Release 5 Draft Ballot

This page is part of the FHIR Specification (v4.6.0: R5 Draft 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 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.

Cardinality0..*
TypeDomainResource
Summaryfalse
SubstanceDefinition.identifier
Element IdSubstanceDefinition.identifier
Definition

Identifier by which this substance is known.

NoteThis is a business identifier, not a resource identifier (see discussion)
Cardinality0..1
TypeIdentifier
Summarytrue
SubstanceDefinition.version
Element IdSubstanceDefinition.version
Definition

A business level 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. approved.

Cardinality0..1
TypeCodeableConcept
Summarytrue
SubstanceDefinition.category
Element IdSubstanceDefinition.category
Definition

High level categorization, e.g. polymer or nucleic acid, or food, chemical, biological.

Cardinality0..1
TypeCodeableConcept
Summarytrue
SubstanceDefinition.classification
Element IdSubstanceDefinition.classification
Definition

A lower level classification than category, such as the general types of polymer (linear or branch chain) or type of impurity (process related or contaminant).

Cardinality0..*
TypeCodeableConcept
Summarytrue
SubstanceDefinition.domain
Element IdSubstanceDefinition.domain
Definition

If the substance applies to only human or veterinary use.

Cardinality0..1
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).

Cardinality0..*
TypeCodeableConcept
Summarytrue
SubstanceDefinition.description
Element IdSubstanceDefinition.description
Definition

Textual description of the substance.

Cardinality0..1
Typemarkdown
Summarytrue
SubstanceDefinition.source
Element IdSubstanceDefinition.source
Definition

Supporting literature.

Cardinality0..*
TypeReference(DocumentReference)
Summarytrue
SubstanceDefinition.note
Element IdSubstanceDefinition.note
Definition

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

Cardinality0..*
TypeAnnotation
Summarytrue
SubstanceDefinition.manufacturer
Element IdSubstanceDefinition.manufacturer
Definition

A company that makes this substance.

Cardinality0..*
TypeReference(Organization)
Summarytrue
SubstanceDefinition.supplier
Element IdSubstanceDefinition.supplier
Definition

A company that supplies this substance.

Cardinality0..*
TypeReference(Organization)
Summarytrue
SubstanceDefinition.moiety
Element IdSubstanceDefinition.moiety
Definition

Moiety, for structural modifications.

Cardinality0..*
Summarytrue
SubstanceDefinition.moiety.role
Element IdSubstanceDefinition.moiety.role
Definition

Role 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.

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.

Cardinality0..1
Typestring
Summarytrue
SubstanceDefinition.moiety.stereochemistry
Element IdSubstanceDefinition.moiety.stereochemistry
Definition

Stereochemistry type.

Cardinality0..1
TypeCodeableConcept
Summarytrue
SubstanceDefinition.moiety.opticalActivity
Element IdSubstanceDefinition.moiety.opticalActivity
Definition

Optical activity type.

Cardinality0..1
TypeCodeableConcept
Summarytrue
SubstanceDefinition.moiety.molecularFormula
Element IdSubstanceDefinition.moiety.molecularFormula
Definition

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

Cardinality0..1
Typestring
Summarytrue
SubstanceDefinition.moiety.amount[x]
Element IdSubstanceDefinition.moiety.amount[x]
Definition

Quantitative value for this moiety.

Cardinality0..1
TypeQuantity|string
[x] NoteSee Choice of Data Types for further information about how to use [x]
Summarytrue
SubstanceDefinition.moiety.amountType
Element IdSubstanceDefinition.moiety.amountType
Definition

The measurement type of the quantitative value.

Cardinality0..1
TypeCodeableConcept
Summarytrue
SubstanceDefinition.property
Element IdSubstanceDefinition.property
Definition

General specifications for this substance, including how it is related to other substances.

Cardinality0..*
Summarytrue
SubstanceDefinition.property.category
Element IdSubstanceDefinition.property.category
Definition

A category for this property, e.g. Physical, Chemical, Enzymatic.

Cardinality0..1
TypeCodeableConcept
Summarytrue
SubstanceDefinition.property.code
Element IdSubstanceDefinition.property.code
Definition

Property type e.g. viscosity, pH, isoelectric point.

Cardinality0..1
TypeCodeableConcept
Summarytrue
SubstanceDefinition.property.parameters
Element IdSubstanceDefinition.property.parameters
Definition

Parameters that were used in the measurement of a property (e.g. for viscosity: measured at 20C with a pH of 7.1).

Cardinality0..1
Typestring
Summarytrue
SubstanceDefinition.property.definingSubstance
Element IdSubstanceDefinition.property.definingSubstance
Definition

A substance upon which a defining property depends (e.g. for solubility: in water, in alcohol).

Cardinality0..1
TypeCodeableReference(SubstanceDefinition | Substance)
PatternsCodeableReference(SubstanceDefinition,Substance): No common pattern
Summarytrue
SubstanceDefinition.property.amount[x]
Element IdSubstanceDefinition.property.amount[x]
Definition

Quantitative value for this property.

