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The IT example below shows tobacco filler and the 4 types of tobacco of which it is comprised composed, each listed as tobacco ingredients (IGDCMPIDin the variable IGDCMPID (ingredient or component identifier) for the Tobacco Product tobacco product CIG01A (SPTOBID). The variable ITSPECIF shows the specification (/variety ) of the first three 3 tobaccos. ITIGDPLX (Ingredient Complexity) is used to indicate that Reconstituted Tobacco is a complex ingredient (it has two more sub-components). 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. ITSPFL 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. File name/number, which should be provided in the data if the component manufacturer has made it available.
Note that there are two 2 varieties of burley tobacco in this tobacco product, thus ; each is given a unique IGDCMPID value (Burley Tobacco and Burley Tobacco 2).

Dataset wrap
Name it
Dataset2 Row DOMAIN STUDYID SPTOBID IGDCMPID TPMF ITSPECIF ITIGDPLX ITCURMTH ITSPFLITCIGIND 1 IT TOB07 CIG01A Tobacco Filler COMPLEX INGREDIENT 2 IT TOB07 CIG01A Burley Tobacco MF5555555 NC 7LC SINGLE INGREDIENT Air 3 IT TOB07 CIG01A Bright Tobacco CC 1063 SINGLE INGREDIENT Flue 4 IT TOB07 CIG01A Oriental Tobacco USDA Nicotiana Collection PI 552747 SINGLE INGREDIENT Sun 5 IT TOB07 CIG01A Reconstituted Tobacco COMPLEX INGREDIENT N 6 IT TOB07 CIG01A Burley Tobacco 2 KT215LC SINGLE INGREDIENT Air

The IN dataset example below shows the list of non-tobacco ingredients

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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. INSPFL indicates  INCIGIND  indicates whether complex ingredients were made to the applicant's specification. Grade, purity, manufacturer name and ID , ingredient unique item number, and the Tobacco Product Master  File number File number complete the dataset.

Dataset wrap
Name IN
Dataset2 Row DOMAIN STUDYID SPTOBID IGDCMPID INMANUF INMANUFNINMANUIN TPMF IUPACNAM CASNO UNII INIGDPLX INSPFLINCIGIND INGRADE INPURTY 1 IN TOB07 CIG01A Cocoa Extract Flavor House A FLVR1234 MF5555555 COMPLEX INGREDIENT N FOOD 2 IN TOB07 CIG01A Butyric Acid butanoic acid 107-92-6 SINGLE INGREDIENT FoodUSP ≥99% 3 IN TOB07 CIG01A Cellulose Filter A MFR A FIL789 - COMPLEX INGREDIENT N USP 4 IN TOB07 CIG01A Cellulose Acetate cellulose acetate 9004-35-7 SINGLE INGREDIENT 99% 5 IN TOB07 CIG01A Triacetin 1,3-diacetyloxypropan-2-yl acetate 102-76-1 SINGLE INGREDIENT USP 6 IN TOB07 CIG01A FSC Paper B MFR B FSC123 MF5678910 COMPLEX INGREDIENT N 7 IN TOB07 CIG01A Cellulose Pulp cellulose pulp 65996-61-4 SINGLE INGREDIENT ≥99% 8 IN TOB07 CIG01A Calcium Carbonate calcium carbonate 471-34-1 SINGLE INGREDIENT USP 9 IN TOB07 CIG01A Sodium Alginate sodium;3,4,5,6-tetrahydroxyoxane-2-carboxylate 9005-38-3 SINGLE INGREDIENT FOOD 10 IN TOB07 CIG01A Trisodium Citrate trisodium;2-hydroxypropane-1,2,3-tricarboxylate 6132-04-3 SINGLE INGREDIENT ≥98% 11 IN TOB07 CIG01A Cationic Starch starch, 2-hydroxy-3-(trimethylammonio)propyl ether, chloride 56780-58-6 SINGLE INGREDIENT FOOD 12 IN TOB07 CIG01A Seam Adhesive MFR C ADV123 MF2345678 - COMPLEX INGREDIENT N 13 IN TOB07 CIG01A Methylcellulose 9004-67-5 SINGLE INGREDIENT FOOD 14 IN TOB07 CIG01A 1,3-Butanediol Butane-1,3-diol 34844-08-1 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 one 1 component of the tobacco product are quantified separately for each component. IQPARENT identifies the ingredient or component of which the sub-ingredient/sub-component shown in IDGCMPID is a parta component or complex ingredient composed of the subcomponents/ingredients shown in IDGCMPID. IQLEVEL is used to identify at what level

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in level in the overall hierarchy the sub-component / sub-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  If parent is null, the ingredient is considered a top-level component and is assigned a an IQLEVEL value of "1" in IQLEVEL.
• Records describing subcomponents/ingredients that are sub-component ingredients of another ingredient/component compose a parent component listed in the dataset will have IQPARENT value equal to the IGDCMPID of that ingredient/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 their constituent ingredientsthe 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.
 
The This concept map below illustrates the representation of the hierarchical relationships between a complex ingredient component and its sub-component subcomponents/ingredients in the IQ domain structure. 

