Characterization of potential impurities and degradation products in electronic cigarette formulations and aerosols

Characterization of potential impurities and degradation products in electronic cigarette formulations and aerosols
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DOI:
10.1016/j.yrtph.2015.11.009
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发表时间:
2016-02-01
影响因子:
3.4
通讯作者:
McKinney, Willie J.
McKinney, Willie J.
中科院分区:
医学3区
文献类型:
--
作者:
Flora, Jason W.;Meruva, Naren;McKinney, Willie J.

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电子烟在美国和其他全球市场越来越受欢迎。目前,已发表的描述电子烟配方(电子液体)和气雾剂的分析数据有限。虽然FDA尚未公布电子烟的有害和潜在有害成分(HPHC)清单,但目前受监管的烟草产品的HPHC清单可能有助于分析电子烟气雾剂的特征。例如,大多数电子烟配方含有丙二醇和甘油,加热时可能会产生醛。此外,与尼古丁相关的化学物质此前曾被报道为电子烟配方中的潜在杂质。这项研究确定了由NuMark LLC生产的部分商业MarkTen(R)电子烟的电子液体配方、杂质和气雾剂中潜在的有害化学物质。还估计了已确定的配方、杂质和气雾剂化学品的潜在危险。电子烟被机器吹气(4次S持续时间,55毫升体积,30次S间隔)到电池耗尽,以最大限度地收集气雾剂。对分析的气雾剂进行20次喷雾收集,以说明分析物的不稳定性。烟草特有的亚硝胺是在药用级尼古丁中观察到的水平上测量的。电子烟配方中与尼古丁相关的杂质低于ICH指南Q3B(R2)中建议的鉴定和合格阈值。在气雾剂中检测到的潜在有害化学物质的水平被确定为低于公布的职业暴露限值。(C)2015年提交人。由爱思唯尔公司出版。
E-cigarettes are gaining popularity in the U.S. as well as in other global markets. Currently, limited published analytical data characterizing e-cigarette formulations (e-liquids) and aerosols exist. While FDA has not published a harmful and potentially harmful constituent (HPHC) list for e-cigarettes, the HPHC list for currently regulated tobacco products may be useful to analytically characterize e-cigarette aerosols. For example, most e-cigarette formulations contain propylene glycol and glycerin, which may produce aldehydes when heated. In addition, nicotine-related chemicals have been previously reported as potential e-cigarette formulation impurities. This study determined e-liquid formulation impurities and potentially harmful chemicals in aerosols of select commercial MarkTen (R) e-cigarettes manufactured by NuMark LLC. The potential hazard of the identified formulation impurities and aerosol chemicals was also estimated. E-cigarettes were machine puffed (4-s duration, 55-mL volume, 30-s intervals) to battery exhaustion to maximize aerosol collection. Aerosols analyzed for carbonyls were collected in 20-puff increments to account for analyte instability. Tobacco specific nitrosamines were measured at levels observed in pharmaceutical grade nicotine. Nicotine-related impurities in the e-cigarette formulations were below the identification and qualification thresholds proposed in ICH Guideline Q3B(R2). Levels of potentially harmful chemicals detected in the aerosols were determined to be below published occupational exposure limits. (C) 2015 The Authors. Published by Elsevier Inc.