Pharmaceutical Quality (Industry)
1.0.0 - STU1 International flag

Pharmaceutical Quality (Industry), published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 1.0.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/uv-dx-pq/ and changes regularly. See the Directory of published versions

Resource Profile: SubstanceDefinition - Component Drug

Official URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/SubstanceDefinition-component-substance-drug-pq Version: 1.0.0
Active as of 2024-04-22 Computable Name: SubstanceDefinitionComponentSubstanceDrugPq
Other Identifiers: OID:2.16.840.1.113883.4.642.40.41.42.40

This SubstanceDefinition profile represents the chemical or biological details about a substance associated with an active ingredient (molecular weight, molecular formula, stereochemistry, protein or nucleic acid subunits).

Usage:

Formal Views of Profile Content

Description of Profiles, Differentials, Snapshots and how the different presentations work.

This structure is derived from SubstanceDefinition

NameFlagsCard.TypeDescription & Constraintsdoco
.. SubstanceDefinition 0..* SubstanceDefinition The detailed description of a substance, typically at a level beyond what is used for prescribing
... grade S 0..* CodeableConcept The quality standard, established benchmark, to which substance complies (e.g. USP/NF, BP)
... informationSource S 0..* Reference(Citation) Supporting literature
... manufacturer S 0..* Reference(Organization - Drug PQ) The entity that creates, makes, produces or fabricates the substance
.... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
.... site-utilization S 0..* Coding site-utilization
URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-site-utilization-pq
Binding: Product Site Utilization (example)
.... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
.... substance-property-range S 0..* Range substance-property-range
URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-substance-property-range-pq
.... substance-property-parameter S 0..* (Complex) substance-property-parameter
URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-substance-property-parameter-pq
.... type S 1..1 CodeableConcept A code expressing the type of property
Binding: Substance Property (example)
.... value[x] S 0..1 CodeableConcept, Quantity, date, boolean, Attachment A value for the property
Binding: Substance Property Value (example)
... name S 0..* BackboneElement Names applicable to this substance
... relationship S 0..* BackboneElement A link between this substance and another
.... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
.... impurity-origin S 0..* CodeableConcept impurity-origin
URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-impurity-origin-pq
Binding: Impurity Origins (example)
.... type S 1..1 CodeableConcept For example "salt to parent", "active moiety"
Binding: Impurity Types (example)
... sourceMaterial S 0..1 BackboneElement Material or taxonomic/anatomical source

doco Documentation for this format

Terminology Bindings (Differential)

PathConformanceValueSetURI
SubstanceDefinition.property.typeexampleVsSubstancePropertyPQ (a valid code from Substance Property - example)
http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-substance-property-pq
from this IG
SubstanceDefinition.property.value[x]exampleVsSubstancePropertyValuePQ (a valid code from Substance Property Value - example)
http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-substance-property-value-pq
from this IG
SubstanceDefinition.relationship.typeexampleVsImpurityTypePQ (a valid code from Impurity Type Codes)
http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-impurity-type-pq
from this IG
NameFlagsCard.TypeDescription & Constraintsdoco
.. SubstanceDefinition 0..* SubstanceDefinition The detailed description of a substance, typically at a level beyond what is used for prescribing
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... contained 0..* Resource Contained, inline Resources
... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored
... informationSource SΣ 0..* Reference(Citation) Supporting literature
... manufacturer SΣ 0..* Reference(Organization - Drug PQ) The entity that creates, makes, produces or fabricates the substance
.... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
.... site-utilization S 0..* Coding site-utilization
URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-site-utilization-pq
Binding: Product Site Utilization (example)
.... reference ΣC 0..1 string Literal reference, Relative, internal or absolute URL
... property SΣ 0..* BackboneElement General specifications for this substance
.... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
.... substance-property-range S 0..* Range substance-property-range
URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-substance-property-range-pq
.... substance-property-parameter S 0..* (Complex) substance-property-parameter
URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-substance-property-parameter-pq
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... type SΣ 1..1 CodeableConcept A code expressing the type of property
Binding: Substance Property (example)
.... value[x] SΣ 0..1 A value for the property
Binding: Substance Property Value (example)
..... valueCodeableConcept CodeableConcept
..... valueQuantity Quantity
..... valueDate date
..... valueBoolean boolean
..... valueAttachment Attachment
... name SΣ 0..* BackboneElement Names applicable to this substance
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... name Σ 1..1 string The actual name
... relationship SΣ 0..* BackboneElement A link between this substance and another
.... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
.... impurity-origin S 0..* CodeableConcept impurity-origin
URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-impurity-origin-pq
Binding: Impurity Origins (example)
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... type SΣ 1..1 CodeableConcept For example "salt to parent", "active moiety"
Binding: Impurity Types (example)
... sourceMaterial SΣ 0..1 BackboneElement Material or taxonomic/anatomical source
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized

doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
SubstanceDefinition.gradeexampleSubstanceGrade
http://hl7.org/fhir/ValueSet/substance-grade
from the FHIR Standard
SubstanceDefinition.property.typeexampleVsSubstancePropertyPQ (a valid code from Substance Property - example)
http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-substance-property-pq
from this IG
SubstanceDefinition.property.value[x]exampleVsSubstancePropertyValuePQ (a valid code from Substance Property Value - example)
http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-substance-property-value-pq
from this IG
SubstanceDefinition.relationship.typeexampleVsImpurityTypePQ (a valid code from Impurity Type Codes)
http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-impurity-type-pq
from this IG

