{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,9]],"date-time":"2026-10-09T06:14:17Z","timestamp":1791526457840,"version":"4.3.4"},"reference-count":58,"publisher":"Elsevier BV","license":[{"start":{"date-parts":[[2025,9,1]],"date-time":"2025-09-01T00:00:00Z","timestamp":1756684800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/tdm\/userlicense\/1.0\/"},{"start":{"date-parts":[[2025,9,1]],"date-time":"2025-09-01T00:00:00Z","timestamp":1756684800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/legal\/tdmrep-license"},{"start":{"date-parts":[[2025,6,4]],"date-time":"2025-06-04T00:00:00Z","timestamp":1748995200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100021130","name":"Bundesministerium f\u00fcr Wirtschaft und Klimaschutz","doi-asserted-by":"publisher","award":["16LP401002"],"award-info":[{"award-number":["16LP401002"]}],"id":[{"id":"10.13039\/100021130","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["elsevier.com","sciencedirect.com"],"crossmark-restriction":true},"short-container-title":["European Journal of Pharmaceutics and Biopharmaceutics"],"published-print":{"date-parts":[[2025,9]]},"DOI":"10.1016\/j.ejpb.2025.114762","type":"journal-article","created":{"date-parts":[[2025,6,4]],"date-time":"2025-06-04T19:28:20Z","timestamp":1749065300000},"page":"114762","update-policy":"https:\/\/doi.org\/10.1016\/elsevier_cm_policy","source":"Crossref","is-referenced-by-count":10,"special_numbering":"C","title":["Impurity profiling of PEGylated myristoyl diglyceride, DMG-PEG 2000, a functional excipient used in mRNA lipid nanoparticle formulations"],"prefix":"10.1016","volume":"214","author":[{"given":"Benedikt","family":"Sperber","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marcus","family":"Gutmann","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Josef","family":"Kehrein","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tessa","family":"L\u00fchmann","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ulrike","family":"Holzgrabe","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lorenz","family":"Meinel","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"78","reference":[{"key":"10.1016\/j.ejpb.2025.114762_b0005","doi-asserted-by":"crossref","DOI":"10.1002\/advs.202411032","article-title":"Targeted CRISPR\/Cas9 lipid nanoparticles elicits therapeutic genome editing in head and neck cancer","volume":"12","author":"Masarwy","year":"2025","journal-title":"Adv. Sci."},{"key":"10.1016\/j.ejpb.2025.114762_b0010","article-title":"Nucleic acid delivery by lipid nanoparticles for organ targeting","volume":"110849","author":"Guo","year":"2025","journal-title":"Chin. Chem. Lett."},{"key":"10.1016\/j.ejpb.2025.114762_b0015","doi-asserted-by":"crossref","DOI":"10.1021\/acs.molpharmaceut.4c00925","article-title":"Intelligent Design of Lipid Nanoparticles for enhanced gene therapeutics","author":"Yuan","year":"2025","journal-title":"Mol. Pharm."},{"key":"10.1016\/j.ejpb.2025.114762_b0020","doi-asserted-by":"crossref","DOI":"10.1073\/pnas.2307798120","article-title":"Recent advances in nanoparticulate RNA delivery systems","volume":"121","author":"Witten","year":"2024","journal-title":"Proc. Natl. Acad. Sci. U.S.A."},{"key":"10.1016\/j.ejpb.2025.114762_b0025","doi-asserted-by":"crossref","first-page":"2","DOI":"10.1021\/acs.accounts.1c00544","article-title":"Chemistry of lipid Nanoparticles for RNA delivery","volume":"55","author":"Eygeris","year":"2022","journal-title":"Acc. Chem. Res."