{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,29]],"date-time":"2026-08-29T22:48:03Z","timestamp":1788043683522,"version":"build-2784847793"},"reference-count":55,"publisher":"Elsevier BV","issue":"5","license":[{"start":{"date-parts":[[2022,10,1]],"date-time":"2022-10-01T00:00:00Z","timestamp":1664582400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/tdm\/userlicense\/1.0\/"},{"start":{"date-parts":[[2022,10,1]],"date-time":"2022-10-01T00:00:00Z","timestamp":1664582400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/legal\/tdmrep-license"},{"start":{"date-parts":[[2022,3,16]],"date-time":"2022-03-16T00:00:00Z","timestamp":1647388800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/100014717","name":"National Natural Science Foundation of China National Outstanding Youth Science Fund Project","doi-asserted-by":"publisher","award":["81741144"],"award-info":[{"award-number":["81741144"]}],"id":[{"id":"10.13039\/100014717","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100001809","name":"National Natural Science Foundation of China","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100001809","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100002855","name":"Ministry of Science and Technology of the People's Republic of China","doi-asserted-by":"publisher","award":["2018ZX09J18107-002"],"award-info":[{"award-number":["2018ZX09J18107-002"]}],"id":[{"id":"10.13039\/501100002855","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["elsevier.com","sciencedirect.com"],"crossmark-restriction":true},"short-container-title":["Journal of Pharmaceutical Analysis"],"published-print":{"date-parts":[[2022,10]]},"DOI":"10.1016\/j.jpha.2022.03.003","type":"journal-article","created":{"date-parts":[[2022,3,23]],"date-time":"2022-03-23T21:37:35Z","timestamp":1648071455000},"page":"774-782","update-policy":"https:\/\/doi.org\/10.1016\/elsevier_cm_policy","source":"Crossref","is-referenced-by-count":18,"title":["Effects of polyol excipient stability during storage and use on the quality of biopharmaceutical formulations"],"prefix":"10.1016","volume":"12","author":[{"given":"Min-Fei","family":"Sun","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jia-Ning","family":"Liao","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zhen-Yi","family":"Jing","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0132-2813","authenticated-orcid":false,"given":"Han","family":"Gao","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bin-Bin","family":"Shen","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"You-Fu","family":"Xu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3375-7360","authenticated-orcid":false,"given":"Wei-Jie","family":"Fang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"78","reference":[{"key":"10.1016\/j.jpha.2022.03.003_bib1","doi-asserted-by":"crossref","first-page":"159","DOI":"10.1016\/j.copbio.2019.01.014","article-title":"Chemical and physical instabilities in manufacturing and storage of therapeutic proteins","volume":"60","author":"Krause","year":"2019","journal-title":"Curr. Opin. Biotechnol."},{"key":"10.1016\/j.jpha.2022.03.003_bib2","first-page":"1012","article-title":"Degradation of biotherapeutics during manufacturing processes and its solution","volume":"44","author":"Fang","year":"2017","journal-title":"J.\u00a0Int. Pharm. Res."},{"key":"10.1016\/j.jpha.2022.03.003_bib3","doi-asserted-by":"crossref","first-page":"2660","DOI":"10.1007\/s11095-012-0782-9","article-title":"Impact of excipient interactions on solid dosage form stability","volume":"29","author":"Narang","year":"2012","journal-title":"Pharm. Res."},{"key":"10.1016\/j.jpha.2022.03.003_bib4","doi-asserted-by":"crossref","first-page":"118505","DOI":"10.1016\/j.ijpharm.2019.118505","article-title":"Science and art of protein formulation development","volume":"568","author":"Wang","year":"2019","journal-title":"Int. J. Pharm."},{"key":"10.1016\/j.jpha.2022.03.003_bib5","doi-asserted-by":"crossref","first-page":"1584","DOI":"10.1016\/j.ijbiomac.2018.07.003","article-title":"Carboxylic acids of different nature induces aggregation of hemoglobin","volume":"118","author":"Hasan","year":"2018","journal-title":"Int. J. Biol. Macromol."