This page is part of the Electronic Medicinal Product Information (ePI) FHIR Implementation Guide (v1.0.0-ballot: STU1 Ballot 1) based on FHIR (HL7® FHIR® Standard) v5.0.0-ballot. The current version which supersedes this version is 1.0.0. For a full list of available versions, see the Directory of published versions

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Resource Profile: SubstanceDefinition (ePI)

SubstanceDefinition (ePI)

Usage:

• Use this Resource Profile: Bundle - ePI
• Examples for this Resource Profile: SubstanceDefinition/da33bd51-a726-4232-aaa0-4168b9bfe249

Formal Views of Profile Content

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

• Differential Table
• Key Elements Table
• Snapshot Table
• Statistics/References
• All

This structure is derived from SubstanceDefinition

Name	Flags	Card.	Type	Description & Constraints
SubstanceDefinition		0..*	SubstanceDefinition	The detailed description of a substance, typically at a level beyond what is used for prescribing
identifier		0..*	Identifier	An identifier or code by which the SubstanceDefinition can be referenced.
status		0..1	CodeableConcept	draft|active|retired|unknown
domain		0..1	CodeableConcept	If the substance applies to human or veterinary use Binding: MedicinalProductDomain (preferred)
description		0..1	markdown	Textual description of the substance.
manufacturer		0..*	Reference(Organization (ePI))	The entity that creates, makes, produces or fabricates the substance
molecularWeight
amount		1..1	Quantity	The molecular weight.
value		0..1	decimal	numerical value.
unit		0..1	string	Unit of measure.
code		0..1	code	coded form of the unit of measure.
structure
molecularFormula		0..1	string	Molecular formula (e.g. using the Hill system).
code		0..*	BackboneElement	Codes associated with the substance.
code		0..1	CodeableConcept	The specific code Binding: Substances (preferred)
name		0..*	BackboneElement	Names applicable to this substance.
name		1..1	string	International Non-Proprietary Name (INN) of the substance.
Documentation for this format

Terminology Bindings (Differential)

Path	Conformance	ValueSet
SubstanceDefinition.domain	preferred	MedicinalProductDomain
SubstanceDefinition.code.code	preferred	VsSubstance (a valid code from https://gsrs.ncats.nih.gov/ginas/app/beta)

Name	Flags	Card.	Type	Description & Constraints
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
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored
identifier	Σ	0..*	Identifier	An identifier or code by which the SubstanceDefinition can be referenced.
status	Σ	0..1	CodeableConcept	draft|active|retired|unknown Binding: PublicationStatus (preferred): The lifecycle status of an artifact.
domain	Σ	0..1	CodeableConcept	If the substance applies to human or veterinary use Binding: MedicinalProductDomain (preferred)
description	Σ	0..1	markdown	Textual description of the substance.
manufacturer	Σ	0..*	Reference(Organization (ePI))	The entity that creates, makes, produces or fabricates the substance
code	Σ	0..*	BackboneElement	Codes associated with the substance.
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
code	Σ	0..1	CodeableConcept	The specific code Binding: Substances (preferred)
name	Σ	0..*	BackboneElement	Names applicable to this substance.
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
name	Σ	1..1	string	International Non-Proprietary Name (INN) of the substance.
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet
SubstanceDefinition.status	preferred	PublicationStatus
SubstanceDefinition.domain	preferred	MedicinalProductDomain
SubstanceDefinition.code.code	preferred	VsSubstance (a valid code from https://gsrs.ncats.nih.gov/ginas/app/beta)

