The Premarket Tobacco Product Applications (PMTA) draft guidance issued by the FDA for Electronic Nicotine Delivery Systems (ENDS) recommends that in addition to other stability information, manufacturers submit chemical changes (e.g. aerosol constituents) to support the product’s shelf-life. Although aerosols from e-vapor products are considerably less complex than aerosols from Heat-Not-Burn (HNB) or mainstream smoke from cigarettes, there are still challenges that arise from the chemical composition of the matrix, variety of flavors used, and the potential for chemical interactions to occur during storage and heating.  There is additional complexity associated with efficiently collecting both volatile and semi-volatile compounds delivered in the aerosol from e-vapor products.<br/><br/>  This Non-targeted analysis (NTA) is a semi-quantitative approach to evaluate the chemical composition of e-vapor products and can be used to assess changes in the product over time.  We have developed a gas chromatography-mass spectrometry (GC-MS) based non-targeted analysis method for evaluation of chemical composition of liquid and aerosol of e-vapor products. This workflow consists of an automated data analysis that includes both Agilent MassHunter Unknowns Analysis and AMDIS (Automated Mass Spectral Deconvolution and Identification System) software for mass spectral deconvolution, peak detection, and library searching and reporting.   A custom library was created using reference standards to aid in compound identification. The performance characteristics of our method were validated for accuracy, precision, repeatability, and selectivity.  A limit of detection was established (~1 ppm). This approach is applicable for the evaluation of volatile and semi volatile compounds in e-vapor products allowing for chemical characterization of e-vapor aerosol and e-liquids to support development of reduced risks products.<br/>

Non-targeted analysis using gas chromatography mass spectrometry to evaluate chemical composition of e-vapor products

2019 Spring National Meeting

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