},{"key":"10.1016\/j.jpha.2022.03.003_bib6","doi-asserted-by":"crossref","first-page":"42","DOI":"10.1208\/s12249-015-0403-0","article-title":"Investigating the degradation behaviors of a therapeutic monoclonal antibody associated with pH and buffer species","volume":"18","author":"Zheng","year":"2017","journal-title":"AAPS PharmSciTech"},{"key":"10.1016\/j.jpha.2022.03.003_bib7","doi-asserted-by":"crossref","first-page":"8932","DOI":"10.1021\/ac502179m","article-title":"Discovery of a chemical modification by citric acid in a recombinant monoclonal antibody","volume":"86","author":"Chumsae","year":"2014","journal-title":"Anal. Chem."},{"key":"10.1016\/j.jpha.2022.03.003_bib8","doi-asserted-by":"crossref","first-page":"8685","DOI":"10.1021\/acs.jpcb.8b06572","article-title":"Sugar-mediated stabilization of protein against chemical or thermal denaturation","volume":"122","author":"Ajito","year":"2018","journal-title":"J.\u00a0Phys. Chem. B"},{"key":"10.1016\/j.jpha.2022.03.003_bib9","doi-asserted-by":"crossref","first-page":"10182","DOI":"10.1021\/jp303898g","article-title":"Thermal and solution stability of lysozyme in the presence of sucrose, glucose, and trehalose","volume":"116","author":"James","year":"2012","journal-title":"J.\u00a0Phys. Chem. B"},{"key":"10.1016\/j.jpha.2022.03.003_bib10","doi-asserted-by":"crossref","first-page":"1315","DOI":"10.1002\/jps.23931","article-title":"Impact of residual impurities and contaminants on protein stability","volume":"103","author":"Wang","year":"2014","journal-title":"J.\u00a0Pharmacol. Sci."},{"key":"10.1016\/j.jpha.2022.03.003_bib11","doi-asserted-by":"crossref","first-page":"71","DOI":"10.1016\/j.jchromb.2012.03.016","article-title":"Residual metals cause variability in methionine oxidation measurements in protein pharmaceuticals using LC-UV\/MS peptide mapping","volume":"895\u2013896","author":"Zang","year":"2012","journal-title":"J.\u00a0Chromatogr. B Analyt. Technol. Biomed. Life Sci."},{"key":"10.1016\/j.jpha.2022.03.003_bib12","doi-asserted-by":"crossref","first-page":"505","DOI":"10.1016\/0003-9861(86)90755-1","article-title":"Cryoprotection of phosphofructokinase with organic solutes: Characterization of enhanced protection in the presence of divalent cations","volume":"250","author":"Carpenter","year":"1986","journal-title":"Arch. Biochem. Biophys."},{"key":"10.1016\/j.jpha.2022.03.003_bib13","doi-asserted-by":"crossref","first-page":"106","DOI":"10.1002\/jps.20726","article-title":"Evaluation of hydroperoxides in common pharmaceutical excipients","volume":"96","author":"Wasylaschuk","year":"2007","journal-title":"J.\u00a0Pharmacol. Sci."},{"key":"10.1016\/j.jpha.2022.03.003_bib14","doi-asserted-by":"crossref","first-page":"52","DOI":"10.1016\/j.ijpharm.2013.04.054","article-title":"Screening for stability and compatibility conditions of recombinant human epidermal growth factor for parenteral formulation: Effect of pH, buffers, and excipients","volume":"452","author":"Santana","year":"2013","journal-title":"Int. J. Pharm."},{"key":"10.1016\/j.jpha.2022.03.003_bib15","doi-asserted-by":"crossref","first-page":"906","DOI":"10.1002\/jps.24299","article-title":"Excipient variability and its impact on dosage form functionality","volume":"104","author":"Dave","year":"2015","journal-title":"J.\u00a0Pharmacol. Sci."},{"key":"10.1016\/j.jpha.2022.03.003_bib16","doi-asserted-by":"crossref","first-page":"1499","DOI":"10.1002\/jps.21119","article-title":"N-methylation and N-formylation of a secondary amine drug (varenicline) in an osmotic tablet","volume":"97","author":"Waterman","year":"2008","journal-title":"J.\u00a0Pharmacol. Sci."},{"key":"10.1016\/j.jpha.2022.03.003_bib17","doi-asserted-by":"crossref","first-page":"393","DOI":"10.1080\/10837450802244918","article-title":"Identification and control of a degradation product in Avapro film-coated tablet: Low dose formulation","volume":"13","author":"Wang","year":"2008","journal-title":"Pharmaceut. Dev. Technol."