Cardinality0..1
TypeQuantity|string
[x] NoteSee Choice of Data Types for further information about how to use [x]
Summarytrue
SubstanceDefinition.property.referenceRange
Element IdSubstanceDefinition.property.referenceRange
Definition

Range of typical values.

Cardinality0..1
TypeRange
Summarytrue
SubstanceDefinition.property.source
Element IdSubstanceDefinition.property.source
Definition

Supporting literature.

Cardinality0..*
TypeReference(DocumentReference)
Summarytrue
SubstanceDefinition.referenceInformation
Element IdSubstanceDefinition.referenceInformation
Definition

General information detailing this substance.

Cardinality0..1
TypeReference(SubstanceReferenceInformation)
Summarytrue
SubstanceDefinition.structure
Element IdSubstanceDefinition.structure
Definition

Structural information.

Cardinality0..1
Summarytrue
SubstanceDefinition.structure.stereochemistry
Element IdSubstanceDefinition.structure.stereochemistry
Definition

Stereochemistry type.

Cardinality0..1
TypeCodeableConcept
Summarytrue
SubstanceDefinition.structure.opticalActivity
Element IdSubstanceDefinition.structure.opticalActivity
Definition

Optical activity type.

Cardinality0..1
TypeCodeableConcept
Summarytrue
SubstanceDefinition.structure.molecularFormula
Element IdSubstanceDefinition.structure.molecularFormula
Definition

Molecular formula of this substance, typically 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.

Cardinality0..1
Typestring
Summarytrue
SubstanceDefinition.structure.isotope
Element IdSubstanceDefinition.structure.isotope
Definition

Applicable for single substances that contain a radionuclide or a non-natural isotopic ratio.

Cardinality0..*
Summarytrue
SubstanceDefinition.structure.isotope.identifier
Element IdSubstanceDefinition.structure.isotope.identifier
Definition

Substance identifier for each non-natural or radioisotope.

NoteThis is a business identifier, not a resource identifier (see discussion)
Cardinality0..1
TypeIdentifier
Summarytrue
SubstanceDefinition.structure.isotope.name
Element IdSubstanceDefinition.structure.isotope.name
Definition

Substance name for each non-natural or radioisotope.

Cardinality0..1
TypeCodeableConcept
Summarytrue
SubstanceDefinition.structure.isotope.substitution
Element IdSubstanceDefinition.structure.isotope.substitution
Definition

The type of isotopic substitution present in a single substance.

Cardinality0..1
TypeCodeableConcept
Summarytrue
SubstanceDefinition.structure.isotope.halfLife
Element IdSubstanceDefinition.structure.isotope.halfLife
Definition

Half life - for a non-natural nuclide.

Cardinality0..1
TypeQuantity
Summarytrue
SubstanceDefinition.structure.isotope.molecularWeight
Element IdSubstanceDefinition.structure.isotope.molecularWeight
Definition

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

Cardinality0..1
Summarytrue
SubstanceDefinition.structure.isotope.molecularWeight.method
Element IdSubstanceDefinition.structure.isotope.molecularWeight.method
Definition

The method by which the molecular weight was determined.

Cardinality0..1
TypeCodeableConcept
Summarytrue
SubstanceDefinition.structure.isotope.molecularWeight.type
Element IdSubstanceDefinition.structure.isotope.molecularWeight.type
Definition

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

Cardinality0..1
TypeCodeableConcept
Summarytrue
SubstanceDefinition.structure.isotope.molecularWeight.amount
Element IdSubstanceDefinition.structure.isotope.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.

Cardinality0..1
TypeQuantity
Summarytrue
SubstanceDefinition.structure.molecularWeight
Element IdSubstanceDefinition.structure.molecularWeight
Definition

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

Cardinality0..1
TypeSee SubstanceDefinition.structure.isotope.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.

Cardinality0..*
TypeCodeableConcept
Summarytrue
SubstanceDefinition.structure.sourceDocument
Element IdSubstanceDefinition.structure.sourceDocument
Definition

Supporting literature about the source of information.

Cardinality0..*
TypeReference(DocumentReference)
Summarytrue
SubstanceDefinition.structure.representation
Element IdSubstanceDefinition.structure.representation
Definition

A 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) or the technique used to derive the analytical characterization of the substance (e.g. x-ray, HPLC, NMR, peptide mapping, ligand binding assay, etc.).

Cardinality0..1
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.

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.

Cardinality0..1
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.

Cardinality0..1
TypeReference(DocumentReference)
Summarytrue
SubstanceDefinition.code
Element IdSubstanceDefinition.code
Definition

Codes associated with the substance.

Cardinality0..*
Summarytrue
SubstanceDefinition.code.code
Element IdSubstanceDefinition.code.code
Definition

The specific code.

