Release 5 Ballot

This page is part of the FHIR Specification (v5.0.0-ballot: R5 Ballot - see ballot notes). The current version which supercedes this version is 5.0.0. For a full list of available versions, see the Directory of published versions . Page versions: R5 R4B

Biomedical Research and Regulation icon Work GroupMaturity Level: 1 Trial UseSecurity Category: Anonymous Compartments: Not linked to any defined compartments

Detailed Descriptions for the elements in the SubstanceDefinition resource.

SubstanceDefinition
Element IdSubstanceDefinition
Definition

The detailed description of a substance, typically at a level beyond what is used for prescribing.

Short DisplayThe detailed description of a substance, typically at a level beyond what is used for prescribing
Cardinality0..*
TypeDomainResource
Summaryfalse
SubstanceDefinition.identifier
Element IdSubstanceDefinition.identifier
Definition

Identifier by which this substance is known.

Short DisplayIdentifier by which this substance is known
NoteThis is a business identifier, not a resource identifier (see discussion)
Cardinality0..*
TypeIdentifier
Summarytrue
SubstanceDefinition.version
Element IdSubstanceDefinition.version
Definition

A business level version identifier of the substance.

Short DisplayA business level version identifier of the substance
NoteThis is a business versionId, not a resource version id (see discussion)
Cardinality0..1
Typestring
Summarytrue
SubstanceDefinition.status
Element IdSubstanceDefinition.status
Definition

Status of substance within the catalogue e.g. active, retired.

Short DisplayStatus of substance within the catalogue e.g. active, retired
Cardinality0..1
Terminology BindingPublicationStatus (Preferred)
TypeCodeableConcept
Summarytrue
SubstanceDefinition.classification
Element IdSubstanceDefinition.classification
Definition

A high level categorization, e.g. polymer or nucleic acid, or food, chemical, biological, or a lower level such as the general types of polymer (linear or branch chain) or type of impurity (process related or contaminant).

Short DisplayA categorization, high level e.g. polymer or nucleic acid, or food, chemical, biological, or lower e.g. polymer linear or branch chain, or type of impurity
Cardinality0..*
TypeCodeableConcept
Summarytrue
SubstanceDefinition.domain
Element IdSubstanceDefinition.domain
Definition

If the substance applies to human or veterinary use.

Short DisplayIf the substance applies to human or veterinary use
Cardinality0..1
Terminology BindingMedicinalProductDomain (Example)
TypeCodeableConcept
Summarytrue
SubstanceDefinition.grade
Element IdSubstanceDefinition.grade
Definition

The quality standard, established benchmark, to which substance complies (e.g. USP/NF, Ph. Eur, JP, BP, Company Standard).

Short DisplayThe quality standard, established benchmark, to which substance complies (e.g. USP/NF, BP)
Cardinality0..*
Terminology BindingSubstanceGrade (Example)
TypeCodeableConcept
Summarytrue
SubstanceDefinition.description
Element IdSubstanceDefinition.description
Definition

Textual description of the substance.

Short DisplayTextual description of the substance
Cardinality0..1
Typemarkdown
Summarytrue
SubstanceDefinition.informationSource
Element IdSubstanceDefinition.informationSource
Definition

Supporting literature.

Short DisplaySupporting literature
Cardinality0..*
TypeReference(Citation)
Summarytrue
SubstanceDefinition.note
Element IdSubstanceDefinition.note
Definition

Textual comment about the substance's catalogue or registry record.

Short DisplayTextual comment about the substance's catalogue or registry record
Cardinality0..*
TypeAnnotation
Summarytrue
SubstanceDefinition.manufacturer
Element IdSubstanceDefinition.manufacturer
Definition

The entity that creates, makes, produces or fabricates the substance. This is a set of potential manufacturers but is not necessarily comprehensive.

Short DisplayThe entity that creates, makes, produces or fabricates the substance
Cardinality0..*
TypeReference(Organization)
Summarytrue
SubstanceDefinition.supplier
Element IdSubstanceDefinition.supplier
Definition

An entity that is the source for the substance. It may be different from the manufacturer. Supplier is synonymous to a distributor.

