This page is part of the FHIR Specification v4.1.0: R4B Ballot. About the R4B version of FHIR. 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
. 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..1 | 
| Type | Identifier | 
| Summary | true | 
| SubstanceDefinition.version | |
| Element Id | SubstanceDefinition.version | 
| Definition | A business level 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. approved. | 
| Cardinality | 0..1 | 
| Type | CodeableConcept | 
| Summary | true | 
| SubstanceDefinition.category | |
| Element Id | SubstanceDefinition.category | 
| Definition | High level categorization, e.g. polymer or nucleic acid, or food, chemical, biological. | 
| Cardinality | 0..1 | 
| Type | CodeableConcept | 
| Summary | true | 
| SubstanceDefinition.classification | |
| Element Id | SubstanceDefinition.classification | 
| Definition | A lower level classification than category, such as the general types of polymer (linear or branch chain) or type of impurity (process related or contaminant). | 
| Cardinality | 0..* | 
| Type | CodeableConcept | 
| Summary | true | 
| SubstanceDefinition.domain | |
| Element Id | SubstanceDefinition.domain | 
| Definition | If the substance applies to only human or veterinary use. | 
| Cardinality | 0..1 | 
| 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..* | 
| Type | CodeableConcept | 
| Summary | true | 
| SubstanceDefinition.description | |
| Element Id | SubstanceDefinition.description | 
| Definition | Textual description of the substance. | 
| Cardinality | 0..1 | 
| Type | markdown | 
| Summary | true | 
| SubstanceDefinition.source | |
| Element Id | SubstanceDefinition.source | 
| Definition | Supporting literature. | 
| Cardinality | 0..* | 
| Type | Reference(DocumentReference) | 
| 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 | A company that makes this substance. | 
| Cardinality | 0..* | 
| Type | Reference(Organization) | 
| Summary | true | 
| SubstanceDefinition.supplier | |
| Element Id | SubstanceDefinition.supplier | 
| Definition | A company that supplies this substance. | 
| 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 | 
| Type | CodeableConcept | 
| Summary | true | 
| SubstanceDefinition.moiety.opticalActivity | |
| Element Id | SubstanceDefinition.moiety.opticalActivity | 
| Definition | Optical activity type. | 
| Cardinality | 0..1 | 
| 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.amountType | |
| Element Id | SubstanceDefinition.moiety.amountType | 
| Definition | The measurement type of the quantitative value. | 
| Cardinality | 0..1 | 
| Type | CodeableConcept | 
| Summary | true | 
| SubstanceDefinition.property | |
| Element Id | SubstanceDefinition.property | 
| Definition | General specifications for this substance, including how it is related to other substances. | 
| Cardinality | 0..* | 
| Summary | true | 
| SubstanceDefinition.property.category | |
| Element Id | SubstanceDefinition.property.category | 
| Definition | A category for this property, e.g. Physical, Chemical, Enzymatic. | 
| Cardinality | 0..1 | 
| Type | CodeableConcept | 
| Summary | true | 
| SubstanceDefinition.property.code | |
| Element Id | SubstanceDefinition.property.code | 
| Definition | Property type e.g. viscosity, pH, isoelectric point. | 
| Cardinality | 0..1 | 
| Type | CodeableConcept | 
| Summary | true | 
| SubstanceDefinition.property.parameters | |
| Element Id | SubstanceDefinition.property.parameters | 
| Definition | Parameters that were used in the measurement of a property (e.g. for viscosity: measured at 20C with a pH of 7.1). | 
| Cardinality | 0..1 | 
| Type | string | 
| Summary | true | 
| SubstanceDefinition.property.definingSubstance | |
| Element Id | SubstanceDefinition.property.definingSubstance | 
| Definition | A substance upon which a defining property depends (e.g. for solubility: in water, in alcohol). | 
| Cardinality | 0..1 | 
| Type | CodeableReference(SubstanceDefinition | Substance) | 
| Summary | true | 
| SubstanceDefinition.property.amount[x] | |
| Element Id | SubstanceDefinition.property.amount[x] | 
| Definition | Quantitative value for this property. | 
| Cardinality | 0..1 | 
| Type | Quantity|string | 
| [x] Note | See Choice of Data Types for further information about how to use [x] | 
| Summary | true | 
| SubstanceDefinition.property.referenceRange | |
| Element Id | SubstanceDefinition.property.referenceRange | 
| Definition | Range of typical values. | 
| Cardinality | 0..1 | 
| Type | Range | 
| Summary | true | 
| SubstanceDefinition.property.source | |
| Element Id | SubstanceDefinition.property.source | 
| Definition | Supporting literature. | 
| Cardinality | 0..* | 
| Type | Reference(DocumentReference) | 
| 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 | 
| Type | CodeableConcept | 
| Summary | true | 
| SubstanceDefinition.structure.opticalActivity | |
| Element Id | SubstanceDefinition.structure.opticalActivity | 
| Definition | Optical activity type. | 
| Cardinality | 0..1 | 
| 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.isotope | |
| Element Id | SubstanceDefinition.structure.isotope | 
| Definition | Applicable for single substances that contain a radionuclide or a non-natural isotopic ratio. | 
| Cardinality | 0..* | 
| Summary | true | 
| SubstanceDefinition.structure.isotope.identifier | |
| Element Id | SubstanceDefinition.structure.isotope.identifier | 
| Definition | Substance identifier for each non-natural or radioisotope. | 
| Note | This is a business identifier, not a resource identifier (see discussion) | 
| Cardinality | 0..1 | 
| Type | Identifier | 
| Summary | true | 
