Pharmaceutical Quality (Industry)
1.0.0 - STU1

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 2024-05-08 | 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:

- Use this Resource Profile: Bundle – Analytical Procedure PQ, Bundle – Batch Analysis PQ, Bundle – Batch Formula PQ, Bundle – Container Closure System PQ... Show 12 more, Bundle – Drug Product Composition PQ, Bundle – Drug Product Excipients PQ, Bundle – Drug Product Specification PQ, Bundle – Drug Reference Standards PQ, Bundle – Drug Stability PQ, Bundle – Drug Substance Batch Information PQ, Bundle – Drug Substance Characterization PQ, Bundle – Drug Substance General Properties PQ, Bundle – Drug Substance Specification PQ, Bundle - Product Impurities PQ, Bundle - Product Manufacturing PQ and Bundle - Product Process Validation PQ
- Refer to this Resource Profile: Extension - Manufacturing Participant PQ and Ingredient - Drug Pq
- Examples for this Resource Profile: SubstanceDefinition/StelbatololAqueousSolution, SubstanceDefinition/StelbatololGranules and SubstanceDefinition/substancedefinition-component-substance-drug-pq-ex1

### 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
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)
property | S | 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
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
Documentation for this format

#### Terminology Bindings (Differential)

Path | Conformance | ValueSet | URI
SubstanceDefinition.property.type | example | VsSubstancePropertyPQ (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] | example | VsSubstancePropertyValuePQ (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.type | example | VsImpurityTypePQ (a valid code from Impurity Type Codes) `http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-impurity-type-pq` from this IG

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
contained |  | 0..* | Resource | Contained, inline Resources
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored
grade | S 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
informationSource | S Σ | 0..* | Reference(Citation) | Supporting literature
manufacturer | S Σ | 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 | Σ C | 0..1 | string | Literal reference, Relative, internal or absolute URL
property | S Σ | 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 | S Σ | 1..1 | CodeableConcept | A code expressing the type of property Binding: Substance Property (example)
value[x] | S Σ | 0..1 |  | A value for the property Binding: Substance Property Value (example)
valueCodeableConcept |  |  | CodeableConcept |
valueQuantity |  |  | Quantity |
valueDate |  |  | date |
valueBoolean |  |  | boolean |
valueAttachment |  |  | Attachment |
name | S 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 | The actual name
relationship | S Σ | 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 | S Σ | 1..1 | CodeableConcept | For example "salt to parent", "active moiety" Binding: Impurity Types (example)
sourceMaterial | S Σ | 0..1 | BackboneElement | Material or taxonomic/anatomical source
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
Documentation for this format

#### Terminology Bindings

Path | Conformance | ValueSet | URI
SubstanceDefinition.grade | example | SubstanceGrade `http://hl7.org/fhir/ValueSet/substance-grade` from the FHIR Standard
SubstanceDefinition.property.type | example | VsSubstancePropertyPQ (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] | example | VsSubstancePropertyValuePQ (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.type | example | VsImpurityTypePQ (a valid code from Impurity Type Codes) `http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-impurity-type-pq` from this IG

#### Constraints

Id | Grade | Path(s) | Details | Requirements
dom-2 | error | SubstanceDefinition | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() |
dom-3 | error | SubstanceDefinition | If 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-4 | error | SubstanceDefinition | If 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-5 | error | SubstanceDefinition | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() |
dom-6 | best practice | SubstanceDefinition | A resource should have narrative for robust management : text.`div`.exists() |
ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) |
ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() |

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: AllLanguages (required): IETF language tag for a human language
Additional Bindings | Purpose
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 | S 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 | S Σ | 0..* | Reference(Citation) | Supporting literature
note | Σ | 0..* | Annotation | Textual comment about the substance's catalogue or registry record
manufacturer | S Σ | 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 | Σ C | 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 | Σ C | 0..1 | Identifier | Logical reference, when literal reference is not known
display | Σ C | 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 | S Σ | 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 | S Σ | 1..1 | CodeableConcept | A code expressing the type of property Binding: Substance Property (example)
value[x] | S Σ | 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 | S 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 | 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 Bindings | Purpose
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 | S Σ | 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 | S Σ | 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 | S 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: CountryValueSet (required): Jurisdiction codes
Documentation for this format