Short DisplayAn entity that is the source for the substance. It may be different from the manufacturer
Cardinality0..*
TypeReference(Organization)
Summarytrue
SubstanceDefinition.moiety
Element IdSubstanceDefinition.moiety
Definition

Moiety, for structural modifications.

Short DisplayMoiety, for structural modifications
Cardinality0..*
Summarytrue
SubstanceDefinition.moiety.role
Element IdSubstanceDefinition.moiety.role
Definition

Role that the moiety is playing.

Short DisplayRole that the moiety is playing
Cardinality0..1
TypeCodeableConcept
Summarytrue
SubstanceDefinition.moiety.identifier
Element IdSubstanceDefinition.moiety.identifier
Definition

Identifier by which this moiety substance is known.

Short DisplayIdentifier by which this moiety substance is known
NoteThis is a business identifier, not a resource identifier (see discussion)
Cardinality0..1
TypeIdentifier
Summarytrue
SubstanceDefinition.moiety.name
Element IdSubstanceDefinition.moiety.name
Definition

Textual name for this moiety substance.

Short DisplayTextual name for this moiety substance
Cardinality0..1
Typestring
Summarytrue
SubstanceDefinition.moiety.stereochemistry
Element IdSubstanceDefinition.moiety.stereochemistry
Definition

Stereochemistry type.

Short DisplayStereochemistry type
Cardinality0..1
Terminology BindingStereochemistry (Example)
TypeCodeableConcept
Summarytrue
SubstanceDefinition.moiety.opticalActivity
Element IdSubstanceDefinition.moiety.opticalActivity
Definition

Optical activity type.

Short DisplayOptical activity type
Cardinality0..1
Terminology BindingOpticalActivity (Example)
TypeCodeableConcept
Summarytrue
SubstanceDefinition.moiety.molecularFormula
Element IdSubstanceDefinition.moiety.molecularFormula
Definition

Molecular formula for this moiety of this substance, typically using the Hill system.

Short DisplayMolecular formula for this moiety (e.g. with the Hill system)
Cardinality0..1
Typestring
Summarytrue
SubstanceDefinition.moiety.amount[x]
Element IdSubstanceDefinition.moiety.amount[x]
Definition

Quantitative value for this moiety.

Short DisplayQuantitative value for this moiety
Cardinality0..1
TypeQuantity|string
[x] NoteSee Choice of Datatypes for further information about how to use [x]
Summarytrue
SubstanceDefinition.moiety.measurementType
Element IdSubstanceDefinition.moiety.measurementType
Definition

The measurement type of the quantitative value. In capturing the actual relative amounts of substances or molecular fragments it may be necessary to indicate whether the amount refers to, for example, a mole ratio or weight ratio.

Short DisplayThe measurement type of the quantitative value
Cardinality0..1
Terminology BindingSubstanceAmountType (Example)
TypeCodeableConcept
Summarytrue
SubstanceDefinition.property
Element IdSubstanceDefinition.property
Definition

General specifications for this substance.

Short DisplayGeneral specifications for this substance
Cardinality0..*
Summarytrue
SubstanceDefinition.property.type
Element IdSubstanceDefinition.property.type
Definition

A code expressing the type of property.

Short DisplayA code expressing the type of property
Cardinality1..1
Terminology BindingProductCharacteristic (Example)
TypeCodeableConcept
Summarytrue
SubstanceDefinition.property.value[x]
Element IdSubstanceDefinition.property.value[x]
Definition

A value for the property.

Short DisplayA value for the property
Cardinality0..1
TypeCodeableConcept|Quantity|date|boolean|Attachment
[x] NoteSee Choice of Datatypes for further information about how to use [x]
Summarytrue
SubstanceDefinition.referenceInformation
Element IdSubstanceDefinition.referenceInformation
Definition

General information detailing this substance.

Short DisplayGeneral information detailing this substance
Cardinality0..1
TypeReference(SubstanceReferenceInformation)
Summarytrue
SubstanceDefinition.molecularWeight
Element IdSubstanceDefinition.molecularWeight
Definition

The molecular weight or weight range (for proteins, polymers or nucleic acids).

Short DisplayThe molecular weight or weight range
Cardinality0..*
Summarytrue
SubstanceDefinition.molecularWeight.method
Element IdSubstanceDefinition.molecularWeight.method
Definition

The method by which the molecular weight was determined.