},{"key":"10.1016\/j.ejpb.2025.114762_b0030","doi-asserted-by":"crossref","DOI":"10.1016\/j.jchromb.2024.124005","article-title":"Monitoring stability indicating impurities and aldehyde content in lipid nanoparticle raw material and formulated drugs","volume":"1234","author":"Birdsall","year":"2024","journal-title":"J. Chromatogr. B Analyt. Technol. Biomed. Life Sci."},{"key":"10.1016\/j.ejpb.2025.114762_b0035","doi-asserted-by":"crossref","first-page":"692","DOI":"10.1038\/s41565-023-01371-w","article-title":"Active ingredient vs excipient debate for nanomedicines","volume":"18","author":"Hemmrich","year":"2023","journal-title":"Nat. Nanotechnol."},{"key":"10.1016\/j.ejpb.2025.114762_b0040","doi-asserted-by":"crossref","DOI":"10.1016\/j.jpba.2022.115011","article-title":"A rapid and quantitative reversed-phase HPLC-DAD\/ELSD method for lipids involved in nanoparticle formulations","volume":"220","author":"Mousli","year":"2022","journal-title":"J. Pharm. Biomed. Anal."},{"key":"10.1016\/j.ejpb.2025.114762_b0045","first-page":"1","article-title":"Chemistry, manufacturing and controls strategies for using novel excipients in lipid nanoparticles","author":"O\u2019Brien Laramy","year":"2025","journal-title":"Nat. Nanotechnol."},{"key":"10.1016\/j.ejpb.2025.114762_b0050","doi-asserted-by":"crossref","first-page":"37","DOI":"10.1016\/j.jpba.2015.11.020","article-title":"A versatile, quantitative analytical method for pharmaceutical relevant lipids in drug delivery systems","volume":"119","author":"Jeschek","year":"2016","journal-title":"J. Pharm. Biomed. Anal."},{"key":"10.1016\/j.ejpb.2025.114762_b0055","doi-asserted-by":"crossref","first-page":"11","DOI":"10.1016\/j.ijpharm.2019.05.038","article-title":"Development and validation of a novel UPLC-ELSD method for the assessment of lipid composition of nanomedicine formulation","volume":"566","author":"Varache","year":"2019","journal-title":"Int. J. Pharm."},{"key":"10.1016\/j.ejpb.2025.114762_b0060","doi-asserted-by":"crossref","first-page":"347","DOI":"10.1016\/j.chroma.2004.12.036","article-title":"A rapid isocratic high-performance liquid chromatography method for determination of cholesterol and 1, 2-dioleoyl-sn-glycero-3-phosphocholine in liposome-based drug formulations","volume":"1073","author":"Singh","year":"2005","journal-title":"J. Chromatogr. A"},{"key":"10.1016\/j.ejpb.2025.114762_b0065","doi-asserted-by":"crossref","first-page":"145","DOI":"10.1016\/j.chroma.2019.04.061","article-title":"Simultaneous separation of small interfering RNA and lipids using ion-pair reversed-phase liquid chromatography","volume":"1601","author":"Li","year":"2019","journal-title":"J. Chromatogr. A"},{"key":"10.1016\/j.ejpb.2025.114762_b0070","doi-asserted-by":"crossref","first-page":"947","DOI":"10.1016\/j.jpba.2009.10.001","article-title":"Analysis of cationic liposomes by reversed-phase HPLC with evaporative light-scattering detection","volume":"51","author":"Zhong","year":"2010","journal-title":"J. Pharm. Biomed. Anal."},{"key":"10.1016\/j.ejpb.2025.114762_b0075","unstructured":"Ph. Eur. 11.6 chapter 2.4.22-2, Composition of fatty acids by gas chromatography, EDQM (Strasbourg, France)."},{"key":"10.1016\/j.ejpb.2025.114762_b0080","unstructured":"Ph. Eur. 11.6 chapter 2.2.29, Liquid chromatography, EDQM (Strasbourg, France)."},{"key":"10.1016\/j.ejpb.2025.114762_b0085","unstructured":"Ph. Eur. 11.6 chapter 2.4.22, Composition of fatty acids by gas chromatography, EDQM (Strasbourg, France)."