#### Terminology Bindings

Path | Conformance | ValueSet | URI
SubstanceDefinition.language | required | AllLanguages `http://hl7.org/fhir/ValueSet/all-languages|5.0.0` from the FHIR Standard
SubstanceDefinition.status | preferred | PublicationStatus `http://hl7.org/fhir/ValueSet/publication-status` from the FHIR Standard
SubstanceDefinition.domain | example | MedicinalProductDomain `http://hl7.org/fhir/ValueSet/medicinal-product-domain` from the FHIR Standard
SubstanceDefinition.grade | example | SubstanceGrade `http://hl7.org/fhir/ValueSet/substance-grade` from the FHIR Standard
SubstanceDefinition.manufacturer.type | extensible | ResourceType `http://hl7.org/fhir/ValueSet/resource-types` from the FHIR Standard
SubstanceDefinition.moiety.stereochemistry | example | Stereochemistry `http://hl7.org/fhir/ValueSet/substance-stereochemistry` from the FHIR Standard
SubstanceDefinition.moiety.opticalActivity | example | OpticalActivity `http://hl7.org/fhir/ValueSet/substance-optical-activity` from the FHIR Standard
SubstanceDefinition.moiety.measurementType | example | SubstanceAmountType `http://hl7.org/fhir/ValueSet/substance-amount-type` from the FHIR Standard
SubstanceDefinition.characterization.technique | example | StructureTechnique `http://hl7.org/fhir/ValueSet/substance-structure-technique` from the FHIR Standard
SubstanceDefinition.characterization.form | example | SubstanceForm `http://hl7.org/fhir/ValueSet/substance-form` from the FHIR Standard
SubstanceDefinition.property.type | example | VsSubstancePropertyPQ (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] | example | VsSubstancePropertyValuePQ (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.method | example | WeightMethod `http://hl7.org/fhir/ValueSet/substance-weight-method` from the FHIR Standard
SubstanceDefinition.molecularWeight.type | example | WeightType `http://hl7.org/fhir/ValueSet/substance-weight-type` from the FHIR Standard
SubstanceDefinition.structure.stereochemistry | example | Stereochemistry `http://hl7.org/fhir/ValueSet/substance-stereochemistry` from the FHIR Standard
SubstanceDefinition.structure.opticalActivity | example | OpticalActivity `http://hl7.org/fhir/ValueSet/substance-optical-activity` from the FHIR Standard
SubstanceDefinition.structure.technique | example | StructureTechnique `http://hl7.org/fhir/ValueSet/substance-structure-technique` from the FHIR Standard
SubstanceDefinition.structure.representation.type | example | SubstanceRepresentationType `http://hl7.org/fhir/ValueSet/substance-representation-type` from the FHIR Standard
SubstanceDefinition.structure.representation.format | example | SubstanceRepresentationFormat `http://hl7.org/fhir/ValueSet/substance-representation-format` from the FHIR Standard
SubstanceDefinition.code.status | preferred | PublicationStatus `http://hl7.org/fhir/ValueSet/publication-status` from the FHIR Standard
SubstanceDefinition.name.type | example | SubstanceNameType `http://hl7.org/fhir/ValueSet/substance-name-type` from the FHIR Standard
SubstanceDefinition.name.status | preferred | PublicationStatus `http://hl7.org/fhir/ValueSet/publication-status` from the FHIR Standard
SubstanceDefinition.name.language | required | AllLanguages `http://hl7.org/fhir/ValueSet/all-languages|5.0.0` from the FHIR Standard
SubstanceDefinition.name.domain | example | SubstanceNameDomain `http://hl7.org/fhir/ValueSet/substance-name-domain` from the FHIR Standard
SubstanceDefinition.name.jurisdiction | example | JurisdictionValueSet `http://hl7.org/fhir/ValueSet/jurisdiction` from the FHIR Standard
SubstanceDefinition.name.official.authority | preferred | SubstanceNameAuthority `http://hl7.org/fhir/ValueSet/substance-name-authority` from the FHIR Standard
SubstanceDefinition.name.official.status | preferred | PublicationStatus `http://hl7.org/fhir/ValueSet/publication-status` from the FHIR Standard
SubstanceDefinition.relationship.type | example | VsImpurityTypePQ (a valid code from Impurity Type Codes) `http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-impurity-type-pq` from this IG
SubstanceDefinition.relationship.comparator | example | SubstanceAmountType `http://hl7.org/fhir/ValueSet/substance-amount-type` from the FHIR Standard
SubstanceDefinition.sourceMaterial.type | example | SourceMaterialType `http://hl7.org/fhir/ValueSet/substance-source-material-type` from the FHIR Standard
SubstanceDefinition.sourceMaterial.genus | example | SourceMaterialGenus `http://hl7.org/fhir/ValueSet/substance-source-material-genus` from the FHIR Standard
SubstanceDefinition.sourceMaterial.species | example | SourceMaterialSpecies `http://hl7.org/fhir/ValueSet/substance-source-material-species` from the FHIR Standard
SubstanceDefinition.sourceMaterial.part | example | SourceMaterialPart `http://hl7.org/fhir/ValueSet/substance-source-material-part` from the FHIR Standard
SubstanceDefinition.sourceMaterial.countryOfOrigin | required | CountryValueSet `http://hl7.org/fhir/ValueSet/country|5.0.0` from the FHIR Standard

