abstractbaseDefinitioncopyrightdate- Values Differ
descriptionexperimentalfhirVersionjurisdiction
jurisdiction[0]kindnamepublisherpurposestatustitletypeurlversion- Values Differ
| Left: | Substance General Information (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-drug-substance-nomenclature-structure) |
| Right: | Substance General Information (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-drug-substance-nomenclature-structure) |
| Error | StructureDefinition.version | Values for version differ: '1.0.0' vs '2.0.0-ballot' |
| Information | StructureDefinition.date | Values for date differ: '2024-12-11T13:47:08+00:00' vs '2024-12-12T01:58:44+00:00' |
| Name | Value | Comments | |
|---|---|---|---|
| abstract | false | ||
| baseDefinition | http://hl7.org/fhir/StructureDefinition/SubstanceDefinition | ||
| copyright | |||
| date | 2024-12-11T13:47:08+00:00 | 2024-12-12T01:58:44+00:00 |
|
| description | Substance General Information containing Drug Substance (Active Ingredient) nomenclature (3.2.S.1.1) and Substance Structure (3.2.S.1.2) profile. | ||
| experimental | |||
| fhirVersion | 5.0.0 | ||
| jurisdiction | |||
| jurisdiction[0] | urn:iso:std:iso:3166#US | ||
| kind | resource | ||
| name | DrugSubstanceNomenclatureStructure | ||
| publisher | HL7 International / Biomedical Research and Regulation | ||
| purpose | |||
| status | active | ||
| title | Substance General Information | ||
| type | SubstanceDefinition | ||
| url | http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-drug-substance-nomenclature-structure | ||
| version | 1.0.0 | 2.0.0-ballot |
|
| Name | L Flags | L Card. | L Type | L Description & Constraints | R Flags | R Card. | R Type | R Description & Constraints | Comments | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
 SubstanceDefinition | C | 0..* | SubstanceDefinition | The detailed description of a substance, typically at a level beyond what is used for prescribing cmc-when-unii-required: A UNII is required in code for any of these categories: 'Chemical', 'Mixture', 'Nucleic Acids','Polymer'. A UniProt code is required for any of these categories: 'Protein' cmc-name-isbt: Name.type ISBT 128 required for blood products. cmc-structure-required: A structure is required in code for any of these categories: 'Chemical', 'Mixture', 'Nucleic Acids','Polymer','Protein'. cmc-substance-structure-graphic-required: A Substance Structure Graphic is required Required for Small Molecules. Equivalent to classification code equals 'Chemical'. | C | 0..* | SubstanceDefinition | The detailed description of a substance, typically at a level beyond what is used for prescribing cmc-when-unii-required: A UNII is required in code for any of these categories: 'Chemical', 'Mixture', 'Nucleic Acids','Polymer'. A UniProt code is required for any of these categories: 'Protein' cmc-name-isbt: Name.type ISBT 128 required for blood products. cmc-structure-required: A structure is required in code for any of these categories: 'Chemical', 'Mixture', 'Nucleic Acids','Polymer','Protein'. cmc-substance-structure-graphic-required: A Substance Structure Graphic is required Required for Small Molecules. Equivalent to classification code equals 'Chemical'. | |||||||||
 id | Σ | 0..1 | id | Logical id of this artifact | Σ | 0..1 | id | Logical id of this artifact | |||||||||
| meta | Σ | 0..1 | Meta | Metadata about the resource | Σ | 0..1 | Meta | Metadata about the resource | |||||||||
| implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created | ?!Σ | 0..1 | uri | A set of rules under which this content was created | |||||||||
| language | 0..1 | code | Language of the resource content Binding: ?? (required): IETF language tag for a human language
| 0..1 | code | Language of the resource content Binding: ?? (required): IETF language tag for a human language
| |||||||||||
| text | 0..1 | Narrative | Text summary of the resource, for human interpretation | 0..1 | Narrative | Text summary of the resource, for human interpretation | |||||||||||
| contained | 0..* | Resource | Contained, inline Resources | 0..* | Resource | Contained, inline Resources | |||||||||||
 extension | 0..* | Extension | Additional content defined by implementations | 0..* | Extension | Additional content defined by implementations | |||||||||||
 modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored | ?!Σ | 0..* | Extension | Extensions that cannot be ignored | |||||||||
| identifier | SΣ | 0..1 | Identifier | optional user designated identifier | SΣ | 0..1 | Identifier | optional user designated identifier | |||||||||
| version | Σ | 0..1 | string | A business level version identifier of the substance | 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: ?? (preferred): The lifecycle status of an artifact. | Σ | 0..1 | CodeableConcept | Status of substance within the catalogue e.g. active, retired Binding: ?? (preferred): The lifecycle status of an artifact. | |||||||||