Name	Flags	Card.	Type	Description & Constraints
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: CommonLanguages (preferred): IETF language tag Additional Bindings Purpose AllLanguages Max Binding
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	An identifier or code by which the SubstanceDefinition can be referenced.
version	Σ	0..1	string	A business level version identifier of the substance
status	Σ	0..1	CodeableConcept	draft|active|retired|unknown 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 (preferred)
grade	Σ	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	Σ	0..*	Reference(Citation)	Supporting literature
note	Σ	0..*	Annotation	Textual comment about the substance's catalogue or registry record
manufacturer	Σ	0..*	Reference(Organization (ePI))	The entity that creates, makes, produces or fabricates the substance
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.
property	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
type	Σ	1..1	CodeableConcept	A code expressing the type of property Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.
value[x]	Σ	0..1		A value for the property
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 molecular weight or weight range
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	The molecular weight.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
value	Σ	0..1	decimal	numerical value.
comparator	?!Σ	0..1	code	< | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required)
unit	Σ	0..1	string	Unit of measure.
system	ΣC	0..1	uri	System that defines coded unit form
code	Σ	0..1	code	coded form of the unit of measure.
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	Molecular formula (e.g. using the Hill system).
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 or characterization of the drug substance.
sourceDocument	Σ	0..*	Reference(DocumentReference)	Source of information for the structure
representation	Σ	0..*	BackboneElement	A depiction of the structure or characterization 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 or characterization 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 Binding: Substances (preferred)
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	Σ	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	International Non-Proprietary Name (INN) of the substance.
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: CommonLanguages (preferred): IETF language tag Additional Bindings Purpose AllLanguages Max Binding
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: Jurisdiction ValueSet (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	Σ	0..*	BackboneElement	A link between this substance and another
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
substanceDefinition[x]	Σ	0..1		A pointer to another substance, as a resource or a representational code
substanceDefinitionReference			Reference(SubstanceDefinition)
substanceDefinitionCodeableConcept			CodeableConcept
type	Σ	1..1	CodeableConcept	For example "salt to parent", "active moiety" Binding: SubstanceRelationshipType (example): The relationship between two substance types.
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	Σ	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: Country ValueSet (required): Jurisdiction codes
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet
SubstanceDefinition.language	preferred	CommonLanguages Additional Bindings Purpose AllLanguages Max Binding
SubstanceDefinition.status	preferred	PublicationStatus
SubstanceDefinition.domain	preferred	MedicinalProductDomain
SubstanceDefinition.grade	example	SubstanceGrade
SubstanceDefinition.moiety.stereochemistry	example	Stereochemistry
SubstanceDefinition.moiety.opticalActivity	example	OpticalActivity
SubstanceDefinition.moiety.measurementType	example	SubstanceAmountType
SubstanceDefinition.property.type	example	ProductCharacteristic
SubstanceDefinition.molecularWeight.method	example	WeightMethod
SubstanceDefinition.molecularWeight.type	example	WeightType
SubstanceDefinition.molecularWeight.amount.comparator	required	QuantityComparator
SubstanceDefinition.structure.stereochemistry	example	Stereochemistry
SubstanceDefinition.structure.opticalActivity	example	OpticalActivity
SubstanceDefinition.structure.technique	example	StructureTechnique
SubstanceDefinition.structure.representation.type	example	SubstanceRepresentationType
SubstanceDefinition.structure.representation.format	example	SubstanceRepresentationFormat
SubstanceDefinition.code.code	preferred	VsSubstance (a valid code from https://gsrs.ncats.nih.gov/ginas/app/beta)
SubstanceDefinition.code.status	preferred	PublicationStatus
SubstanceDefinition.name.type	example	SubstanceNameType
SubstanceDefinition.name.status	preferred	PublicationStatus
SubstanceDefinition.name.language	preferred	CommonLanguages Additional Bindings Purpose AllLanguages Max Binding
SubstanceDefinition.name.domain	example	SubstanceNameDomain
SubstanceDefinition.name.jurisdiction	example	Jurisdiction ValueSet
SubstanceDefinition.name.official.authority	preferred	SubstanceNameAuthority
SubstanceDefinition.name.official.status	preferred	PublicationStatus
SubstanceDefinition.relationship.type	example	SubstanceRelationshipType
SubstanceDefinition.relationship.comparator	example	SubstanceAmountType
SubstanceDefinition.sourceMaterial.type	example	SourceMaterialType
SubstanceDefinition.sourceMaterial.genus	example	SourceMaterialGenus
SubstanceDefinition.sourceMaterial.species	example	SourceMaterialSpecies
SubstanceDefinition.sourceMaterial.part	example	SourceMaterialPart
SubstanceDefinition.sourceMaterial.countryOfOrigin	required	Country ValueSet