Constraints

IdGradePath(s)DetailsRequirements
dom-2errorSubstanceDefinitionIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorSubstanceDefinitionIf the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource
: contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4errorSubstanceDefinitionIf a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated
: contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5errorSubstanceDefinitionIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceSubstanceDefinitionA resource should have narrative for robust management
: text.`div`.exists()
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()
NameFlagsCard.TypeDescription & Constraintsdoco
.. SubstanceDefinition 0..* SubstanceDefinition The detailed description of a substance, typically at a level beyond what is used for prescribing
... id Σ 0..1 id Logical id of this artifact
... meta Σ 0..1 Meta Metadata about the resource
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... language 0..1 code Language of the resource content
Binding: AllLanguages (required): IETF language tag for a human language

Additional BindingsPurpose
CommonLanguages Starter Set
... text 0..1 Narrative Text summary of the resource, for human interpretation
... contained 0..* Resource Contained, inline Resources
... extension 0..* Extension Additional content defined by implementations
... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored
... identifier Σ 0..* Identifier Identifier by which this substance is known
... version Σ 0..1 string A business level version identifier of the substance
... status Σ 0..1 CodeableConcept Status of substance within the catalogue e.g. active, retired
Binding: PublicationStatus (preferred): The lifecycle status of an artifact.

... classification Σ 0..* CodeableConcept A 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
... domain Σ 0..1 CodeableConcept If the substance applies to human or veterinary use
Binding: MedicinalProductDomain (example): Applicable domain for this product (e.g. human, veterinary).

... grade SΣ 0..* CodeableConcept The quality standard, established benchmark, to which substance complies (e.g. USP/NF, BP)
Binding: SubstanceGrade (example): The quality standard, established benchmark, to which a substance complies


... description Σ 0..1 markdown Textual description of the substance
... informationSource SΣ 0..* Reference(Citation) Supporting literature
... note Σ 0..* Annotation Textual comment about the substance's catalogue or registry record
... manufacturer SΣ 0..* Reference(Organization - Drug PQ) The entity that creates, makes, produces or fabricates the substance
.... id 0..1 id Unique id for inter-element referencing
.... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
.... site-utilization S 0..* Coding site-utilization
URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-site-utilization-pq
Binding: Product Site Utilization (example)
.... reference ΣC 0..1 string Literal reference, Relative, internal or absolute URL
.... type Σ 0..1 uri Type the reference refers to (e.g. "Patient") - must be a resource in resources
Binding: ResourceType (extensible): Aa resource (or, for logical models, the URI of the logical model).

.... identifier ΣC 0..1 Identifier Logical reference, when literal reference is not known
.... display ΣC 0..1 string Text alternative for the resource
... supplier Σ 0..* Reference(Organization) An entity that is the source for the substance. It may be different from the manufacturer
... moiety Σ 0..* BackboneElement Moiety, for structural modifications
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... role Σ 0..1 CodeableConcept Role that the moiety is playing
.... identifier Σ 0..1 Identifier Identifier by which this moiety substance is known
.... name Σ 0..1 string Textual name for this moiety substance
.... stereochemistry Σ 0..1 CodeableConcept Stereochemistry type
Binding: Stereochemistry (example): The optical rotation type of a substance.

.... opticalActivity Σ 0..1 CodeableConcept Optical activity type
Binding: OpticalActivity (example): The optical rotation type of a substance.

.... molecularFormula Σ 0..1 string Molecular formula for this moiety (e.g. with the Hill system)
.... amount[x] Σ 0..1 Quantitative value for this moiety
..... amountQuantity Quantity
..... amountString string
.... measurementType Σ 0..1 CodeableConcept The measurement type of the quantitative value
Binding: SubstanceAmountType (example): The relationship between two substance types.

... characterization Σ 0..* BackboneElement General specifications for this substance
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... technique Σ 0..1 CodeableConcept The method used to find the characterization e.g. HPLC
Binding: StructureTechnique (example): The method used to elucidate the characterization of the drug substance.

.... form Σ 0..1 CodeableConcept Describes the nature of the chemical entity and explains, for instance, whether this is a base or a salt form
Binding: SubstanceForm (example)
.... description Σ 0..1 markdown The description or justification in support of the interpretation of the data file
.... file Σ 0..* Attachment The data produced by the analytical instrument or a pictorial representation of that data. Examples: a JCAMP, JDX, or ADX file, or a chromatogram or spectrum analysis
... property SΣ 0..* BackboneElement General specifications for this substance
.... id 0..1 string Unique id for inter-element referencing
.... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
.... substance-property-range S 0..* Range substance-property-range
URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-substance-property-range-pq
.... substance-property-parameter S 0..* (Complex) substance-property-parameter
URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-substance-property-parameter-pq
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... type SΣ 1..1 CodeableConcept A code expressing the type of property
Binding: Substance Property (example)
.... value[x] SΣ 0..1 A value for the property
Binding: Substance Property Value (example)
..... valueCodeableConcept CodeableConcept
..... valueQuantity Quantity
..... valueDate date
..... valueBoolean boolean
..... valueAttachment Attachment
... referenceInformation Σ 0..1 Reference(SubstanceReferenceInformation) General information detailing this substance
... molecularWeight Σ 0..* BackboneElement The average mass of a molecule of a compound
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... method Σ 0..1 CodeableConcept The method by which the weight was determined
Binding: WeightMethod (example): The method by which the substance weight was measured.

.... type Σ 0..1 CodeableConcept Type of molecular weight e.g. exact, average, weight average
Binding: WeightType (example): The type of substance weight measurement.

.... amount Σ 1..1 Quantity Used to capture quantitative values for a variety of elements
... structure Σ 0..1 BackboneElement Structural information
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... stereochemistry Σ 0..1 CodeableConcept Stereochemistry type
Binding: Stereochemistry (example): The optical rotation type of a substance.

.... opticalActivity Σ 0..1 CodeableConcept Optical activity type
Binding: OpticalActivity (example): The optical rotation type of a substance.

