type: resource-definitionsresource: SubstanceDefinition

SubstanceDefinition Definitions

SubstanceDefinition

The detailed description of a substance, typically at a level beyond what is used for prescribing

Definition: The detailed description of a substance, typically at a level beyond what is used for prescribing.

Cardinality: 0..*

Mappings: idmp-substance=Substance (and derived classes: Chemical, Polymer, Protein, Nucleic_Acid, Structurally_Diverse); w5=administrative.medication

SubstanceDefinition.identifier

Identifier by which this substance is known

Definition: Identifier by which this substance is known.

Cardinality: 0..*

Type: Identifier

Summary: true

Mappings: idmp-substance=Substance.Substance_Id

SubstanceDefinition.version

A business level edition or revision identifier

Definition: A business level edition or revision identifier.

Cardinality: 0..1

Type: string

Summary: true

Mappings: idmp-substance=Version.Version_Number

SubstanceDefinition.status

Status of substance within the catalogue e.g. active, retired

Definition: Status of substance within the catalogue e.g. active, retired.

Cardinality: 0..1

Type: CodeableConcept

Binding: preferred:publication-status

Summary: true

Is Modifier: true (Reason: This element is labelled as a modifier because it is a status element that can indicate that a record should not be treated as valid)

Mappings: idmp-substance=n/a

SubstanceDefinition.classification

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

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

Mappings: idmp-substance=Substance_Classification.Substance_Classification and Substance_classification.Substance_Classification_Subtype

SubstanceDefinition.domain

The applicable usage of the substance, as an example human or veterinary

Definition: The applicable usage of the substance, as an example human or veterinary.

Cardinality: 0..1

Type: CodeableConcept

Binding: example:medicinal-product-domain

Summary: true

Mappings: idmp-substance=Substance_Classification.Substance_Classification (and Code and Type) and Substance_Classification.Substance_Classification_Subtype

SubstanceDefinition.grade

The quality standard, established benchmark, to which substance complies (e.g. USP/NF, BP)

Definition: The quality standard, established benchmark, to which substance complies (e.g. USP/NF, Ph. Eur, JP, BP, Company Standard).

Cardinality: 0..*

Type: CodeableConcept

Binding: example:substance-grade

Summary: true

Mappings: idmp-substance=Substance_Specified_Substance_Group_3.Grade

SubstanceDefinition.description

Textual description of the substance

Definition: Textual description of the substance.

Cardinality: 0..1

Type: markdown

Summary: true

Mappings: idmp-substance=Substance.Comment

SubstanceDefinition.note

Textual comment about the substance's catalogue or registry record

Definition: Textual comment about the substance's catalogue or registry record.

Cardinality: 0..*

Type: Annotation

Summary: true

Mappings: idmp-substance=n/a

SubstanceDefinition.manufacturer

The entity that creates, makes, produces or fabricates the substance

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

Mappings: idmp-substance=n/a

SubstanceDefinition.supplier

An entity that is the source for the substance. It may be different from the manufacturer

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

Mappings: idmp-substance=n/a

SubstanceDefinition.moiety

Moiety, for structural modifications

Definition: Moiety, for structural modifications.

Cardinality: 0..*

Type: BackboneElement

Summary: true

Mappings: idmp-substance=Substance.Moiety

SubstanceDefinition.moiety.role

Role that the moiety is playing

Definition: Role that the moiety is playing.

Cardinality: 0..1

Type: CodeableConcept

Summary: true

Mappings: idmp-substance=Moiety.Moiety_Role

SubstanceDefinition.moiety.identifier

Identifier by which this moiety substance is known

Definition: Identifier by which this moiety substance is known.

Cardinality: 0..1

Type: Identifier

Summary: true

Mappings: idmp-substance=Moiety.Moiety_Id

SubstanceDefinition.moiety.name

Textual name for this moiety substance

Definition: Textual name for this moiety substance.

Cardinality: 0..1

Type: string

Summary: true

Mappings: idmp-substance=Moiety.Moiety_Name

SubstanceDefinition.moiety.stereochemistry

Stereochemistry type

Definition: Stereochemistry type.

Cardinality: 0..1

Type: CodeableConcept

Binding: example:substance-stereochemistry

Summary: true

Mappings: idmp-substance=Moiety.Stereochemistry

SubstanceDefinition.moiety.opticalActivity

Optical activity type

Definition: Optical activity type.