| classification | SΣ | 1..1 | CodeableConcept | Substance Type Binding: ?? (required) | SΣ | 1..1 | CodeableConcept | Substance Type Binding: ?? (required) | |||||||||
| domain | Σ | 0..1 | CodeableConcept | If the substance applies to human or veterinary use Binding: ?? (example): Applicable domain for this product (e.g. human, veterinary). | Σ | 0..1 | CodeableConcept | If the substance applies to human or veterinary use Binding: ?? (example): Applicable domain for this product (e.g. human, veterinary). | |||||||||
| grade | Σ | 0..* | CodeableConcept | The quality standard, established benchmark, to which substance complies (e.g. USP/NF, BP) Binding: ?? (example): The quality standard, established benchmark, to which a substance complies | Σ | 0..* | CodeableConcept | The quality standard, established benchmark, to which substance complies (e.g. USP/NF, BP) Binding: ?? (example): The quality standard, established benchmark, to which a substance complies | |||||||||
| description | Σ | 0..1 | markdown | Textual description of the substance | Σ | 0..1 | markdown | Textual description of the substance | |||||||||
| informationSource | Σ | 0..* | Reference(Citation) | Supporting literature | Σ | 0..* | Reference(Citation) | Supporting literature | |||||||||
| note | Σ | 0..* | Annotation | Textual comment about the substance's catalogue or registry record | Σ | 0..* | Annotation | Textual comment about the substance's catalogue or registry record | |||||||||
| manufacturer | SΣ | 1..1 | LiteralReference(Basic Organization) {b} | The entity that creates, makes, produces or fabricates the substance | SΣ | 1..1 | LiteralReference(Basic Organization) {b} | The entity that creates, makes, produces or fabricates the substance | |||||||||
| supplier | SΣ | 0..1 | LiteralReference(Basic Organization) {b} | An entity that is the source for the substance. It may be different from the manufacturer | SΣ | 0..1 | LiteralReference(Basic Organization) {b} | An entity that is the source for the substance. It may be different from the manufacturer | |||||||||
 moiety | Σ | 0..* | BackboneElement | Moiety, for structural modifications | Σ | 0..* | BackboneElement | Moiety, for structural modifications | |||||||||
 id | 0..1 | string | Unique id for inter-element referencing | 0..1 | string | Unique id for inter-element referencing | |||||||||||
| extension | 0..* | Extension | Additional content defined by implementations | 0..* | Extension | Additional content defined by implementations | |||||||||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | |||||||||
| role | Σ | 0..1 | CodeableConcept | Role that the moiety is playing | Σ | 0..1 | CodeableConcept | Role that the moiety is playing | |||||||||
| identifier | Σ | 0..1 | Identifier | Identifier by which this moiety substance is known | Σ | 0..1 | Identifier | Identifier by which this moiety substance is known | |||||||||
| name | Σ | 0..1 | string | Textual name for this moiety substance | Σ | 0..1 | string | Textual name for this moiety substance | |||||||||
| stereochemistry | Σ | 0..1 | CodeableConcept | Stereochemistry type Binding: ?? (example): The optical rotation type of a substance. | Σ | 0..1 | CodeableConcept | Stereochemistry type Binding: ?? (example): The optical rotation type of a substance. | |||||||||
| opticalActivity | Σ | 0..1 | CodeableConcept | Optical activity type Binding: ?? (example): The optical rotation type of a substance. | Σ | 0..1 | CodeableConcept | Optical activity type Binding: ?? (example): The optical rotation type of a substance. | |||||||||
| molecularFormula | Σ | 0..1 | string | Molecular formula for this moiety (e.g. with the Hill system) | Σ | 0..1 | string | Molecular formula for this moiety (e.g. with the Hill system) | |||||||||
| amount[x] | Σ | 0..1 | Quantity, string | Quantitative value for this moiety | Σ | 0..1 | Quantity, string | Quantitative value for this moiety | |||||||||
| measurementType | Σ | 0..1 | CodeableConcept | The measurement type of the quantitative value Binding: ?? (example): The relationship between two substance types. | Σ | 0..1 | CodeableConcept | The measurement type of the quantitative value Binding: ?? (example): The relationship between two substance types. | |||||||||
| characterization | Σ | 0..* | BackboneElement | General specifications for this substance | Σ | 0..* | BackboneElement | General specifications for this substance | |||||||||
| id | 0..1 | string | Unique id for inter-element referencing | 0..1 | string | Unique id for inter-element referencing | |||||||||||
| extension | 0..* | Extension | Additional content defined by implementations | 0..* | Extension | Additional content defined by implementations | |||||||||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ?!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: ?? (example): The method used to elucidate the characterization of the drug substance. | Σ | 0..1 | CodeableConcept | The method used to find the characterization e.g. HPLC Binding: ?? (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: ?? (example) | 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: ?? (example) | |||||||||