Short DisplayThe method by which the weight was determined
Cardinality0..1
Terminology BindingWeightMethod (Example)
TypeCodeableConcept
Summarytrue
SubstanceDefinition.molecularWeight.type
Element IdSubstanceDefinition.molecularWeight.type
Definition

Type of molecular weight such as exact, average (also known as. number average), weight average.

Short DisplayType of molecular weight e.g. exact, average, weight average
Cardinality0..1
Terminology BindingWeightType (Example)
TypeCodeableConcept
Summarytrue
SubstanceDefinition.molecularWeight.amount
Element IdSubstanceDefinition.molecularWeight.amount
Definition

Used to capture quantitative values for a variety of elements. If only limits are given, the arithmetic mean would be the average. If only a single definite value for a given element is given, it would be captured in this field.

Short DisplayUsed to capture quantitative values for a variety of elements
Cardinality1..1
TypeQuantity
Summarytrue
SubstanceDefinition.structure
Element IdSubstanceDefinition.structure
Definition

Structural information.

Short DisplayStructural information
Cardinality0..1
Summarytrue
SubstanceDefinition.structure.stereochemistry
Element IdSubstanceDefinition.structure.stereochemistry
Definition

Stereochemistry type.

Short DisplayStereochemistry type
Cardinality0..1
Terminology BindingStereochemistry (Example)
TypeCodeableConcept
Summarytrue
SubstanceDefinition.structure.opticalActivity
Element IdSubstanceDefinition.structure.opticalActivity
Definition

Optical activity type.

Short DisplayOptical activity type
Cardinality0..1
Terminology BindingOpticalActivity (Example)
TypeCodeableConcept
Summarytrue
SubstanceDefinition.structure.molecularFormula
Element IdSubstanceDefinition.structure.molecularFormula
Definition

Molecular formula of this substance, typically using the Hill system.

Short DisplayMolecular formula (e.g. using the Hill system)
Cardinality0..1
Typestring
Summarytrue
SubstanceDefinition.structure.molecularFormulaByMoiety
Element IdSubstanceDefinition.structure.molecularFormulaByMoiety
Definition

Specified per moiety according to the Hill system, i.e. first C, then H, then alphabetical, each moiety separated by a dot.

Short DisplaySpecified per moiety according to the Hill system
Cardinality0..1
Typestring
Summarytrue
SubstanceDefinition.structure.molecularWeight
Element IdSubstanceDefinition.structure.molecularWeight
Definition

The molecular weight or weight range (for proteins, polymers or nucleic acids).

Short DisplayThe molecular weight or weight range
Cardinality0..1
TypeSee SubstanceDefinition.molecularWeight
Summarytrue
SubstanceDefinition.structure.technique
Element IdSubstanceDefinition.structure.technique
Definition

The method used to elucidate the structure or characterization of the drug substance. Examples: X-ray, HPLC, NMR, Peptide mapping, Ligand binding assay.

Short DisplayThe method used to find the structure e.g. X-ray, NMR
Cardinality0..*
Terminology BindingStructureTechnique (Example)
TypeCodeableConcept
Summarytrue
SubstanceDefinition.structure.sourceDocument
Element IdSubstanceDefinition.structure.sourceDocument
Definition

The source of information about the structure.

Short DisplaySource of information for the structure
Cardinality0..*
TypeReference(DocumentReference)
Summarytrue
SubstanceDefinition.structure.representation
Element IdSubstanceDefinition.structure.representation
Definition

A depiction of the structure or characterization of the substance.

Short DisplayA depiction of the structure or characterization of the substance
Cardinality0..*
Summarytrue
SubstanceDefinition.structure.representation.type
Element IdSubstanceDefinition.structure.representation.type
Definition

The kind of structural representation (e.g. full, partial).

Short DisplayThe kind of structural representation (e.g. full, partial)
Cardinality0..1
Terminology BindingSubstanceRepresentationType (Example)
TypeCodeableConcept
Summarytrue
SubstanceDefinition.structure.representation.representation
Element IdSubstanceDefinition.structure.representation.representation
Definition

The structural representation or characterization as a text string in a standard format.

