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The IT example shows tobacco filler and the types of tobacco of which it is composed, each listed as tobacco ingredients in the variable IGDCMPID (ingredient or component identifier) for the tobacco product CIG01A (SPTOBID). The variable ITSPECIF shows the specification/variety of the first 3 tobaccos. ITIGDPLX (Ingredient Complexity) is used to indicate that the tobacco filler and the reconstituted tobacco are complex ingredients (i.e., have 2 or more subcomponents). The details of which single tobacco ingredients compose these complex ingredients is made explicit in the IQ dataset example. ITCURMTH indicates the cure method. ITCIGIND (applicant-customized ingredient indicator) is used to indicate whether complex ingredients were made to the applicant's specification. TPMF indicates the Tobacco Product Master File name/number, which should be provided in the data if the component manufacturer has made it available.
Note that there are 2 varieties of burley tobacco in this tobacco product; each is given a unique IGDCMPID value (Burley Tobacco and Burley Tobacco 2).

Sun
Dataset wrap
NameILit
Dataset2
Row 

Row

DOMAIN

STUDYIDSPTOBID
STRFIDIUPACNAM CASNOILCATILSPECILMETHODILMANUFILMANUFNILGRADEILPURTYILCMPLXILSPFLTOBTMRFBurley Tobacco 

8037-19-2

TOBACCO PRODUCTAirNC 7LC
IGDCMPIDTPMFITSPECIFITIGDPLXITCURMTHITCIGIND
1ITTOB07CIG01ATobacco Filler

COMPLEX INGREDIENT

2ITTOB07CIG01ABurley TobaccoMF5555555NC 7LCSINGLE INGREDIENTAir
3ITTOB07CIG01ABright Tobacco
CC 1063SINGLE INGREDIENTFlue
4ITTOB07CIG01AOriental Tobacco
Bright Tobacco

8037-19-2

TOBACCO PRODUCTFlueCC 1063Oriental Tobacco8037-19-2TOBACCO PRODUCT

USDA Nicotiana Collection PI 552747SINGLE INGREDIENTSun
5ITTOB07CIG01AReconstituted Tobacco
?????TOBACCO PRODUCTBright Tobacco8037-19-2TOBACCO PRODUCTFlueCC 1063Oriental Tobacco8037-19-2TOBACCO PRODUCTSunUSDA Nicotiana Collection PI 552747Burley Tobacco8037-19-2TOBACCO PRODUCTAirNC 7LC1IL


COMPLEX INGREDIENT
N
6ITTOB07CIG01ABurley Tobacco 2
KT215LCSINGLE INGREDIENTAir

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 IGDCMPID. Where applicable, IUPAC name and CAS number are listed (IUPACNAM and CASNO variables, respectively). INIGDPLX is used to indicate whether an ingredient is a single ingredient or a complex ingredient. INCIGIND  indicates whether complex ingredients were made to the applicant's specification. Grade, purity, manufacturer name, ingredient unique item number, and the Tobacco Product Master File number complete the dataset.

Dataset wrap
NameIN
Dataset2
RowDOMAINSTUDYIDSPTOBIDIGDCMPIDINMANUFINMANUINTPMFIUPACNAMCASNOUNIIINIGDPLXINCIGINDINGRADEINPURTY
1INTOB07CIG01ACocoa Extract
NON TOBACCO PRODUCT
Flavor House AFLVR1234
Complex Substance Purchased No
MF5555555


COMPLEX INGREDIENTNFOOD
MF5555555

2
IL
INTOB07CIG01AButyric Acid


butanoic acid107-92-6
NON TOBACCO PRODUCTFood≥99%Single Substance3

SINGLE INGREDIENT
USP≥99%
3IN
IL
TOB07CIG01ACellulose Filter A
-NON TOBACCO PRODUCT
MFR AFIL789
Complex Substance Purchased 


-
COMPLEX INGREDIENTNUSP
No

4
IL
INTOB07CIG01ACellulose Acetate


cellulose acetate9004-35-
7 
7
SINGLE INGREDIENT

99%
NON TOBACCO PRODUCTSingle Substance
5
IL
INTOB07CIG01ATriacetin


1,3-diacetyloxypropan-2-yl
acetate 
acetate102-76-
1 
1
SINGLE INGREDIENT
USP
NON TOBACCO PRODUCTSingle Substance

6
IL
INTOB07CIG01AFSC Paper B
NON TOBACCO PRODUCT
MFR BFSC123
Complex Substance Purchased 
MF5678910


COMPLEX INGREDIENTN
No


7
IL
INTOB07CIG01ACellulose Pulp


cellulose pulp65996-61-
4 
4
SINGLE INGREDIENT

≥99%
NON TOBACCO PRODUCTSingle Substance
8
IL
INTOB07CIG01ACalcium Carbonate


calcium carbonate471-34-
1 
1
SINGLE INGREDIENT
USP
NON TOBACCO PRODUCTSingle Substance

9
IL
INTOB07CIG01ASodium Alginate


sodium;3,4,5,6-tetrahydroxyoxane-2-
carboxylate 
carboxylate9005-38-3
NON TOBACCO PRODUCT