This structure is derived from SubstanceDefinition

Summary

Structures

This structure refers to these other structures:

• Organization (ePI) (http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Organization-uv-epi)

Differential View

This structure is derived from SubstanceDefinition

Name	Flags	Card.	Type	Description & Constraints
SubstanceDefinition		0..*	SubstanceDefinition	The detailed description of a substance, typically at a level beyond what is used for prescribing
identifier		0..*	Identifier	An identifier or code by which the SubstanceDefinition can be referenced.
status		0..1	CodeableConcept	draft|active|retired|unknown
domain		0..1	CodeableConcept	If the substance applies to human or veterinary use Binding: MedicinalProductDomain (preferred)
description		0..1	markdown	Textual description of the substance.
manufacturer		0..*	Reference(Organization (ePI))	The entity that creates, makes, produces or fabricates the substance
molecularWeight
amount		1..1	Quantity	The molecular weight.
value		0..1	decimal	numerical value.
unit		0..1	string	Unit of measure.
code		0..1	code	coded form of the unit of measure.
structure
molecularFormula		0..1	string	Molecular formula (e.g. using the Hill system).
code		0..*	BackboneElement	Codes associated with the substance.
code		0..1	CodeableConcept	The specific code Binding: Substances (preferred)
name		0..*	BackboneElement	Names applicable to this substance.
name		1..1	string	International Non-Proprietary Name (INN) of the substance.
Documentation for this format

Terminology Bindings (Differential)

Path	Conformance	ValueSet
SubstanceDefinition.domain	preferred	MedicinalProductDomain
SubstanceDefinition.code.code	preferred	VsSubstance (a valid code from https://gsrs.ncats.nih.gov/ginas/app/beta)

Key Elements View

Name	Flags	Card.	Type	Description & Constraints
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
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored
identifier	Σ	0..*	Identifier	An identifier or code by which the SubstanceDefinition can be referenced.
status	Σ	0..1	CodeableConcept	draft|active|retired|unknown Binding: PublicationStatus (preferred): The lifecycle status of an artifact.
domain	Σ	0..1	CodeableConcept	If the substance applies to human or veterinary use Binding: MedicinalProductDomain (preferred)
description	Σ	0..1	markdown	Textual description of the substance.
manufacturer	Σ	0..*	Reference(Organization (ePI))	The entity that creates, makes, produces or fabricates the substance
code	Σ	0..*	BackboneElement	Codes associated with the substance.
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
code	Σ	0..1	CodeableConcept	The specific code Binding: Substances (preferred)
name	Σ	0..*	BackboneElement	Names applicable to this substance.
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
name	Σ	1..1	string	International Non-Proprietary Name (INN) of the substance.
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet
SubstanceDefinition.status	preferred	PublicationStatus
SubstanceDefinition.domain	preferred	MedicinalProductDomain
SubstanceDefinition.code.code	preferred	VsSubstance (a valid code from https://gsrs.ncats.nih.gov/ginas/app/beta)

