This page is part of the FHIR Specification (v4.3.0: R4B - STU). The current version which supercedes this version is 5.0.0. For a full list of available versions, see the Directory of published versions . Page versions: R5 R4B
Biomedical Research and Regulation Work Group | Maturity Level: 1 | Trial Use | Security Category: Anonymous | Compartments: Not linked to any defined compartments |
Detailed Descriptions for the elements in the SubstanceDefinition resource.
SubstanceDefinition | |
Element Id | SubstanceDefinition |
Definition | The detailed description of a substance, typically at a level beyond what is used for prescribing. |
Cardinality | 0..* |
Type | DomainResource |
Summary | false |
SubstanceDefinition.identifier | |
Element Id | SubstanceDefinition.identifier |
Definition | Identifier by which this substance is known. |
Note | This is a business identifier, not a resource identifier (see discussion) |
Cardinality | 0..* |
Type | Identifier |
Summary | true |
SubstanceDefinition.version | |
Element Id | SubstanceDefinition.version |
Definition | A business level version identifier of the substance. |
Note | This is a business versionId, not a resource version id (see discussion) |
Cardinality | 0..1 |
Type | string |
Summary | true |
SubstanceDefinition.status | |
Element Id | SubstanceDefinition.status |
Definition | Status of substance within the catalogue e.g. active, retired. |
Cardinality | 0..1 |
Terminology Binding | PublicationStatus (Preferred) |
Type | CodeableConcept |
Summary | true |
SubstanceDefinition.classification | |
Element Id | SubstanceDefinition.classification |
Definition | A high level categorization, e.g. polymer or nucleic acid, or food, chemical, biological, or a lower level such as the general types of polymer (linear or branch chain) or type of impurity (process related or contaminant). |
Cardinality | 0..* |
Type | CodeableConcept |
Summary | true |
SubstanceDefinition.domain | |
Element Id | SubstanceDefinition.domain |
Definition | If the substance applies to human or veterinary use. |
Cardinality | 0..1 |
Terminology Binding | MedicinalProductDomain (Example) |
Type | CodeableConcept |
Summary | true |
SubstanceDefinition.grade | |
Element Id | SubstanceDefinition.grade |
Definition | The quality standard, established benchmark, to which substance complies (e.g. USP/NF, Ph. Eur, JP, BP, Company Standard). |
Cardinality | 0..* |
Terminology Binding | SubstanceGrade (Example) |
Type | CodeableConcept |
Summary | true |
SubstanceDefinition.description | |
Element Id | SubstanceDefinition.description |
Definition | Textual description of the substance. |
Cardinality | 0..1 |
Type | markdown |
Summary | true |
SubstanceDefinition.informationSource | |
Element Id | SubstanceDefinition.informationSource |
Definition | Supporting literature. |
Cardinality | 0..* |
Type | Reference(Citation) |
Summary | true |
SubstanceDefinition.note | |
Element Id | SubstanceDefinition.note |
Definition | Textual comment about the substance's catalogue or registry record. |
Cardinality | 0..* |
Type | Annotation |
Summary | true |
SubstanceDefinition.manufacturer | |
Element Id | SubstanceDefinition.manufacturer |
Definition | The entity that creates, makes, produces or fabricates the substance. This is a set of potential manufacturers but is not necessarily comprehensive. |
Cardinality | 0..* |
Type | Reference(Organization) |
Summary | true |
SubstanceDefinition.supplier | |
Element Id | SubstanceDefinition.supplier |
Definition | An entity that is the source for the substance. It may be different from the manufacturer. Supplier is synonymous to a distributor. |
Cardinality | 0..* |
Type | Reference(Organization) |
Summary | true |
SubstanceDefinition.moiety | |
Element Id | SubstanceDefinition.moiety |
Definition | Moiety, for structural modifications. |
Cardinality | 0..* |
Summary | true |
SubstanceDefinition.moiety.role | |
Element Id | SubstanceDefinition.moiety.role |
Definition | Role that the moiety is playing. |
Cardinality | 0..1 |
Type | CodeableConcept |
Summary | true |
SubstanceDefinition.moiety.identifier | |
Element Id | SubstanceDefinition.moiety.identifier |
Definition | Identifier by which this moiety substance is known. |
Note | This is a business identifier, not a resource identifier (see discussion) |