| description | Σ | 0..1 | markdown | The description or justification in support of the interpretation of the data file | 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 | 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 | Σ | 0..* | BackboneElement | General specifications for this substance | Σ | 0..* | BackboneElement | General specifications for this substance | |||||||||
| id | 0..1 | string | Unique id for inter-element referencing | 0..1 | string | Unique id for inter-element referencing | |||||||||||
| extension | 0..* | Extension | Additional content defined by implementations | 0..* | Extension | Additional content defined by implementations | |||||||||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | |||||||||
| type | Σ | 1..1 | CodeableConcept | A code expressing the type of property Binding: ?? (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. | Σ | 1..1 | CodeableConcept | A code expressing the type of property Binding: ?? (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. | |||||||||
| value[x] | Σ | 0..1 | CodeableConcept, Quantity, date, boolean, Attachment | A value for the property | Σ | 0..1 | CodeableConcept, Quantity, date, boolean, Attachment | A value for the property | |||||||||
| referenceInformation | Σ | 0..1 | Reference(SubstanceReferenceInformation) | General information detailing this substance | Σ | 0..1 | Reference(SubstanceReferenceInformation) | General information detailing this substance | |||||||||
| molecularWeight | SΣ | 0..1 | BackboneElement | Molecular Weight | SΣ | 0..1 | BackboneElement | Molecular Weight | |||||||||
| id | 0..1 | string | Unique id for inter-element referencing | 0..1 | string | Unique id for inter-element referencing | |||||||||||
| extension | 0..* | Extension | Additional content defined by implementations | 0..* | Extension | Additional content defined by implementations | |||||||||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ?!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: ?? (example): The method by which the substance weight was measured. | Σ | 0..1 | CodeableConcept | The method by which the weight was determined Binding: ?? (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: ?? (example): The type of substance weight measurement. | Σ | 0..1 | CodeableConcept | Type of molecular weight e.g. exact, average, weight average Binding: ?? (example): The type of substance weight measurement. | |||||||||
 amount | SΣ | 1..1 | Quantity | Used to capture quantitative values for a variety of elements Binding: ?? (extensible) | SΣ | 1..1 | Quantity | Used to capture quantitative values for a variety of elements Binding: ?? (extensible) | |||||||||
 id | 0..1 | id | Unique id for inter-element referencing | 0..1 | id | Unique id for inter-element referencing | |||||||||||
| Slices for extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||||||||
| value | Σ | 0..1 | decimal | Numerical value (with implicit precision) | Σ | 0..1 | decimal | Numerical value (with implicit precision) | |||||||||
| comparator | ?!Σ | 0..1 | code | < | <= | >= | > | ad - how to understand the value Binding: ?? (required): How the Quantity should be understood and represented. | ?!Σ | 0..1 | code | < | <= | >= | > | ad - how to understand the value Binding: ?? (required): How the Quantity should be understood and represented. | |||||||||
| unit | Σ | 0..1 | string | Molecular Weight UOM | Σ | 0..1 | string | Molecular Weight UOM | |||||||||
| system | ΣC | 0..1 | uri | System that defines coded unit form | ΣC | 0..1 | uri | System that defines coded unit form | |||||||||
| code | SΣC | 1..1 | code | Coded form of the unit | SΣC | 1..1 | code | Coded form of the unit | |||||||||
| structure | SΣC | 1..1 | BackboneElement | Structural information cmc-structure-representation-required: Either a file or string structure representation is required | SΣC | 1..1 | BackboneElement | Structural information cmc-structure-representation-required: Either a file or string structure representation is required | |||||||||
| id | 0..1 | string | Unique id for inter-element referencing | 0..1 | string | Unique id for inter-element referencing | |||||||||||
| extension | 0..* | Extension | Additional content defined by implementations | 0..* | Extension | Additional content defined by implementations | |||||||||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | |||||||||
| stereochemistry | Σ | 0..1 | CodeableConcept | Stereochemistry type Binding: ?? (example): The optical rotation type of a substance. | Σ | 0..1 | CodeableConcept | Stereochemistry type Binding: ?? (example): The optical rotation type of a substance. | |||||||||