},{"key":"10.1016\/j.ejpb.2025.114762_b0090","doi-asserted-by":"crossref","first-page":"3667","DOI":"10.1016\/j.jchromb.2009.09.015","article-title":"Quantitative determination of free glycerol and myo-inositol from plasma and tissue by high-performance liquid chromatography","volume":"877","author":"Frieler","year":"2009","journal-title":"J. Chromatogr. B Analyt. Technol. Biomed. Life Sci."},{"key":"10.1016\/j.ejpb.2025.114762_b0095","doi-asserted-by":"crossref","first-page":"569","DOI":"10.1016\/j.ejpb.2014.11.018","article-title":"Fatty acid composition analysis in polysorbate 80 with high performance liquid chromatography coupled to charged aerosol detection","volume":"94","author":"Ilko","year":"2015","journal-title":"Eur. J. Pharm. Biopharm."},{"key":"10.1016\/j.ejpb.2025.114762_b0100","doi-asserted-by":"crossref","first-page":"1137","DOI":"10.1194\/jlr.D700041-JLR200","article-title":"Lipid extraction by methyl-tert-butyl ether for high-throughput lipidomics","volume":"49","author":"Matyash","year":"2008","journal-title":"J. Lipid Res."},{"key":"10.1016\/j.ejpb.2025.114762_b0105","unstructured":"European Directorate for the Quality of Medicines (EDQM), 2.4.22. Composition of fatty acids by GC, in: European Pharmacopoeia, European Directorate for the Quality of Medicines (EDQM),, Strasbourg, France, 2024."},{"key":"10.1016\/j.ejpb.2025.114762_b0110","series-title":"Massenspektrometrie : ein lehrbuch","author":"Gross","year":"2013"},{"key":"10.1016\/j.ejpb.2025.114762_b0115","doi-asserted-by":"crossref","first-page":"1668","DOI":"10.1002\/(SICI)1097-0231(199610)10:13<1668::AID-RCM703>3.0.CO;2-I","article-title":"The application of matrix\u2010assisted laser desorption\/ionization combined with collision\u2010induced dissociation to the analysis of synthetic polymers","volume":"10","author":"Jackson","year":"1996","journal-title":"Rapid Commun. Mass Spectrom."},{"key":"10.1016\/j.ejpb.2025.114762_b0120","doi-asserted-by":"crossref","DOI":"10.1016\/j.ijpharm.2021.120907","article-title":"Effect of polymer source on in vitro drug release from PLGA microspheres","volume":"607","author":"Wan","year":"2021","journal-title":"Int J Pharmaceut"},{"key":"10.1016\/j.ejpb.2025.114762_b0125","doi-asserted-by":"crossref","DOI":"10.3390\/pharmaceutics10020057","article-title":"Impact of Particle size and polydispersity index on the clinical applications of lipidic Nanocarrier systems","volume":"10","author":"Danaei","year":"2018","journal-title":"Pharmaceutics"},{"key":"10.1016\/j.ejpb.2025.114762_b0130","doi-asserted-by":"crossref","first-page":"372","DOI":"10.1016\/j.ijpharm.2018.12.012","article-title":"How changes in molecular weight and PDI of a polymer in amorphous solid dispersions impact dissolution performance","volume":"556","author":"Auch","year":"2019","journal-title":"Int J Pharmaceut"},{"key":"10.1016\/j.ejpb.2025.114762_b0135","doi-asserted-by":"crossref","first-page":"2170","DOI":"10.1021\/acs.chemrev.5b00441","article-title":"Polymerization of ethylene oxide, propylene oxide, and other alkylene oxides: synthesis, novel polymer architectures, and bioconjugation","volume":"116","author":"Herzberger","year":"2016","journal-title":"Chem. Rev."},{"key":"10.1016\/j.ejpb.2025.114762_b0140","unstructured":"Ph. Eur. 11.6 monograph 0495, Glycerol monostearate 40-55, EDQM (Strasbourg, France)."