{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,28]],"date-time":"2026-08-28T18:18:54Z","timestamp":1787941134555,"version":"build-2784847793"},"reference-count":22,"publisher":"Public Library of Science (PLoS)","issue":"8","license":[{"start":{"date-parts":[[2026,8,28]],"date-time":"2026-08-28T00:00:00Z","timestamp":1787875200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["www.plosone.org"],"crossmark-restriction":false},"short-container-title":["PLoS One"],"abstract":"<jats:p>Idarubicine is a mainstay of the treatment strategy for hematological cancer. The literature lacks stability data that comply with current preparation practices and recommendations for conducting stability studies. The aim of the present work is to establish the stability of idarubicin preparations diluted in polyolefin-type bags (Freeflex\u2009+\u2009\u00ae) for intravenous administration in hematological clinical settings. Preparations were produced by diluting Zavedos\u00ae idarubicin in Freeflex\u2009+\u2009\u00ae bags containing 0.9% sodium chloride (NaCl) or 5% dextrose (Dex) at concentrations of 0.04 mg\/mL and 0.2 mg\/mL. These preparations were stored at 5\u2009\u00b1\u20093 \u00b0C or 22\u2009\u00b1\u20093 \u00b0C. Three bags were prepared to evaluate each condition, for a total of 24 bags. To assess chemical stability, a stability-indicating high pressure liquid chromatography-ultraviolet\/visible diode array detector assay was used. Samples were assayed on days D0, D1, D2, D7, D15, D22 and D30. A physical stability study was carried out on days D0, D15 and D30, looking for visible and sub-visible particles, measuring pH and osmolality. During the study, sample concentrations remained above 95% of the initial concentration, and no degradation products were detected. No color change or precipitation were observed with the naked eye. Sub-visible particles count remained below recommended limits. The pH and osmolality values remained unchanged from D0. This study demonstrates the stability of idarubicin, diluted to concentrations between 0.04 and 0.2 mg\/mL in solutions of 0.9% NaCl and 5% Dex, stored at 5\u2009\u00b1\u20093 \u00b0C or 22\u2009\u00b1\u20093 \u00b0C for 30 days.<\/jats:p>","DOI":"10.1371\/journal.pone.0356906","type":"journal-article","created":{"date-parts":[[2026,8,28]],"date-time":"2026-08-28T17:38:01Z","timestamp":1787938681000},"page":"e0356906","update-policy":"https:\/\/doi.org\/10.1371\/journal.pone.corrections_policy","source":"Crossref","is-referenced-by-count":0,"title":["One-month physicochemical stability study of idarubicin prepared in polyolefin-type bags for the treatment of hematological diseases"],"prefix":"10.1371","volume":"21","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-2447-5310","authenticated-orcid":true,"given":"Guillaume","family":"Bougu\u00e9on","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Arthur","family":"Jouvien","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jean-Marc","family":"Bernadou","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Arnaud","family":"Venet","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3912-7028","authenticated-orcid":true,"given":"Aude","family":"Berroneau","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0287-0849","authenticated-orcid":true,"given":"Pierre","family":"Mora","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fabien","family":"Xuereb","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"340","published-online":{"date-parts":[[2026,8,28]]},"reference":[{"key":"pone.0356906.ref001","author":"ANSM","year":"2024"},{"issue":"24","key":"pone.0356906.ref002","doi-asserted-by":"crossref","DOI":"10.1097\/MD.0000000000020094","article-title":"The efficacy and safety of daunorubicin versus idarubicin combined with cytarabine for induction therapy in acute myeloid leukemia: a meta-analysis of randomized clinical trials","volume":"99","author":"H Wang","year":"2020","journal-title":"Medicine (Baltimore)"},{"issue":"12","key":"pone.0356906.ref003","doi-asserted-by":"crossref","DOI":"10.1016\/j.clml.2018.08.008","article-title":"Efficacy and toxicity of idarubicin versus high-dose daunorubicin for induction chemotherapy in adult acute myeloid leukemia: a systematic review and meta-analysis","volume":"18","author":"W Owattanapanich","year":"2018","journal-title":"Clin Lymphoma Myeloma