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Tobacco product HPHC testing results are represented in the PT domain. This example assumes testing at a single time point, not serial testing over multiple timepoints as in stability studies. See the Stability Studies section for more information and examples on handling illustrating how to represent those data.

This example only shows test results for each constituent for one replicate of one sample of one product that was tested (PTREPNUM = 1 for all records). Details of the sampling and testing plan, including the number of samples of the products tested, are determined by the sponsor or by regulatory requirement.  Sponsors would likely have multiple product samples tested in multiple replicates, and those would be distinguished in the dataset by values of PTREPNUM being set to 1 through n, where n = the number of replicates being performed.

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