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6 IT TOB07 CIG01A Reconstituted Burley Tobacco 2 KT215LC SINGLE INGREDIENT Air

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.

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Name IN
Dataset2 Row DOMAIN STUDYID SPTOBID IGDCMPID INMANUF INMANUIN TPMF IUPACNAM CASNO UNII INIGDPLX INCIGIND INGRADE INPURTY 1 IN ????? TOBACCO PRODUCT Single Substance 2 IL TOB07 CIG01A Bright Tobacco 8037-19-2 TOBACCO PRODUCT Flue CC 1063 Single Substance 3 IL TOB07 CIG01A Oriental Tobacco 8037-19-2 TOBACCO PRODUCT Sun USDA Nicotiana Collection PI 552747 Single Substance 4 IL TOB07 CIG01A Burley Tobacco 8037-19-2 TOBACCO PRODUCT Air NC 7LC Single Substance 5 IL TOB07 CIG01A Cocoa Extract NON TOBACCO PRODUCT Complex Substance Purchased  Flavor House A FLVR1234 MF5555555 COMPLEX INGREDIENT NoN MF5555555FOOD 62 ILIN TOB07 CIG01A Butyric Acid butanoic acid 107-92-6 SINGLE INGREDIENT USPNON TOBACCO PRODUCT ≥99%Single Substance 37 IN IL TOB07 CIG01A Cellulose Filter A - NON TOBACCO PRODUCT Complex Substance Purchased  MFR A FIL789 No MFR A FIL789 - COMPLEX INGREDIENT N USP 4 IN 8 IL TOB07 CIG01A Cellulose Acetate cellulose acetate 9004-35-7  NON TOBACCO PRODUCT Single Substance 7 SINGLE INGREDIENT 99% 5 IN 9 IL TOB07 CIG01A Triacetin 1,3-diacetyloxypropan-2-yl acetate 102-76-1  NON TOBACCO PRODUCT Single Substance 1 SINGLE INGREDIENT USP 6 IN 10 IL TOB07 CIG01A FSC Paper BNON TOBACCO PRODUCT Complex Substance Purchased  MFR B FSC123 MF5678910 COMPLEX INGREDIENT NoN 117 ILIN TOB07 CIG01A Cellulose Pulp cellulose pulp 65996-61-4  NON TOBACCO PRODUCT Single Substance 4 SINGLE INGREDIENT ≥99% 8 IN 12 IL TOB07 CIG01A Calcium Carbonate calcium carbonate 471-34-1  NON TOBACCO PRODUCT Single Substance 1 SINGLE INGREDIENT USP 9 IN 13 IL TOB07 CIG01A Sodium Alginate sodium;3,4,5,6-tetrahydroxyoxane-2-carboxylate 9005-38-3 NON TOBACCO PRODUCT Single Substance SINGLE INGREDIENT FOOD 10 IN 14 IL TOB07 CIG01A Trisodium Citrate trisodium;2-hydroxypropane-1,2,3-tricarboxylate 6132-04-3 NON TOBACCO PRODUCT Single Substance SINGLE INGREDIENT ≥98% 11 IN 15 IL TOB07 CIG01A Cationic Starch starch, 2-hydroxy-3-(trimethylammonio)propyl ether, chloride 56780-58-6  NON TOBACCO PRODUCT Single Substance 6 SINGLE INGREDIENT FOOD 12 IN 16 IL TOB07 CIG01A Seam Adhesive - NON TOBACCO PRODUCT Complex Substance Purchased  MFR C ADV123 MF2345678No COMPLEX INGREDIENT MF2345678N 1713 ILIN TOB07 CIG01A Methylcellulose(5R)-2,3,4-trimethoxy-6-(methoxymethyl)-5-[(2S)-3,4,5-trimethoxy-6-(methoxymethyl)oxan-2-yl]oxyoxane 9004-67-5 NON TOBACCO PRODUCT Single Substance SINGLE INGREDIENT FOOD 14 IN 18 IL TOB07 CIG01A 1,3-Butanediol 4,4,4-trifluoro-2-methyl-1-phenyl-3-(trifluoromethyl)butane-1Butane-1,3-diol 34844-08-1 NON TOBACCO PRODUCT Single Substance

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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.      

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:

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Name IQ
Dataset wrap
Name IQ
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 Row DOMAIN STUDYID SPTOBID STRFID IGDCMPID IQCAT IQPARENT IQLEVEL IQFUNCT IQTARG IQVALTRG IGMIN IQVALMIN IQMAX 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 7 10 IQ TOB07 CIG01A 1,3-Butanediol NON-TOBACCO INGREDIENT Reconstituted Tobacco 3 Humectant 24 23 25 mg/cigarette 8 11 IQ TOB07 CIG01A Cocoa Extract NON-TOBACCO INGREDIENT Tobacco Filler 2 Flavor 7 6.75 7.25 mg/cigarette 9 12 IQ TOB07 CIG01A Butyric Acid NON-TOBACCO INGREDIENT Tobacco Filler 2 Flavor 0.5 0.55 0.45 mg/cigarette 10 13 IQ TOB07 CIG01A Cellulose Filter A NON-TOBACCO INGREDIENT 1 Filter 164 163 165 mg/cigarette 11 14 IQ TOB07 CIG01A Cellulose Acetate NON-TOBACCO INGREDIENT Cellulose Filter A 2 Filtration 155 154 156 mg/cigarette 12 15 IQ TOB07 CIG01A Triacetin NON-TOBACCO INGREDIENT Cellulose Filter A 2 Plasticizer 9 8 10 mg/cigarette 13 16 IQ TOB07 CIG01A FSC Paper B NON-TOBACCO INGREDIENT 1 Cigarette Paper (Wrapper) 50 49 51 mg/cigarette 14 17 IQ TOB07 CIG01A Cellulose Pulp NON-TOBACCO INGREDIENT FSC Paper B 2 Fiber 30 29 31 mg/cigarette 15 18 IQ TOB07 CIG01A Calcium Carbonate NON-TOBACCO INGREDIENT FSC Paper B 2 Filler 15 14 16 mg/cigarette 16 19 IQ TOB07 CIG01A Sodium Alginate NON-TOBACCO INGREDIENT FSC Paper B 2 Reduced ignition propensity 2 1.75 2.25 mg/cigarette 17 20 IQ TOB07 CIG01A Trisodium Citrate NON-TOBACCO INGREDIENT FSC Paper B 2 Combustion Modifier 0.5 0.45 0.55 mg/cigarette 18 21 IQ TOB07 CIG01A Cationic Starch NON-TOBACCO INGREDIENT FSC Paper B 2 Binder 0.5 0.45 0.55 mg/cigarette 19 22 IQ TOB07 CIG01A Seam Adhesive NON-TOBACCO INGREDIENT FSC Paper B 2 Adhesive 2 1.75 2.25 mg/cigarette