致《Heliyon》编辑的信：关于通过离子色谱法测定药品中的二甲胺和亚硝酸盐以评估亚硝胺形成可能性的研究，《Heliyon》，2021年；77卷：e06179 。
Letter to the editor of Heliyon re: determination of dimethylamine and nitrite in pharmaceuticals by ion chromatography to assess the likelihood of nitrosamine formation Heliyon. 2021; 77: e06179.
作者信息
Schlingemann Joerg, Hickert Sebastian, Blom Giorgio, Kocks Grace, Allain Leonardo
机构信息
Merck KGaA, Frankfurter Str. 250, Darmstadt, 64293, Germany.
Chemical Development, Pharmaceutical Technology and Development, Operations, AstraZeneca, Macclesfield, UK.
出版信息
Heliyon. 2022 Jun 14;8(6):e09607. doi: 10.1016/j.heliyon.2022.e09607. eCollection 2022 Jun.
Abstract
Our letter to the editor of Heliyon outlines queries on the methodology and sample preparation used in article e06179, published in 2021. The nitrite measurements reported are higher than those observed in our experience. In the interest of reporting nitrite levels that are fully accurate, we would like to discuss the findings with the article authors.
摘要
我们致《Heliyon》编辑的信概述了对2021年发表的文章e06179中所使用的方法和样本制备的质疑。报告的亚硝酸盐测量值高于我们经验中观察到的值。为了报告完全准确的亚硝酸盐水平，我们希望与文章作者讨论这些发现。
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本文引用的文献
1
A Nitrite Excipient Database: A Useful Tool to Support N-Nitrosamine Risk Assessments for Drug Products.亚硝酸盐辅料数据库：支持药物产品中 N-亚硝胺风险评估的有用工具。
J Pharm Sci. 2023 Jun;112(6):1615-1624. doi: 10.1016/j.xphs.2022.04.016. Epub 2022 Apr 29.
2
Determination of dimethylamine and nitrite in pharmaceuticals by ion chromatography to assess the likelihood of nitrosamine formation.采用离子色谱法测定药品中的二甲胺和亚硝酸盐，以评估亚硝胺形成的可能性。
Heliyon. 2021 Feb 19;7(2):e06179. doi: 10.1016/j.heliyon.2021.e06179. eCollection 2021 Feb.
3
Sonochemical formation of nitrate and nitrite in water.
Ultrason Sonochem. 2000 Jul;7(3):109-13. doi: 10.1016/s1350-4177(99)00043-7.
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