Identification and Quantitation of Nicotine Polacrilex in Nicotine Pouches and Other Oral Nicotine Delivery Products

Abstract

SUMMARY Nicotine polacrilex (CAS-No. 96055-45-7) can be used as the source of nicotine in nicotine pouches and other oral nicotine delivery products such as lozenges, tablets, and gums. The compound is the salt of nicotine with Amberlite IRP64, a copolymer of methacrylic acid and divinylbenzene. Present study describes a unique procedure to identify the presence of the compound nicotine polacrilex in oral nicotine delivery products and to evaluate its level. In oral nicotine delivery products, nicotine polacrilex is used in a mixture with other ingredients such as microcrystalline cellulose (MCC), maltitol, sweeteners, flavors, salts (such as Na2CO3, NaHCO3), water, etc. These ingredients make the analysis of the compound nicotine polacrilex by spectroscopic techniques such as IR or Raman difficult. Also, since nicotine polacrilex is insoluble in common solvents, the analysis using solutions is not possible. The study is also attempting to detect if the product contains only nicotine polacrilex or if it has additional nicotine in a different form (e.g., nicotine or nicotine tartrate). The analysis uses pyrolysis-GC/MS (Py-GC/MS) and the detection and quantitation of nicotine polacrilex is based on measuring the pyrolysis products of divinylbenzene (DVB) moiety from the Amberlite IRP64. The detection was proven very reliable by this procedure, while the quantitation showed some variability caused by the typical variability in the pyrolysis process. [Contrib. Tob. Nicotine Res. 32 (2023) 43–49]