Short DisplayThe structural representation or characterization as a text string in a standard format
Cardinality0..1
Typestring
Summarytrue
SubstanceDefinition.structure.representation.format
Element IdSubstanceDefinition.structure.representation.format
Definition

The format of the representation e.g. InChI, SMILES, MOLFILE, CDX, SDF, PDB, mmCIF. The logical content type rather than the physical file format of a document.

Short DisplayThe format of the representation e.g. InChI, SMILES, MOLFILE (note: not the physical file format)
Cardinality0..1
Terminology BindingSubstanceRepresentationFormat (Example)
TypeCodeableConcept
Summarytrue
SubstanceDefinition.structure.representation.document
Element IdSubstanceDefinition.structure.representation.document
Definition

An attached file with the structural representation or characterization e.g. a molecular structure graphic of the substance, a JCAMP or AnIML file.

Short DisplayAn attachment with the structural representation e.g. a structure graphic or AnIML file
Cardinality0..1
TypeReference(DocumentReference)
Summarytrue
SubstanceDefinition.code
Element IdSubstanceDefinition.code
Definition

Codes associated with the substance.

Short DisplayCodes associated with the substance
Cardinality0..*
Summarytrue
SubstanceDefinition.code.code
Element IdSubstanceDefinition.code.code
Definition

The specific code.

Short DisplayThe specific code
Cardinality0..1
TypeCodeableConcept
Summarytrue
SubstanceDefinition.code.status
Element IdSubstanceDefinition.code.status
Definition

Status of the code assignment, for example 'provisional', 'approved'.

Short DisplayStatus of the code assignment, for example 'provisional', 'approved'
Cardinality0..1
Terminology BindingPublicationStatus (Preferred)
TypeCodeableConcept
Summarytrue
SubstanceDefinition.code.statusDate
Element IdSubstanceDefinition.code.statusDate
Definition

The date at which the code status was changed as part of the terminology maintenance.

Short DisplayThe date at which the code status was changed
Cardinality0..1
TypedateTime
Summarytrue
SubstanceDefinition.code.note
Element IdSubstanceDefinition.code.note
Definition

Any comment can be provided in this field, if necessary.

Short DisplayAny comment can be provided in this field
Cardinality0..*
TypeAnnotation
Summarytrue
SubstanceDefinition.code.source
Element IdSubstanceDefinition.code.source
Definition

Supporting literature.

Short DisplaySupporting literature
Cardinality0..*
TypeReference(DocumentReference)
Summarytrue
SubstanceDefinition.name
Element IdSubstanceDefinition.name
Definition

Names applicable to this substance.

Short DisplayNames applicable to this substance
Cardinality0..*
Summarytrue
SubstanceDefinition.name.name
Element IdSubstanceDefinition.name.name
Definition

The actual name.

Short DisplayThe actual name
Cardinality1..1
Typestring
Summarytrue
SubstanceDefinition.name.type
Element IdSubstanceDefinition.name.type
Definition

Name type, for example 'systematic', 'scientific, 'brand'.

Short DisplayName type e.g. 'systematic', 'scientific, 'brand'
Cardinality0..1
Terminology BindingSubstanceNameType (Example)
TypeCodeableConcept
Summarytrue
SubstanceDefinition.name.status
Element IdSubstanceDefinition.name.status
Definition

The status of the name, for example 'current', 'proposed'.

Short DisplayThe status of the name e.g. 'current', 'proposed'
Cardinality0..1
Terminology BindingPublicationStatus (Preferred)
TypeCodeableConcept
Summarytrue
SubstanceDefinition.name.preferred
Element IdSubstanceDefinition.name.preferred
Definition

If this is the preferred name for this substance.

Short DisplayIf this is the preferred name for this substance
Cardinality0..1
Typeboolean
Meaning if MissingIf this value is not present, there is no statement being made about whether this is the preferred name or not. No inference can be made
Summarytrue
SubstanceDefinition.name.language
Element IdSubstanceDefinition.name.language
Definition

Human language that the name is written in.

Short DisplayHuman language that the name is written in
Cardinality0..*
Terminology BindingCommon Languages (Preferred but limited to All Languages)
TypeCodeableConcept
Summarytrue
SubstanceDefinition.name.domain
Element IdSubstanceDefinition.name.domain
Definition

The use context of this name for example if there is a different name a drug active ingredient as opposed to a food colour additive.