Cardinality | 0..1 |
Type | Identifier |
Summary | true |
SubstanceDefinition.moiety.name | |
Element Id | SubstanceDefinition.moiety.name |
Definition | Textual name for this moiety substance. |
Cardinality | 0..1 |
Type | string |
Summary | true |
SubstanceDefinition.moiety.stereochemistry | |
Element Id | SubstanceDefinition.moiety.stereochemistry |
Definition | Stereochemistry type. |
Cardinality | 0..1 |
Terminology Binding | Stereochemistry (Example) |
Type | CodeableConcept |
Summary | true |
SubstanceDefinition.moiety.opticalActivity | |
Element Id | SubstanceDefinition.moiety.opticalActivity |
Definition | Optical activity type. |
Cardinality | 0..1 |
Terminology Binding | OpticalActivity (Example) |
Type | CodeableConcept |
Summary | true |
SubstanceDefinition.moiety.molecularFormula | |
Element Id | SubstanceDefinition.moiety.molecularFormula |
Definition | Molecular formula for this moiety of this substance, typically using the Hill system. |
Cardinality | 0..1 |
Type | string |
Summary | true |
SubstanceDefinition.moiety.amount[x] | |
Element Id | SubstanceDefinition.moiety.amount[x] |
Definition | Quantitative value for this moiety. |
Cardinality | 0..1 |
Type | Quantity|string |
[x] Note | See Choice of Data Types for further information about how to use [x] |
Summary | true |
SubstanceDefinition.moiety.measurementType | |
Element Id | SubstanceDefinition.moiety.measurementType |
Definition | The measurement type of the quantitative value. In capturing the actual relative amounts of substances or molecular fragments it may be necessary to indicate whether the amount refers to, for example, a mole ratio or weight ratio. |
Cardinality | 0..1 |
Terminology Binding | SubstanceAmountType (Example) |
Type | CodeableConcept |
Summary | true |
SubstanceDefinition.property | |
Element Id | SubstanceDefinition.property |
Definition | General specifications for this substance. |
Cardinality | 0..* |
Summary | true |
SubstanceDefinition.property.type | |
Element Id | SubstanceDefinition.property.type |
Definition | A code expressing the type of property. |
Cardinality | 1..1 |
Terminology Binding | SNOMEDCTCharacteristicCodes : |
Type | CodeableConcept |
Summary | true |
SubstanceDefinition.property.value[x] | |
Element Id | SubstanceDefinition.property.value[x] |
Definition | A value for the property. |
Cardinality | 0..1 |
Type | CodeableConcept|Quantity|date|boolean|Attachment |
[x] Note | See Choice of Data Types for further information about how to use [x] |
Summary | true |
SubstanceDefinition.molecularWeight | |
Element Id | SubstanceDefinition.molecularWeight |
Definition | The molecular weight or weight range (for proteins, polymers or nucleic acids). |
Cardinality | 0..* |
Summary | true |
SubstanceDefinition.molecularWeight.method | |
Element Id | SubstanceDefinition.molecularWeight.method |
Definition | The method by which the molecular weight was determined. |
Cardinality | 0..1 |
Terminology Binding | WeightMethod (Example) |
Type | CodeableConcept |
Summary | true |
SubstanceDefinition.molecularWeight.type | |
Element Id | SubstanceDefinition.molecularWeight.type |
Definition | Type of molecular weight such as exact, average (also known as. number average), weight average. |
Cardinality | 0..1 |
Terminology Binding | WeightType (Example) |
Type | CodeableConcept |
Summary | true |
SubstanceDefinition.molecularWeight.amount | |
Element Id | SubstanceDefinition.molecularWeight.amount |
Definition | Used to capture quantitative values for a variety of elements. If only limits are given, the arithmetic mean would be the average. If only a single definite value for a given element is given, it would be captured in this field. |
Cardinality | 1..1 |
Type | Quantity |
Summary | true |
SubstanceDefinition.structure | |
Element Id | SubstanceDefinition.structure |
Definition | Structural information. |
Cardinality | 0..1 |
Summary | true |
SubstanceDefinition.structure.stereochemistry | |
Element Id | SubstanceDefinition.structure.stereochemistry |
Definition | Stereochemistry type. |
Cardinality | 0..1 |
Terminology Binding | Stereochemistry (Example) |
Type | CodeableConcept |
Summary | true |
SubstanceDefinition.structure.opticalActivity | |
Element Id | SubstanceDefinition.structure.opticalActivity |
