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?)
it.xpt
it.xpt
Row
DOMAIN
STUDYID
SPTOBID
STRFID
ITSPECIF
ITCAT
ITCURMTH
ITSPFL
RTOBMF
1
IT
TOB07
CIG01A
Burley Tobacco
NC 7LC
Air
MF5555555
2
IT
TOB07
CIG01A
Bright Tobacco
CC 1063
Flue
3
IT
TOB07
CIG01A
Oriental Tobacco
USDA Nicotiana Collection PI 552747
Sun
4
IT
TOB07
CIG01A
Reconstituted Tobacco
COMPLEX PURCHASED INGREDIENT
No
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The IN dataset example shows the list of non-tobacco ingredients used in the tobacco product identified as CIG01A. Each unique ingredient is listed in STRFID. Where applicable, IUPAC name and CAS number are listed (IUPACNAM and CASNO, respectively). INCAT is used to indicate whether an ingredient is a single chemical substance or a complex purchased ingredient. INSPFL indicates whether complex purchased ingredients were made to the applicant's specification. Grade, purity, manufacturer name and ID number, and the reference tobacco master file number complete the dataset.
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 (IN) domain. IQUNIT is the unot assoicated with the target, min, and max.