Development of C-reactive protein certified reference material NMIJ CRM 6201-b: optimization of a hydrolysis process to improve the accuracy of amino acid analysis
To standardize C-reactive protein (CRP) assays, the National Metrology Institute of Japan (NMIJ) has developed a C-reactive protein solution certified reference material, CRM 6201-b, which is intended for use as a primary reference material to enable the SI-traceable measurement of CRP. This study d...
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| Veröffentlicht in: | Analytical and bioanalytical chemistry 2015-04, Vol.407 (11), p.3137-3146 |
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| creator | Kato, Megumi Kinumi, Tomoya Yoshioka, Mariko Goto, Mari Fujii, Shin-ichiro Takatsu, Akiko |
| description | To standardize C-reactive protein (CRP) assays, the National Metrology Institute of Japan (NMIJ) has developed a C-reactive protein solution certified reference material, CRM 6201-b, which is intended for use as a primary reference material to enable the SI-traceable measurement of CRP. This study describes the development process of CRM 6201-b. As a candidate material of the CRM, recombinant human CRP solution was selected because of its higher purity and homogeneity than the purified material from human serum. Gel filtration chromatography was used to examine the homogeneity and stability of the present CRM. The total protein concentration of CRP in the present CRM was determined by amino acid analysis coupled to isotope-dilution mass spectrometry (IDMS-AAA). To improve the accuracy of IDMS-AAA, we optimized the hydrolysis process by examining the effect of parameters such as the volume of protein samples taken for hydrolysis, the procedure of sample preparation prior to the hydrolysis, hydrolysis temperature, and hydrolysis time. Under optimized conditions, we conducted two independent approaches in which the following independent hydrolysis and liquid chromatography-isotope dilution mass spectrometry (LC-IDMS) were combined: one was vapor-phase acid hydrolysis (130 °C, 24 h) and hydrophilic interaction liquid chromatography-mass spectrometry (HILIC-MS) method, and the other was microwave-assisted liquid-phase acid hydrolysis (150 °C, 3 h) and pre-column derivatization liquid chromatography-tandem mass spectrometry (LC-MS/MS) method. The quantitative values of the two different amino acid analyses were in agreement within their uncertainties. The certified value was the weighted mean of the results of the two methods. Uncertainties from the value-assignment method, between-method variance, homogeneity, long-term stability, and short-term stability were taken into account in evaluating the uncertainty for a certified value. The certified value and the expanded uncertainty (
k
= 2) of CRM 6201-b are (40.0 ± 1.6) μmol kg
–1
. |
| doi_str_mv | 10.1007/s00216-014-8190-0 |
| format | Article |
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k
= 2) of CRM 6201-b are (40.0 ± 1.6) μmol kg
–1
.</description><identifier>ISSN: 1618-2642</identifier><identifier>EISSN: 1618-2650</identifier><identifier>DOI: 10.1007/s00216-014-8190-0</identifier><identifier>PMID: 25303928</identifier><language>eng</language><publisher>Berlin/Heidelberg: Springer Berlin Heidelberg</publisher><subject>Accuracy ; Amino acids ; Amino Acids - analysis ; Amino Acids - standards ; Analytical Chemistry ; Biochemistry ; C-Reactive Protein - analysis ; C-Reactive Protein - standards ; Calibration ; Characterization and Evaluation of Materials ; Chemical analysis ; Chemistry ; Chemistry and Materials Science ; Chromatography ; Chromatography, Gel - methods ; Chromatography, Gel - standards ; Chromatography, High Pressure Liquid - methods ; Chromatography, High Pressure Liquid - standards ; Food Science ; Homogeneity ; Humans ; Hydrolysis ; Laboratory Medicine ; Liquid chromatography ; Liquids ; Mass spectrometry ; Mass Spectrometry - methods ; Mass Spectrometry - standards ; Methods ; Microwaves ; Monitoring/Environmental Analysis ; Optimization ; Peptides ; Proteins ; Radioisotope Dilution Technique - standards ; Recombinant Proteins - analysis ; Recombinant Proteins - standards ; Reference materials ; Reference Materials for Chemical Analysis ; Reference Standards ; Research Paper ; Sample preparation ; Scientific imaging ; Tandem Mass Spectrometry - methods ; Tandem Mass Spectrometry - standards ; Temperature ; Uncertainty</subject><ispartof>Analytical