Cardinality0..1
TypeCodeableConcept
Summarytrue
SubstanceDefinition.code.status
Element IdSubstanceDefinition.code.status
Definition

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

Cardinality0..1
TypeCodeableConcept
Summarytrue
SubstanceDefinition.code.statusDate
Element IdSubstanceDefinition.code.statusDate
Definition

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

Cardinality0..1
TypedateTime
Summarytrue
SubstanceDefinition.code.note
Element IdSubstanceDefinition.code.note
Definition

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

Cardinality0..*
TypeAnnotation
Summarytrue
SubstanceDefinition.code.source
Element IdSubstanceDefinition.code.source
Definition

Supporting literature.

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

Names applicable to this substance.

Cardinality0..*
Summarytrue
SubstanceDefinition.name.name
Element IdSubstanceDefinition.name.name
Definition

The actual name.

Cardinality1..1
Typestring
Summarytrue
SubstanceDefinition.name.type
Element IdSubstanceDefinition.name.type
Definition

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

Cardinality0..1
TypeCodeableConcept
Summarytrue
SubstanceDefinition.name.status
Element IdSubstanceDefinition.name.status
Definition

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

Cardinality0..1
TypeCodeableConcept
Summarytrue
SubstanceDefinition.name.preferred
Element IdSubstanceDefinition.name.preferred
Definition

If this is the preferred name for this substance.

Cardinality0..1
Typeboolean
Summarytrue
SubstanceDefinition.name.language
Element IdSubstanceDefinition.name.language
Definition

Human language that the name is written in.

Cardinality0..*
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.

Cardinality0..*
TypeCodeableConcept
Summarytrue
SubstanceDefinition.name.jurisdiction
Element IdSubstanceDefinition.name.jurisdiction
Definition

The jurisdiction where this name applies.

Cardinality0..*
TypeCodeableConcept
Summarytrue
SubstanceDefinition.name.synonym
Element IdSubstanceDefinition.name.synonym
Definition

A 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.

Cardinality0..*
TypeSee SubstanceDefinition.name
Summarytrue
SubstanceDefinition.name.official
Element IdSubstanceDefinition.name.official
Definition

Details 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.

Cardinality0..1
TypeCodeableConcept
Summarytrue
SubstanceDefinition.name.official.status
Element IdSubstanceDefinition.name.official.status
Definition

The status of the official name, for example 'provisional', 'approved'.

Cardinality0..1
TypeCodeableConcept
Summarytrue
SubstanceDefinition.name.official.date
Element IdSubstanceDefinition.name.official.date
Definition

Date of official name change.

Cardinality0..1
TypedateTime
Summarytrue
SubstanceDefinition.name.source
Element IdSubstanceDefinition.name.source
Definition

Supporting literature.

Cardinality0..*
TypeReference(DocumentReference)
Summarytrue
SubstanceDefinition.molecularWeight
Element IdSubstanceDefinition.molecularWeight
Definition

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

Cardinality0..*
TypeSee SubstanceDefinition.structure.isotope.molecularWeight
Summarytrue
SubstanceDefinition.relationship
Element IdSubstanceDefinition.relationship
Definition

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

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.

Cardinality0..1
TypeReference(SubstanceDefinition)|CodeableConcept
[x] NoteSee Choice of Data Types 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".

Cardinality0..1
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.

Cardinality0..1
Typeboolean
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.

Cardinality0..1
TypeQuantity|Range|Ratio|string
[x] NoteSee Choice of Data Types for further information about how to use [x]
Summarytrue
SubstanceDefinition.relationship.amountRatioHighLimit
Element IdSubstanceDefinition.relationship.amountRatioHighLimit
Definition

For use when the numeric has an uncertain range.

Cardinality0..1
TypeRatio
Summarytrue
SubstanceDefinition.relationship.amountType
Element IdSubstanceDefinition.relationship.amountType
Definition

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

Cardinality0..1
TypeCodeableConcept
Summarytrue
SubstanceDefinition.relationship.source
Element IdSubstanceDefinition.relationship.source
Definition

Supporting literature.

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

Data items specific to nucleic acids.

Cardinality0..1
TypeReference(SubstanceNucleicAcid)
Summarytrue
SubstanceDefinition.polymer
Element IdSubstanceDefinition.polymer
Definition

Data items specific to polymers.

Cardinality0..1
TypeReference(SubstancePolymer)
Summarytrue
SubstanceDefinition.protein
Element IdSubstanceDefinition.protein
Definition

Data items specific to proteins.

Cardinality0..1
TypeReference(SubstanceProtein)
Summarytrue
SubstanceDefinition.sourceMaterial
Element IdSubstanceDefinition.sourceMaterial
Definition

Material or taxonomic/anatomical source for the substance.

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.

Cardinality0..1
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.

Cardinality0..1
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.

Cardinality0..1
TypeCodeableConcept
Summarytrue
SubstanceDefinition.sourceMaterial.part
Element IdSubstanceDefinition.sourceMaterial.part
Definition

An anatomical origin of the source material within an organism.

Cardinality0..1
TypeCodeableConcept
Summarytrue
SubstanceDefinition.sourceMaterial.countryOfOrigin
Element IdSubstanceDefinition.sourceMaterial.countryOfOrigin
Definition

The country or countries where the material is harvested.

Cardinality0..*
TypeCodeableConcept
Summarytrue