{"id":"https://openalex.org/W4393345274","doi":"https://doi.org/10.14233/ajchem.2024.31178","title":"Trace Level Quantification of Genotoxic Impurities through Atmospheric Pressure Chemical Ionization (APCI) Coupled with Triple Quardrapole Analyzer in Combination Diabetic Drug Product","display_name":"Trace Level Quantification of Genotoxic Impurities through Atmospheric Pressure Chemical Ionization (APCI) Coupled with Triple Quardrapole Analyzer in Combination Diabetic Drug Product","publication_year":2024,"publication_date":"2024-03-30","ids":{"openalex":"https://openalex.org/W4393345274","doi":"https://doi.org/10.14233/ajchem.2024.31178"},"language":"en","primary_location":{"id":"doi:10.14233/ajchem.2024.31178","doi":"https://doi.org/10.14233/ajchem.2024.31178","is_oa":true,"landing_page_url":"https://doi.org/10.14233/ajchem.2024.31178","pdf_url":"https://asianpubs.org/index.php/ajchem/article/download/36_4_4/36_4_4","source":{"id":"https://openalex.org/S194824834","display_name":"Asian Journal of Chemistry","issn_l":"0970-7077","issn":["0970-7077","0975-427X"],"is_oa":true,"is_in_doaj":false,"is_core":true,"listed_in":["cwts-core","jufo-1","norway-1","poland-20","russia-white-list-4"],"host_organization":"https://openalex.org/P4322697052","host_organization_name":"ASIAN PUBLICATION CORPORATION","host_organization_lineage":["https://openalex.org/P4322697052"],"host_organization_lineage_names":["ASIAN PUBLICATION CORPORATION"],"type":"journal"},"license":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Asian Journal of Chemistry","raw_type":"journal-article"},"volume":null,"type":"article","is_traditional":true,"indexed_in":["crossref"],"open_access":{"is_oa":true,"oa_status":"diamond","oa_url":"https://asianpubs.org/index.php/ajchem/article/download/36_4_4/36_4_4","any_repository_has_fulltext":false},"authorships":[{"author_position":"first","author":{"id":"https://openalex.org/A5102876840","display_name":"Mehul Pathak","orcid":"https://orcid.org/0009-0007-8567-7481","observed_orcids":["https://orcid.org/0009-0007-8567-7481"]},"institutions":[{"id":"https://openalex.org/I4387154200","display_name":"Sankalchand Patel University","ror":"https://ror.org/037y7xs42","country_code":"IN","type":"education","lineage":["https://openalex.org/I4387154200"]}],"countries":["IN"],"is_corresponding":false,"raw_author_name":"Mehul Pathak","raw_affiliation_strings":["Department of Chemistry, Smt. S.S. Patel Nootan Science & Commerce College, Sankalchand Patel University, Visnagar-384315, India"],"raw_orcid":"https://orcid.org/0009-0007-8567-7481","affiliations":[{"raw_affiliation_string":"Department of Chemistry, Smt. S.S. Patel Nootan Science & Commerce College, Sankalchand Patel University, Visnagar-384315, India","institution_ids":["https://openalex.org/I4387154200"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5102857836","display_name":"Dhara D. Patel","orcid":"https://orcid.org/0000-0003-3047-631X","observed_orcids":["https://orcid.org/0000-0003-3047-631X"]},"institutions":[{"id":"https://openalex.org/I4387154200","display_name":"Sankalchand Patel University","ror":"https://ror.org/037y7xs42","country_code":"IN","type":"education","lineage":["https://openalex.org/I4387154200"]}],"countries":["IN"],"is_corresponding":true,"raw_author_name":"Dhara D. Patel","raw_affiliation_strings":["Department of Chemistry, Smt. S.S. Patel Nootan Science & Commerce College, Sankalchand Patel University, Visnagar-384315, India"],"raw_orcid":"https://orcid.org/0000-0003-3047-631X","affiliations":[{"raw_affiliation_string":"Department of Chemistry, Smt. S.S. Patel Nootan Science & Commerce College, Sankalchand Patel University, Visnagar-384315, India","institution_ids":["https://openalex.org/I4387154200"]}]},{"author_position":"middle","author":{"id":null,"display_name":"Dalip Sharma","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I4210108063","display_name":"Cadila Pharmaceuticals (India)","ror":"https://ror.org/01yknwh75","country_code":"IN","type":"company","lineage":["https://openalex.org/I4210108063"]}],"countries":["IN"],"is_corresponding":false,"raw_author_name":"Dalip Sharma","raw_affiliation_strings":["Analytical Research Laboratory, Cadila