and bioanalytical chemistry, 2015-04, Vol.407 (11), p.3137-3146</ispartof><rights>Springer-Verlag Berlin Heidelberg 2014</rights><rights>Springer-Verlag Berlin Heidelberg 2015</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c471t-e4b2f76a10023a32f5c58040942a9cb51894f1ad66e91ab8d1a8a24eb396b7193</citedby><cites>FETCH-LOGICAL-c471t-e4b2f76a10023a32f5c58040942a9cb51894f1ad66e91ab8d1a8a24eb396b7193</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://link.springer.com/content/pdf/10.1007/s00216-014-8190-0$$EPDF$$P50$$Gspringer$$H</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1007/s00216-014-8190-0$$EHTML$$P50$$Gspringer$$H</linktohtml><link.rule.ids>314,776,780,27901,27902,41464,42533,51294</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/25303928$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Kato, Megumi</creatorcontrib><creatorcontrib>Kinumi, Tomoya</creatorcontrib><creatorcontrib>Yoshioka, Mariko</creatorcontrib><creatorcontrib>Goto, Mari</creatorcontrib><creatorcontrib>Fujii, Shin-ichiro</creatorcontrib><creatorcontrib>Takatsu, Akiko</creatorcontrib><title>Development of C-reactive protein certified reference material NMIJ CRM 6201-b: optimization of a hydrolysis process to improve the accuracy of amino acid analysis</title><title>Analytical and bioanalytical chemistry</title><addtitle>Anal Bioanal Chem</addtitle><addtitle>Anal Bioanal Chem</addtitle><description>To standardize C-reactive protein (CRP) assays, the National Metrology Institute of Japan (NMIJ) has developed a C-reactive protein solution certified reference material, CRM 6201-b, which is intended for use as a primary reference material to enable the SI-traceable measurement of CRP. This study describes the development process of CRM 6201-b. As a candidate material of the CRM, recombinant human CRP solution was selected because of its higher purity and homogeneity than the purified material from human serum. Gel filtration chromatography was used to examine the homogeneity and stability of the present CRM. The total protein concentration of CRP in the present CRM was determined by amino acid analysis coupled to isotope-dilution mass spectrometry (IDMS-AAA). To improve the accuracy of IDMS-AAA, we optimized the hydrolysis process by examining the effect of parameters such as the volume of protein samples taken for hydrolysis, the procedure of sample preparation prior to the hydrolysis, hydrolysis temperature, and hydrolysis time. Under optimized conditions, we conducted two independent approaches in which the following independent hydrolysis and liquid chromatography-isotope dilution mass spectrometry (LC-IDMS) were combined: one was vapor-phase acid hydrolysis (130 °C, 24 h) and hydrophilic interaction liquid chromatography-mass spectrometry (HILIC-MS) method, and the other was microwave-assisted liquid-phase acid hydrolysis (150 °C, 3 h) and pre-column derivatization liquid chromatography-tandem mass spectrometry (LC-MS/MS) method. The quantitative values of the two different amino acid analyses were in agreement within their uncertainties. The certified value was the weighted mean of the results of the two methods. Uncertainties from the value-assignment method, between-method variance, homogeneity, long-term stability, and short-term stability were taken into account in evaluating the uncertainty for a certified value. The certified value and the expanded uncertainty (
k
= 2) of CRM 6201-b are (40.0 ± 1.6) μmol kg
–1
.</description><subject>Accuracy</subject><subject>Amino acids</subject><subject>Amino Acids - analysis</subject><subject>Amino Acids - standards</subject><subject>Analytical Chemistry</subject><subject>Biochemistry</subject><subject>C-Reactive Protein - analysis</subject><subject>C-Reactive Protein - standards</subject><subject>Calibration</subject><subject>Characterization and Evaluation of Materials</subject><subject>Chemical analysis</subject><subject>Chemistry</subject><subject>Chemistry and Materials Science</subject><subject>Chromatography</subject><subject>Chromatography, Gel - methods</subject><subject>Chromatography, Gel - standards</subject><subject>Chromatography, High Pressure Liquid - methods</subject><subject>Chromatography, High Pressure Liquid - standards</subject><subject>Food Science</subject><subject>Homogeneity</subject><subject>Humans</subject><subject>Hydrolysis</subject><subject>Laboratory Medicine</subject><subject>Liquid