Cardinality: 0..1

Type: CodeableConcept

Binding: example:substance-optical-activity

Summary: true

Mappings: idmp-substance=Moiety.Optical_Activity

SubstanceDefinition.moiety.molecularFormula

Molecular formula for this moiety (e.g. with the Hill system)

Definition: Molecular formula for this moiety of this substance, typically using the Hill system.

Cardinality: 0..1

Type: string

Summary: true

Mappings: idmp-substance=Moiety.Molecular_Formula

SubstanceDefinition.moiety.amount[x]

Quantitative value for this moiety

Definition: Quantitative value for this moiety.

Cardinality: 0..1

Type: Quantity, string

Summary: true

Mappings: idmp-substance=Moiety.Amount

SubstanceDefinition.moiety.measurementType

The measurement type of the quantitative value

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

Type: CodeableConcept

Binding: example:substance-amount-type

Summary: true

Mappings: idmp-substance=Amount.Amount_Type

SubstanceDefinition.characterization

General specifications for this substance

Definition: General specifications for this substance.

Cardinality: 0..*

Type: BackboneElement

Summary: true

Mappings: idmp-substance=n/a

SubstanceDefinition.characterization.technique

The method used to find the characterization e.g. HPLC

Definition: The method used to elucidate the characterization of the drug substance. Example: HPLC.

Cardinality: 0..1

Type: CodeableConcept

Binding: example:substance-structure-technique

Summary: true

Mappings: idmp-substance=n/a

SubstanceDefinition.characterization.form

Describes the nature of the chemical entity and explains, for instance, whether this is a base or a salt form

Definition: Describes the nature of the chemical entity and explains, for instance, whether this is a base or a salt form.

Cardinality: 0..1

Type: CodeableConcept

Binding: example:substance-form

Summary: true

Mappings: idmp-substance=n/a

SubstanceDefinition.characterization.description

The description or justification in support of the interpretation of the data file

Definition: The description or justification in support of the interpretation of the data file.

Cardinality: 0..1

Type: markdown

Summary: true

Mappings: idmp-substance=n/a

SubstanceDefinition.characterization.file

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

Definition: 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.

Cardinality: 0..*

Type: Attachment

Summary: true

Mappings: idmp-substance=n/a

SubstanceDefinition.property

General specifications for this substance

Definition: General specifications for this substance.

Cardinality: 0..*

Type: BackboneElement

Summary: true

Mappings: idmp-substance=Substance.Property

SubstanceDefinition.property.type

A code expressing the type of property

Definition: A code expressing the type of property.

Cardinality: 1..1

Type: CodeableConcept

Binding: example:product-characteristic-codes

Summary: true

Mappings: idmp-substance=Property.Property_Type

SubstanceDefinition.property.value[x]

A value for the property

Definition: A value for the property.

Cardinality: 0..1

Type: CodeableConcept, Quantity, Range, date, boolean, Attachment

Summary: true

Mappings: idmp-substance=Physical Characteristics, attribute's value

SubstanceDefinition.molecularWeight

The average mass of a molecule of a compound

Definition: The average mass of a molecule of a compound compared to 1/12 the mass of carbon 12 and calculated as the sum of the atomic weights of the constituent atoms.

Cardinality: 0..*

Type: BackboneElement

Summary: true

SubstanceDefinition.molecularWeight.method

The method by which the weight was determined

Definition: The method by which the molecular weight was determined.

Cardinality: 0..1

Type: CodeableConcept

Binding: example:substance-weight-method

Summary: true

Mappings: idmp-substance=Molecular_Weight.Molecular_Weight_Method

SubstanceDefinition.molecularWeight.type

Type of molecular weight e.g. exact, average, weight average

Definition: Type of molecular weight such as exact, average (also known as. number average), weight average.

Cardinality: 0..1

Type: CodeableConcept

Binding: example:substance-weight-type

Summary: true

Mappings: idmp-substance=Molecular_Weight.Molecular_Weight_Type

SubstanceDefinition.molecularWeight.amount

Used to capture quantitative values for a variety of elements

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

Mappings: idmp-substance=Molecular_Weight.Amount

SubstanceDefinition.structure

Structural information

Definition: Structural information.