.... molecularFormula Σ 0..1 string An expression which states the number and type of atoms present in a molecule of a substance
.... molecularFormulaByMoiety Σ 0..1 string Specified per moiety according to the Hill system
.... molecularWeight Σ 0..1 See molecularWeight (SubstanceDefinition) The molecular weight or weight range
.... technique Σ 0..* CodeableConcept The method used to find the structure e.g. X-ray, NMR
Binding: StructureTechnique (example): The method used to elucidate the structure of the drug substance.


.... sourceDocument Σ 0..* Reference(DocumentReference) Source of information for the structure
.... representation Σ 0..* BackboneElement A depiction of the structure of the substance
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... type Σ 0..1 CodeableConcept The kind of structural representation (e.g. full, partial)
Binding: SubstanceRepresentationType (example): A format of a substance representation.

..... representation Σ 0..1 string The structural representation as a text string in a standard format
..... format Σ 0..1 CodeableConcept The format of the representation e.g. InChI, SMILES, MOLFILE (note: not the physical file format)
Binding: SubstanceRepresentationFormat (example): A format of a substance representation.

..... document Σ 0..1 Reference(DocumentReference) An attachment with the structural representation e.g. a structure graphic or AnIML file
... code Σ 0..* BackboneElement Codes associated with the substance
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... code Σ 0..1 CodeableConcept The specific code
.... status Σ 0..1 CodeableConcept Status of the code assignment, for example 'provisional', 'approved'
Binding: PublicationStatus (preferred): The lifecycle status of an artifact.

.... statusDate Σ 0..1 dateTime The date at which the code status was changed
.... note Σ 0..* Annotation Any comment can be provided in this field
.... source Σ 0..* Reference(DocumentReference) Supporting literature
... name SΣ 0..* BackboneElement Names applicable to this substance
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... name Σ 1..1 string The actual name
.... type Σ 0..1 CodeableConcept Name type e.g. 'systematic', 'scientific, 'brand'
Binding: SubstanceNameType (example): The type of a name given to a substance.

.... status Σ 0..1 CodeableConcept The status of the name e.g. 'current', 'proposed'
Binding: PublicationStatus (preferred): The lifecycle status of an artifact.

.... preferred Σ 0..1 boolean If this is the preferred name for this substance
.... language Σ 0..* CodeableConcept Human language that the name is written in
Binding: AllLanguages (required): IETF language tag for a human language

Additional BindingsPurpose
CommonLanguages Starter Set

.... domain Σ 0..* CodeableConcept The use context of this name e.g. as an active ingredient or as a food colour additive
Binding: SubstanceNameDomain (example): The use context of a substance name for example if there is a different name when used as a drug active ingredient as opposed to a food colour additive.


.... jurisdiction Σ 0..* CodeableConcept The jurisdiction where this name applies
Binding: JurisdictionValueSet (example): Jurisdiction codes


.... synonym Σ 0..* See name (SubstanceDefinition) A synonym of this particular name, by which the substance is also known
.... translation Σ 0..* See name (SubstanceDefinition) A translation for this name into another human language
.... official Σ 0..* BackboneElement Details of the official nature of this name
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... authority Σ 0..1 CodeableConcept Which authority uses this official name
Binding: SubstanceNameAuthority (preferred): An authority that officates substance names.

..... status Σ 0..1 CodeableConcept The status of the official name, for example 'draft', 'active'
Binding: PublicationStatus (preferred): The lifecycle status of an artifact.

..... date Σ 0..1 dateTime Date of official name change
.... source Σ 0..* Reference(DocumentReference) Supporting literature
... relationship SΣ 0..* BackboneElement A link between this substance and another
.... id 0..1 string Unique id for inter-element referencing
.... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
.... impurity-origin S 0..* CodeableConcept impurity-origin
URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-impurity-origin-pq
Binding: Impurity Origins (example)
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... substanceDefinition[x] Σ 0..1 A pointer to another substance, as a resource or a representational code
..... substanceDefinitionReference Reference(SubstanceDefinition)
..... substanceDefinitionCodeableConcept CodeableConcept
.... type SΣ 1..1 CodeableConcept For example "salt to parent", "active moiety"
Binding: Impurity Types (example)
.... isDefining Σ 0..1 boolean For example where an enzyme strongly bonds with a particular substance, this is a defining relationship for that enzyme, out of several possible relationships
.... amount[x] Σ 0..1 A numeric factor for the relationship, e.g. that a substance salt has some percentage of active substance in relation to some other
..... amountQuantity Quantity
..... amountRatio Ratio
..... amountString string
.... ratioHighLimitAmount Σ 0..1 Ratio For use when the numeric has an uncertain range
.... comparator Σ 0..1 CodeableConcept An operator for the amount, for example "average", "approximately", "less than"
Binding: SubstanceAmountType (example): The relationship between two substance types.

.... source Σ 0..* Reference(DocumentReference) Supporting literature
... nucleicAcid Σ 0..1 Reference(SubstanceNucleicAcid) Data items specific to nucleic acids
... polymer Σ 0..1 Reference(SubstancePolymer) Data items specific to polymers
... protein Σ 0..1 Reference(SubstanceProtein) Data items specific to proteins
... sourceMaterial SΣ 0..1 BackboneElement Material or taxonomic/anatomical source
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... type Σ 0..1 CodeableConcept Classification of the origin of the raw material. e.g. cat hair is an Animal source type
Binding: SourceMaterialType (example): A classification that provides the origin of the substance raw material.

.... genus Σ 0..1 CodeableConcept The genus of an organism e.g. the Latin epithet of the plant/animal scientific name
Binding: SourceMaterialGenus (example): The genus of an organism, typically referring to the Latin epithet of the genus element of the plant/animal scientific name.

.... species Σ 0..1 CodeableConcept The species of an organism e.g. the Latin epithet of the species of the plant/animal
Binding: SourceMaterialSpecies (example): A species of origin a substance raw material.

