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- IN is a special-purpose domain for listing the non-tobacco ingredients (only) for a tobacco product.
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- Tobacco ingredients (e.g., individual tobacco varieties) would not be represented in this domain (see
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- Section 2.8.8.4, SDTM Tobacco Ingredients, for IT domain specification and assumptions
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- ).
- IN is
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- 1 of
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- 2 domains (along with IT) that serve as the origin of the consistent identifier variable IGDCMPID (Ingredient or Component Identifier).
- IGDCMPID must represent a
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- non-tobacco ingredient that is unique with regard to the attributes listed in
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- assumption 3 below. If
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- 2 or more sources of the same
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- non-tobacco ingredient differ on any of these attributes, they must each be assigned a different value for
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- IGDCMPID (e.g.
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- , 1,3-Butanediol A, 1,3-Butanediol B).
- IGDCMPID is also used
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- in the Ingredient Quantities by Component (IQ) domain, where the ingredients identified by those values are quantified by component
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- . When quantifying ingredients in IQ, every ingredient (every value of IGDCMPID in IN) must be accounted for in IQ (see Section 2.8.8.6 for IQ domain specification and assumptions
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- ).
- Additionally, IN contains variables for representing the following attributes:
- Manufacturer's name and registration number (INMANUF)
- Manufacturer's unique identifying item number for the ingredient or component (INMANUIN)
- Tobacco product master file number (TPMF)
- IUPAC name (IUPACNAM), CAS registry number (CASNO), and FDA Unique Ingredient Identifier (UNII), with the following requirements for inclusion in the IN dataset:
- IUPACNAM is an expected variable, and should be populated with the preferred IUPAC name for all ingredients for which an IUPAC name is available. IUPAC nomenclature is available at https://iupac.org/.
- At least 1 of the 2 permissible variables CASNO or UNII should also be provided if available. CAS numbers are available at https://www.cas.org/. UNII identifiers are available https://precision.fda.gov/uniisearch.
- The complexity of the ingredient (INIGDPLX), to differentiate between single ingredients and complex ingredients, and a separate indicator (INCIGIND) as to whether a complex ingredient was made to the applicant's specifications
- Ingredient grade (INGRADE) and purity (INPURITY). According to the PMTA rule, at least 1 of these 2 attributes must be included. If the data are proprietary and only available via the TPMF, then TPMF should be populated.
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