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TSRC, Tob. Sci. Res. Conf., 2017, 71, abstr. 094

Concept of characterization and certification of the 1R6F reference cigarette

CAÑETE S.J.P.
University of Kentucky, Lexington, KY, USA

The quality and reliability of data generated by validated methods are strongly reinforced by the use of reference materials (RMs) and, in particular, certified reference materials (CRMs). The 1R6F is designed to mimic a matrix that closely resembles currently marketed cigarette products in the United States. The planned production inventory is such that it will allow consistent distribution to stakeholders over five years or longer. This paper discusses the concept of characterization of the 1R6F discussing the sampling as well as the statistical treatment of analytical data from contracted laboratories. The statistical processing of analytical data involved a two-tier approach to better reflect the two-tier concept of characterization of the 1R6F. The two-tier approach reflects two uncertainties; one is the expected uncertainty that can be expected for single-laboratory use of the RM and the other is the expected uncertainty when two or more laboratories compare their data on the 1R6F. The certification of these two uncertainties allows for individual labs to set their upper and lower limits in their quality control monitoring while allowing for assessments of results (on the 1R6F) between labs.