},{"key":"10.1016\/j.ejpb.2025.114762_b0145","unstructured":"Ph. Eur. 11.6 monograph 1429, Glycerole monolinoleate, EDQM (Strasbourg, France)."},{"key":"10.1016\/j.ejpb.2025.114762_b0150","unstructured":"Ph. Eur. 11.6 monograph 1430, Glycerol mono-oleate, EDQM (Strasbourg, France)."},{"key":"10.1016\/j.ejpb.2025.114762_b0155","doi-asserted-by":"crossref","first-page":"108","DOI":"10.1016\/j.jconrel.2025.01.071","article-title":"Role of PEGylated lipid in lipid nanoparticle formulation for in vitro and in vivo delivery of mRNA vaccines","volume":"380","author":"Zhang","year":"2025","journal-title":"J. Controlled Release"},{"key":"10.1016\/j.ejpb.2025.114762_b0160","doi-asserted-by":"crossref","first-page":"131","DOI":"10.3390\/pharmaceutics16010131","article-title":"Chemistry and art of developing lipid Nanoparticles for biologics delivery: focus on development and scale-up","volume":"16","author":"John","year":"2024","journal-title":"Pharmaceutics"},{"key":"10.1016\/j.ejpb.2025.114762_b0165","doi-asserted-by":"crossref","DOI":"10.1016\/j.addr.2022.114416","article-title":"The role of lipid components in lipid nanoparticles for vaccines and gene therapy","author":"Hald Albertsen","year":"2022","journal-title":"Adv. Drug Delivery Rev."},{"key":"10.1016\/j.ejpb.2025.114762_b0170","doi-asserted-by":"crossref","first-page":"1","DOI":"10.1038\/s41598-024-52685-1","article-title":"A careful look at lipid nanoparticle characterization: analysis of benchmark formulations for encapsulation of RNA cargo size gradient","volume":"14","author":"Schober","year":"2024","journal-title":"Sci. Rep."},{"key":"10.1016\/j.ejpb.2025.114762_b0175","doi-asserted-by":"crossref","first-page":"1377","DOI":"10.1016\/j.nano.2016.12.014","article-title":"Design of lipid nanoparticles for in vitro and in vivo delivery of plasmid DNA","volume":"13","author":"Kulkarni","year":"2017","journal-title":"Nanomed. Nanotechnol. Biol. Med."},{"key":"10.1016\/j.ejpb.2025.114762_b0180","doi-asserted-by":"crossref","first-page":"5848","DOI":"10.1002\/anie.202013927","article-title":"A systematic study of unsaturation in lipid Nanoparticles leads to improved mRNA transfection in vivo","volume":"60","author":"Lee","year":"2021","journal-title":"Angew. Chem. Int. Ed."},{"key":"10.1016\/j.ejpb.2025.114762_b0185","doi-asserted-by":"crossref","first-page":"594","DOI":"10.1515\/tsd-2023-2544","article-title":"Preparation, characterization, and stability of lipid nanoparticles including unsaturated lipids","volume":"60","author":"Park","year":"2023","journal-title":"Tenside, Surfactants, Deterg."},{"key":"10.1016\/j.ejpb.2025.114762_b0190","doi-asserted-by":"crossref","first-page":"2357","DOI":"10.3390\/pharmaceutics14112357","article-title":"Stability study of mRNA-lipid Nanoparticles exposed to Various conditions based on the evaluation between physicochemical properties and their Relation with protein expression ability","volume":"14","author":"Kamiya","year":"2022","journal-title":"Pharmaceutics"},{"key":"10.1016\/j.ejpb.2025.114762_b0195","doi-asserted-by":"crossref","first-page":"559","DOI":"10.1016\/j.ejpb.2014.12.015","article-title":"Predicting critical micelle concentration and micelle molecular weight of polysorbate 80 using compendial methods","volume":"94","author":"Braun","year":"2015","journal-title":"Eur. J. Pharm. Biopharm."},{"key":"10.1016\/j.ejpb.2025.114762_b0200","unstructured":"ter Mors et al., Comparison of polysorbate 20 qualities, pharmind, (2020)."