},{"key":"10.1016\/j.jpha.2022.03.003_bib18","doi-asserted-by":"crossref","first-page":"12","DOI":"10.1208\/s12249-017-0864-4","article-title":"Excipient stability in oral solid dosage forms: A review","volume":"19","author":"Darji","year":"2018","journal-title":"AAPS PharmSciTech"},{"key":"10.1016\/j.jpha.2022.03.003_bib19","doi-asserted-by":"crossref","first-page":"1676","DOI":"10.1002\/jps.2600671211","article-title":"Autoxidation of polysorbates","volume":"67","author":"Donbrow","year":"1978","journal-title":"J.\u00a0Pharmacol. Sci."},{"key":"10.1016\/j.jpha.2022.03.003_bib20","doi-asserted-by":"crossref","first-page":"2924","DOI":"10.1002\/jps.21190","article-title":"Polysorbates 20 and 80 used in the formulation of protein biotherapeutics: Structure and degradation pathways","volume":"97","author":"Kerwin","year":"2008","journal-title":"J.\u00a0Pharmacol. Sci."},{"key":"10.1016\/j.jpha.2022.03.003_bib21","first-page":"163","article-title":"Identification of antioxidants for prevention of peroxide-mediated oxidation of recombinant human ciliary neurotrophic factor and recombinant human nerve growth factor","volume":"50","author":"Knepp","year":"1996","journal-title":"PDA J. Pharm. Sci. Technol."},{"key":"10.1016\/j.jpha.2022.03.003_bib22","doi-asserted-by":"crossref","first-page":"2986","DOI":"10.1016\/j.xphs.2020.06.030","article-title":"Evaluation of super refined\u2122 polysorbate 20 with respect to polysorbate degradation, particle formation and protein stability","volume":"109","author":"Doshi","year":"2020","journal-title":"J.\u00a0Pharmacol. Sci."},{"key":"10.1016\/j.jpha.2022.03.003_bib23","doi-asserted-by":"crossref","first-page":"3805","DOI":"10.1021\/acs.molpharmaceut.5b00311","article-title":"Polysorbate 20 degradation in biopharmaceutical formulations: Quantification of free fatty acids, characterization of particulates, and insights into the degradation mechanism","volume":"12","author":"Tomlinson","year":"2015","journal-title":"Mol. Pharm."},{"key":"10.1016\/j.jpha.2022.03.003_bib24","doi-asserted-by":"crossref","first-page":"2877","DOI":"10.1007\/s11095-015-1670-x","article-title":"Identification of subvisible particles in biopharmaceutical formulations using Raman spectroscopy provides insight into polysorbate 20 degradation pathway","volume":"32","author":"Saggu","year":"2015","journal-title":"Pharm. Res."},{"key":"10.1016\/j.jpha.2022.03.003_bib25","doi-asserted-by":"crossref","first-page":"148","DOI":"10.1007\/s11095-018-2430-5","article-title":"Considerations for the use of polysorbates in biopharmaceuticals","volume":"35","author":"Jones","year":"2018","journal-title":"Pharm. Res."},{"key":"10.1016\/j.jpha.2022.03.003_bib26","doi-asserted-by":"crossref","first-page":"6S","DOI":"10.1177\/1091581819883820","article-title":"Safety assessment of glycerin as used in cosmetics","volume":"38","author":"Becker","year":"2019","journal-title":"Int. J. Toxicol."},{"key":"10.1016\/j.jpha.2022.03.003_bib27","doi-asserted-by":"crossref","first-page":"342","DOI":"10.1016\/j.ejpb.2018.03.003","article-title":"Impact of fast and conservative freeze-drying on product quality of protein-mannitol-sucrose-glycerol lyophilizates","volume":"127","author":"Horn","year":"2018","journal-title":"Eur. J. Pharm. Biopharm."},{"key":"10.1016\/j.jpha.2022.03.003_bib28","doi-asserted-by":"crossref","first-page":"400","DOI":"10.1016\/j.ijpharm.2019.05.063","article-title":"Effect of disaccharide-polyol systems on the thermal stability of freeze-dried Mycobacterium bovis","volume":"566","author":"Tan","year":"2019","journal-title":"Int. J. Pharm."},{"key":"10.1016\/j.jpha.2022.03.003_bib29","doi-asserted-by":"crossref","first-page":"1960","DOI":"10.1039\/c1gc15320j","article-title":"Selective catalytic oxidation of glycerol: Perspectives for high value chemicals","volume":"13","author":"Katryniok","year":"2011","journal-title":"Green Chem"},{"key":"10.1016\/j.jpha.2022.03.003_bib30","doi-asserted-by":"crossref","first-page":"527","DOI":"10.1039\/B707343G","article-title":"Chemoselective catalytic conversion of glycerol as a biorenewable source to valuable commodity chemicals","volume":"37","author":"Zhou","year":"2008","journal-title":"Chem. Soc. Rev."