Snapshot View

Name	Flags	Card.	Type	Description & Constraints
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: CommonLanguages (preferred): IETF language tag Additional Bindings Purpose AllLanguages Max Binding
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	An identifier or code by which the SubstanceDefinition can be referenced.
version	Σ	0..1	string	A business level version identifier of the substance
status	Σ	0..1	CodeableConcept	draft|active|retired|unknown 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 (preferred)
grade	Σ	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	Σ	0..*	Reference(Citation)	Supporting literature
note	Σ	0..*	Annotation	Textual comment about the substance's catalogue or registry record
manufacturer	Σ	0..*	Reference(Organization (ePI))	The entity that creates, makes, produces or fabricates the substance
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.
property	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
type	Σ	1..1	CodeableConcept	A code expressing the type of property Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.
value[x]	Σ	0..1		A value for the property
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 molecular weight or weight range
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	The molecular weight.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
value	Σ	0..1	decimal	numerical value.
comparator	?!Σ	0..1	code	< | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required)
unit	Σ	0..1	string	Unit of measure.
system	ΣC	0..1	uri	System that defines coded unit form
code	Σ	0..1	code	coded form of the unit of measure.
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	Molecular formula (e.g. using the Hill system).
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 or characterization of the drug substance.
sourceDocument	Σ	0..*	Reference(DocumentReference)	Source of information for the structure
representation	Σ	0..*	BackboneElement	A depiction of the structure or characterization 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 or characterization 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 Binding: Substances (preferred)
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	Σ	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	International Non-Proprietary Name (INN) of the substance.
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: CommonLanguages (preferred): IETF language tag Additional Bindings Purpose AllLanguages Max Binding
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: Jurisdiction ValueSet (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	Σ	0..*	BackboneElement	A link between this substance and another
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
substanceDefinition[x]	Σ	0..1		A pointer to another substance, as a resource or a representational code
substanceDefinitionReference			Reference(SubstanceDefinition)
substanceDefinitionCodeableConcept			CodeableConcept
type	Σ	1..1	CodeableConcept	For example "salt to parent", "active moiety" Binding: SubstanceRelationshipType (example): The relationship between two substance types.
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	Σ	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: Country ValueSet (required): Jurisdiction codes
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet
SubstanceDefinition.language	preferred	CommonLanguages Additional Bindings Purpose AllLanguages Max Binding
SubstanceDefinition.status	preferred	PublicationStatus
SubstanceDefinition.domain	preferred	MedicinalProductDomain
SubstanceDefinition.grade	example	SubstanceGrade
SubstanceDefinition.moiety.stereochemistry	example	Stereochemistry
SubstanceDefinition.moiety.opticalActivity	example	OpticalActivity
SubstanceDefinition.moiety.measurementType	example	SubstanceAmountType
SubstanceDefinition.property.type	example	ProductCharacteristic
SubstanceDefinition.molecularWeight.method	example	WeightMethod
SubstanceDefinition.molecularWeight.type	example	WeightType
SubstanceDefinition.molecularWeight.amount.comparator	required	QuantityComparator
SubstanceDefinition.structure.stereochemistry	example	Stereochemistry
SubstanceDefinition.structure.opticalActivity	example	OpticalActivity
SubstanceDefinition.structure.technique	example	StructureTechnique
SubstanceDefinition.structure.representation.type	example	SubstanceRepresentationType
SubstanceDefinition.structure.representation.format	example	SubstanceRepresentationFormat
SubstanceDefinition.code.code	preferred	VsSubstance (a valid code from https://gsrs.ncats.nih.gov/ginas/app/beta)
SubstanceDefinition.code.status	preferred	PublicationStatus
SubstanceDefinition.name.type	example	SubstanceNameType
SubstanceDefinition.name.status	preferred	PublicationStatus
SubstanceDefinition.name.language	preferred	CommonLanguages Additional Bindings Purpose AllLanguages Max Binding
SubstanceDefinition.name.domain	example	SubstanceNameDomain
SubstanceDefinition.name.jurisdiction	example	Jurisdiction ValueSet
SubstanceDefinition.name.official.authority	preferred	SubstanceNameAuthority
SubstanceDefinition.name.official.status	preferred	PublicationStatus
SubstanceDefinition.relationship.type	example	SubstanceRelationshipType
SubstanceDefinition.relationship.comparator	example	SubstanceAmountType
SubstanceDefinition.sourceMaterial.type	example	SourceMaterialType
SubstanceDefinition.sourceMaterial.genus	example	SourceMaterialGenus
SubstanceDefinition.sourceMaterial.species	example	SourceMaterialSpecies
SubstanceDefinition.sourceMaterial.part	example	SourceMaterialPart
SubstanceDefinition.sourceMaterial.countryOfOrigin	required	Country ValueSet

This structure is derived from SubstanceDefinition

Summary

Structures

This structure refers to these other structures:

• Organization (ePI) (http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Organization-uv-epi)

Other representations of profile: CSV, Excel, Schematron