Pharmaceuticals Ltd., Dholka, Ahmedabad-382225, India"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Analytical Research Laboratory, Cadila Pharmaceuticals Ltd., Dholka, Ahmedabad-382225, India","institution_ids":["https://openalex.org/I4210108063"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5104884367","display_name":"Avineesh Singh","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I4210108063","display_name":"Cadila Pharmaceuticals (India)","ror":"https://ror.org/01yknwh75","country_code":"IN","type":"company","lineage":["https://openalex.org/I4210108063"]}],"countries":["IN"],"is_corresponding":false,"raw_author_name":"Avineesh Singh","raw_affiliation_strings":["Analytical Research Laboratory, Cadila Pharmaceuticals Ltd., Dholka, Ahmedabad-382225, India"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Analytical Research Laboratory, Cadila Pharmaceuticals Ltd., Dholka, Ahmedabad-382225, India","institution_ids":["https://openalex.org/I4210108063"]}]},{"author_position":"last","author":{"id":null,"display_name":"Suresh Agrawal","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I4210108063","display_name":"Cadila Pharmaceuticals (India)","ror":"https://ror.org/01yknwh75","country_code":"IN","type":"company","lineage":["https://openalex.org/I4210108063"]}],"countries":["IN"],"is_corresponding":false,"raw_author_name":"Suresh Agrawal","raw_affiliation_strings":["Analytical Research Laboratory, Cadila Pharmaceuticals Ltd., Dholka, Ahmedabad-382225, India"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Analytical Research Laboratory, Cadila Pharmaceuticals Ltd., Dholka, Ahmedabad-382225, India","institution_ids":["https://openalex.org/I4210108063"]}]}],"institutions":[],"countries_distinct_count":1,"institutions_distinct_count":2,"corresponding_author_ids":["https://openalex.org/A5102857836"],"corresponding_institution_ids":["https://openalex.org/I4387154200"],"apc_list":null,"apc_paid":null,"fwci":0.3783,"has_fulltext":true,"cited_by_count":3,"citation_normalized_percentile":{"value":0.4056157,"is_in_top_1_percent":false,"is_in_top_10_percent":false},"cited_by_percentile_year":{"min":91,"max":95},"biblio":{"volume":"36","issue":"4","first_page":"795","last_page":"801"},"is_retracted":false,"is_paratext":false,"is_xpac":false,"primary_topic":{"id":"https://openalex.org/T11460","display_name":"Analytical Methods in Pharmaceuticals","score":0.9990000128746033,"subfield":{"id":"https://openalex.org/subfields/1602","display_name":"Analytical Chemistry"},"field":{"id":"https://openalex.org/fields/16","display_name":"Chemistry"},"domain":{"id":"https://openalex.org/domains/3","display_name":"Physical Sciences"}},"topics":[{"id":"https://openalex.org/T11460","display_name":"Analytical Methods in Pharmaceuticals","score":0.9990000128746033,"subfield":{"id":"https://openalex.org/subfields/1602","display_name":"Analytical Chemistry"},"field":{"id":"https://openalex.org/fields/16","display_name":"Chemistry"},"domain":{"id":"https://openalex.org/domains/3","display_name":"Physical Sciences"}},{"id":"https://openalex.org/T12878","display_name":"Pharmaceutical Quality and Counterfeiting","score":0.0005000000237487257,"subfield":{"id":"https://openalex.org/subfields/2739","display_name":"Public Health, Environmental and Occupational Health"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}},{"id":"https://openalex.org/T11423","display_name":"Pesticide Residue Analysis and Safety","score":0.00019999999494757503,"subfield":{"id":"https://openalex.org/subfields/1106","display_name":"Food Science"},"field":{"id":"https://openalex.org/fields/11","display_name":"Agricultural and Biological Sciences"},"domain":{"id":"https://openalex.org/domains/1","display_name":"Life Sciences"}}],"keywords":[{"id":"https://openalex.org/keywords/nitrosamine-impurities","display_name":"nitrosamine impurities","score":0.9309999942779541},{"id":"https://openalex.org/keywords/genotoxic-impurities","display_name":"genotoxic