Leuk"},{"issue":"3","key":"pone.0356906.ref004","doi-asserted-by":"crossref","first-page":"324","DOI":"10.3748\/wjg.v26.i3.324","article-title":"Idarubicin vs doxorubicin in transarterial chemoembolization of intermediate stage hepatocellular carcinoma","volume":"26","author":"GS Roth","year":"2020","journal-title":"World J Gastroenterol"},{"issue":"4","key":"pone.0356906.ref005","first-page":"143","article-title":"Stability studies: a scientific mission of the hospital pharmacist","volume":"2","author":"J Vigneron","year":"2018","journal-title":"Pharm Technol Hosp Pharm"},{"key":"pone.0356906.ref006","doi-asserted-by":"crossref","first-page":"278","DOI":"10.1136\/ejhpharm-2012-000112","article-title":"Guidelines for the practical stability studies of anticancer drugs: a European consensus conference","author":"C Bardin","year":"2012","journal-title":"Eur J Hosp Pharm"},{"key":"pone.0356906.ref007","author":"A N S M","year":"2024"},{"issue":"6","key":"pone.0356906.ref008","first-page":"220","article-title":"Stability of anthracycline antitumour agents in infusion fluids","volume":"39","author":"JH Beijnen","year":"1985","journal-title":"J Parenter Sci Technol"},{"key":"pone.0356906.ref009","author":"SFPC\/GERPAC","year":"2013"},{"key":"pone.0356906.ref010","year":"2003"},{"key":"pone.0356906.ref011","doi-asserted-by":"crossref","first-page":"123","DOI":"10.1016\/j.jpba.2013.07.002","article-title":"Characterization of degradation products of idarubicin through LC-UV, MS(n) and LC-MS-TOF studies","volume":"85","author":"D Kaushik","year":"2013","journal-title":"J Pharm Biomed Anal"},{"key":"pone.0356906.ref012","author":"ICH Q2(R2)","year":"2023"},{"key":"pone.0356906.ref013","year":"2025"},{"key":"pone.0356906.ref014","doi-asserted-by":"crossref","first-page":"114543","DOI":"10.1016\/j.jpba.2021.114543","article-title":"Stability of a high-concentrated aqueous solution of idarubicin stored in a polypropylene syringe for transarterial chemoembolization","volume":"210","author":"B Bourcier","year":"2022","journal-title":"J Pharm Biomed Anal"},{"issue":"1","key":"pone.0356906.ref015","article-title":"GERPAC consensus conference \u2013 guidance on the assignment of microbiological shelf-life for hospital pharmacy aseptic preparations","volume":"5","author":"S Crauste-Manciet","year":"2020","journal-title":"Pharm Technol Hosp Pharm"},{"key":"pone.0356906.ref016"},{"key":"pone.0356906.ref017"},{"key":"pone.0356906.ref018"},{"issue":"5","key":"pone.0356906.ref019","doi-asserted-by":"crossref","DOI":"10.1208\/s12248-025-01104-y","article-title":"Doxorubicin stability-indicating method and its main degradation products in vitro toxicity","volume":"27","author":"M de Almeida Ultramari","year":"2025","journal-title":"AAPS Journal"},{"key":"pone.0356906.ref020","doi-asserted-by":"crossref","first-page":"164","DOI":"10.1016\/j.jpba.2013.05.007","article-title":"A stability-indicating, ion-pairing, reversed-phase liquid chromatography method for studies of daunorubicin degradation in i.v. infusion fluids","volume":"83","author":"R Respaud","year":"2013","journal-title":"J Pharm Biomed Anal"},{"issue":"1","key":"pone.0356906.ref021","doi-asserted-by":"crossref","first-page":"32","DOI":"10.1177\/107815529800400104","article-title":"Viability of microorganisms in novel antineoplastic and antiviral drug solutions","volume":"4","author":"I Kr\u00e4mer","year":"1998","journal-title":"J Oncol Pharm Pract"},{"key":"pone.0356906.ref022","volume-title":"Protocols for the integrity testing of syringes","author":"J Sizer","year":"2013"}],"container-title":["PLOS One"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/dx.plos.org\/10.1371\/journal.pone.0356906","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,8,28]],"date-time":"2026-08-28T17:38:05Z","timestamp":1787938685000},"score":1,"resource":{"primary":{"URL":"https:\/\/dx.plos.org\/10.1371\/journal.pone.0356906"}},"subtitle":[],"editor":[{"given":"Christophe","family":"Curti","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"editor"}]}],"short-title":[],"issued":{"date-parts":[[2026,8,28]]},"references-count":22,"journal-issue":{"issue":"8","published-online":{"date-parts":[[2026,8,28]]}},"URL":"https:\/\/doi.org\/10.1371\/journal.pone.0356906","relation":{},"ISSN":["1932-6203"],"issn-type":[{"value":"1932-6203","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,8,28]]}}}