#### Constraints

Id | Grade | Path(s) | Details | Requirements
dom-2 | error | SubstanceDefinition | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() |
dom-3 | error | SubstanceDefinition | If 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-4 | error | SubstanceDefinition | If 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-5 | error | SubstanceDefinition | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() |
dom-6 | best practice | SubstanceDefinition | A resource should have narrative for robust management : text.`div`.exists() |
ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) |
ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() |

This structure is derived from SubstanceDefinition

Summary

Must-Support: 14 elements

Structures

This structure refers to these other structures:

- Organization - Drug PQ (http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Organization-drug-pq)

Extensions

This structure refers to these extensions:

- http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-site-utilization-pq
- http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-substance-property-range-pq
- http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-substance-property-parameter-pq
- http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-impurity-origin-pq

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
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)
property | S | 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
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
Documentation for this format

#### Terminology Bindings (Differential)

Path | Conformance | ValueSet | URI
SubstanceDefinition.property.type | example | VsSubstancePropertyPQ (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] | example | VsSubstancePropertyValuePQ (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.type | example | VsImpurityTypePQ (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

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
contained |  | 0..* | Resource | Contained, inline Resources
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored
grade | S 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
informationSource | S Σ | 0..* | Reference(Citation) | Supporting literature
manufacturer | S Σ | 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 | Σ C | 0..1 | string | Literal reference, Relative, internal or absolute URL
property | S Σ | 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 | S Σ | 1..1 | CodeableConcept | A code expressing the type of property Binding: Substance Property (example)
value[x] | S Σ | 0..1 |  | A value for the property Binding: Substance Property Value (example)
valueCodeableConcept |  |  | CodeableConcept |
valueQuantity |  |  | Quantity |
valueDate |  |  | date |
valueBoolean |  |  | boolean |
valueAttachment |  |  | Attachment |
name | S 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 | The actual name
relationship | S Σ | 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 | S Σ | 1..1 | CodeableConcept | For example "salt to parent", "active moiety" Binding: Impurity Types (example)
sourceMaterial | S Σ | 0..1 | BackboneElement | Material or taxonomic/anatomical source
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
Documentation for this format

