Jimenez-Heffernan, Amelia</creator><general>Lippincott Williams &amp; 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derivatives</topic><topic>Somatostatin - analysis</topic><topic>Somatostatin - standards</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Salgado-Garcia, Carlos</creatorcontrib><creatorcontrib>Montoza-Aguado, Manuel</creatorcontrib><creatorcontrib>Luna-Alcaide, Ana B</creatorcontrib><creatorcontrib>Segovia-Gonzalez, Maria M</creatorcontrib><creatorcontrib>de Mora, Elena Sanchez</creatorcontrib><creatorcontrib>Lopez-Martin, Juana</creatorcontrib><creatorcontrib>Ramos-Font, Carlos</creatorcontrib><creatorcontrib>Jimenez-Heffernan, Amelia</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>Nuclear medicine communications</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Salgado-Garcia, Carlos</au><au>Montoza-Aguado, Manuel</au><au>Luna-Alcaide, Ana B</au><au>Segovia-Gonzalez, Maria M</au><au>de Mora, Elena Sanchez</au><au>Lopez-Martin, Juana</au><au>Ramos-Font, Carlos</au><au>Jimenez-Heffernan, Amelia</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>A new method for the radiochemical purity measurement of 111In-pentetreotide</atitle><jtitle>Nuclear medicine communications</jtitle><addtitle>Nucl Med Commun</addtitle><date>2011-12</date><risdate>2011</risdate><volume>32</volume><issue>12</issue><spage>1241</spage><epage>1244</epage><pages>1241-1244</pages><issn>0143-3636</issn><eissn>1473-5628</eissn><abstract>OBJECTIVES AND METHODSThe recommended method for the measurement of radiochemical purity (RCP) of In-labelled pentetreotide is thin-layer chromatography with a silica gel as the stationary phase and a 0.1 N sodium citrate solution (pH 5) as the mobile phase. According to the supplier’s instructions, the mobile phase must be prepared before the test is carried out, and the recommended stationary phase is off-market. We propose a new method for RCP measurement in which the mobile phase is acid citrate dextrose, solution A, which does not need to be prepared beforehand, and thin-layer chromatography is performed with a silica gel-impregnated glass fibre sheet as the stationary phase. We used both methods to measure the percentages of radiopharmaceutical and impurities. RESULTSThe range of RCP values obtained was 98.0–99.9% (mean=99.3%) by the standard method and 98.1–99.9% (mean=99.2%) by the new method. We observed no differences between the RCP values of both methods (P=0.070). 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subjects Chromatography, Thin Layer - methods
Citric Acid
Glass
Glucose - analogs & derivatives
Humans
Indium Radioisotopes
Radiochemistry - methods
Radiopharmaceuticals - analysis
Radiopharmaceuticals - standards
Reproducibility of Results
Silica Gel
Somatostatin - analogs & derivatives
Somatostatin - analysis
Somatostatin - standards
title A new method for the radiochemical purity measurement of 111In-pentetreotide
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