},{"key":"10.1016\/j.jpha.2022.03.003_bib31","series-title":"Preparation method of hydroxyacetone by dehydration of glycerol, China Patent CN109665952A","author":"Liu","year":"2019"},{"key":"10.1016\/j.jpha.2022.03.003_bib32","first-page":"345","article-title":"Dehydration of glycerol to acetol over copper-based catalysts","volume":"32","author":"Niu","year":"2011","journal-title":"Chin. J. Catal."},{"key":"10.1016\/j.jpha.2022.03.003_bib33","doi-asserted-by":"crossref","first-page":"879","DOI":"10.1248\/bpb.b19-01120","article-title":"Oxidative formation of methylglyoxal in glycerol preparations during storage","volume":"43","author":"Sugiura","year":"2020","journal-title":"Biol. Pharm. Bull."},{"key":"10.1016\/j.jpha.2022.03.003_bib34","series-title":"Pharmacopoeia of People's Republic of China","first-page":"490","year":"2015"},{"key":"10.1016\/j.jpha.2022.03.003_bib35","first-page":"2599","article-title":"Effectiveness of thymopentin as adjuvant therapy: An evidence-based analysis","volume":"24","author":"Xie","year":"2015","journal-title":"Chin. J. New Drugs"},{"key":"10.1016\/j.jpha.2022.03.003_bib36","first-page":"709","article-title":"Stability of thymopentin solution","volume":"38","author":"Jin","year":"2007","journal-title":"Chin. J. Pharm."},{"key":"10.1016\/j.jpha.2022.03.003_bib37","doi-asserted-by":"crossref","first-page":"298","DOI":"10.1038\/nrd1695","article-title":"Protein drug stability: A formulation challenge","volume":"4","author":"Frokjaer","year":"2005","journal-title":"Nat. Rev. Drug Discov."},{"key":"10.1016\/j.jpha.2022.03.003_bib38","series-title":"European Pharmacopoeia","first-page":"2595","year":"2017"},{"key":"10.1016\/j.jpha.2022.03.003_bib39","first-page":"57","article-title":"Progress in studies of mannitol in medicinal application","volume":"3","author":"Zhan","year":"2003","journal-title":"Chin. J. Marine Drugs"},{"key":"10.1016\/j.jpha.2022.03.003_bib40","doi-asserted-by":"crossref","first-page":"3115","DOI":"10.1021\/ja01385a034","article-title":"Studies on reactions relating to carbohydrates and polysaccharides. XXIII. Synthesis and properties of hydroxy alkylidene glycols and glycerols","volume":"51","author":"Hibbert","year":"1929","journal-title":"J.\u00a0Am. Chem. Soc."},{"key":"10.1016\/j.jpha.2022.03.003_bib41","series-title":"Inventors; United Polyols, United States patent US2888492","author":"Fisher","year":"1959"},{"key":"10.1016\/j.jpha.2022.03.003_bib42","doi-asserted-by":"crossref","first-page":"1013","DOI":"10.1021\/cs5010932","article-title":"Origins of the regioselectivity in the lutetium triflate catalyzed ketalization of acetone with glycerol: A DFT study","volume":"5","author":"Pierpont","year":"2015","journal-title":"ACS Catal"},{"key":"10.1016\/j.jpha.2022.03.003_bib43","series-title":"Organic compounds: Cycloalkanes and their stereochemistry. Organic Chemistry","first-page":"121","author":"McMurry","year":"1999"},{"key":"10.1016\/j.jpha.2022.03.003_bib44","doi-asserted-by":"crossref","first-page":"1051","DOI":"10.1021\/ja00316a039","article-title":"Ring-closure reactions. 22. Kinetics of cyclization of diethyl (.omega.-bromoalkyl)malonates in the range of 4- to 21-membered rings. Role of ring strain","volume":"106","author":"Casadei","year":"1984","journal-title":"J.\u00a0Am. Chem. Soc."},{"key":"10.1016\/j.jpha.2022.03.003_bib45","doi-asserted-by":"crossref","first-page":"1619","DOI":"10.1134\/S1070427216100094","article-title":"Choice of a catalyst and technological scheme for synthesis of solketal","volume":"89","author":"Dmitriev","year":"2016","journal-title":"Russ. J. Appl. Chem."},{"key":"10.1016\/j.jpha.2022.03.003_bib46","doi-asserted-by":"crossref","first-page":"428","DOI":"10.1016\/j.jcat.2006.11.006","article-title":"Investigations on heterogeneously catalysed condensations of glycerol to cyclic acetals","volume":"245","author":"Deutsch","year":"2007","journal-title":"J.\u00a0Catal."