#### Terminology Bindings

Path | Conformance | ValueSet | URI
SubstanceDefinition.grade | example | SubstanceGrade `http://hl7.org/fhir/ValueSet/substance-grade` from the FHIR Standard
SubstanceDefinition.property.type | example | VsSubstancePropertyPQ (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] | example | VsSubstancePropertyValuePQ (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.type | example | VsImpurityTypePQ (a valid code from Impurity Type Codes) `http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-impurity-type-pq` from this IG

#### Constraints

Id | Grade | Path(s) | Details | Requirements
dom-2 | error | SubstanceDefinition | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() |
dom-3 | error | SubstanceDefinition | If 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-4 | error | SubstanceDefinition | If 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-5 | error | SubstanceDefinition | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() |
dom-6 | best practice | SubstanceDefinition | A resource should have narrative for robust management : text.`div`.exists() |
ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) |
ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() |

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: AllLanguages (required): IETF language tag for a human language
Additional Bindings | Purpose
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 | S 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 | S Σ | 0..* | Reference(Citation) | Supporting literature
note | Σ | 0..* | Annotation | Textual comment about the substance's catalogue or registry record
manufacturer | S Σ | 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 | Σ C | 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 | Σ C | 0..1 | Identifier | Logical reference, when literal reference is not known
display | Σ C | 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 | S Σ | 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 | S Σ | 1..1 | CodeableConcept | A code expressing the type of property Binding: Substance Property (example)
value[x] | S Σ | 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 | S 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 | 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 Bindings | Purpose
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 | S Σ | 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 | S Σ | 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 | S 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: CountryValueSet (required): Jurisdiction codes
Documentation for this format