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

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

Dataset wrap
Name IQ
Rowcaps Rows 1, 13, 16: Show three 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 four 4 types of tobacco used in the product. IQPARENT=Tobacco Filler and IQLEVEL=2, together indicating that these are sub-components of subcomponents/ingredients in the tobacco filler, a top level-component of the cigarette product. Rows 6-8: Show the three sub-component 3 tobacco ingredients that comprise 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 three 3 rows plus the sum of the quantities shown in rows 12-34.  IQLEVEL=3 to show that these ingredients are at the 3rd level of the hierarchy (sub-components of an ingredient with IQLEVEL=2). Rows 9-10: Show the quantities of two 2 non-tobacco ingredients, Methylcellulose methylcellulose and 1,3-Butanediolbutanediol, which are further sub-component ingredients of subcomponents/ingredients in Reconstituted Tobacco, as indicated by IQPARENT. IQFUNCT shows that Methylcellulose methylcellulose functions as a binder and 1,3-Butanediol butanediol functions as a humectant. IQLEVEL=3 to show that these ingredients are at the 3rd third level of the hierarchy. Rows 11-12: Show the quantities of two sub-component 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 two sub-component 2 subcomponents/ingredients that function as filtration and plasticizer, respectively, in the filter portion of the cigarette (Cellulose Filter cellulose filter A, a top-level component shown in row 13). Rows 17-22: Show the quantities and functions of six sub-component ingredients of 6 subcomponents/ingredients in the top-level component FSC Paper paper B (the cigarette paper shown in row 16). Dataset2 Row DOMAIN STUDYID SPTOBID IGDCMPID IQCAT IQPARENT IQLEVEL IQFUNCT IQVALTRG IQVALMIN IQVALMAX IQUNIT 1 IQ TOB07 CIG01A Tobacco Filler TOBACCO INGREDIENT 1 672.5 661.3 683.7 mg/cigarette 2 IQ TOB07 CIG01A Burley Tobacco TOBACCO INGREDIENT Tobacco Filler 2 19 17 21 mg/cigarette 3 IQ TOB07 CIG01A Bright Tobacco TOBACCO INGREDIENT Tobacco Filler 2 300 295 305 mg/cigarette 4 IQ TOB07 CIG01A Oriental Tobacco TOBACCO INGREDIENT Tobacco Filler 2 115 113 117 mg/cigarette 5 IQ TOB07 CIG01A Reconstituted Tobacco TOBACCO INGREDIENT Tobacco Filler 2 231 229 233 mg/cigarette 6 IQ TOB07 CIG01A Burley Tobacco 2 TOBACCO INGREDIENT Reconstituted Tobacco 3 19 18 20 mg/cigarette 7 IQ TOB07 CIG01A Bright Tobacco TOBACCO INGREDIENT Reconstituted Tobacco 3 103 101 105 mg/cigarette 8 IQ TOB07 CIG01A Oriental Tobacco TOBACCO INGREDIENT Reconstituted Tobacco 3 65 63 67 mg/cigarette 9 IQ TOB07 CIG01A Methylcellulose NON-TOBACCO INGREDIENT Reconstituted Tobacco 3 Binder 20 19 21 mg/cigarette 10 IQ TOB07 CIG01A 1,3-Butanediol NON-TOBACCO INGREDIENT Reconstituted Tobacco 3 Humectant 24 23 25 mg/cigarette 11 IQ TOB07 CIG01A Cocoa Extract NON-TOBACCO INGREDIENT Tobacco Filler 2 Flavor 7 6.75 7.25 mg/cigarette 12 IQ TOB07 CIG01A Butyric Acid NON-TOBACCO INGREDIENT Tobacco Filler 2 Flavor 0.5 0.55 0.45 mg/cigarette 13 IQ TOB07 CIG01A Cellulose Filter A NON-TOBACCO INGREDIENT 1 Filter 164 163 165 mg/cigarette 14 IQ TOB07 CIG01A Cellulose Acetate NON-TOBACCO INGREDIENT Cellulose Filter A 2 Filtration 155 154 156 mg/cigarette 15 IQ TOB07 CIG01A Triacetin NON-TOBACCO INGREDIENT Cellulose Filter A 2 Plasticizer 9 8 10 mg/cigarette 16 IQ TOB07 CIG01A FSC Paper B NON-TOBACCO INGREDIENT 1 Cigarette Paper (Wrapper) 50 49 51 mg/cigarette 17 IQ TOB07 CIG01A Cellulose Pulp NON-TOBACCO INGREDIENT FSC Paper B 2 Fiber 30 29 31 mg/cigarette 18 IQ TOB07 CIG01A Calcium Carbonate NON-TOBACCO INGREDIENT FSC Paper B 2 Filler 15 14 16 mg/cigarette 19 IQ TOB07 CIG01A Sodium Alginate NON-TOBACCO INGREDIENT FSC Paper B 2 Reduced ignition propensity 2 1.75 2.25 mg/cigarette 20 IQ TOB07 CIG01A Trisodium Citrate NON-TOBACCO INGREDIENT FSC Paper B 2 Combustion Modifier 0.5 0.45 0.55 mg/cigarette 21 IQ TOB07 CIG01A Cationic Starch NON-TOBACCO INGREDIENT FSC Paper B 2 Binder 0.5 0.45 0.55 mg/cigarette 22 IQ TOB07 CIG01A Seam Adhesive NON-TOBACCO INGREDIENT FSC Paper B 2 Adhesive 2 1.75 2.25 mg/cigarette