.... part Σ 0..1 CodeableConcept An anatomical origin of the source material within an organism
Binding: SourceMaterialPart (example): An anatomical origin of the source material within an organism.

.... countryOfOrigin Σ 0..* CodeableConcept The country or countries where the material is harvested
Binding: CountryValueSet (required): Jurisdiction codes



doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
SubstanceDefinition.languagerequiredAllLanguages
http://hl7.org/fhir/ValueSet/all-languages|5.0.0
from the FHIR Standard
SubstanceDefinition.statuspreferredPublicationStatus
http://hl7.org/fhir/ValueSet/publication-status
from the FHIR Standard
SubstanceDefinition.domainexampleMedicinalProductDomain
http://hl7.org/fhir/ValueSet/medicinal-product-domain
from the FHIR Standard
SubstanceDefinition.gradeexampleSubstanceGrade
http://hl7.org/fhir/ValueSet/substance-grade
from the FHIR Standard
SubstanceDefinition.manufacturer.typeextensibleResourceType
http://hl7.org/fhir/ValueSet/resource-types
from the FHIR Standard
SubstanceDefinition.moiety.stereochemistryexampleStereochemistry
http://hl7.org/fhir/ValueSet/substance-stereochemistry
from the FHIR Standard
SubstanceDefinition.moiety.opticalActivityexampleOpticalActivity
http://hl7.org/fhir/ValueSet/substance-optical-activity
from the FHIR Standard
SubstanceDefinition.moiety.measurementTypeexampleSubstanceAmountType
http://hl7.org/fhir/ValueSet/substance-amount-type
from the FHIR Standard
SubstanceDefinition.characterization.techniqueexampleStructureTechnique
http://hl7.org/fhir/ValueSet/substance-structure-technique
from the FHIR Standard
SubstanceDefinition.characterization.formexampleSubstanceForm
http://hl7.org/fhir/ValueSet/substance-form
from the FHIR Standard
SubstanceDefinition.property.typeexampleVsSubstancePropertyPQ (a valid code from Substance Property - example)
http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-substance-property-pq
from this IG
SubstanceDefinition.property.value[x]exampleVsSubstancePropertyValuePQ (a valid code from Substance Property Value - example)
http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-substance-property-value-pq
from this IG
SubstanceDefinition.molecularWeight.methodexampleWeightMethod
http://hl7.org/fhir/ValueSet/substance-weight-method
from the FHIR Standard
SubstanceDefinition.molecularWeight.typeexampleWeightType
http://hl7.org/fhir/ValueSet/substance-weight-type
from the FHIR Standard
SubstanceDefinition.structure.stereochemistryexampleStereochemistry
http://hl7.org/fhir/ValueSet/substance-stereochemistry
from the FHIR Standard
SubstanceDefinition.structure.opticalActivityexampleOpticalActivity
http://hl7.org/fhir/ValueSet/substance-optical-activity
from the FHIR Standard
SubstanceDefinition.structure.techniqueexampleStructureTechnique
http://hl7.org/fhir/ValueSet/substance-structure-technique
from the FHIR Standard
SubstanceDefinition.structure.representation.typeexampleSubstanceRepresentationType
http://hl7.org/fhir/ValueSet/substance-representation-type
from the FHIR Standard
SubstanceDefinition.structure.representation.formatexampleSubstanceRepresentationFormat
http://hl7.org/fhir/ValueSet/substance-representation-format
from the FHIR Standard
SubstanceDefinition.code.statuspreferredPublicationStatus
http://hl7.org/fhir/ValueSet/publication-status
from the FHIR Standard
SubstanceDefinition.name.typeexampleSubstanceNameType
http://hl7.org/fhir/ValueSet/substance-name-type
from the FHIR Standard
SubstanceDefinition.name.statuspreferredPublicationStatus
http://hl7.org/fhir/ValueSet/publication-status
from the FHIR Standard
SubstanceDefinition.name.languagerequiredAllLanguages
http://hl7.org/fhir/ValueSet/all-languages|5.0.0
from the FHIR Standard
SubstanceDefinition.name.domainexampleSubstanceNameDomain
http://hl7.org/fhir/ValueSet/substance-name-domain
from the FHIR Standard
SubstanceDefinition.name.jurisdictionexampleJurisdictionValueSet
http://hl7.org/fhir/ValueSet/jurisdiction
from the FHIR Standard
SubstanceDefinition.name.official.authoritypreferredSubstanceNameAuthority
http://hl7.org/fhir/ValueSet/substance-name-authority
from the FHIR Standard
SubstanceDefinition.name.official.statuspreferredPublicationStatus
http://hl7.org/fhir/ValueSet/publication-status
from the FHIR Standard
SubstanceDefinition.relationship.typeexampleVsImpurityTypePQ (a valid code from Impurity Type Codes)
http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-impurity-type-pq
from this IG
SubstanceDefinition.relationship.comparatorexampleSubstanceAmountType
http://hl7.org/fhir/ValueSet/substance-amount-type
from the FHIR Standard
SubstanceDefinition.sourceMaterial.typeexampleSourceMaterialType
http://hl7.org/fhir/ValueSet/substance-source-material-type
from the FHIR Standard
SubstanceDefinition.sourceMaterial.genusexampleSourceMaterialGenus
http://hl7.org/fhir/ValueSet/substance-source-material-genus
from the FHIR Standard
SubstanceDefinition.sourceMaterial.speciesexampleSourceMaterialSpecies
http://hl7.org/fhir/ValueSet/substance-source-material-species
from the FHIR Standard
SubstanceDefinition.sourceMaterial.partexampleSourceMaterialPart
http://hl7.org/fhir/ValueSet/substance-source-material-part
from the FHIR Standard
SubstanceDefinition.sourceMaterial.countryOfOriginrequiredCountryValueSet
http://hl7.org/fhir/ValueSet/country|5.0.0
from the FHIR Standard