Cardinality: 0..1

Type: BackboneElement

Summary: true

Mappings: idmp-substance=Substance.Structure

SubstanceDefinition.structure.stereochemistry

Stereochemistry type

Definition: Stereochemistry type.

Cardinality: 0..1

Type: CodeableConcept

Binding: example:substance-stereochemistry

Summary: true

Mappings: idmp-substance=Structure.Stereochemistry

SubstanceDefinition.structure.opticalActivity

Optical activity type

Definition: Optical activity type.

Cardinality: 0..1

Type: CodeableConcept

Binding: example:substance-optical-activity

Summary: true

Mappings: idmp-substance=Structure.Optical_Activity

SubstanceDefinition.structure.molecularFormula

An expression which states the number and type of atoms present in a molecule of a substance

Definition: An expression which states the number and type of atoms present in a molecule of a substance.

Cardinality: 0..1

Type: string

Summary: true

Mappings: idmp-substance=Structure.Molecular_Formula

SubstanceDefinition.structure.molecularFormulaByMoiety

Specified per moiety according to the Hill system

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

Mappings: idmp-substance=Structure.Molecular_Formula_By_Moiety

SubstanceDefinition.structure.molecularWeight

The molecular weight or weight range

Definition: The molecular weight or weight range (for proteins, polymers or nucleic acids).

Cardinality: 0..1

Summary: true

Mappings: idmp-substance=Structure.Molecular_Weight

SubstanceDefinition.structure.technique

The method used to find the structure e.g. X-ray, NMR

Definition: The method used to elucidate the structure of the drug substance. Examples: X-ray, NMR, Peptide mapping, Ligand binding assay.

Cardinality: 0..*

Type: CodeableConcept

Binding: example:substance-structure-technique

Summary: true

Mappings: idmp-substance=n/a

SubstanceDefinition.structure.sourceDocument

Source of information for the structure

Definition: The source of information about the structure.

Cardinality: 0..*

Type: Reference(DocumentReference)

Summary: true

Mappings: idmp-substance=Structure.Reference_Source

SubstanceDefinition.structure.representation

A depiction of the structure of the substance

Definition: A depiction of the structure of the substance.

Cardinality: 0..*

Type: BackboneElement

Summary: true

Mappings: idmp-substance=Structure.Structural_Representation

SubstanceDefinition.structure.representation.type

The kind of structural representation (e.g. full, partial)

Definition: The kind of structural representation (e.g. full, partial).

Cardinality: 0..1

Type: CodeableConcept

Binding: example:substance-representation-type

Summary: true

Mappings: idmp-substance=Structural_Representation.Structural_Representation_Type

SubstanceDefinition.structure.representation.representation

The structural representation as a text string in a standard format

Definition: The structural representation as a text string in a standard format.

Cardinality: 0..1

Type: string

Summary: true

Mappings: idmp-substance=Structural_Representation.Structural_Representation

SubstanceDefinition.structure.representation.format

The format of the representation e.g. InChI, SMILES, MOLFILE (note: not the physical file 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

Binding: example:substance-representation-format

Summary: true

Mappings: idmp-substance=n/a

SubstanceDefinition.structure.representation.document

An attachment with the structural representation e.g. a structure graphic or AnIML file

Definition: An attached file with the structural representation e.g. a molecular structure graphic of the substance, a JCAMP or AnIML file.

Cardinality: 0..1

Type: Reference(DocumentReference)

Summary: true

Mappings: idmp-substance=Structural_Representation.Structural_Representation_Attachment

SubstanceDefinition.code

Codes associated with the substance

Definition: Codes associated with the substance.

Cardinality: 0..*

Type: BackboneElement

Summary: true

Mappings: idmp-substance=Substance.Substance_Code

SubstanceDefinition.code.code

The specific code

Definition: The specific code.

Cardinality: 0..1

Type: CodeableConcept

Summary: true

Mappings: idmp-substance=Substance_Code.Code, Substance_Code.Code_System, Substance_Code.Code_System_Id

SubstanceDefinition.code.status

Status of the code assignment, for example 'provisional', 'approved'

Definition: Status of the code assignment, for example 'provisional', 'approved'.

Cardinality: 0..1

Type: CodeableConcept

Binding: preferred:publication-status

Summary: true

Mappings: idmp-substance=Substance_Code.Code_System_Status

SubstanceDefinition.code.statusDate

The date at which the code status was changed

Definition: The date at which the code status was changed as part of the terminology maintenance.