Short DisplayThe use context of this name e.g. as an active ingredient or as a food colour additive
Cardinality0..*
Terminology BindingSubstanceNameDomain (Example)
TypeCodeableConcept
Summarytrue
SubstanceDefinition.name.jurisdiction
Element IdSubstanceDefinition.name.jurisdiction
Definition

The jurisdiction where this name applies.

Short DisplayThe jurisdiction where this name applies
Cardinality0..*
Terminology BindingJurisdiction (Example)
TypeCodeableConcept
Summarytrue
SubstanceDefinition.name.synonym
Element IdSubstanceDefinition.name.synonym
Definition

A synonym of this particular name, by which the substance is also known.

Short DisplayA synonym of this particular name, by which the substance is also known
Cardinality0..*
TypeSee SubstanceDefinition.name
Summarytrue
SubstanceDefinition.name.translation
Element IdSubstanceDefinition.name.translation
Definition

A translation for this name into another human language.

Short DisplayA translation for this name into another human language
Cardinality0..*
TypeSee SubstanceDefinition.name
Summarytrue
SubstanceDefinition.name.official
Element IdSubstanceDefinition.name.official
Definition

Details of the official nature of this name.

Short DisplayDetails of the official nature of this name
Cardinality0..*
Summarytrue
SubstanceDefinition.name.official.authority
Element IdSubstanceDefinition.name.official.authority
Definition

Which authority uses this official name.

Short DisplayWhich authority uses this official name
Cardinality0..1
Terminology BindingSubstanceNameAuthority (Preferred)
TypeCodeableConcept
Summarytrue
SubstanceDefinition.name.official.status
Element IdSubstanceDefinition.name.official.status
Definition

The status of the official name, for example 'draft', 'active', 'retired'.

Short DisplayThe status of the official name, for example 'draft', 'active'
Cardinality0..1
Terminology BindingPublicationStatus (Preferred)
TypeCodeableConcept
Summarytrue
SubstanceDefinition.name.official.date
Element IdSubstanceDefinition.name.official.date
Definition

Date of the official name change.

Short DisplayDate of official name change
Cardinality0..1
TypedateTime
Summarytrue
SubstanceDefinition.name.source
Element IdSubstanceDefinition.name.source
Definition

Supporting literature.

Short DisplaySupporting literature
Cardinality0..*
TypeReference(DocumentReference)
Summarytrue
SubstanceDefinition.relationship
Element IdSubstanceDefinition.relationship
Definition

A link between this substance and another, with details of the relationship.

Short DisplayA link between this substance and another
Cardinality0..*
Summarytrue
SubstanceDefinition.relationship.substanceDefinition[x]
Element IdSubstanceDefinition.relationship.substanceDefinition[x]
Definition

A pointer to another substance, as a resource or just a representational code.

Short DisplayA pointer to another substance, as a resource or a representational code
Cardinality0..1
TypeReference(SubstanceDefinition)|CodeableConcept
[x] NoteSee Choice of Datatypes for further information about how to use [x]
Summarytrue
SubstanceDefinition.relationship.type
Element IdSubstanceDefinition.relationship.type
Definition

For example "salt to parent", "active moiety", "starting material", "polymorph", "impurity of".

Short DisplayFor example "salt to parent", "active moiety"
Cardinality1..1
Terminology BindingSubstanceRelationshipType (Example)
TypeCodeableConcept
Summarytrue
SubstanceDefinition.relationship.isDefining
Element IdSubstanceDefinition.relationship.isDefining
Definition

For example where an enzyme strongly bonds with a particular substance, this is a defining relationship for that enzyme, out of several possible substance relationships.

Short DisplayFor example where an enzyme strongly bonds with a particular substance, this is a defining relationship for that enzyme, out of several possible relationships
Cardinality0..1
Typeboolean
Meaning if MissingIf this value is not present, there is no statement being made about whether this is a defining relationship or not. No inference can be made
Summarytrue
SubstanceDefinition.relationship.amount[x]
Element IdSubstanceDefinition.relationship.amount[x]
Definition

A numeric factor for the relationship, for instance to express that the salt of a substance has some percentage of the active substance in relation to some other.

