{"id":"https://openalex.org/W2339840227","doi":"https://doi.org/10.1021/acs.oprd.5b00061","title":"A Generic Industry Approach To Demonstrate Efficient Purification of Potential Mutagenic Impurities in the Synthesis of Drug Substances","display_name":"A Generic Industry Approach To Demonstrate Efficient Purification of Potential Mutagenic Impurities in the Synthesis of Drug Substances","publication_year":2015,"publication_date":"2015-07-13","ids":{"openalex":"https://openalex.org/W2339840227","doi":"https://doi.org/10.1021/acs.oprd.5b00061","mag":"2339840227"},"language":"en","primary_location":{"id":"doi:10.1021/acs.oprd.5b00061","doi":"https://doi.org/10.1021/acs.oprd.5b00061","is_oa":false,"landing_page_url":"https://doi.org/10.1021/acs.oprd.5b00061","pdf_url":null,"source":{"id":"https://openalex.org/S107255770","display_name":"Organic Process Research & Development","issn_l":"1083-6160","issn":["1083-6160","1520-586X"],"is_oa":false,"is_in_doaj":false,"is_core":true,"listed_in":["cwts-core","dongbi-b","jufo-1","norway-1","poland-100","russia-white-list-1","vabb-shw"],"host_organization":"https://openalex.org/P4310320006","host_organization_name":"American Chemical Society","host_organization_lineage":["https://openalex.org/P4310320006"],"host_organization_lineage_names":["American Chemical Society"],"type":"journal"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Organic Process Research &amp; Development","raw_type":"journal-article"},"volume":null,"type":"article","indexed_in":["crossref"],"open_access":{"is_oa":false,"oa_status":"closed","oa_url":null,"any_repository_has_fulltext":false},"authorships":[{"author_position":"first","author":{"id":"https://openalex.org/A5054025216","display_name":"Nevenka Kragelj Lapanja","orcid":"https://orcid.org/0000-0002-0225-2645","observed_orcids":["https://orcid.org/0000-0002-0225-2645"]},"institutions":[],"countries":[],"is_corresponding":true,"raw_author_name":"Nevenka Lapanja","raw_affiliation_strings":["Lek Pharmaceuticals\rd.d., Verov\u0161kova 57, 1526 Ljubljana, Slovenia"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Lek Pharmaceuticals\rd.d., Verov\u0161kova 57, 1526 Ljubljana, Slovenia","institution_ids":[]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5075335642","display_name":"Borut Zupan\u010di\u010d","orcid":null,"observed_orcids":[]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Borut Zupan\u010di\u010d","raw_affiliation_strings":["Lek Pharmaceuticals\rd.d., Verov\u0161kova 57, 1526 Ljubljana, Slovenia"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Lek Pharmaceuticals\rd.d., Verov\u0161kova 57, 1526 Ljubljana, Slovenia","institution_ids":[]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5079605620","display_name":"Renata Toplak","orcid":null,"observed_orcids":[]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Renata Toplak \u010casar","raw_affiliation_strings":["Lek Pharmaceuticals\rd.d., Verov\u0161kova 57, 1526 Ljubljana, Slovenia"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Lek Pharmaceuticals\rd.d., Verov\u0161kova 57, 1526 Ljubljana, Slovenia","institution_ids":[]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5037504530","display_name":"Damir Orki\u0107","orcid":null,"observed_orcids":[]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Damir Orki\u010d","raw_affiliation_strings":["Lek Pharmaceuticals\rd.d., Verov\u0161kova 57, 1526 Ljubljana, Slovenia"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Lek Pharmaceuticals\rd.d., Verov\u0161kova 57, 1526 Ljubljana, Slovenia","institution_ids":[]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5043281583","display_name":"Matja\u017e U\u0161tar","orcid":null,"observed_orcids":[]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Matja\u017e U\u0161tar","raw_affiliation_strings":["Lek Pharmaceuticals\rd.d., Verov\u0161kova 57, 1526 Ljubljana, Slovenia"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Lek Pharmaceuticals\rd.d., Verov\u0161kova 57, 1526 Ljubljana, Slovenia","institution_ids":[]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5080600768","display_name":"Astrid Satler","orcid":null,"observed_orcids":[]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Astrid Satler","raw_affiliation_strings":["Lek Pharmaceuticals\rd.d., Verov\u0161kova 57, 1526 Ljubljana, Slovenia"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Lek Pharmaceuticals\rd.d., Verov\u0161kova 57, 1526 Ljubljana, Slovenia","institution_ids":[]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5084774277","display_name":"Sabina Jurca","orcid":null,"observed_orcids":[]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Sabina Jurca","raw_affiliation_strings":["Lek