},{"key":"10.1016\/j.ejpb.2025.114762_b0205","doi-asserted-by":"crossref","first-page":"58","DOI":"10.1016\/j.chroma.2018.09.031","article-title":"Influence of charged aerosol detector instrument settings on the ultra-high-performance liquid chromatography analysis of fatty acids in polysorbate 80","volume":"1576","author":"Schilling","year":"2018","journal-title":"J. Chromatogr. A"},{"key":"10.1016\/j.ejpb.2025.114762_b0210","unstructured":"ICH, Validation of analytical procedures Q2 (R2), ICH: Geneva, Switzerland, (2022)."},{"key":"10.1016\/j.ejpb.2025.114762_b0215","doi-asserted-by":"crossref","first-page":"68","DOI":"10.1016\/j.jpba.2017.05.013","article-title":"A simplified guide for charged aerosol detection of non-chromophoric compounds-analytical method development and validation for the HPLC assay of aerosol particle size distribution for amikacin","volume":"143","author":"Soliven","year":"2017","journal-title":"J. Pharm. Biomed. Anal."},{"key":"10.1016\/j.ejpb.2025.114762_b0220","doi-asserted-by":"crossref","first-page":"50","DOI":"10.1016\/j.jpba.2012.03.019","article-title":"Charged aerosol detection in pharmaceutical analysis","volume":"69","author":"Almeling","year":"2012","journal-title":"J. Pharm. Biomed. Anal."},{"key":"10.1016\/j.ejpb.2025.114762_b0225","doi-asserted-by":"crossref","DOI":"10.1016\/j.chroma.2020.461844","article-title":"Power function setting in charged aerosol detection for the linearization of detector response - optimization strategies and their application","volume":"1637","author":"Pawellek","year":"2021","journal-title":"J. Chromatogr. A"},{"key":"10.1016\/j.ejpb.2025.114762_b0230","unstructured":"Ph. Eur. 11.6 chapter 5.10, Control of impurities in substances for pharmaceutical use, EDQM (Strasbourg, France)."},{"key":"10.1016\/j.ejpb.2025.114762_b0235","unstructured":"Ph. Eur. 11.6 monograph 2034, Substances for pharmaceutical use, EDQM (Strasbourg, France)."},{"key":"10.1016\/j.ejpb.2025.114762_b0240","doi-asserted-by":"crossref","first-page":"1","DOI":"10.1186\/s13321-021-00532-0","article-title":"Charged aerosol detector response modeling for fatty acids based on experimental settings and molecular features: a machine learning approach","volume":"13","author":"Pawellek","year":"2021","journal-title":"J. Cheminf."},{"key":"10.1016\/j.ejpb.2025.114762_b0245","doi-asserted-by":"crossref","first-page":"125","DOI":"10.1016\/j.chroma.2016.05.079","article-title":"High performance liquid chromatography-charged aerosol detection applying an inverse gradient for quantification of rhamnolipid biosurfactants","volume":"1455","author":"Behrens","year":"2016","journal-title":"J. Chromatogr. A"},{"key":"10.1016\/j.ejpb.2025.114762_b0250","doi-asserted-by":"crossref","first-page":"3186","DOI":"10.1021\/ac060078j","article-title":"Universal response in liquid chromatography using charged aerosol detection","volume":"78","author":"Gorecki","year":"2006","journal-title":"Anal. Chem."},{"key":"10.1016\/j.ejpb.2025.114762_b0255","article-title":"Optimized MALDI-TOF MS strategy for Characterizing Polymers","volume":"9","author":"Wang","year":"2021","journal-title":"Front. Chem."},{"key":"10.1016\/j.ejpb.2025.114762_b0260","doi-asserted-by":"crossref","first-page":"456A","DOI":"10.1021\/ac981910q","article-title":"Peer reviewed: characterizing synthetic polymers by MALDI MS","volume":"70","author":"Wu","year":"1998","journal-title":"Anal. Chem."