Constraints

IdGradePath(s)DetailsRequirements
dom-2errorSubstanceDefinitionIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorSubstanceDefinitionIf the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource
: contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4errorSubstanceDefinitionIf a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated
: contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5errorSubstanceDefinitionIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceSubstanceDefinitionA resource should have narrative for robust management
: text.`div`.exists()
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()

Differential View

This structure is derived from SubstanceDefinition

NameFlagsCard.TypeDescription & Constraintsdoco
.. SubstanceDefinition 0..* SubstanceDefinition The detailed description of a substance, typically at a level beyond what is used for prescribing
... grade S 0..* CodeableConcept The quality standard, established benchmark, to which substance complies (e.g. USP/NF, BP)
... informationSource S 0..* Reference(Citation) Supporting literature
... manufacturer S 0..* Reference(Organization - Drug PQ) The entity that creates, makes, produces or fabricates the substance
.... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
.... site-utilization S 0..* Coding site-utilization
URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-site-utilization-pq
Binding: Product Site Utilization (example)
.... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
.... substance-property-range S 0..* Range substance-property-range
URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-substance-property-range-pq
.... substance-property-parameter S 0..* (Complex) substance-property-parameter
URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-substance-property-parameter-pq
.... type S 1..1 CodeableConcept A code expressing the type of property
Binding: Substance Property (example)
.... value[x] S 0..1 CodeableConcept, Quantity, date, boolean, Attachment A value for the property
Binding: Substance Property Value (example)
... name S 0..* BackboneElement Names applicable to this substance
... relationship S 0..* BackboneElement A link between this substance and another
.... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
.... impurity-origin S 0..* CodeableConcept impurity-origin
URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-impurity-origin-pq
Binding: Impurity Origins (example)
.... type S 1..1 CodeableConcept For example "salt to parent", "active moiety"
Binding: Impurity Types (example)
... sourceMaterial S 0..1 BackboneElement Material or taxonomic/anatomical source

doco Documentation for this format

Terminology Bindings (Differential)

PathConformanceValueSetURI
SubstanceDefinition.property.typeexampleVsSubstancePropertyPQ (a valid code from Substance Property - example)
http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-substance-property-pq
from this IG
SubstanceDefinition.property.value[x]exampleVsSubstancePropertyValuePQ (a valid code from Substance Property Value - example)
http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-substance-property-value-pq
from this IG
SubstanceDefinition.relationship.typeexampleVsImpurityTypePQ (a valid code from Impurity Type Codes)
http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-impurity-type-pq
from this IG

Key Elements View

NameFlagsCard.TypeDescription & Constraintsdoco
.. SubstanceDefinition 0..* SubstanceDefinition The detailed description of a substance, typically at a level beyond what is used for prescribing
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... contained 0..* Resource Contained, inline Resources
... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored
... informationSource SΣ 0..* Reference(Citation) Supporting literature
... manufacturer SΣ 0..* Reference(Organization - Drug PQ) The entity that creates, makes, produces or fabricates the substance
.... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
.... site-utilization S 0..* Coding site-utilization
URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-site-utilization-pq
Binding: Product Site Utilization (example)
.... reference ΣC 0..1 string Literal reference, Relative, internal or absolute URL
... property SΣ 0..* BackboneElement General specifications for this substance
.... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
.... substance-property-range S 0..* Range substance-property-range
URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-substance-property-range-pq
.... substance-property-parameter S 0..* (Complex) substance-property-parameter
URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-substance-property-parameter-pq
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... type SΣ 1..1 CodeableConcept A code expressing the type of property
Binding: Substance Property (example)
.... value[x] SΣ 0..1 A value for the property
Binding: Substance Property Value (example)
..... valueCodeableConcept CodeableConcept
..... valueQuantity Quantity
..... valueDate date
..... valueBoolean boolean
..... valueAttachment Attachment
... name SΣ 0..* BackboneElement Names applicable to this substance
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... name Σ 1..1 string The actual name
... relationship SΣ 0..* BackboneElement A link between this substance and another
.... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
.... impurity-origin S 0..* CodeableConcept impurity-origin
URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-impurity-origin-pq
Binding: Impurity Origins (example)
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... type SΣ 1..1 CodeableConcept For example "salt to parent", "active moiety"
Binding: Impurity Types (example)
... sourceMaterial SΣ 0..1 BackboneElement Material or taxonomic/anatomical source
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized

doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
SubstanceDefinition.gradeexampleSubstanceGrade
http://hl7.org/fhir/ValueSet/substance-grade
from the FHIR Standard
SubstanceDefinition.property.typeexampleVsSubstancePropertyPQ (a valid code from Substance Property - example)
http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-substance-property-pq
from this IG
SubstanceDefinition.property.value[x]exampleVsSubstancePropertyValuePQ (a valid code from Substance Property Value - example)
http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-substance-property-value-pq
from this IG
SubstanceDefinition.relationship.typeexampleVsImpurityTypePQ (a valid code from Impurity Type Codes)
http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-impurity-type-pq
from this IG

Constraints

IdGradePath(s)DetailsRequirements
dom-2errorSubstanceDefinitionIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorSubstanceDefinitionIf the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource
: contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4errorSubstanceDefinitionIf a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated
: contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5errorSubstanceDefinitionIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceSubstanceDefinitionA resource should have narrative for robust management
: text.`div`.exists()
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()

Snapshot View

NameFlagsCard.TypeDescription & Constraintsdoco
.. SubstanceDefinition 0..* SubstanceDefinition The detailed description of a substance, typically at a level beyond what is used for prescribing
... id Σ 0..1 id Logical id of this artifact
... meta Σ 0..1 Meta Metadata about the resource
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... language 0..1 code Language of the resource content
Binding: AllLanguages (required): IETF language tag for a human language

Additional BindingsPurpose
CommonLanguages Starter Set
... text 0..1 Narrative Text summary of the resource, for human interpretation
... contained 0..* Resource Contained, inline Resources
... extension 0..* Extension Additional content defined by implementations
... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored
... identifier Σ 0..* Identifier Identifier by which this substance is known
... version Σ 0..1 string A business level version identifier of the substance
... status Σ 0..1 CodeableConcept Status of substance within the catalogue e.g. active, retired
Binding: PublicationStatus (preferred): The lifecycle status of an artifact.