Definition | Optical activity type. |
Cardinality | 0..1 |
Terminology Binding | OpticalActivity (Example) |
Type | CodeableConcept |
Summary | true |
SubstanceDefinition.structure.molecularFormula | |
Element Id | SubstanceDefinition.structure.molecularFormula |
Definition | Molecular formula of this substance, typically using the Hill system. |
Cardinality | 0..1 |
Type | string |
Summary | true |
SubstanceDefinition.structure.molecularFormulaByMoiety | |
Element Id | SubstanceDefinition.structure.molecularFormulaByMoiety |
Definition | Specified per moiety according to the Hill system, i.e. first C, then H, then alphabetical, each moiety separated by a dot. |
Cardinality | 0..1 |
Type | string |
Summary | true |
SubstanceDefinition.structure.molecularWeight | |
Element Id | SubstanceDefinition.structure.molecularWeight |
Definition | The molecular weight or weight range (for proteins, polymers or nucleic acids). |
Cardinality | 0..1 |
Type | See SubstanceDefinition.molecularWeight |
Summary | true |
SubstanceDefinition.structure.technique | |
Element Id | SubstanceDefinition.structure.technique |
Definition | The method used to elucidate the structure or characterization of the drug substance. Examples: X-ray, HPLC, NMR, Peptide mapping, Ligand binding assay. |
Cardinality | 0..* |
Terminology Binding | StructureTechnique (Example) |
Type | CodeableConcept |
Summary | true |
SubstanceDefinition.structure.sourceDocument | |
Element Id | SubstanceDefinition.structure.sourceDocument |
Definition | The source of information about the structure. |
Cardinality | 0..* |
Type | Reference(DocumentReference) |
Summary | true |
SubstanceDefinition.structure.representation | |
Element Id | SubstanceDefinition.structure.representation |
Definition | A depiction of the structure or characterization of the substance. |
Cardinality | 0..* |
Summary | true |
SubstanceDefinition.structure.representation.type | |
Element Id | SubstanceDefinition.structure.representation.type |
Definition | The kind of structural representation (e.g. full, partial). |
Cardinality | 0..1 |
Terminology Binding | SubstanceRepresentationType (Example) |
Type | CodeableConcept |
Summary | true |
SubstanceDefinition.structure.representation.representation | |
Element Id | SubstanceDefinition.structure.representation.representation |
Definition | The structural representation or characterization as a text string in a standard format. |
Cardinality | 0..1 |
Type | string |
Summary | true |
SubstanceDefinition.structure.representation.format | |
Element Id | SubstanceDefinition.structure.representation.format |
Definition | The format of the representation e.g. InChI, SMILES, MOLFILE, CDX, SDF, PDB, mmCIF. The logical content type rather than the physical file format of a document. |
Cardinality | 0..1 |
Terminology Binding | SubstanceRepresentationFormat (Example) |
Type | CodeableConcept |
Summary | true |
SubstanceDefinition.structure.representation.document | |
Element Id | SubstanceDefinition.structure.representation.document |
Definition | An attached file with the structural representation or characterization e.g. a molecular structure graphic of the substance, a JCAMP or AnIML file. |
Cardinality | 0..1 |
Type | Reference(DocumentReference) |
Summary | true |
SubstanceDefinition.code | |
Element Id | SubstanceDefinition.code |
Definition | Codes associated with the substance. |
Cardinality | 0..* |
Summary | true |
SubstanceDefinition.code.code | |
Element Id | SubstanceDefinition.code.code |
Definition | The specific code. |
Cardinality | 0..1 |
Type | CodeableConcept |
Summary | true |
SubstanceDefinition.code.status | |
Element Id | SubstanceDefinition.code.status |
Definition | Status of the code assignment, for example 'provisional', 'approved'. |
Cardinality | 0..1 |
Terminology Binding | PublicationStatus (Preferred) |
Type | CodeableConcept |
Summary | true |
SubstanceDefinition.code.statusDate | |
Element Id | SubstanceDefinition.code.statusDate |
Definition | The date at which the code status was changed as part of the terminology maintenance. |
Cardinality | 0..1 |
Type | dateTime |
Summary | true |
SubstanceDefinition.code.note | |
Element Id | SubstanceDefinition.code.note |
Definition | Any comment can be provided in this field, if necessary. |