},{"key":"10.1016\/j.ejpb.2025.114762_b0265","doi-asserted-by":"crossref","first-page":"4591","DOI":"10.1021\/acs.biomac.4c00651","article-title":"Tailored Monoacyl Poly(2-oxazoline)- and Poly(2-oxazine)-lipids as PEG-lipid alternatives for stabilization and delivery of mRNA-lipid Nanoparticles","volume":"25","author":"He","year":"2024","journal-title":"Biomacromolecules"},{"key":"10.1016\/j.ejpb.2025.114762_b0270","doi-asserted-by":"crossref","first-page":"5561","DOI":"10.1038\/s41467-022-33157-4","article-title":"Payload distribution and capacity of mRNA lipid nanoparticles","volume":"13","author":"Li","year":"2022","journal-title":"Nat. Commun."},{"key":"10.1016\/j.ejpb.2025.114762_b0275","doi-asserted-by":"crossref","first-page":"2223","DOI":"10.1182\/blood.2024024405","article-title":"Genetic engineering of transfusable platelets with mRNA-lipid nanoparticles is compatible with blood banking practices","volume":"144","author":"Strong","year":"2024","journal-title":"Blood"},{"key":"10.1016\/j.ejpb.2025.114762_b0280","article-title":"RP-HPLC-CAD method for the rapid analysis of lipids used in lipid nanoparticles derived from dual centrifugation","volume":"7","author":"Bender","year":"2024","journal-title":"International Journal of Pharmaceutics: X"},{"key":"10.1016\/j.ejpb.2025.114762_b0285","doi-asserted-by":"crossref","first-page":"1217","DOI":"10.3390\/ph17091217","article-title":"RP-CAD for lipid quantification: systematic method development and intensified LNP process Characterization","volume":"17","author":"Beckert","year":"2024","journal-title":"Pharmaceuticals"},{"key":"10.1016\/j.ejpb.2025.114762_b0290","doi-asserted-by":"crossref","first-page":"937","DOI":"10.3390\/vaccines11050937","article-title":"Validation of an HPLC-CAD method for determination of lipid content in LNP-encapsulated COVID-19 mRNA vaccines","volume":"11","author":"Yu","year":"2023","journal-title":"Vaccines"}],"container-title":["European Journal of Pharmaceutics and Biopharmaceutics"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S0939641125001390?httpAccept=text\/xml","content-type":"text\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S0939641125001390?httpAccept=text\/plain","content-type":"text\/plain","content-version":"vor","intended-application":"text-mining"}],"deposited":{"date-parts":[[2025,11,5]],"date-time":"2025-11-05T08:39:54Z","timestamp":1762331994000},"score":1,"resource":{"primary":{"URL":"https:\/\/linkinghub.elsevier.com\/retrieve\/pii\/S0939641125001390"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,9]]},"references-count":58,"alternative-id":["S0939641125001390"],"URL":"https:\/\/doi.org\/10.1016\/j.ejpb.2025.114762","relation":{},"ISSN":["0939-6411"],"issn-type":[{"value":"0939-6411","type":"print"}],"subject":[],"published":{"date-parts":[[2025,9]]},"assertion":[{"value":"Elsevier","name":"publisher","label":"This article is maintained by"},{"value":"Impurity profiling of PEGylated myristoyl diglyceride, DMG-PEG 2000, a functional excipient used in mRNA lipid nanoparticle formulations","name":"articletitle","label":"Article Title"},{"value":"European Journal of Pharmaceutics and Biopharmaceutics","name":"journaltitle","label":"Journal Title"},{"value":"https:\/\/doi.org\/10.1016\/j.ejpb.2025.114762","name":"articlelink","label":"CrossRef DOI link to publisher maintained version"},{"value":"article","name":"content_type","label":"Content Type"},{"value":"\u00a9 2025 The Author(s). Published by Elsevier B.V.","name":"copyright","label":"Copyright"}],"article-number":"114762"}}