| opticalActivity | Σ | 0..1 | CodeableConcept | Optical activity type Binding: ?? (example): The optical rotation type of a substance. | Σ | 0..1 | CodeableConcept | Optical activity type Binding: ?? (example): The optical rotation type of a substance. | |||||||||
| molecularFormula | SΣ | 0..1 | string | Molecular Formula | Biopolymer Sequence | SΣ | 0..1 | string | Molecular Formula | Biopolymer Sequence | |||||||||
| molecularFormulaByMoiety | Σ | 0..1 | string | Specified per moiety according to the Hill system | 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 | Σ | 0..1 | See molecularWeight (SubstanceDefinition) | The molecular weight or weight range | |||||||||
| technique | S | 1..1 | ?? | Substance Characterisation Technique Binding: ?? (example): The method used to elucidate the structure of the drug substance. | S | 1..1 | ?? | Substance Characterisation Technique Binding: ?? (example): The method used to elucidate the structure of the drug substance. | |||||||||
| sourceDocument | Σ | 0..* | Reference(DocumentReference) | Source of information for the structure | Σ | 0..* | Reference(DocumentReference) | Source of information for the structure | |||||||||
| Slices for representation | SΣ | 1..* | BackboneElement | Impurity Structure Graphic | Impurity Structure Data File Slice: Unordered, Closed by value:type | SΣ | 1..* | BackboneElement | Impurity Structure Graphic | Impurity Structure Data File Slice: Unordered, Closed by value:type | |||||||||
| id | 0..1 | string | Unique id for inter-element referencing | 0..1 | string | Unique id for inter-element referencing | |||||||||||
| extension | 0..* | Extension | Additional content defined by implementations | 0..* | Extension | Additional content defined by implementations | |||||||||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | |||||||||
| type | SΣ | 1..1 | CodeableConcept | The kind of structural representation (e.g. full, partial) Binding: ?? (required) | SΣ | 1..1 | CodeableConcept | The kind of structural representation (e.g. full, partial) Binding: ?? (required) | |||||||||
| representation | Σ | 0..1 | string | The structural representation as a text string in a standard format | 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: ?? (example): A format of a substance representation. | Σ | 0..1 | CodeableConcept | The format of the representation e.g. InChI, SMILES, MOLFILE (note: not the physical file format) Binding: ?? (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 | Σ | 0..1 | Reference(DocumentReference) | An attachment with the structural representation e.g. a structure graphic or AnIML file | |||||||||
| Slices for code | SΣ | 1..* | BackboneElement | Codes associated with the substance Slice: Unordered, Open by value:code.coding.system | SΣ | 1..* | BackboneElement | Codes associated with the substance Slice: Unordered, Open by value:code.coding.system | |||||||||
| id | 0..1 | string | Unique id for inter-element referencing | 0..1 | string | Unique id for inter-element referencing | |||||||||||
| extension | 0..* | Extension | Additional content defined by implementations | 0..* | Extension | Additional content defined by implementations | |||||||||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | |||||||||
| code | Σ | 0..1 | CodeableConcept | The specific code | Σ | 0..1 | CodeableConcept | The specific code | |||||||||
| status | Σ | 0..1 | CodeableConcept | Status of the code assignment, for example 'provisional', 'approved' Binding: ?? (preferred): The lifecycle status of an artifact. | Σ | 0..1 | CodeableConcept | Status of the code assignment, for example 'provisional', 'approved' Binding: ?? (preferred): The lifecycle status of an artifact. | |||||||||
| statusDate | Σ | 0..1 | dateTime | The date at which the code status was changed | 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 | Σ | 0..* | Annotation | Any comment can be provided in this field | |||||||||
| source | Σ | 0..* | Reference(DocumentReference) | Supporting literature | Σ | 0..* | Reference(DocumentReference) | Supporting literature | |||||||||
| Slices for name | SΣC | 1..* | BackboneElement | Subtance Name Slice: Unordered, Closed by value:type cmc-name-preferred: Name.preferred: at most one = true | SΣC | 1..* | BackboneElement | Subtance Name Slice: Unordered, Closed by value:type cmc-name-preferred: Name.preferred: at most one = true | |||||||||
| id | 0..1 | string | Unique id for inter-element referencing | 0..1 | string | Unique id for inter-element referencing | |||||||||||
| extension | 0..* | Extension | Additional content defined by implementations | 0..* | Extension | Additional content defined by implementations | |||||||||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | |||||||||
| name | Σ | 1..1 | string | The actual name | Σ | 1..1 | string | The actual name | |||||||||
