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实时直接分析-质谱法(DART-MS)用于甘油制品中有毒二醇的快速定性筛选。

Direct analysis in real time-mass spectrometry (DART-MS) for rapid qualitative screening of toxic glycols in glycerin-containing products.

机构信息

U.S. Food and Drug Administration, Office of Regulatory Affairs, Pacific Regional Laboratory Northwest/Applied Technology Center, Bothell, WA 98021, USA.

出版信息

J Pharm Biomed Anal. 2013 Jun;80:155-8. doi: 10.1016/j.jpba.2013.02.037. Epub 2013 Mar 26.

Abstract

In 2007, the United States Food and Drug Administration released guidance recommending testing of glycerin used in regulated consumer products, such as cough syrup preparations, toothpaste, and other pharmaceutical and food products, for the toxic compounds ethylene glycol and diethylene glycol. Regulatory laboratories routinely test glycerin, and products containing glycerin or related compounds for these toxic glycols, using an official gas chromatographic method, to ensure the safety of these products. The current work describes a companion technique to compliment this GC-FID method utilizing Orbitrap mass spectrometry with direct analysis in real time ionization to rapidly screen these samples qualitatively, with results in as little as five seconds, with no sample preparation required. This allows the more time and resource intensive method to be reserved for those rare cases when these compounds are detected, potentially greatly improving laboratory efficiency. The technique was evaluated for qualitative sensitivity and repeatability, and compared against the GC-FID method. The method appears to perform well against these metrics.

摘要

2007 年,美国食品和药物管理局发布了指导意见,建议对在监管的消费产品中使用的甘油进行测试,如咳嗽糖浆制剂、牙膏和其他医药和食品产品,以检测有毒化合物乙二醇和二甘醇。监管实验室通常使用官方的气相色谱法来测试甘油以及含有甘油或相关化合物的产品中的这些有毒二醇,以确保这些产品的安全。目前的工作描述了一种伴生技术,利用直接实时分析的轨道阱质谱法对这些样品进行快速定性筛选,只需五秒即可得出结果,无需进行样品制备。这使得更耗时和资源密集型的方法能够保留到这些化合物被检测到的极少数情况下,从而有可能极大地提高实验室效率。该技术针对定性灵敏度和重复性进行了评估,并与 GC-FID 方法进行了比较。该方法在这些指标上表现良好。

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