... classification Σ 0..* CodeableConcept A 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
... domain Σ 0..1 CodeableConcept If the substance applies to human or veterinary use
Binding: MedicinalProductDomain (example): Applicable domain for this product (e.g. human, veterinary).

... grade SΣ 0..* CodeableConcept The quality standard, established benchmark, to which substance complies (e.g. USP/NF, BP)
Binding: SubstanceGrade (example): The quality standard, established benchmark, to which a substance complies


... description Σ 0..1 markdown Textual description of the substance
... informationSource SΣ 0..* Reference(Citation) Supporting literature
... note Σ 0..* Annotation Textual comment about the substance's catalogue or registry record
... manufacturer SΣ 0..* Reference(Organization - Drug PQ) The entity that creates, makes, produces or fabricates the substance
.... id 0..1 id Unique id for inter-element referencing
.... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
.... site-utilization S 0..* Coding site-utilization
URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-site-utilization-pq
Binding: Product Site Utilization (example)
.... reference ΣC 0..1 string Literal reference, Relative, internal or absolute URL
.... type Σ 0..1 uri Type the reference refers to (e.g. "Patient") - must be a resource in resources
Binding: ResourceType (extensible): Aa resource (or, for logical models, the URI of the logical model).

.... identifier ΣC 0..1 Identifier Logical reference, when literal reference is not known
.... display ΣC 0..1 string Text alternative for the resource
... supplier Σ 0..* Reference(Organization) An entity that is the source for the substance. It may be different from the manufacturer
... moiety Σ 0..* BackboneElement Moiety, for structural modifications
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... role Σ 0..1 CodeableConcept Role that the moiety is playing
.... identifier Σ 0..1 Identifier Identifier by which this moiety substance is known
.... name Σ 0..1 string Textual name for this moiety substance
.... stereochemistry Σ 0..1 CodeableConcept Stereochemistry type
Binding: Stereochemistry (example): The optical rotation type of a substance.

.... opticalActivity Σ 0..1 CodeableConcept Optical activity type
Binding: OpticalActivity (example): The optical rotation type of a substance.

.... molecularFormula Σ 0..1 string Molecular formula for this moiety (e.g. with the Hill system)
.... amount[x] Σ 0..1 Quantitative value for this moiety
..... amountQuantity Quantity
..... amountString string
.... measurementType Σ 0..1 CodeableConcept The measurement type of the quantitative value
Binding: SubstanceAmountType (example): The relationship between two substance types.

... characterization Σ 0..* BackboneElement General specifications for this substance
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... technique Σ 0..1 CodeableConcept The method used to find the characterization e.g. HPLC
Binding: StructureTechnique (example): The method used to elucidate the characterization of the drug substance.

.... form Σ 0..1 CodeableConcept Describes the nature of the chemical entity and explains, for instance, whether this is a base or a salt form
Binding: SubstanceForm (example)
.... description Σ 0..1 markdown The description or justification in support of the interpretation of the data file
.... file Σ 0..* Attachment The data produced by the analytical instrument or a pictorial representation of that data. Examples: a JCAMP, JDX, or ADX file, or a chromatogram or spectrum analysis
... property SΣ 0..* BackboneElement General specifications for this substance
.... id 0..1 string Unique id for inter-element referencing
.... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
.... substance-property-range S 0..* Range substance-property-range
URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-substance-property-range-pq
.... substance-property-parameter S 0..* (Complex) substance-property-parameter
URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-substance-property-parameter-pq
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... type SΣ 1..1 CodeableConcept A code expressing the type of property
Binding: Substance Property (example)
.... value[x] SΣ 0..1 A value for the property
Binding: Substance Property Value (example)
..... valueCodeableConcept CodeableConcept
..... valueQuantity Quantity
..... valueDate date
..... valueBoolean boolean
..... valueAttachment Attachment
... referenceInformation Σ 0..1 Reference(SubstanceReferenceInformation) General information detailing this substance
... molecularWeight Σ 0..* BackboneElement The average mass of a molecule of a compound
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... method Σ 0..1 CodeableConcept The method by which the weight was determined
Binding: WeightMethod (example): The method by which the substance weight was measured.

.... type Σ 0..1 CodeableConcept Type of molecular weight e.g. exact, average, weight average
Binding: WeightType (example): The type of substance weight measurement.

.... amount Σ 1..1 Quantity Used to capture quantitative values for a variety of elements
... structure Σ 0..1 BackboneElement Structural information
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... stereochemistry Σ 0..1 CodeableConcept Stereochemistry type
Binding: Stereochemistry (example): The optical rotation type of a substance.

.... opticalActivity Σ 0..1 CodeableConcept Optical activity type
Binding: OpticalActivity (example): The optical rotation type of a substance.

.... molecularFormula Σ 0..1 string An expression which states the number and type of atoms present in a molecule of a substance
.... molecularFormulaByMoiety Σ 0..1 string Specified per moiety according to the Hill system
.... molecularWeight Σ 0..1 See molecularWeight (SubstanceDefinition) The molecular weight or weight range
.... technique Σ 0..* CodeableConcept The method used to find the structure e.g. X-ray, NMR
Binding: StructureTechnique (example): The method used to elucidate the structure of the drug substance.


