Determination of the impurities in drug products containing montelukast and in silico/in vitro genotoxicological assessments of sulfoxide impurity. Issue 2 (14th October 2015)

• Record Type: Journal Article
• Authors: Emerce, Esra; Cok, Ismet; Degim, I.Tuncer
• Is Part Of: Toxicology letters. Volume 238:Issue 2(2015)
• Page Start: 90
• Page End: 99
• Publication Date: 2015-10-14
• Subjects: Toxicology -- Periodicals; 363.179
• DOI: 10.1016/j.toxlet.2015.07.003
• Languages: English
• ISSNs: 0378-4274

Abstract

<abstract abstract-type="author-highlights" id="abs0005"> <title id="sect0005">Highlights</title> <sec> <p id="spar0080"> <list id="lis0005"> <list-item id="lsti0005"> <label></label> <p id="par0005">Several impurities in commercial drugs containing montelukast were quantified.</p> </list-item> <list-item id="lsti0010"> <label></label> <p id="par0010">Sulfoxide impurity was higher than qualification threshold in some drugs.</p> </list-item> <list-item id="lsti0015"> <label></label> <p id="par0015">Qualification for sulfoxide impurity was done using in silico/in vitro tests.</p> </list-item> <list-item id="lsti0020"> <label></label> <p id="par0020">Sulfoxide impurity was dose-dependent cytotoxic in human peripheral lymphocytes.</p> </list-item> <list-item id="lsti0025"> <label></label> <p id="par0025">Sulfoxide impurity was concluded to be classified as a nonmutagenic impurity.</p> </list-item> </list> </p> </sec> </abstract>