SINGLE INGREDIENT
FOOD
Single Substance

10
IL
INTOB07CIG01ATrisodium Citrate


trisodium;2-hydroxypropane-1,2,3-
tricarboxylate 
tricarboxylate6132-04-3
NON TOBACCO PRODUCT

SINGLE INGREDIENT

≥98%
Single Substance
11
IL
INTOB07CIG01ACationic Starch


starch, 2-hydroxy-3-(trimethylammonio)propyl ether,
chloride 
chloride56780-58-
6 
6
SINGLE INGREDIENT
FOOD
NON TOBACCO PRODUCTSingle Substance

12
IL
INTOB07CIG01ASeam Adhesive
-NON TOBACCO PRODUCT
MFR CADV123
Complex Substance Purchased No
MF2345678


COMPLEX INGREDIENTN
MF2345678


13
IL
INTOB07CIG01AMethylcellulose
(5R)-2,3,4-trimethoxy-6-(methoxymethyl)-5-[(2S)-3,4,5-trimethoxy-6-(methoxymethyl)oxan-2-yl]oxyoxane 9004-67-5NON TOBACCO PRODUCTSingle Substance14ILTOB07CIG01A1,3-Butanediol4,4,4-trifluoro-2-methyl-1-phenyl-3-(trifluoromethyl)butane-1,3-diol34844-08-1NON TOBACCO PRODUCTSingle Substance




9004-67-5
SINGLE INGREDIENT
FOOD
14INTOB07CIG01A1,3-Butanediol


Butane-1,3-diol34844-08-1
SINGLE INGREDIENT
USP≥99%

Finally, the IQ domain is used to represent the quantity (target, minimum, and maximum) of each ingredient identified in IGDCMPID that the product (SPTOBID) is designed to contain, with the units for these values represented in IQUNIT. The function of each ingredient is described in IQFUNCT. Note: Ingredients that appear in more than 1 component of the tobacco product are quantified separately for each component. IQPARENT identifies a component or complex ingredient composed of the subcomponents/ingredients shown in IDGCMPID. IQLEVEL is used to identify at what level in the overall hierarchy that subcomponent/ingredient appears.

The following implementation rules apply, as described in more detail in Section 2.8.8.6, SDTM Ingredient Quantities by Component (IQ), Assumptions:

  • IQPARENT must correspond to a value of IGDCMPID in the same dataset. If parent is null, the ingredient is considered a top-level component and is assigned an IQLEVEL value of "1".
  • Records describing subcomponents/ingredients that compose a parent component listed in the dataset will have IQPARENT value equal to the IGDCMPID of that parent component. IQLEVEL will be set to n +1, where n = the parent record's value of IQLEVEL
  • Every value of IGDCMPID used in the IQ dataset must have a matching value of IGDCMPID:
    • In the IT dataset (when IQCAT=TOBACCO INGREDIENT), or
    • In the IN dataset (when IQCAT=NON-TOBACCO INGREDIENT)

Therefore, IQCAT is required to relate ingredient quantity records in IQ to the associated ingredient attributes described in either IT or IN.

The use of IQPARENT and IQLEVEL help make explicit the relationship between complex ingredients or components and the subcomponents/ingredients of which they are composed, and can assist when totaling the quantities of an ingredient that appears in multiple components of a tobacco product.
 
This concept map illustrates the representation of the hierarchical relationships between a component and its subcomponents/ingredients in the IQ domain structure. 

Excerpt Include
Concept Map. Relationships of Components, Subcomponents and Ingredients in IQ
Concept Map. Relationships of Components, Subcomponents and Ingredients in IQ

The IQ dataset example illustrates these principles, using a cigarette tobacco product:

 mg
Dataset wrap
NameIQ
Rowcaps
Rows 1, 13, 16:Show 3 top-level components of a cigarette product: tobacco filler, filter, and cigarette paper, respectively. Their target, minimum, and maximum quantities expressed in units of mg/cigarette are shown in IQVALTRG, IQVALMIN, IQVALMAX and IQUNIT. Because there is no parent component other than the finished product itself, IQPARENT is null, and IQLEVEL=1, indicating that these are top-level ingredients/components of the finished product.
Rows 2-5:Show the quantities of 4 types of tobacco used in the product. IQPARENT=Tobacco Filler and IQLEVEL=2, together indicating that these are subcomponents/ingredients in the tobacco filler, a top level-component of the cigarette product.
Rows 6-8:Show the 3 tobacco ingredients that compose reconstituted tobacco in row 5 (IQPARENT=Reconstituted Tobacco). The quantities of these tobaccos pertain to the quantity at which they appear in the reconstituted tobacco ONLY. IQLEVEL=3 to show that these ingredients are at the third level of the hierarchy (subcomponents/ingredients in Reconstituted Tobacco, which has IQLEVEL=2). Therefore, the total quantity of the individual tobaccos used in this tobacco product is the sum of these 3 rows plus the sum of the quantities shown in rows 2-4. 
Rows 9-10:Show the quantities of 2 non-tobacco ingredients, methylcellulose and 1,3-butanediol, which are further subcomponents/ingredients in Reconstituted Tobacco, as indicated by IQPARENT. IQFUNCT shows that methylcellulose functions as a binder and 1,3-butanediol functions as a humectant. IQLEVEL=3 to show that these ingredients are at the third level of the hierarchy.
Rows 11-12:Show the quantities of 2 subcomponents/ingredients that both function as a flavorant in the tobacco filler (as indicated by IQFUNCT= Flavor and IQPARENT=Tobacco Filler).
Rows 14-15:Show the quantities of 2 subcomponents/ingredients that function as filtration and plasticizer, respectively, in the filter portion of the cigarette (cellulose filter A, a top-level component shown in row 13).
Rows 17-22:Show the quantities and functions of 6 subcomponents/ingredients in the top-level component FSC paper B (the cigarette paper shown in row 16).
Dataset2
Dataset wrap
NameIQ
Dataset2
RowDOMAINSTUDYID SPTOBID STRFID IQCOMP IQSCOMP IQFUNCTIQTARGETIQLL IGULIQUNIT 
1
RowDOMAINSTUDYIDSPTOBIDIGDCMPIDIQCATIQPARENTIQLEVELIQFUNCTIQVALTRGIQVALMINIQVALMAXIQUNIT
1IQTOB07CIG01ATobacco FillerTOBACCO INGREDIENT
1
672.5661.3683.7mg/cigarette
2IQTOB07CIG01ABurley TobaccoTOBACCO INGREDIENTTobacco Filler2
191721mg/cigarette
3IQTOB07CIG01ABright TobaccoTOBACCO INGREDIENTTobacco Filler2
300295305mg/cigarette
4IQTOB07CIG01AOriental TobaccoTOBACCO INGREDIENTTobacco Filler2
115113117mg/cigarette
5IQTOB07CIG01AReconstituted TobaccoTOBACCO INGREDIENTTobacco Filler2
231229233mg/cigarette
6IQTOB07CIG01ABurley Tobacco 2TOBACCO INGREDIENTReconstituted Tobacco3
191820mg/cigarette
7IQTOB07CIG01ABright TobaccoTOBACCO INGREDIENTReconstituted Tobacco3
103101105mg/cigarette
8IQTOB07CIG01AOriental TobaccoTOBACCO INGREDIENTReconstituted Tobacco3
656367mg/cigarette
9IQTOB07CIG01AMethylcelluloseNON-TOBACCO INGREDIENTReconstituted Tobacco3Binder201921mg/cigarette
10IQTOB07CIG01A1,3-ButanediolNON-TOBACCO INGREDIENTReconstituted Tobacco3Humectant242325mg/cigarette
11
IQTOB07CIG01ACocoa ExtractNON-TOBACCO INGREDIENTTobacco Filler2Flavor
7 
76.757.25mg/cigarette
2
12IQTOB07CIG01AButyric AcidNON-TOBACCO INGREDIENTTobacco Filler2Flavor0.50.
5 
550.45mg
 mg
/cigarette
3
13IQTOB07CIG01ACellulose Filter ANON-TOBACCO INGREDIENT
1Filter164
Filter
163
164 
165
 mg
mg/cigarette
4
14IQTOB07CIG01ACellulose Acetate
Filter
NON-TOBACCO INGREDIENTCellulose Filter A2Filtration155
155 
154156
 mg
mg/cigarette
5
15IQTOB07CIG01ATriacetin
Filter
NON-TOBACCO INGREDIENTCellulose Filter A2Plasticizer9
9 
810mg/cigarette
6
16IQTOB07CIG01AFSC Paper BNON-TOBACCO INGREDIENT
1Cigarette Paper
Wrapper50 
(Wrapper)504951mg/cigarette
7
17IQTOB07CIG01ACellulose Pulp
Cigarette Paper
NON-TOBACCO INGREDIENTFSC Paper B2Fiber3029
30 
31mg/cigarette
8
18IQTOB07CIG01ACalcium Carbonate
Cigarette Paper
NON-TOBACCO INGREDIENTFSC Paper B2Filler15
15 
1416mg/cigarette
9
19IQTOB07CIG01ASodium Alginate
Cigarette Paper
NON-TOBACCO INGREDIENTFSC Paper B2Reduced ignition
propensity 2 
propensity21.752.25mg/cigarette
10
20IQTOB07CIG01ATrisodium Citrate
Cigarette Paper
NON-TOBACCO INGREDIENTFSC Paper B2Combustion Modifier0.
5 
50.450.55mg
 mg
/cigarette
11
21IQTOB07CIG01ACationic Starch
Cigarette Paper
NON-TOBACCO INGREDIENTFSC Paper B2Binder0.
5 
50.450.55mg
 mg
/cigarette
12
22IQTOB07CIG01ASeam Adhesive
Cigarette Paper
NON-TOBACCO INGREDIENTFSC Paper B
Adhesive2  mg/cigarette13IQTOB07CIG01AMethylcelluloseTobacco FillerReconstituted TobaccoBinder20  mg/cigarette14IQTOB07CIG01A1,3-ButanediolTobacco FillerReconstituted TobaccoHumectant24 
2Adhesive21.752.25mg
 mg
/cigarette