Pharmaceuticals\rd.d., Verov\u0161kova 57, 1526 Ljubljana, Slovenia"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Lek Pharmaceuticals\rd.d., Verov\u0161kova 57, 1526 Ljubljana, Slovenia","institution_ids":[]}]},{"author_position":"last","author":{"id":"https://openalex.org/A5082474963","display_name":"Bojan Doljak","orcid":"https://orcid.org/0009-0005-0741-3830","observed_orcids":["https://orcid.org/0009-0005-0741-3830"]},"institutions":[{"id":"https://openalex.org/I153976015","display_name":"University of Ljubljana","ror":"https://ror.org/05njb9z20","country_code":"SI","type":"education","lineage":["https://openalex.org/I153976015"]}],"countries":["SI"],"is_corresponding":false,"raw_author_name":"Bojan Doljak","raw_affiliation_strings":["Faculty of Pharmacy, University of Ljubljana, A\u0161ker\u010deva 7, 1000 Ljubljana, Slovenia"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Faculty of Pharmacy, University of Ljubljana, A\u0161ker\u010deva 7, 1000 Ljubljana, Slovenia","institution_ids":["https://openalex.org/I153976015"]}]}],"institutions":[],"countries_distinct_count":1,"institutions_distinct_count":1,"corresponding_author_ids":["https://openalex.org/A5054025216"],"corresponding_institution_ids":[],"apc_list":{"value":4500,"currency":"USD","value_usd":4500},"apc_paid":null,"fwci":1.3025,"has_fulltext":false,"cited_by_count":12,"citation_normalized_percentile":{"value":0.78609508,"is_in_top_1_percent":false,"is_in_top_10_percent":false},"cited_by_percentile_year":{"min":89,"max":98},"biblio":{"volume":"19","issue":"11","first_page":"1524","last_page":"1530"},"is_retracted":false,"is_paratext":false,"is_xpac":false,"primary_topic":{"id":"https://openalex.org/T11460","display_name":"Analytical Methods in Pharmaceuticals","score":0.6395999789237976,"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":0.6395999789237976,"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/T13180","display_name":"Chemistry and Chemical Engineering","score":0.26269999146461487,"subfield":{"id":"https://openalex.org/subfields/2304","display_name":"Environmental Chemistry"},"field":{"id":"https://openalex.org/fields/23","display_name":"Environmental Science"},"domain":{"id":"https://openalex.org/domains/3","display_name":"Physical Sciences"}},{"id":"https://openalex.org/T11881","display_name":"Crystallization and Solubility Studies","score":0.014299999922513962,"subfield":{"id":"https://openalex.org/subfields/2505","display_name":"Materials Chemistry"},"field":{"id":"https://openalex.org/fields/25","display_name":"Materials Science"},"domain":{"id":"https://openalex.org/domains/3","display_name":"Physical Sciences"}}],"keywords":[{"id":"https://openalex.org/keywords/mutagenic-impurities","display_name":"mutagenic impurities","score":0.9480000138282776},{"id":"https://openalex.org/keywords/active-pharmaceutical-ingredients","display_name":"active pharmaceutical ingredients","score":0.6899999976158142},{"id":"https://openalex.org/keywords/vortioxetine","display_name":"vortioxetine","score":0.8830000162124634},{"id":"https://openalex.org/keywords/purification-efficiency","display_name":"purification efficiency","score":0.6990000009536743},{"id":"https://openalex.org/keywords/process-risk-assessment","display_name":"process risk assessment","score":0.36500000953674316}],"concepts":[{"id":"https://openalex.org/C2776722196","wikidata":"https://www.wikidata.org/wiki/Q1262732","display_name":"Purge","level":2,"score":0.858279824256897},{"id":"https://openalex.org/C71987851","wikidata":"https://www.wikidata.org/wiki/Q7216430","display_name":"Impurity","level":2,"score":0.7521007657051086},{"id":"https://openalex.org/C45904493","wikidata":"https://www.wikidata.org/wiki/Q912807","display_name":"Active ingredient","level":2,"score":0.669837236404419},{"id":"https://openalex.org/C185592680","wikidata":"https://www.wikidata.org/wiki/Q2329","display_name":"Chemistry","level":0,"score":0.6675680875778198},{"id":"https://openalex.org/C21951064","wikidata":"https://www.wikidata.org/wiki/Q899212","display_name":"Combinatorial chemistry","level":1,"score":0.4802165925502777},{"id":"https://openalex.org/C2780035454","wikidata":"https://www.wikidata.org/wiki/Q8386","display_name":"Drug","level":2,"score":0.47492748498916626},{"id":"https://openalex.org/C183696295","wikidata":"https://www.wikidata.org/wiki/Q2487696","display_name":"Biochemical engineering","level":1,"score":0.4563097059726715},{"id":"https://openalex.org/C43617362","wikidata":"https://www.wikidata.org/wiki/Q170050","display_name":"Chromatography","level":1,"score":0.4126214385032654},{"id":"https://openalex.org/C21880701","wikidata":"https://www.wikidata.org/wiki/Q2144042","display_name":"Process