chromatography</subject><subject>Liquids</subject><subject>Mass spectrometry</subject><subject>Mass Spectrometry - methods</subject><subject>Mass Spectrometry - standards</subject><subject>Methods</subject><subject>Microwaves</subject><subject>Monitoring/Environmental Analysis</subject><subject>Optimization</subject><subject>Peptides</subject><subject>Proteins</subject><subject>Radioisotope Dilution Technique - standards</subject><subject>Recombinant Proteins - analysis</subject><subject>Recombinant Proteins - standards</subject><subject>Reference materials</subject><subject>Reference Materials for Chemical Analysis</subject><subject>Reference Standards</subject><subject>Research Paper</subject><subject>Sample preparation</subject><subject>Scientific imaging</subject><subject>Tandem Mass Spectrometry - methods</subject><subject>Tandem Mass Spectrometry - standards</subject><subject>Temperature</subject><subject>Uncertainty</subject><issn>1618-2642</issn><issn>1618-2650</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2015</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>BENPR</sourceid><recordid>eNqNkstu1TAQhiMEohd4ADbIEhs2Bo_jOA47dEqhqAUJwTqaOBPqKokPtlPp8Dq8KE5PqRASgpVv33xj2X9RPAHxAoSoX0YhJGguQHEDjeDiXnEIGgyXuhL37-ZKHhRHMV4JAZUB_bA4kFUpykaaw-LHCV3T6LcTzYn5gW14ILTJXRPbBp_IzcxSSG5w1LNAAwWaLbEJEwWHI_twcfaebT5dMC0F8O4V89vkJvcdk_PzKkR2ueuDH3fRxVVpKUaWPHNTXuQu6ZIYWrsEtLsbfnKzzzuuZzjjTdmj4sGAY6THt-Nx8eX0zefNO37-8e3Z5vU5t6qGxEl1cqg15qeRJZZyqGxlhBKNktjYrgLTqAGw15oawM70gAaloq5sdFdDUx4Xz_fefLNvC8XUTi5aGkecyS-xhVrp7NAg_41qU9WNKUv4D1RnMEurjD77A73yS8ivsPaulC5lXa8U7CkbfIz5T9ptcBOGXQuiXXPR7nPR5ly0ay5akWue3pqXbqL-ruJXEDIg90DMR_NXCr-1_qv1JxgPwhY</recordid><startdate>20150401</startdate><enddate>20150401</enddate><creator>Kato, Megumi</creator><creator>Kinumi, Tomoya</creator><creator>Yoshioka, Mariko</creator><creator>Goto, Mari</creator><creator>Fujii, Shin-ichiro</creator><creator>Takatsu, Akiko</creator><general>Springer Berlin Heidelberg</general><general>Springer Nature B.V</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>3V.</scope><scope>7QF</scope><scope>7QO</scope><scope>7QQ</scope><scope>7SC</scope><scope>7SE</scope><scope>7SP</scope><scope>7SR</scope><scope>7TA</scope><scope>7TB</scope><scope>7U5</scope><scope>7U7</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8BQ</scope><scope>8FD</scope><scope>8FE</scope><scope>8FG</scope><scope>8FH</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABJCF</scope><scope>ABUWG</scope><scope>AEUYN</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BBNVY</scope><scope>BENPR</scope><scope>BGLVJ</scope><scope>BHPHI</scope><scope>C1K</scope><scope>CCPQU</scope><scope>D1I</scope><scope>DWQXO</scope><scope>F28</scope><scope>FR3</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>H8D</scope><scope>H8G</scope><scope>HCIFZ</scope><scope>JG9</scope><scope>JQ2</scope><scope>K9.</scope><scope>KB.</scope><scope>KR7</scope><scope>L7M</scope><scope>LK8</scope><scope>L~C</scope><scope>L~D</scope><scope>M0S</scope><scope>M1P</scope><scope>M7P</scope><scope>P64</scope><scope>PDBOC</scope><scope>PHGZM</scope><scope>PHGZT</scope><scope>PJZUB</scope><scope>PKEHL</scope><scope>PPXIY</scope><scope>PQEST</scope><scope>PQGLB</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>7X8</scope><scope>7QH</scope><scope>7UA</scope></search><sort><creationdate>20150401</creationdate><title>Development of C-reactive protein certified reference material NMIJ CRM 6201-b: optimization of a hydrolysis process to improve the accuracy of amino acid analysis</title><author>Kato, Megumi ; Kinumi, Tomoya ; Yoshioka, Mariko ; Goto, Mari ; Fujii, Shin-ichiro ; Takatsu, Akiko</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c471t-e4b2f76a10023a32f5c58040942a9cb51894f1ad66e91ab8d1a8a24eb396b7193</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2015</creationdate><topic>Accuracy</topic><topic>Amino acids</topic><topic>Amino Acids - analysis</topic><topic>Amino Acids - standards</topic><topic>Analytical Chemistry</topic><topic>Biochemistry</topic><topic>C-Reactive Protein - analysis</topic><topic>C-Reactive Protein - standards</topic><topic>Calibration</topic><topic>Characterization and Evaluation of Materials</topic><topic>Chemical analysis</topic><topic>Chemistry</topic><topic>Chemistry and Materials Science</topic><topic>Chromatography</topic><topic>Chromatography, Gel - methods</topic><topic>Chromatography, Gel - standards</topic><topic>Chromatography, High Pressure Liquid - methods</topic><topic>Chromatography, High Pressure Liquid - standards</topic><topic>Food Science</topic><topic>Homogeneity</topic><topic>Humans</topic><topic>Hydrolysis</topic><topic>Laboratory Medicine</topic><topic>Liquid chromatography</topic><topic>Liquids</topic><topic>Mass spectrometry</topic><topic>Mass Spectrometry - methods</topic><topic>Mass Spectrometry - standards</topic><topic>Methods</topic><topic>Microwaves</topic><topic>Monitoring/Environmental Analysis</topic><topic>Optimization</topic><topic>Peptides</topic><topic>Proteins</topic><topic>Radioisotope Dilution Technique - standards</topic><topic>Recombinant Proteins - analysis</topic><topic>Recombinant Proteins - standards</topic><topic>Reference materials</topic><topic>Reference Materials for Chemical Analysis</topic><topic>Reference Standards</topic><topic>Research Paper</topic><topic>Sample preparation</topic><topic>Scientific imaging</topic><topic>Tandem Mass Spectrometry - methods</topic><topic>Tandem Mass Spectrometry - standards</topic><topic>Temperature</topic><topic>Uncertainty</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Kato, Megumi</creatorcontrib><creatorcontrib>Kinumi, Tomoya</creatorcontrib><creatorcontrib>Yoshioka, Mariko</creatorcontrib><creatorcontrib>Goto, Mari</creatorcontrib><creatorcontrib>Fujii, Shin-ichiro</creatorcontrib><creatorcontrib>Takatsu, Akiko</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Aluminium Industry Abstracts</collection><collection>Biotechnology Research Abstracts</collection><collection>Ceramic Abstracts</collection><collection>Computer and Information Systems Abstracts</collection><collection>Corrosion Abstracts</collection><collection>Electronics & Communications Abstracts</collection><collection>Engineered Materials Abstracts</collection><collection>Materials Business File</collection><collection>Mechanical & Transportation Engineering Abstracts</collection><collection>Solid State and Superconductivity Abstracts</collection><collection>Toxicology Abstracts</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>METADEX</collection><collection>Technology Research Database</collection><collection>ProQuest SciTech Collection</collection><collection>ProQuest Technology Collection</collection><collection>ProQuest Natural Science Collection</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>Materials Science & Engineering Collection</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest One Sustainability</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central Essentials</collection><collection>Biological Science Collection</collection><collection>ProQuest Central</collection><collection>Technology Collection</collection><collection>Natural Science Collection</collection><collection>Environmental Sciences and Pollution Management</collection><collection>ProQuest One Community College</collection><collection>ProQuest Materials Science Collection</collection><collection>ProQuest Central Korea</collection><collection>ANTE: Abstracts in New Technology & Engineering</collection><collection>Engineering Research Database</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Central Student</collection><collection>Aerospace Database</collection><collection>Copper Technical Reference Library</collection><collection>SciTech Premium Collection</collection><collection>Materials Research Database</collection><collection>ProQuest Computer Science Collection</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Materials Science Database</collection><collection>Civil Engineering Abstracts</collection><collection>Advanced Technologies Database with Aerospace</collection><collection>ProQuest Biological Science Collection</collection><collection>Computer and Information Systems Abstracts Academic</collection><collection>Computer and Information Systems Abstracts Professional</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>Biological Science Database</collection><collection>Biotechnology and BioEngineering Abstracts</collection><collection>Materials Science Collection</collection><collection>ProQuest Central (New)</collection><collection>ProQuest One Academic (New)</collection><collection>ProQuest Health & Medical Research Collection</collection><collection>ProQuest One Academic Middle East (New)</collection><collection>ProQuest One Health & Nursing</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Applied & Life Sciences</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>MEDLINE - Academic</collection><collection>Aqualine</collection><collection>Water Resources Abstracts</collection><jtitle>Analytical and bioanalytical chemistry</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Kato, Megumi</au><au>Kinumi, Tomoya</au><au>Yoshioka, Mariko</au><au>Goto, Mari</au><au>Fujii, Shin-ichiro</au><au>Takatsu, Akiko</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Development of C-reactive protein certified reference material NMIJ CRM 6201-b: optimization of a hydrolysis process to improve the accuracy of amino acid analysis</atitle><jtitle>Analytical and bioanalytical chemistry</jtitle><stitle>Anal Bioanal Chem</stitle><addtitle>Anal Bioanal Chem</addtitle><date>2015-04-01</date><risdate>2015</risdate><volume>407</volume><issue>11</issue><spage>3137</spage><epage>3146</epage><pages>3137-3146</pages><issn>1618-2642</issn><eissn>1618-2650</eissn><abstract>To standardize C-reactive protein (CRP) assays, the National Metrology Institute of Japan (NMIJ) has developed a C-reactive protein solution certified reference material, CRM 6201-b, which is intended for use as a primary reference material to enable the SI-traceable measurement of CRP. This study describes the development process of CRM 6201-b. As a candidate material of the CRM, recombinant human CRP solution was selected because of its higher purity and homogeneity than the purified material from human serum. Gel filtration chromatography was used to examine the homogeneity and stability of the present CRM. The total protein concentration of CRP in the present CRM was determined by amino acid analysis coupled to isotope-dilution mass spectrometry (IDMS-AAA). To improve the accuracy of IDMS-AAA, we optimized the hydrolysis process by examining the effect of parameters such as the volume of protein samples taken for hydrolysis, the procedure of sample preparation prior to the hydrolysis, hydrolysis temperature, and hydrolysis time. Under optimized conditions, we conducted two independent approaches in which the following independent hydrolysis and liquid chromatography-isotope dilution mass spectrometry (LC-IDMS) were combined: one was vapor-phase acid hydrolysis (130 °C, 24 h) and hydrophilic interaction liquid chromatography-mass spectrometry (HILIC-MS) method, and the other was microwave-assisted liquid-phase acid hydrolysis (150 °C, 3 h) and pre-column derivatization liquid chromatography-tandem mass spectrometry (LC-MS/MS) method. The quantitative values of the two different amino acid analyses were in agreement within their uncertainties. The certified value was the weighted mean of the results of the two methods. Uncertainties from the value-assignment method, between-method variance, homogeneity, long-term stability, and short-term stability were taken into account in evaluating the uncertainty for a certified value. The certified value and the expanded uncertainty (
k
= 2) of CRM 6201-b are (40.0 ± 1.6) μmol kg
–1
.</abstract><cop>Berlin/Heidelberg</cop><pub>Springer Berlin Heidelberg</pub><pmid>25303928</pmid><doi>10.1007/s00216-014-8190-0</doi><tpages>10</tpages></addata></record> |
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| subjects | Accuracy Amino acids Amino Acids - analysis Amino Acids - standards Analytical Chemistry Biochemistry C-Reactive Protein - analysis C-Reactive Protein - standards Calibration Characterization and Evaluation of Materials Chemical analysis Chemistry Chemistry and Materials Science Chromatography Chromatography, Gel - methods Chromatography, Gel - standards Chromatography, High Pressure Liquid - methods Chromatography, High Pressure Liquid - standards Food Science Homogeneity Humans Hydrolysis Laboratory Medicine Liquid chromatography Liquids Mass spectrometry Mass Spectrometry - methods Mass Spectrometry - standards Methods Microwaves Monitoring/Environmental Analysis Optimization Peptides Proteins Radioisotope Dilution Technique - standards Recombinant Proteins - analysis Recombinant Proteins - standards Reference materials Reference Materials for Chemical Analysis Reference Standards Research Paper Sample preparation Scientific imaging Tandem Mass Spectrometry - methods Tandem Mass Spectrometry - standards Temperature Uncertainty |
| title | Development of C-reactive protein certified reference material NMIJ CRM 6201-b: optimization of a hydrolysis process to improve the accuracy of amino acid analysis |
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