Cardinality | 0..* |
Type | Annotation |
Summary | true |
SubstanceDefinition.code.source | |
Element Id | SubstanceDefinition.code.source |
Definition | Supporting literature. |
Cardinality | 0..* |
Type | Reference(DocumentReference) |
Summary | true |
SubstanceDefinition.name | |
Element Id | SubstanceDefinition.name |
Definition | Names applicable to this substance. |
Cardinality | 0..* |
Summary | true |
SubstanceDefinition.name.name | |
Element Id | SubstanceDefinition.name.name |
Definition | The actual name. |
Cardinality | 1..1 |
Type | string |
Summary | true |
SubstanceDefinition.name.type | |
Element Id | SubstanceDefinition.name.type |
Definition | Name type, for example 'systematic', 'scientific, 'brand'. |
Cardinality | 0..1 |
Terminology Binding | SubstanceNameType (Example) |
Type | CodeableConcept |
Summary | true |
SubstanceDefinition.name.status | |
Element Id | SubstanceDefinition.name.status |
Definition | The status of the name, for example 'current', 'proposed'. |
Cardinality | 0..1 |
Terminology Binding | PublicationStatus (Preferred) |
Type | CodeableConcept |
Summary | true |
SubstanceDefinition.name.preferred | |
Element Id | SubstanceDefinition.name.preferred |
Definition | If this is the preferred name for this substance. |
Cardinality | 0..1 |
Type | boolean |
Meaning if Missing | If this value is not present, there is no statement being made about whether this is the preferred name or not. No inference can be made |
Summary | true |
SubstanceDefinition.name.language | |
Element Id | SubstanceDefinition.name.language |
Definition | Human language that the name is written in. |
Cardinality | 0..* |
Terminology Binding | Common Languages (Preferred but limited to All Languages) |
Type | CodeableConcept |
Summary | true |
SubstanceDefinition.name.domain | |
Element Id | SubstanceDefinition.name.domain |
Definition | The use context of this name for example if there is a different name a drug active ingredient as opposed to a food colour additive. |
Cardinality | 0..* |
Terminology Binding | SubstanceNameDomain (Example) |
Type | CodeableConcept |
Summary | true |
SubstanceDefinition.name.jurisdiction | |
Element Id | SubstanceDefinition.name.jurisdiction |
Definition | The jurisdiction where this name applies. |
Cardinality | 0..* |
Terminology Binding | Jurisdiction (Example) |
Type | CodeableConcept |
Summary | true |
SubstanceDefinition.name.synonym | |
Element Id | SubstanceDefinition.name.synonym |
Definition | A synonym of this particular name, by which the substance is also known. |
Cardinality | 0..* |
Type | See SubstanceDefinition.name |
Summary | true |
SubstanceDefinition.name.translation | |
Element Id | SubstanceDefinition.name.translation |
Definition | A translation for this name into another human language. |
Cardinality | 0..* |
Type | See SubstanceDefinition.name |
Summary | true |
SubstanceDefinition.name.official | |
Element Id | SubstanceDefinition.name.official |
Definition | Details of the official nature of this name. |
Cardinality | 0..* |
Summary | true |
SubstanceDefinition.name.official.authority | |
Element Id | SubstanceDefinition.name.official.authority |
Definition | Which authority uses this official name. |
Cardinality | 0..1 |
Terminology Binding | SubstanceNameAuthority (Preferred) |
Type | CodeableConcept |
Summary | true |
SubstanceDefinition.name.official.status | |
Element Id | SubstanceDefinition.name.official.status |
Definition | The status of the official name, for example 'draft', 'active', 'retired'. |
Cardinality | 0..1 |
Terminology Binding | PublicationStatus (Preferred) |
Type | CodeableConcept |
Summary | true |
SubstanceDefinition.name.official.date | |
Element Id | SubstanceDefinition.name.official.date |
Definition | Date of the official name change. |
Cardinality | 0..1 |
Type | dateTime |
Summary | true |
SubstanceDefinition.name.source | |
Element Id | SubstanceDefinition.name.source |
Definition | Supporting literature. |
Cardinality | 0..* |
Type | Reference(DocumentReference) |
Summary | true |
SubstanceDefinition.relationship | |
Element Id | SubstanceDefinition.relationship |
Definition | A link between this substance and another, with details of the relationship. |
Cardinality | 0..* |
Summary | true |
