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TSRC, Tob. Sci. Res. Conf., 2019, 73, abstr. 058

USP elemental impurities: limit test for metals in nicotine by ICP-MS

LOTFI H.; ARROYO M.
Global Laboratory Services, Wilson, NC, USA

Nicotine included in e-cigarette formulations usually originates as a 90%+ solution, which is purified further prior to use. While the FDA oversees the tobacco industry, there is currently little regulation regarding the quality of raw materials or mandated testing. However, manufactures have a duty of care to ensure the quality of their products, and to practice good product stewardship, and in the absence of such guidelines have turned to the USP monograph for nicotine as the gold standard to assess its quality. Although the USP nicotine monograph specifies several analytical tests to assess its quality, this presentation will focus solely on the evaluation of elemental impurities, which is a limit test, and the challenges encountered. Quantitation of metals by ICP-MS can be subject to both spectral interferences and matrix effects resulting in suppression or enhancement of the signal response and error in quantitation. These interferences were eliminated or negated through the use of advanced analytical techniques such as dynamic reaction cell (DRC) and kinetic energy discrimination (KED) as well as the judicious selection of each metal isotope to monitor and choice of internal standards used. The developed method was validated according to ICH and FDA guidelines. The validated method is both accurate and precise and is able to analyze the mandated Class 1 metals (cadmium, lead, arsenic, and mercury) and the optional Class 2a and Class 3 metals in nicotine samples to ensure that the product meets USP requirements.