.... sourceDocument Σ 0..* Reference(DocumentReference) Source of information for the structure
.... representation Σ 0..* BackboneElement A depiction of the structure of the substance
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... type Σ 0..1 CodeableConcept The kind of structural representation (e.g. full, partial)
Binding: SubstanceRepresentationType (example): A format of a substance representation.

..... representation Σ 0..1 string The structural representation as a text string in a standard format
..... format Σ 0..1 CodeableConcept The format of the representation e.g. InChI, SMILES, MOLFILE (note: not the physical file format)
Binding: SubstanceRepresentationFormat (example): A format of a substance representation.

..... document Σ 0..1 Reference(DocumentReference) An attachment with the structural representation e.g. a structure graphic or AnIML file
... code Σ 0..* BackboneElement Codes associated with the substance
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... code Σ 0..1 CodeableConcept The specific code
.... status Σ 0..1 CodeableConcept Status of the code assignment, for example 'provisional', 'approved'
Binding: PublicationStatus (preferred): The lifecycle status of an artifact.

.... statusDate Σ 0..1 dateTime The date at which the code status was changed
.... note Σ 0..* Annotation Any comment can be provided in this field
.... source Σ 0..* Reference(DocumentReference) Supporting literature
... name SΣ 0..* BackboneElement Names applicable to this substance
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... name Σ 1..1 string The actual name
.... type Σ 0..1 CodeableConcept Name type e.g. 'systematic', 'scientific, 'brand'
Binding: SubstanceNameType (example): The type of a name given to a substance.

.... status Σ 0..1 CodeableConcept The status of the name e.g. 'current', 'proposed'
Binding: PublicationStatus (preferred): The lifecycle status of an artifact.

.... preferred Σ 0..1 boolean If this is the preferred name for this substance
.... language Σ 0..* CodeableConcept Human language that the name is written in
Binding: AllLanguages (required): IETF language tag for a human language

Additional BindingsPurpose
CommonLanguages Starter Set

.... domain Σ 0..* CodeableConcept The use context of this name e.g. as an active ingredient or as a food colour additive
Binding: SubstanceNameDomain (example): The use context of a substance name for example if there is a different name when used as a drug active ingredient as opposed to a food colour additive.


.... jurisdiction Σ 0..* CodeableConcept The jurisdiction where this name applies
Binding: JurisdictionValueSet (example): Jurisdiction codes


.... synonym Σ 0..* See name (SubstanceDefinition) A synonym of this particular name, by which the substance is also known
.... translation Σ 0..* See name (SubstanceDefinition) A translation for this name into another human language
.... official Σ 0..* BackboneElement Details of the official nature of this name
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... authority Σ 0..1 CodeableConcept Which authority uses this official name
Binding: SubstanceNameAuthority (preferred): An authority that officates substance names.

..... status Σ 0..1 CodeableConcept The status of the official name, for example 'draft', 'active'
Binding: PublicationStatus (preferred): The lifecycle status of an artifact.

..... date Σ 0..1 dateTime Date of official name change
.... source Σ 0..* Reference(DocumentReference) Supporting literature
... relationship SΣ 0..* BackboneElement A link between this substance and another
.... id 0..1 string Unique id for inter-element referencing
.... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
.... impurity-origin S 0..* CodeableConcept impurity-origin
URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-impurity-origin-pq
Binding: Impurity Origins (example)
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... substanceDefinition[x] Σ 0..1 A pointer to another substance, as a resource or a representational code
..... substanceDefinitionReference Reference(SubstanceDefinition)
..... substanceDefinitionCodeableConcept CodeableConcept
.... type SΣ 1..1 CodeableConcept For example "salt to parent", "active moiety"
Binding: Impurity Types (example)
.... isDefining Σ 0..1 boolean For example where an enzyme strongly bonds with a particular substance, this is a defining relationship for that enzyme, out of several possible relationships
.... amount[x] Σ 0..1 A numeric factor for the relationship, e.g. that a substance salt has some percentage of active substance in relation to some other
..... amountQuantity Quantity
..... amountRatio Ratio
..... amountString string
.... ratioHighLimitAmount Σ 0..1 Ratio For use when the numeric has an uncertain range
.... comparator Σ 0..1 CodeableConcept An operator for the amount, for example "average", "approximately", "less than"
Binding: SubstanceAmountType (example): The relationship between two substance types.

.... source Σ 0..* Reference(DocumentReference) Supporting literature
... nucleicAcid Σ 0..1 Reference(SubstanceNucleicAcid) Data items specific to nucleic acids
... polymer Σ 0..1 Reference(SubstancePolymer) Data items specific to polymers
... protein Σ 0..1 Reference(SubstanceProtein) Data items specific to proteins
... sourceMaterial SΣ 0..1 BackboneElement Material or taxonomic/anatomical source
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... type Σ 0..1 CodeableConcept Classification of the origin of the raw material. e.g. cat hair is an Animal source type
Binding: SourceMaterialType (example): A classification that provides the origin of the substance raw material.

.... genus Σ 0..1 CodeableConcept The genus of an organism e.g. the Latin epithet of the plant/animal scientific name
Binding: SourceMaterialGenus (example): The genus of an organism, typically referring to the Latin epithet of the genus element of the plant/animal scientific name.

.... species Σ 0..1 CodeableConcept The species of an organism e.g. the Latin epithet of the species of the plant/animal
Binding: SourceMaterialSpecies (example): A species of origin a substance raw material.

.... part Σ 0..1 CodeableConcept An anatomical origin of the source material within an organism
Binding: SourceMaterialPart (example): An anatomical origin of the source material within an organism.

