SubstanceDefinition (14)

#NameSourceVerDescription
1Component Substancehl7.fhir.us.pq-cmc#currentR5Any raw material intended for use in the manufacture of a drug substance, or any ingredient intended for use in the manufacture of a drug product including those that may not appear in such drug product.
2Drug Substancehl7.fhir.us.pq-cmc#currentR5Drug Substance (Active Ingredient) nomenclature and characterization.
3Drug Substance Container Closurehl7.fhir.us.pq-cmc#currentR5Description and coding of the container closure system. Profile on Drug Substance profile.
4Drug Substance Impurityhl7.fhir.us.pq-cmc#currentR5Any component of the drug substance that is not the chemical entity for procduct composition.
5Drug Substance Molecular Structurehl7.fhir.us.pq-cmc#currentR5Drug Substance (Active Ingredient) molecular structure. Profile on Drug Substance profile.
6Excipient Drug Substancehl7.fhir.us.pq-cmc#currentR5Provides sufficient information to identify an inactive substance and raw materials and its source when stability data is required in the submission.
7Polymorphic Formhl7.fhir.us.pq-cmc#currentR5Alternate structure present in the drug substance
8Routine Drug Substancehl7.fhir.us.pq-cmc#currentR5Provides sufficient information to identify a drug substance. Profile on Drug Substance profile.
9SubmittedIngredientDefinitionhl7.fhir.us.spl#currentR4BUsed to represent an substance's active moiety.
10Substance Impuritieshl7.fhir.us.pq-cmc#currentR5Drug Substance Impurities
11Substance Nomenclaturehl7.fhir.us.pq-cmc#currentR5Drug Substance (Active Ingredient) nomenclature. Profile on Drug Substance profile.
12SubstanceDefinition (ePI)hl7.fhir.uv.emedicinal-product-info#currentR5SubstanceDefinition (ePI)
13SubstanceDefinition (ePI)hl7.fhir.uv.vulcan-eproduct-info#currentR5SubstanceDefinition (ePI)
14SubstanceDefinition - Component Substance dx-PQhl7.fhir.uv.dx-pq#currentR5Section 2.1 - DP Composition - Product Component
1 2 3 4 5 6 7 8 9 10 11 12 13 14
SubstanceDefinition I I I I I I I I I
SubstanceDefinition.meta
SubstanceDefinition.meta.profile C C C C C C C C C
SubstanceDefinition.implicitRules
SubstanceDefinition.language
SubstanceDefinition.text
SubstanceDefinition.contained
SubstanceDefinition.extension S C (2)
SubstanceDefinition.modifierExtension
SubstanceDefinition.identifier C C C C C C C C C C C C
SubstanceDefinition.identifier.value C
SubstanceDefinition.identifier.system C
SubstanceDefinition.version
SubstanceDefinition.status
SubstanceDefinition.classification C D B M C D B M D C D B M C D B M C D B M C D B M C D B M
SubstanceDefinition.classification.coding B M
SubstanceDefinition.domain B M B M
SubstanceDefinition.grade C D C D C D
SubstanceDefinition.grade.coding B M B M B M
SubstanceDefinition.description
SubstanceDefinition.informationSource
SubstanceDefinition.note
SubstanceDefinition.manufacturer C C C C C C
SubstanceDefinition.supplier C C C C C
SubstanceDefinition.moiety C
SubstanceDefinition.moiety.extension
SubstanceDefinition.moiety.modifierExtension
SubstanceDefinition.moiety.role
SubstanceDefinition.moiety.identifier C
SubstanceDefinition.moiety.name C
SubstanceDefinition.moiety.stereochemistry
SubstanceDefinition.moiety.opticalActivity
SubstanceDefinition.moiety.molecularFormula
SubstanceDefinition.moiety.amount[x]
SubstanceDefinition.moiety.measurementType
SubstanceDefinition.characterization
SubstanceDefinition.characterization.extension
SubstanceDefinition.characterization.modifierExtension
SubstanceDefinition.characterization.technique
SubstanceDefinition.characterization.technique.text C C C
SubstanceDefinition.characterization.form
SubstanceDefinition.characterization.form.text
SubstanceDefinition.characterization.description
SubstanceDefinition.characterization.file C D C D C D
SubstanceDefinition.characterization.file.title C C C
SubstanceDefinition.characterization.file.data C C C
SubstanceDefinition.property
SubstanceDefinition.property.extension
SubstanceDefinition.property.modifierExtension
SubstanceDefinition.property.type
SubstanceDefinition.property.value[x]
SubstanceDefinition.referenceInformation
SubstanceDefinition.molecularWeight C D C D
SubstanceDefinition.molecularWeight.extension
SubstanceDefinition.molecularWeight.modifierExtension
SubstanceDefinition.molecularWeight.method
SubstanceDefinition.molecularWeight.type
SubstanceDefinition.molecularWeight.amount
SubstanceDefinition.molecularWeight.amount.value
SubstanceDefinition.molecularWeight.amount.code C B M C B M
