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Commentary on “time-dependent selected reaction monitoring-based GC-MS/MS method for estimation of genotoxic impurities in a new antibacterial agent: alalevonadifloxin mesylate”
Journal of Analytical Science and Technology ( IF 2.5 ) Pub Date : 2020-11-10 , DOI: 10.1186/s40543-020-00247-1
D. J. Snodin , A. Teasdale , D. P. Elder

The references cited in this article to justify the analysis of alkyl mesylates in alalevonadifloxin mesylate (ALA) are considered totally inappropriate since they all present evidence showing that such esters are not formed during the synthesis of a sulfonic-acid salt using an alcohol as solvent. Relevant mechanistic and kinetic data, first published over a decade ago, demonstrate that no alkyl-sulfonate impurities are produced when an equimolar amount of methanesulfonic acid is added to the base form of a drug substance dissolved in ethanol (or a similar alcohol solvent), and so confirmatory assay data should not be required.

中文翻译:

评论“基于时间依赖性选择反应监测的 GC-MS/MS 方法用于估计新抗菌剂中的基因毒性杂质:甲磺酸丙二氧嘧啶”

本文中引用的用于证明对甲磺酸丙二氧嘧啶 (ALA) 中甲磺酸烷基酯进行分析的参考文献被认为是完全不合适的,因为它们都提供了证据表明在使用醇作为溶剂合成磺酸盐期间不会形成此类酯。十多年前首次发表的相关机械和动力学数据表明,当将等摩尔量的甲磺酸添加到溶解在乙醇(或类似醇溶剂)中的原料药的基础形式中时,不会产生烷基磺酸盐杂质,因此不需要验证性分析数据。
更新日期:2020-11-10
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