.... countryOfOrigin Σ 0..* CodeableConcept The country or countries where the material is harvested
Binding: CountryValueSet (required): Jurisdiction codes



doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
SubstanceDefinition.languagerequiredAllLanguages
http://hl7.org/fhir/ValueSet/all-languages|5.0.0
from the FHIR Standard
SubstanceDefinition.statuspreferredPublicationStatus
http://hl7.org/fhir/ValueSet/publication-status
from the FHIR Standard
SubstanceDefinition.domainexampleMedicinalProductDomain
http://hl7.org/fhir/ValueSet/medicinal-product-domain
from the FHIR Standard
SubstanceDefinition.gradeexampleSubstanceGrade
http://hl7.org/fhir/ValueSet/substance-grade
from the FHIR Standard
SubstanceDefinition.manufacturer.typeextensibleResourceType
http://hl7.org/fhir/ValueSet/resource-types
from the FHIR Standard
SubstanceDefinition.moiety.stereochemistryexampleStereochemistry
http://hl7.org/fhir/ValueSet/substance-stereochemistry
from the FHIR Standard
SubstanceDefinition.moiety.opticalActivityexampleOpticalActivity
http://hl7.org/fhir/ValueSet/substance-optical-activity
from the FHIR Standard
SubstanceDefinition.moiety.measurementTypeexampleSubstanceAmountType
http://hl7.org/fhir/ValueSet/substance-amount-type
from the FHIR Standard
SubstanceDefinition.characterization.techniqueexampleStructureTechnique
http://hl7.org/fhir/ValueSet/substance-structure-technique
from the FHIR Standard
SubstanceDefinition.characterization.formexampleSubstanceForm
http://hl7.org/fhir/ValueSet/substance-form
from the FHIR Standard
SubstanceDefinition.property.typeexampleVsSubstancePropertyPQ (a valid code from Substance Property - example)
http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-substance-property-pq
from this IG
SubstanceDefinition.property.value[x]exampleVsSubstancePropertyValuePQ (a valid code from Substance Property Value - example)
http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-substance-property-value-pq
from this IG
SubstanceDefinition.molecularWeight.methodexampleWeightMethod
http://hl7.org/fhir/ValueSet/substance-weight-method
from the FHIR Standard
SubstanceDefinition.molecularWeight.typeexampleWeightType
http://hl7.org/fhir/ValueSet/substance-weight-type
from the FHIR Standard
SubstanceDefinition.structure.stereochemistryexampleStereochemistry
http://hl7.org/fhir/ValueSet/substance-stereochemistry
from the FHIR Standard
SubstanceDefinition.structure.opticalActivityexampleOpticalActivity
http://hl7.org/fhir/ValueSet/substance-optical-activity
from the FHIR Standard
SubstanceDefinition.structure.techniqueexampleStructureTechnique
http://hl7.org/fhir/ValueSet/substance-structure-technique
from the FHIR Standard
SubstanceDefinition.structure.representation.typeexampleSubstanceRepresentationType
http://hl7.org/fhir/ValueSet/substance-representation-type
from the FHIR Standard
SubstanceDefinition.structure.representation.formatexampleSubstanceRepresentationFormat
http://hl7.org/fhir/ValueSet/substance-representation-format
from the FHIR Standard
SubstanceDefinition.code.statuspreferredPublicationStatus
http://hl7.org/fhir/ValueSet/publication-status
from the FHIR Standard
SubstanceDefinition.name.typeexampleSubstanceNameType
http://hl7.org/fhir/ValueSet/substance-name-type
from the FHIR Standard
SubstanceDefinition.name.statuspreferredPublicationStatus
http://hl7.org/fhir/ValueSet/publication-status
from the FHIR Standard
SubstanceDefinition.name.languagerequiredAllLanguages
http://hl7.org/fhir/ValueSet/all-languages|5.0.0
from the FHIR Standard
SubstanceDefinition.name.domainexampleSubstanceNameDomain
http://hl7.org/fhir/ValueSet/substance-name-domain
from the FHIR Standard
SubstanceDefinition.name.jurisdictionexampleJurisdictionValueSet
http://hl7.org/fhir/ValueSet/jurisdiction
from the FHIR Standard
SubstanceDefinition.name.official.authoritypreferredSubstanceNameAuthority
http://hl7.org/fhir/ValueSet/substance-name-authority
from the FHIR Standard
SubstanceDefinition.name.official.statuspreferredPublicationStatus
http://hl7.org/fhir/ValueSet/publication-status
from the FHIR Standard
SubstanceDefinition.relationship.typeexampleVsImpurityTypePQ (a valid code from Impurity Type Codes)
http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-impurity-type-pq
from this IG
SubstanceDefinition.relationship.comparatorexampleSubstanceAmountType
http://hl7.org/fhir/ValueSet/substance-amount-type
from the FHIR Standard
SubstanceDefinition.sourceMaterial.typeexampleSourceMaterialType
http://hl7.org/fhir/ValueSet/substance-source-material-type
from the FHIR Standard
SubstanceDefinition.sourceMaterial.genusexampleSourceMaterialGenus
http://hl7.org/fhir/ValueSet/substance-source-material-genus
from the FHIR Standard
SubstanceDefinition.sourceMaterial.speciesexampleSourceMaterialSpecies
http://hl7.org/fhir/ValueSet/substance-source-material-species
from the FHIR Standard
SubstanceDefinition.sourceMaterial.partexampleSourceMaterialPart
http://hl7.org/fhir/ValueSet/substance-source-material-part
from the FHIR Standard
SubstanceDefinition.sourceMaterial.countryOfOriginrequiredCountryValueSet
http://hl7.org/fhir/ValueSet/country|5.0.0
from the FHIR Standard

Constraints

IdGradePath(s)DetailsRequirements
dom-2errorSubstanceDefinitionIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorSubstanceDefinitionIf the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource
: contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4errorSubstanceDefinitionIf a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated
: contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5errorSubstanceDefinitionIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceSubstanceDefinitionA resource should have narrative for robust management
: text.`div`.exists()
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()