SubstanceDefinition.molecularWeight.amount.unit D D
SubstanceDefinition.structure C C
SubstanceDefinition.structure.extension
SubstanceDefinition.structure.modifierExtension
SubstanceDefinition.structure.stereochemistry
SubstanceDefinition.structure.opticalActivity
SubstanceDefinition.structure.molecularFormula D D D D
SubstanceDefinition.structure.molecularFormulaByMoiety
SubstanceDefinition.structure.molecularWeight
SubstanceDefinition.structure.technique D D C D C D D
SubstanceDefinition.structure.technique.text C C C C C
SubstanceDefinition.structure.sourceDocument
SubstanceDefinition.structure.representation C C C C C
SubstanceDefinition.structure.representation.extension
SubstanceDefinition.structure.representation.modifierExtension
SubstanceDefinition.structure.representation.type
SubstanceDefinition.structure.representation.representation D D D D D
SubstanceDefinition.structure.representation.format D D D D D
SubstanceDefinition.structure.representation.format.coding B M B M B M B M B M B M
SubstanceDefinition.structure.representation.document D D D D D
SubstanceDefinition.code C
SubstanceDefinition.code.extension
SubstanceDefinition.code.modifierExtension
SubstanceDefinition.code.code B M B M
SubstanceDefinition.code.code.coding S C D (3) S C D (3) S C D (3) S C D (3) S C D (3) S C D (3) D S C D (3) S C D (3)
SubstanceDefinition.code.code.coding.system C F (2) C F (2) C F (2) C F (2) C F (2) C F (2) F C F (2) C F (2)
SubstanceDefinition.code.status
SubstanceDefinition.code.statusDate
SubstanceDefinition.code.note
SubstanceDefinition.code.source
SubstanceDefinition.name S C I (5) S C I (13) S C I (5) S C I (5) S C I (13) S C I (5) S C I (5) S C I (5) C S C I (13) S C I (13)
SubstanceDefinition.name.extension
SubstanceDefinition.name.modifierExtension
SubstanceDefinition.name.name D (4) D (12) D (4) D (4) D (12) D (4) D (4) D (4) D (12) D (12)
SubstanceDefinition.name.type C (4) C (12) C (4) C (4) C (12) C (4) C (4) C (4) C (12) C (12)
SubstanceDefinition.name.type.coding C F (4) C F (12) C F (4) C F (4) C F (12) C F (4) C F (4) C F (4) C F (12) C F (12)
SubstanceDefinition.name.status
SubstanceDefinition.name.preferred (5) (13) (5) (5) (13) (5) (5) (5) (13) (13)
SubstanceDefinition.name.language
SubstanceDefinition.name.domain
SubstanceDefinition.name.jurisdiction
SubstanceDefinition.name.synonym
SubstanceDefinition.name.translation
SubstanceDefinition.name.official
SubstanceDefinition.name.official.extension
SubstanceDefinition.name.official.modifierExtension
SubstanceDefinition.name.official.authority
SubstanceDefinition.name.official.status
SubstanceDefinition.name.official.date
SubstanceDefinition.name.source
SubstanceDefinition.relationship
SubstanceDefinition.relationship.extension
SubstanceDefinition.relationship.modifierExtension
SubstanceDefinition.relationship.substanceDefinition[x] S C (2) S C (2) S C (2)
SubstanceDefinition.relationship.type
SubstanceDefinition.relationship.type.text F F
SubstanceDefinition.relationship.isDefining
SubstanceDefinition.relationship.amount[x]
SubstanceDefinition.relationship.ratioHighLimitAmount
SubstanceDefinition.relationship.comparator
SubstanceDefinition.relationship.source
SubstanceDefinition.nucleicAcid
SubstanceDefinition.polymer
SubstanceDefinition.protein
SubstanceDefinition.sourceMaterial
SubstanceDefinition.sourceMaterial.extension
SubstanceDefinition.sourceMaterial.modifierExtension
SubstanceDefinition.sourceMaterial.type D C D
SubstanceDefinition.sourceMaterial.type.coding B M B M
SubstanceDefinition.sourceMaterial.genus
SubstanceDefinition.sourceMaterial.genus.text C D C D
SubstanceDefinition.sourceMaterial.genus.coding C C
SubstanceDefinition.sourceMaterial.species D D
SubstanceDefinition.sourceMaterial.species.text C C
SubstanceDefinition.sourceMaterial.species.coding C C
SubstanceDefinition.sourceMaterial.part D D
SubstanceDefinition.sourceMaterial.part.text C C
SubstanceDefinition.sourceMaterial.part.coding C C
SubstanceDefinition.sourceMaterial.countryOfOrigin C D C D
SubstanceDefinition.sourceMaterial.countryOfOrigin.coding C B M C B M
S: There is slicing defined in the element(s)
C: There is cardinality erstrictions defined in the element(s)
I: There is invariants defined in the element(s)
F: There is a fixed or pattern value defined in the element(s)
D: There is document provided in the element(s)
B: There is terminology bindings defined in the element(s)
M: At least one of the element(s) has must-support = true
(N): The number of elements if > 1

Produced 08 Sep 2023