impurities","score":0.8820000290870667},{"id":"https://openalex.org/keywords/vildagliptin","display_name":"vildagliptin","score":0.871999979019165},{"id":"https://openalex.org/keywords/metformin","display_name":"metformin","score":1.0},{"id":"https://openalex.org/keywords/n-nitrosodimethylamine","display_name":"N-nitrosodimethylamine","score":0.7279999852180481},{"id":"https://openalex.org/keywords/national-medical-products-administration","display_name":"National Medical Products Administration","score":0.7070000171661377},{"id":"https://openalex.org/keywords/diethylnitrosamine","display_name":"diethylnitrosamine","score":0.7630000114440918},{"id":"https://openalex.org/keywords/atmospheric-pressure-chemical-ionization","display_name":"atmospheric pressure chemical ionization","score":0.8809999823570251},{"id":"https://openalex.org/keywords/triple-quadrupole-mass-spectrometry","display_name":"triple quadrupole mass spectrometry","score":0.8119999766349792},{"id":"https://openalex.org/keywords/lc-ms-ms-method-validation","display_name":"LC-MS/MS method validation","score":0.8740000128746033}],"concepts":[{"id":"https://openalex.org/C185592680","wikidata":"https://www.wikidata.org/wiki/Q2329","display_name":"Chemistry","level":0,"score":0.8995112180709839},{"id":"https://openalex.org/C148065180","wikidata":"https://www.wikidata.org/wiki/Q900711","display_name":"Atmospheric-pressure chemical ionization","level":5,"score":0.8817874789237976},{"id":"https://openalex.org/C75291252","wikidata":"https://www.wikidata.org/wiki/Q1315756","display_name":"TRACE (psycholinguistics)","level":2,"score":0.6000276803970337},{"id":"https://openalex.org/C113196181","wikidata":"https://www.wikidata.org/wiki/Q485223","display_name":"Analytical Chemistry (journal)","level":2,"score":0.5640914440155029},{"id":"https://openalex.org/C51884965","wikidata":"https://www.wikidata.org/wiki/Q471254","display_name":"Chemical ionization","level":4,"score":0.5591468811035156},{"id":"https://openalex.org/C158007255","wikidata":"https://www.wikidata.org/wiki/Q1055222","display_name":"Spectrum analyzer","level":2,"score":0.5386519432067871},{"id":"https://openalex.org/C71987851","wikidata":"https://www.wikidata.org/wiki/Q7216430","display_name":"Impurity","level":2,"score":0.5219887495040894},{"id":"https://openalex.org/C198291218","wikidata":"https://www.wikidata.org/wiki/Q190382","display_name":"Ionization","level":3,"score":0.5121781826019287},{"id":"https://openalex.org/C43617362","wikidata":"https://www.wikidata.org/wiki/Q170050","display_name":"Chromatography","level":1,"score":0.40894877910614014},{"id":"https://openalex.org/C145148216","wikidata":"https://www.wikidata.org/wiki/Q36496","display_name":"Ion","level":2,"score":0.13501662015914917},{"id":"https://openalex.org/C178790620","wikidata":"https://www.wikidata.org/wiki/Q11351","display_name":"Organic chemistry","level":1,"score":0.07037976384162903},{"id":"https://openalex.org/C119599485","wikidata":"https://www.wikidata.org/wiki/Q43035","display_name":"Electrical engineering","level":1,"score":0.0},{"id":"https://openalex.org/C41895202","wikidata":"https://www.wikidata.org/wiki/Q8162","display_name":"Linguistics","level":1,"score":0.0},{"id":"https://openalex.org/C138885662","wikidata":"https://www.wikidata.org/wiki/Q5891","display_name":"Philosophy","level":0,"score":0.0},{"id":"https://openalex.org/C127413603","wikidata":"https://www.wikidata.org/wiki/Q11023","display_name":"Engineering","level":0,"score":0.0}],"mesh":[],"locations_count":1,"locations":[{"id":"doi:10.14233/ajchem.2024.31178","doi":"https://doi.org/10.14233/ajchem.2024.31178","is_oa":true,"landing_page_url":"https://doi.org/10.14233/ajchem.2024.31178","pdf_url":"https://asianpubs.org/index.php/ajchem/article/download/36_4_4/36_4_4","source":{"id":"https://openalex.org/S194824834","display_name":"Asian Journal of Chemistry","issn_l":"0970-7077","issn":["0970-7077","0975-427X"],"is_oa":true,"is_in_doaj":false,"is_core":true,"listed_in":["cwts-core","jufo-1","norway-1","poland-20","russia-white-list-4"],"host_organization":"https://openalex.org/P4322697052","host_organization_name":"ASIAN PUBLICATION CORPORATION","host_organization_lineage":["https://openalex.org/P4322697052"],"host_organization_lineage_names":["ASIAN PUBLICATION CORPORATION"],"type":"journal"},"license":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Asian Journal of