Cardinality: 0..1

Type: dateTime

Summary: true

Mappings: idmp-substance=Substance_Code.Code_Change_Date

SubstanceDefinition.code.note

Any comment can be provided in this field

Definition: Any comment can be provided in this field, if necessary.

Cardinality: 0..*

Type: Annotation

Summary: true

Mappings: idmp-substance=Substance_Code.Comment

SubstanceDefinition.code.source

Supporting literature

Definition: Supporting literature.

Cardinality: 0..*

Type: Reference(DocumentReference)

Summary: true

Mappings: idmp-substance=Substance_Code.Reference_Source

SubstanceDefinition.name

Names applicable to this substance

Definition: Names applicable to this substance.

Cardinality: 0..*

Type: BackboneElement

Summary: true

Mappings: idmp-substance=Substance.Substance_Name

SubstanceDefinition.name.name

The actual name

Definition: The actual name.

Cardinality: 1..1

Type: string

Summary: true

Mappings: idmp-substance=Substance_Name.Substance_Name

SubstanceDefinition.name.type

Name type e.g. 'systematic', 'scientific, 'brand'

Definition: Name type, for example 'systematic', 'scientific, 'brand'.

Cardinality: 0..1

Type: CodeableConcept

Binding: example:substance-name-type

Summary: true

Mappings: idmp-substance=Substance_Name.Substance_Name_Type

SubstanceDefinition.name.status

The status of the name e.g. 'current', 'proposed'

Definition: The status of the name, for example 'current', 'proposed'.

Cardinality: 0..1

Type: CodeableConcept

Binding: preferred:publication-status

Summary: true

Mappings: idmp-substance=n/a

SubstanceDefinition.name.preferred

If this is the preferred name for this substance

Definition: If this is the preferred name for this substance.

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

Cardinality: 0..1

Type: boolean

Summary: true

Mappings: idmp-substance=n/a

SubstanceDefinition.name.language

Human language that the name is written in

Definition: Human language that the name is written in.

Cardinality: 0..*

Type: CodeableConcept

Binding: required:all-languages

Summary: true

Mappings: idmp-substance=Substance_Name.Language

SubstanceDefinition.name.domain

The use context of this name e.g. as an active ingredient or as a food colour additive

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

Binding: example:substance-name-domain

Summary: true

Mappings: idmp-substance=Substance_Name.Substance_Name_Domain

SubstanceDefinition.name.jurisdiction

The jurisdiction where this name applies

Definition: The jurisdiction where this name applies.

Cardinality: 0..*

Type: CodeableConcept

Binding: example:jurisdiction

Summary: true

Mappings: idmp-substance=Substance_Name.Jurisdiction

SubstanceDefinition.name.synonym

A synonym of this particular name, by which the substance is also known

Definition: A synonym of this particular name, by which the substance is also known.

Cardinality: 0..*

Summary: true

Mappings: idmp-substance=n/a

SubstanceDefinition.name.translation

A translation for this name into another human language

Definition: A translation for this name into another human language.

Cardinality: 0..*

Summary: true

Mappings: idmp-substance=n/a

SubstanceDefinition.name.official

Details of the official nature of this name

Definition: Details of the official nature of this name.

Cardinality: 0..*

Type: BackboneElement

Summary: true

Mappings: idmp-substance=Substance_Name.Official_Name

SubstanceDefinition.name.official.authority

Which authority uses this official name

Definition: Which authority uses this official name.

Cardinality: 0..1

Type: CodeableConcept

Binding: preferred:substance-name-authority

Summary: true

Mappings: idmp-substance=Official_Name.Official_Name_Type

SubstanceDefinition.name.official.status

The status of the official name, for example 'draft', 'active'

Definition: The status of the official name, for example 'draft', 'active', 'retired'.

Cardinality: 0..1

Type: CodeableConcept

Binding: preferred:publication-status

Summary: true

Mappings: idmp-substance=Official_Name.Official_Name_Status

SubstanceDefinition.name.official.date

Date of official name change

Definition: Date of the official name change.

Cardinality: 0..1

Type: dateTime

Summary: true

Mappings: idmp-substance=Official_Name.Official_Name_Status_Change_Date

SubstanceDefinition.name.source

Supporting literature

Definition: Supporting literature.