SubstanceDefinition.relationship.substanceDefinition[x] | |
Element Id | SubstanceDefinition.relationship.substanceDefinition[x] |
Definition | A pointer to another substance, as a resource or just a representational code. |
Cardinality | 0..1 |
Type | Reference(SubstanceDefinition)|CodeableConcept |
[x] Note | See Choice of Data Types for further information about how to use [x] |
Summary | true |
SubstanceDefinition.relationship.type | |
Element Id | SubstanceDefinition.relationship.type |
Definition | For example "salt to parent", "active moiety", "starting material", "polymorph", "impurity of". |
Cardinality | 1..1 |
Terminology Binding | SubstanceRelationshipType (Example) |
Type | CodeableConcept |
Summary | true |
SubstanceDefinition.relationship.isDefining | |
Element Id | SubstanceDefinition.relationship.isDefining |
Definition | For example where an enzyme strongly bonds with a particular substance, this is a defining relationship for that enzyme, out of several possible substance relationships. |
Cardinality | 0..1 |
Type | boolean |
Meaning if Missing | If this value is not present, there is no statement being made about whether this is a defining relationship or not. No inference can be made |
Summary | true |
SubstanceDefinition.relationship.amount[x] | |
Element Id | SubstanceDefinition.relationship.amount[x] |
Definition | A numeric factor for the relationship, for instance to express that the salt of a substance has some percentage of the active substance in relation to some other. |
Cardinality | 0..1 |
Type | Quantity|Ratio|string |
[x] Note | See Choice of Data Types for further information about how to use [x] |
Summary | true |
SubstanceDefinition.relationship.ratioHighLimitAmount | |
Element Id | SubstanceDefinition.relationship.ratioHighLimitAmount |
Definition | For use when the numeric has an uncertain range. |
Cardinality | 0..1 |
Type | Ratio |
Summary | true |
SubstanceDefinition.relationship.comparator | |
Element Id | SubstanceDefinition.relationship.comparator |
Definition | An operator for the amount, for example "average", "approximately", "less than". |
Cardinality | 0..1 |
Terminology Binding | SubstanceAmountType (Example) |
Type | CodeableConcept |
Summary | true |
SubstanceDefinition.relationship.source | |
Element Id | SubstanceDefinition.relationship.source |
Definition | Supporting literature. |
Cardinality | 0..* |
Type | Reference(DocumentReference) |
Summary | true |
SubstanceDefinition.sourceMaterial | |
Element Id | SubstanceDefinition.sourceMaterial |
Definition | Material or taxonomic/anatomical source for the substance. |
Cardinality | 0..1 |
Summary | true |
SubstanceDefinition.sourceMaterial.type | |
Element Id | SubstanceDefinition.sourceMaterial.type |
Definition | A classification that provides the origin of the raw material. Example: cat hair would be an Animal source type. |
Cardinality | 0..1 |
Terminology Binding | SourceMaterialType (Example) |
Type | CodeableConcept |
Summary | true |
SubstanceDefinition.sourceMaterial.genus | |
Element Id | SubstanceDefinition.sourceMaterial.genus |
Definition | The genus of an organism, typically referring to the Latin epithet of the genus element of the plant/animal scientific name. |
Cardinality | 0..1 |
Terminology Binding | SourceMaterialGenus (Example) |
Type | CodeableConcept |
Summary | true |
SubstanceDefinition.sourceMaterial.species | |
Element Id | SubstanceDefinition.sourceMaterial.species |
Definition | The species of an organism, typically referring to the Latin epithet of the species of the plant/animal. |
Cardinality | 0..1 |
Terminology Binding | SourceMaterialSpecies (Example) |
Type | CodeableConcept |
Summary | true |
SubstanceDefinition.sourceMaterial.part | |
Element Id | SubstanceDefinition.sourceMaterial.part |
Definition | An anatomical origin of the source material within an organism. |
Cardinality | 0..1 |
Terminology Binding | SourceMaterialPart (Example) |
Type | CodeableConcept |
Summary | true |
SubstanceDefinition.sourceMaterial.countryOfOrigin | |
Element Id | SubstanceDefinition.sourceMaterial.countryOfOrigin |
Definition | The country or countries where the material is harvested. |
Cardinality | 0..* |
Terminology Binding | Country (Required) |
Type | CodeableConcept |
Summary | true |