The following examples illustrate how the list of ingredients of a tobacco product would be represented and quantified using three datasets:
Tobacco Ingredients (IT) is used for listing the tobacco types and their attributes within the tobacco product under study.
Non-tobacco Ingredients (IN) is used for listing other ingredients and additives and their attributes as used in the tobacco product under study,
Quantified Ingredients (IQ) is used for representing the quantity of each ingredient by component of the tobacco product in which they are included. These values represent the design/formulation of the product, not experimentally determined values (as the latter would be represented in the Product Testing (TP) dataset, not shown here).
All three datasets make use of the SPTOBID variable to represent the tobacco product under study, and the STRFID (Substance Reference Identifier) variable to represent the ingredient name. STRFID must be assigned by study sponsors to be unique with regard to the attributes that describe it. If, for instance, the same ingredient varies on one or more attribute (e.g., a different manufacturer supplied a compound that is used in one component of the product than the same ingredient used in another component), STRFID must be unique for each use to reflect this difference, even if they share the same IUPAC name and CAS number.
The IT example below shows 4 types of tobacco listed as tobacco ingredients (STRFID) for the Tobacco Product CIG01A (SPTOBID). The variable ITSPECIF shows the specification (variety) of the first three tobaccos. ITCAT is used to indicate that Reconstituted Tobacco is a complex, purchased ingredient. ITCURMTH indicates the cure method. ITSPFL is used to indicate whether complex purchased ingredients were made to the applicants specification. RTOBMF indicates the reference tobacco master file (what is this? why does only one row have this info?)
This example represents the target and max and minimum quanity of each unique ingredients in each compoment of a tobacco product. STRFID must be represented using the identical value defined by the sponosr in the Ingredient (IL) domain. IQUNIT is the unot assoicated with the target, min, and max.