| SubstanceDefinition.structure.isotope.name | |
| Element Id | SubstanceDefinition.structure.isotope.name | 
| Definition | Substance name for each non-natural or radioisotope. | 
| Cardinality | 0..1 | 
| Type | CodeableConcept | 
| Summary | true | 
| SubstanceDefinition.structure.isotope.substitution | |
| Element Id | SubstanceDefinition.structure.isotope.substitution | 
| Definition | The type of isotopic substitution present in a single substance. | 
| Cardinality | 0..1 | 
| Type | CodeableConcept | 
| Summary | true | 
| SubstanceDefinition.structure.isotope.halfLife | |
| Element Id | SubstanceDefinition.structure.isotope.halfLife | 
| Definition | Half life - for a non-natural nuclide. | 
| Cardinality | 0..1 | 
| Type | Quantity | 
| Summary | true | 
| SubstanceDefinition.structure.isotope.molecularWeight | |
| Element Id | SubstanceDefinition.structure.isotope.molecularWeight | 
| Definition | The molecular weight or weight range (for proteins, polymers or nucleic acids). | 
| Cardinality | 0..1 | 
| Summary | true | 
| SubstanceDefinition.structure.isotope.molecularWeight.method | |
| Element Id | SubstanceDefinition.structure.isotope.molecularWeight.method | 
| Definition | The method by which the molecular weight was determined. | 
| Cardinality | 0..1 | 
| Type | CodeableConcept | 
| Summary | true | 
| SubstanceDefinition.structure.isotope.molecularWeight.type | |
| Element Id | SubstanceDefinition.structure.isotope.molecularWeight.type | 
| Definition | Type of molecular weight such as exact, average (also known as. number average), weight average. | 
| Cardinality | 0..1 | 
| Type | CodeableConcept | 
| Summary | true | 
| SubstanceDefinition.structure.isotope.molecularWeight.amount | |
| Element Id | SubstanceDefinition.structure.isotope.molecularWeight.amount | 
| Definition | Used to capture quantitative values for a variety of elements. If only limits are given, the arithmetic mean would be the average. If only a single definite value for a given element is given, it would be captured in this field. | 
| Cardinality | 0..1 | 
| Type | Quantity | 
| 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.structure.isotope.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..* | 
| Type | CodeableConcept | 
| Summary | true | 
| SubstanceDefinition.structure.sourceDocument | |
| Element Id | SubstanceDefinition.structure.sourceDocument | 
| Definition | Supporting literature about the source of information. | 
| 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) or the technique used to derive the analytical characterization of the substance (e.g. x-ray, HPLC, NMR, peptide mapping, ligand binding assay, etc.). | 
| Cardinality | 0..1 | 
| 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 | 
| 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 | 
| Type | CodeableConcept | 
| Summary | true | 
| SubstanceDefinition.code.statusDate | |
| Element Id | SubstanceDefinition.code.statusDate | 
| Definition | The date at which the code status is 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 | 
| 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 | 
| 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 | 
| Summary | true | 
| SubstanceDefinition.name.language | |
| Element Id | SubstanceDefinition.name.language | 
| Definition | Human language that the name is written in. | 
| Cardinality | 0..* | 
| 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..* | 
| Type | CodeableConcept | 
| Summary | true | 
| SubstanceDefinition.name.jurisdiction | |
| Element Id | SubstanceDefinition.name.jurisdiction | 
| Definition | The jurisdiction where this name applies. | 
| Cardinality | 0..* | 
| 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 | 
| Type | CodeableConcept | 
| Summary | true | 
| SubstanceDefinition.name.official.status | |
| Element Id | SubstanceDefinition.name.official.status | 
| Definition | The status of the official name, for example 'provisional', 'approved'. | 
| Cardinality | 0..1 | 
| Type | CodeableConcept | 
| Summary | true | 
| SubstanceDefinition.name.official.date | |
| Element Id | SubstanceDefinition.name.official.date | 
| Definition | Date of 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.molecularWeight | |
| Element Id | SubstanceDefinition.molecularWeight | 
| Definition | The molecular weight or weight range (for proteins, polymers or nucleic acids). | 
| Cardinality | 0..* | 
| Type | See SubstanceDefinition.structure.isotope.molecularWeight | 
| 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 | 0..1 | 
| 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 | 
| 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|Range|Ratio|string | 
| [x] Note | See Choice of Data Types for further information about how to use [x] | 
| Summary | true | 
| SubstanceDefinition.relationship.amountRatioHighLimit | |
| Element Id | SubstanceDefinition.relationship.amountRatioHighLimit | 
| Definition | For use when the numeric has an uncertain range. | 
| Cardinality | 0..1 | 
| Type | Ratio | 
| Summary | true | 
| SubstanceDefinition.relationship.amountType | |
| Element Id | SubstanceDefinition.relationship.amountType | 
| Definition | An operator for the amount, for example "average", "approximately", "less than". | 
| Cardinality | 0..1 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| Type | CodeableConcept | 
| Summary | true | 
| SubstanceDefinition.sourceMaterial.countryOfOrigin | |
| Element Id | SubstanceDefinition.sourceMaterial.countryOfOrigin | 
| Definition | The country or countries where the material is harvested. | 
| Cardinality | 0..* | 
| Type | CodeableConcept | 
| Summary | true |