engineering","level":1,"score":0.39217156171798706},{"id":"https://openalex.org/C178790620","wikidata":"https://www.wikidata.org/wiki/Q11351","display_name":"Organic chemistry","level":1,"score":0.2501083016395569},{"id":"https://openalex.org/C548081761","wikidata":"https://www.wikidata.org/wiki/Q180388","display_name":"Waste management","level":1,"score":0.1173015832901001},{"id":"https://openalex.org/C127413603","wikidata":"https://www.wikidata.org/wiki/Q11023","display_name":"Engineering","level":0,"score":0.10734814405441284},{"id":"https://openalex.org/C98274493","wikidata":"https://www.wikidata.org/wiki/Q128406","display_name":"Pharmacology","level":1,"score":0.10690692067146301},{"id":"https://openalex.org/C71924100","wikidata":"https://www.wikidata.org/wiki/Q11190","display_name":"Medicine","level":0,"score":0.0}],"mesh":[],"locations_count":1,"locations":[{"id":"doi:10.1021/acs.oprd.5b00061","doi":"https://doi.org/10.1021/acs.oprd.5b00061","is_oa":false,"landing_page_url":"https://doi.org/10.1021/acs.oprd.5b00061","pdf_url":null,"source":{"id":"https://openalex.org/S107255770","display_name":"Organic Process Research & Development","issn_l":"1083-6160","issn":["1083-6160","1520-586X"],"is_oa":false,"is_in_doaj":false,"is_core":true,"listed_in":["cwts-core","dongbi-b","jufo-1","norway-1","poland-100","russia-white-list-1","vabb-shw"],"host_organization":"https://openalex.org/P4310320006","host_organization_name":"American Chemical Society","host_organization_lineage":["https://openalex.org/P4310320006"],"host_organization_lineage_names":["American Chemical Society"],"type":"journal"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Organic Process Research &amp; Development","raw_type":"journal-article"}],"best_oa_location":null,"sustainable_development_goals":[],"study_designs":[],"awards":[],"funders":[],"has_content":{"pdf":false,"grobid_xml":false},"content_urls":null,"referenced_works_count":13,"referenced_works":["https://openalex.org/W1709109739","https://openalex.org/W1976917904","https://openalex.org/W1994053770","https://openalex.org/W2002331381","https://openalex.org/W2014433035","https://openalex.org/W2018151649","https://openalex.org/W2022975283","https://openalex.org/W2027451083","https://openalex.org/W2088230515","https://openalex.org/W2148690874","https://openalex.org/W2163433231","https://openalex.org/W2325914382","https://openalex.org/W2334227121"],"related_works":["https://openalex.org/W2611963600","https://openalex.org/W2515428665","https://openalex.org/W2401834187","https://openalex.org/W2773188590","https://openalex.org/W2325914382","https://openalex.org/W2978193130","https://openalex.org/W3134798475","https://openalex.org/W2787545230","https://openalex.org/W4416075069","https://openalex.org/W2022975283"],"abstract_inverted_index":{"Determination":[0],"of":[1,8,10,12,35,47,67,79,106,141],"theoretical":[2],"purge":[3,53,85,99],"factors":[4,54,86],"for":[5,55],"the":[6,18,45,48,56,64,83,107,134,139],"evaluation":[7],"risk":[9],"carryover":[11],"potential":[13,36,58],"mutagenic":[14],"impurities":[15,92,124],"(MIs)":[16],"into":[17,133],"final":[19,135],"active":[20],"pharmaceutical":[21,118],"ingredient":[22],"(API)":[23],"has":[24],"been":[25],"discussed":[26],"as":[27],"a":[28,96],"possible":[29],"approach":[30,115],"to":[31,72,76,109,120,129],"demonstrate":[32],"efficient":[33],"purification":[34],"MIs":[37,59],"(Substances":[38],"I,":[39],"II,":[40],"III,":[41,82],"and":[42,81],"IV)":[43],"in":[44,70,90],"synthesis":[46],"vortioxetine":[49],"drug":[50],"substance.":[51],"Theoretical":[52],"four":[57],"were":[60,87],"determined":[61],"based":[62],"on":[63,122],"physicochemical":[65],"properties":[66],"an":[68],"MI":[69],"relation":[71],"processing":[73],"conditions.":[74],"Compared":[75],"depletion":[77],"studies":[78],"I":[80],"calculated":[84,98],"very":[88],"conservative":[89],"predicting":[91],"reduction.":[93],"However,":[94],"even":[95],"conservatively":[97],"factor":[100],"correctly":[101],"predicted":[102],"high":[103],"purging":[104],"capability":[105],"process":[108],"eliminate":[110],"substance":[111],"I.":[112],"This":[113],"novel":[114],"could":[116],"help":[117],"companies":[119],"focus":[121],"those":[123],"that":[125],"are":[126],"more":[127],"likely":[128],"be":[130],"carried":[131],"over":[132],"API,":[136],"thus":[137],"obviating":[138],"use":[140],"analytical":[142],"testing":[143],"where":[144],"not":[145],"necessary.":[146]},"counts_by_year":[{"year":2025,"cited_by_count":1},{"year":2021,"cited_by_count":4},{"year":2019,"cited_by_count":2},{"year":2017,"cited_by_count":4},{"year":2016,"cited_by_count":1}],"updated_date":"2026-10-12T09:40:04.860316","created_date":"2016-06-24T00:00:00"}