},{"key":"10.1016\/j.jpha.2022.03.003_bib47","doi-asserted-by":"crossref","first-page":"965","DOI":"10.1208\/s12249-017-0878-y","article-title":"Regulatory notes on impact of excipients on drug products and the Maillard reaction","volume":"19","author":"Chowdhury","year":"2018","journal-title":"AAPS PharmSciTech"},{"key":"10.1016\/j.jpha.2022.03.003_bib48","doi-asserted-by":"crossref","first-page":"297","DOI":"10.1002\/bip.20852","article-title":"Use of Merrifield solid phase peptide synthesis in investigations of biological deamidation of peptides and proteins","volume":"90","author":"Robinson","year":"2008","journal-title":"Biopolymers"},{"key":"10.1016\/j.jpha.2022.03.003_bib49","doi-asserted-by":"crossref","first-page":"2321","DOI":"10.1002\/jps.20740","article-title":"Formulation considerations for proteins susceptible to asparagine deamidation and aspartate isomerization","volume":"95","author":"Wakankar","year":"2006","journal-title":"J.\u00a0Pharmacol. Sci."},{"key":"10.1016\/j.jpha.2022.03.003_bib50","doi-asserted-by":"crossref","first-page":"8752","DOI":"10.1021\/jp8015497","article-title":"Computational study on nonenzymatic peptide bond cleavage at asparagine and aspartic acid","volume":"112","author":"Catak","year":"2008","journal-title":"J.\u00a0Phys. Chem."},{"key":"10.1016\/j.jpha.2022.03.003_bib51","series-title":"Chemical instability in peptide and protein pharmaceuticals. Formulation and Process Development Strategies for Manufacturing Biopharmaceuticals","first-page":"41","author":"Topp","year":"2010"},{"key":"10.1016\/j.jpha.2022.03.003_bib52","doi-asserted-by":"crossref","first-page":"29","DOI":"10.1016\/0378-5173(91)90160-P","article-title":"Stability of the synthetic pentapeptide thymopentin in aqueous solution: Effect of pH and buffer on degradation","volume":"70","author":"Helm","year":"1991","journal-title":"Int. J. Pharm."},{"key":"10.1016\/j.jpha.2022.03.003_bib53","doi-asserted-by":"crossref","first-page":"303","DOI":"10.1016\/j.jpha.2013.12.006","article-title":"Risk evaluation of impurities in topical excipients: The acetol case","volume":"4","author":"Boonen","year":"2014","journal-title":"J.\u00a0Pharm. Anal."},{"key":"10.1016\/j.jpha.2022.03.003_bib54","doi-asserted-by":"crossref","first-page":"815","DOI":"10.1021\/bc050340f","article-title":"Identification of formaldehyde-induced modifications in proteins: Reactions with insulin","volume":"17","author":"Metz","year":"2006","journal-title":"Bioconjugate Chem"},{"key":"10.1016\/j.jpha.2022.03.003_bib55","doi-asserted-by":"crossref","first-page":"6646","DOI":"10.1002\/anie.202016267","article-title":"Cooperative stapling of native peptides at lysine and tyrosine or arginine with formaldehyde","volume":"60","author":"Li","year":"2021","journal-title":"Angew. Chem. Int. Ed. Engl."}],"container-title":["Journal of Pharmaceutical Analysis"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S2095177922000211?httpAccept=text\/xml","content-type":"text\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S2095177922000211?httpAccept=text\/plain","content-type":"text\/plain","content-version":"vor","intended-application":"text-mining"}],"deposited":{"date-parts":[[2025,10,30]],"date-time":"2025-10-30T21:33:15Z","timestamp":1761859995000},"score":1,"resource":{"primary":{"URL":"https:\/\/linkinghub.elsevier.com\/retrieve\/pii\/S2095177922000211"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2022,10]]},"references-count":55,"journal-issue":{"issue":"5","published-print":{"date-parts":[[2022,10]]}},"alternative-id":["S2095177922000211"],"URL":"https:\/\/doi.org\/10.1016\/j.jpha.2022.03.003","relation":{},"ISSN":["2095-1779"],"issn-type":[{"value":"2095-1779","type":"print"}],"subject":[],"published":{"date-parts":[[2022,10]]},"assertion":[{"value":"Elsevier","name":"publisher","label":"This article is maintained by"},{"value":"Effects of polyol excipient stability during storage and use on the quality of biopharmaceutical formulations","name":"articletitle","label":"Article Title"},{"value":"Journal of Pharmaceutical Analysis","name":"journaltitle","label":"Journal Title"},{"value":"https:\/\/doi.org\/10.1016\/j.jpha.2022.03.003","name":"articlelink","label":"CrossRef DOI link to publisher maintained version"},{"value":"article","name":"content_type","label":"Content Type"},{"value":"\u00a9 2022 The Author(s). Published by Elsevier B.V. on behalf of Xi\u2019an Jiaotong University.","name":"copyright","label":"Copyright"}]}}