Chemistry","raw_type":"journal-article"}],"best_oa_location":{"id":"doi:10.14233/ajchem.2024.31178","doi":"https://doi.org/10.14233/ajchem.2024.31178","is_oa":true,"landing_page_url":"https://doi.org/10.14233/ajchem.2024.31178","pdf_url":"https://asianpubs.org/index.php/ajchem/article/download/36_4_4/36_4_4","source":{"id":"https://openalex.org/S194824834","display_name":"Asian Journal of Chemistry","issn_l":"0970-7077","issn":["0970-7077","0975-427X"],"is_oa":true,"is_in_doaj":false,"is_core":true,"listed_in":["cwts-core","jufo-1","norway-1","poland-20","russia-white-list-4"],"host_organization":"https://openalex.org/P4322697052","host_organization_name":"ASIAN PUBLICATION CORPORATION","host_organization_lineage":["https://openalex.org/P4322697052"],"host_organization_lineage_names":["ASIAN PUBLICATION CORPORATION"],"type":"journal"},"license":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Asian Journal of Chemistry","raw_type":"journal-article"},"sustainable_development_goals":[{"display_name":"Good health and well-being","score":0.9391000270843506,"id":"https://metadata.un.org/sdg/3"}],"study_designs":[],"awards":[],"funders":[],"has_content":{"pdf":true,"grobid_xml":true},"content_urls":{"pdf":"https://content.openalex.org/works/W4393345274.pdf","grobid_xml":"https://content.openalex.org/works/W4393345274.grobid-xml"},"referenced_works_count":7,"referenced_works":["https://openalex.org/W2011409747","https://openalex.org/W2022174370","https://openalex.org/W2920964042","https://openalex.org/W2943163745","https://openalex.org/W3098865253","https://openalex.org/W4226153983","https://openalex.org/W4244844338"],"related_works":["https://openalex.org/W4297999237","https://openalex.org/W4405811407","https://openalex.org/W7217266072","https://openalex.org/W3170568072","https://openalex.org/W4399011731","https://openalex.org/W4321438529","https://openalex.org/W4406856228","https://openalex.org/W4410440723","https://openalex.org/W3211492420","https://openalex.org/W4386151036"],"abstract_inverted_index":{"N-Nitrosamine":[0],"impurities":[1,167],"have":[2],"been":[3],"found":[4,94,125],"in":[5,31,104,112,126,204],"several":[6],"drug":[7,35,208],"products,":[8],"showing":[9],"a":[10,23],"concern":[11],"for":[12,27,48,52,56,60,64,68,72,77,117,163],"regulatory":[13],"aspects.":[14],"The":[15,37,100,184],"study":[16],"presents":[17],"the":[18,105,113,127,164,190,202],"development":[19],"and":[20,33,42,74,87,154,179,195,206],"validation":[21,186],"of":[22,89,107,115,129,174],"sensitive":[24],"LC-MS/MS":[25],"method":[26,39,185,191],"detecting":[28],"eight":[29,118,165],"nitrosamines":[30,119,203],"vildagliptin":[32,205],"metformin":[34,207],"products.":[36,209],"developed":[38],"was":[40,44,83,93,124],"specific":[41],"linearity":[43],"ranged":[45],"3.53-55.92":[46],"ppb":[47,51,55,59,63,67,71,76,109],"NDMA,":[49],"3.18-50.37":[50],"NMBA,":[53],"0.97-15.41":[54],"NDEA,":[57],"0.98-15.52":[58],"NEIPA,":[61],"1.00-15.86":[62],"NDIPA,":[65],"0.98-15.46":[66],"NDBA,":[69],"0.98-15.58":[70],"NMPA":[73],"0.7-15.32":[75],"NDPA":[78],"with":[79,110],"correlation":[80,90],"coefficient":[81,91],"(r)":[82],"more":[84,181],"than":[85,98,177,182],"0.98":[86],"square":[88],"(r2)":[92],"to":[95,200],"be":[96,198],"greater":[97],"0.96.":[99],"LOQ":[101,136],"were":[102,169],"obtained":[103],"range":[106,114,128],"0.97-3.53":[108],"%RSD":[111],"2.5-10.9%":[116],"showed":[120],"good":[121],"sensitivity.":[122],"Accuracy":[123],"98.63":[130],"\u00b1":[131,133,139,141,147,149,156,158],"5.77-125.17":[132],"3.68%":[134],"at":[135,143,151,160],"level,":[137,145],"74.77":[138],"0.83-88.17":[140],"0.15%":[142],"50%":[144],"79.93":[146],"8.47-89.00":[148],"0.61%":[150],"100%":[152],"level":[153,162],"74.67":[155],"2.31-84.03":[157],"0.93%":[159],"150%":[161],"nitrosamine":[166],"that":[168,189],"well":[170],"within":[171],"acceptance":[172],"criteria":[173],"not":[175,180],"less":[176],"70%":[178],"130%.":[183],"results":[187],"demonstrated":[188],"is":[192],"precise,":[193],"accurate":[194],"linear,":[196],"can":[197],"applied":[199],"quantify":[201]},"counts_by_year":[{"year":2026,"cited_by_count":1},{"year":2025,"cited_by_count":2}],"updated_date":"2026-11-04T10:54:05.112534","created_date":"2024-03-31T00:00:00"}