#### Terminology Bindings

Path | Conformance | ValueSet | URI
SubstanceDefinition.language | required | AllLanguages `http://hl7.org/fhir/ValueSet/all-languages|5.0.0` from the FHIR Standard
SubstanceDefinition.status | preferred | PublicationStatus `http://hl7.org/fhir/ValueSet/publication-status` from the FHIR Standard
SubstanceDefinition.domain | example | MedicinalProductDomain `http://hl7.org/fhir/ValueSet/medicinal-product-domain` from the FHIR Standard
SubstanceDefinition.grade | example | SubstanceGrade `http://hl7.org/fhir/ValueSet/substance-grade` from the FHIR Standard
SubstanceDefinition.manufacturer.type | extensible | ResourceType `http://hl7.org/fhir/ValueSet/resource-types` from the FHIR Standard
SubstanceDefinition.moiety.stereochemistry | example | Stereochemistry `http://hl7.org/fhir/ValueSet/substance-stereochemistry` from the FHIR Standard
SubstanceDefinition.moiety.opticalActivity | example | OpticalActivity `http://hl7.org/fhir/ValueSet/substance-optical-activity` from the FHIR Standard
SubstanceDefinition.moiety.measurementType | example | SubstanceAmountType `http://hl7.org/fhir/ValueSet/substance-amount-type` from the FHIR Standard
SubstanceDefinition.characterization.technique | example | StructureTechnique `http://hl7.org/fhir/ValueSet/substance-structure-technique` from the FHIR Standard
SubstanceDefinition.characterization.form | example | SubstanceForm `http://hl7.org/fhir/ValueSet/substance-form` from the FHIR Standard
SubstanceDefinition.property.type | example | VsSubstancePropertyPQ (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] | example | VsSubstancePropertyValuePQ (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.method | example | WeightMethod `http://hl7.org/fhir/ValueSet/substance-weight-method` from the FHIR Standard
SubstanceDefinition.molecularWeight.type | example | WeightType `http://hl7.org/fhir/ValueSet/substance-weight-type` from the FHIR Standard
SubstanceDefinition.structure.stereochemistry | example | Stereochemistry `http://hl7.org/fhir/ValueSet/substance-stereochemistry` from the FHIR Standard
SubstanceDefinition.structure.opticalActivity | example | OpticalActivity `http://hl7.org/fhir/ValueSet/substance-optical-activity` from the FHIR Standard
SubstanceDefinition.structure.technique | example | StructureTechnique `http://hl7.org/fhir/ValueSet/substance-structure-technique` from the FHIR Standard
SubstanceDefinition.structure.representation.type | example | SubstanceRepresentationType `http://hl7.org/fhir/ValueSet/substance-representation-type` from the FHIR Standard
SubstanceDefinition.structure.representation.format | example | SubstanceRepresentationFormat `http://hl7.org/fhir/ValueSet/substance-representation-format` from the FHIR Standard
SubstanceDefinition.code.status | preferred | PublicationStatus `http://hl7.org/fhir/ValueSet/publication-status` from the FHIR Standard
SubstanceDefinition.name.type | example | SubstanceNameType `http://hl7.org/fhir/ValueSet/substance-name-type` from the FHIR Standard
SubstanceDefinition.name.status | preferred | PublicationStatus `http://hl7.org/fhir/ValueSet/publication-status` from the FHIR Standard
SubstanceDefinition.name.language | required | AllLanguages `http://hl7.org/fhir/ValueSet/all-languages|5.0.0` from the FHIR Standard
SubstanceDefinition.name.domain | example | SubstanceNameDomain `http://hl7.org/fhir/ValueSet/substance-name-domain` from the FHIR Standard
SubstanceDefinition.name.jurisdiction | example | JurisdictionValueSet `http://hl7.org/fhir/ValueSet/jurisdiction` from the FHIR Standard
SubstanceDefinition.name.official.authority | preferred | SubstanceNameAuthority `http://hl7.org/fhir/ValueSet/substance-name-authority` from the FHIR Standard
SubstanceDefinition.name.official.status | preferred | PublicationStatus `http://hl7.org/fhir/ValueSet/publication-status` from the FHIR Standard
SubstanceDefinition.relationship.type | example | VsImpurityTypePQ (a valid code from Impurity Type Codes) `http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-impurity-type-pq` from this IG
SubstanceDefinition.relationship.comparator | example | SubstanceAmountType `http://hl7.org/fhir/ValueSet/substance-amount-type` from the FHIR Standard
SubstanceDefinition.sourceMaterial.type | example | SourceMaterialType `http://hl7.org/fhir/ValueSet/substance-source-material-type` from the FHIR Standard
SubstanceDefinition.sourceMaterial.genus | example | SourceMaterialGenus `http://hl7.org/fhir/ValueSet/substance-source-material-genus` from the FHIR Standard
SubstanceDefinition.sourceMaterial.species | example | SourceMaterialSpecies `http://hl7.org/fhir/ValueSet/substance-source-material-species` from the FHIR Standard
SubstanceDefinition.sourceMaterial.part | example | SourceMaterialPart `http://hl7.org/fhir/ValueSet/substance-source-material-part` from the FHIR Standard
SubstanceDefinition.sourceMaterial.countryOfOrigin | required | CountryValueSet `http://hl7.org/fhir/ValueSet/country|5.0.0` from the FHIR Standard

#### Constraints

Id | Grade | Path(s) | Details | Requirements
dom-2 | error | SubstanceDefinition | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() |
dom-3 | error | SubstanceDefinition | If 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-4 | error | SubstanceDefinition | If 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-5 | error | SubstanceDefinition | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() |
dom-6 | best practice | SubstanceDefinition | A resource should have narrative for robust management : text.`div`.exists() |
ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) |
ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() |

This structure is derived from SubstanceDefinition

Summary

Must-Support: 14 elements

Structures

This structure refers to these other structures:

- Organization - Drug PQ (http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Organization-drug-pq)

Extensions

This structure refers to these extensions:

- http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-site-utilization-pq
- http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-substance-property-range-pq
- http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-substance-property-parameter-pq
- http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-impurity-origin-pq

Other representations of profile: CSV, Excel, Schematron