Short DisplayA numeric factor for the relationship, e.g. that a substance salt has some percentage of active substance in relation to some other
Cardinality0..1
TypeQuantity|Ratio|string
[x] NoteSee Choice of Datatypes for further information about how to use [x]
Summarytrue
SubstanceDefinition.relationship.ratioHighLimitAmount
Element IdSubstanceDefinition.relationship.ratioHighLimitAmount
Definition

For use when the numeric has an uncertain range.

Short DisplayFor use when the numeric has an uncertain range
Cardinality0..1
TypeRatio
Summarytrue
SubstanceDefinition.relationship.comparator
Element IdSubstanceDefinition.relationship.comparator
Definition

An operator for the amount, for example "average", "approximately", "less than".

Short DisplayAn operator for the amount, for example "average", "approximately", "less than"
Cardinality0..1
Terminology BindingSubstanceAmountType (Example)
TypeCodeableConcept
Summarytrue
SubstanceDefinition.relationship.source
Element IdSubstanceDefinition.relationship.source
Definition

Supporting literature.

Short DisplaySupporting literature
Cardinality0..*
TypeReference(DocumentReference)
Summarytrue
SubstanceDefinition.nucleicAcid
Element IdSubstanceDefinition.nucleicAcid
Definition

Data items specific to nucleic acids.

Short DisplayData items specific to nucleic acids
Cardinality0..1
TypeReference(SubstanceNucleicAcid)
Summarytrue
SubstanceDefinition.polymer
Element IdSubstanceDefinition.polymer
Definition

Data items specific to polymers.

Short DisplayData items specific to polymers
Cardinality0..1
TypeReference(SubstancePolymer)
Summarytrue
SubstanceDefinition.protein
Element IdSubstanceDefinition.protein
Definition

Data items specific to proteins.

Short DisplayData items specific to proteins
Cardinality0..1
TypeReference(SubstanceProtein)
Summarytrue
SubstanceDefinition.sourceMaterial
Element IdSubstanceDefinition.sourceMaterial
Definition

Material or taxonomic/anatomical source for the substance.

Short DisplayMaterial or taxonomic/anatomical source
Cardinality0..1
Summarytrue
SubstanceDefinition.sourceMaterial.type
Element IdSubstanceDefinition.sourceMaterial.type
Definition

A classification that provides the origin of the raw material. Example: cat hair would be an Animal source type.

Short DisplayClassification of the origin of the raw material. e.g. cat hair is an Animal source type
Cardinality0..1
Terminology BindingSourceMaterialType (Example)
TypeCodeableConcept
Summarytrue
SubstanceDefinition.sourceMaterial.genus
Element IdSubstanceDefinition.sourceMaterial.genus
Definition

The genus of an organism, typically referring to the Latin epithet of the genus element of the plant/animal scientific name.

Short DisplayThe genus of an organism e.g. the Latin epithet of the plant/animal scientific name
Cardinality0..1
Terminology BindingSourceMaterialGenus (Example)
TypeCodeableConcept
Summarytrue
SubstanceDefinition.sourceMaterial.species
Element IdSubstanceDefinition.sourceMaterial.species
Definition

The species of an organism, typically referring to the Latin epithet of the species of the plant/animal.

Short DisplayThe species of an organism e.g. the Latin epithet of the species of the plant/animal
Cardinality0..1
Terminology BindingSourceMaterialSpecies (Example)
TypeCodeableConcept
Summarytrue
SubstanceDefinition.sourceMaterial.part
Element IdSubstanceDefinition.sourceMaterial.part
Definition

An anatomical origin of the source material within an organism.

Short DisplayAn anatomical origin of the source material within an organism
Cardinality0..1
Terminology BindingSourceMaterialPart (Example)
TypeCodeableConcept
Summarytrue
SubstanceDefinition.sourceMaterial.countryOfOrigin
Element IdSubstanceDefinition.sourceMaterial.countryOfOrigin
Definition

The country or countries where the material is harvested.

Short DisplayThe country or countries where the material is harvested
Cardinality0..*
Terminology BindingCountry (Required)
TypeCodeableConcept
Summarytrue