Cardinality: 0..*

Type: Reference(DocumentReference)

Summary: true

Mappings: idmp-substance=Substance_Name.Reference_Source

SubstanceDefinition.relationship

A link between this substance and another

Definition: A link between this substance and another, with details of the relationship.

Cardinality: 0..*

Type: BackboneElement

Summary: true

Mappings: idmp-substance=Substance.Reference_Information.Relationship

SubstanceDefinition.relationship.substanceDefinition[x]

A pointer to another substance, as a resource or a representational code

Definition: A pointer to another substance, as a resource or just a representational code.

Cardinality: 0..1

Type: Reference(SubstanceDefinition), CodeableConcept

Summary: true

Mappings: idmp-substance=Substance_Relationship.Related_Substance_Id

SubstanceDefinition.relationship.type

For example "salt to parent", "active moiety"

Definition: For example "salt to parent", "active moiety", "starting material", "polymorph", "impurity of".

Cardinality: 1..1

Type: CodeableConcept

Binding: example:substance-relationship-type

Summary: true

Mappings: idmp-substance=Substance_Relationship.Relationship_Type

SubstanceDefinition.relationship.isDefining

For example where an enzyme strongly bonds with a particular substance, this is a defining relationship for that enzyme, out of several possible relationships

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.

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

Cardinality: 0..1

Type: boolean

Summary: true

Mappings: idmp-substance=Substance_Relationship.Is_Defining

SubstanceDefinition.relationship.amount[x]

A numeric factor for the relationship, e.g. that a substance salt has some percentage of active substance in relation to some other

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

Summary: true

Mappings: idmp-substance=Substance_Relationship.Amount.Quantity

SubstanceDefinition.relationship.ratioHighLimitAmount

For use when the numeric has an uncertain range

Definition: For use when the numeric has an uncertain range.

Cardinality: 0..1

Type: Ratio

Summary: true

Mappings: idmp-substance=Substance_Relationship.Amount.Quantity.High_Limit

SubstanceDefinition.relationship.comparator

An operator for the amount, for example "average", "approximately", "less than"

Definition: An operator for the amount, for example "average", "approximately", "less than".

Cardinality: 0..1

Type: CodeableConcept

Binding: example:substance-amount-type

Summary: true

Mappings: idmp-substance=Substance_Relationship.Amount_Type

SubstanceDefinition.relationship.source

Supporting literature

Definition: Supporting literature.

Cardinality: 0..*

Type: Reference(DocumentReference)

Summary: true

Mappings: idmp-substance=Substance_Relationship.Reference_Source

SubstanceDefinition.sourceMaterial

Material or taxonomic/anatomical source

Definition: Material or taxonomic/anatomical source for the substance.

Cardinality: 0..1

Type: BackboneElement

Summary: true

Mappings: idmp-substance=Substance.Source_Material

SubstanceDefinition.sourceMaterial.type

Classification of the origin of the raw material. e.g. cat hair is an Animal source 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

Binding: example:substance-source-material-type

Summary: true

Mappings: idmp-substance=Source_Material.Source_Material_Type

SubstanceDefinition.sourceMaterial.genus

The genus of an organism e.g. the Latin epithet of the plant/animal scientific name

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

Binding: example:substance-source-material-genus

Summary: true

Mappings: idmp-substance=Source_Material.Organism.Genus

SubstanceDefinition.sourceMaterial.species

The species of an organism e.g. the Latin epithet of the species of the plant/animal

Definition: The species of an organism, typically referring to the Latin epithet of the species of the plant/animal.

Cardinality: 0..1

Type: CodeableConcept

Binding: example:substance-source-material-species

Summary: true

Mappings: idmp-substance=Source_Material.Organism.Species

SubstanceDefinition.sourceMaterial.part

An anatomical origin of the source material within an organism

Definition: An anatomical origin of the source material within an organism.

Cardinality: 0..1

Type: CodeableConcept

Binding: example:substance-source-material-part

Summary: true

Mappings: idmp-substance=Source_Material.Part_Description.Part

SubstanceDefinition.sourceMaterial.countryOfOrigin

The country or countries where the material is harvested

Definition: The country or countries where the material is harvested.

Cardinality: 0..*

Type: CodeableConcept

Binding: required:country

Summary: true

Mappings: idmp-substance=Source_Material.Country_Of_Origin