| type | Σ | 0..1 | CodeableConcept | Name type e.g. 'systematic', 'scientific, 'brand' Binding: ?? (required) | Σ | 0..1 | CodeableConcept | Name type e.g. 'systematic', 'scientific, 'brand' Binding: ?? (required) | |||||||||
| status | Σ | 0..1 | CodeableConcept | The status of the name e.g. 'current', 'proposed' Binding: ?? (preferred): The lifecycle status of an artifact. | Σ | 0..1 | CodeableConcept | The status of the name e.g. 'current', 'proposed' Binding: ?? (preferred): The lifecycle status of an artifact. | |||||||||
| preferred | SΣ | 0..1 | boolean | True when the name type is Substance Name | SΣ | 0..1 | boolean | True when the name type is Substance Name | |||||||||
| language | Σ | 0..* | CodeableConcept | Human language that the name is written in Binding: ?? (required): IETF language tag for a human language
| Σ | 0..* | CodeableConcept | Human language that the name is written in Binding: ?? (required): IETF language tag for a human language
| |||||||||
| domain | Σ | 0..* | CodeableConcept | The use context of this name e.g. as an active ingredient or as a food colour additive Binding: ?? (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. | Σ | 0..* | CodeableConcept | The use context of this name e.g. as an active ingredient or as a food colour additive Binding: ?? (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: ?? (example): Jurisdiction codes | Σ | 0..* | CodeableConcept | The jurisdiction where this name applies Binding: ?? (example): Jurisdiction codes | |||||||||
| synonym | Σ | 0..* | See name (SubstanceDefinition) | A synonym of this particular name, by which the substance is also known | 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 | 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 | Σ | 0..* | BackboneElement | Details of the official nature of this name | |||||||||
| id | 0..1 | string | Unique id for inter-element referencing | 0..1 | string | Unique id for inter-element referencing | |||||||||||
| extension | 0..* | Extension | Additional content defined by implementations | 0..* | Extension | Additional content defined by implementations | |||||||||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | |||||||||
| authority | Σ | 0..1 | CodeableConcept | Which authority uses this official name Binding: ?? (preferred): An authority that officates substance names. | Σ | 0..1 | CodeableConcept | Which authority uses this official name Binding: ?? (preferred): An authority that officates substance names. | |||||||||
| status | Σ | 0..1 | CodeableConcept | The status of the official name, for example 'draft', 'active' Binding: ?? (preferred): The lifecycle status of an artifact. | Σ | 0..1 | CodeableConcept | The status of the official name, for example 'draft', 'active' Binding: ?? (preferred): The lifecycle status of an artifact. | |||||||||
| date | Σ | 0..1 | dateTime | Date of official name change | Σ | 0..1 | dateTime | Date of official name change | |||||||||
| source | Σ | 0..* | Reference(DocumentReference) | Supporting literature | Σ | 0..* | Reference(DocumentReference) | Supporting literature | |||||||||
| relationship | SΣ | 0..* | BackboneElement | A link between this substance and another | SΣ | 0..* | BackboneElement | A link between this substance and another | |||||||||
| id | 0..1 | string | Unique id for inter-element referencing | 0..1 | string | Unique id for inter-element referencing | |||||||||||
| extension | 0..* | Extension | Additional content defined by implementations | 0..* | Extension | Additional content defined by implementations | |||||||||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | |||||||||
| substanceDefinition[x] | Σ | 0..1 | LiteralReference(Polymorphic Form) {b} | The substance definition of a polyphorm of the Drug Substance | Σ | 0..1 | LiteralReference(Polymorphic Form) {b} | The substance definition of a polyphorm of the Drug Substance | |||||||||
| type | 1..1 | ?? | Polymorph Binding: ?? (example): The relationship between two substance types. | 1..1 | ?? | Polymorph Binding: ?? (example): The relationship between two substance types. | |||||||||||
| id | 0..1 | id | Unique id for inter-element referencing | 0..1 | id | Unique id for inter-element referencing | |||||||||||
| Slices for extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||||||||
| coding | Σ | 0..* | Coding | Code defined by a terminology system | Σ | 0..* | Coding | Code defined by a terminology system | |||||||||
| text | SΣ | 1..1 | string | Plain text representation of the concept Required Pattern: Polymorph | SΣ | 1..1 | string | Plain text representation of the concept Required Pattern: Polymorph | |||||||||
| 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 | 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 | Quantity, Ratio, string | A numeric factor for the relationship, e.g. that a substance salt has some percentage of active substance in relation to some other | Σ | 0..1 | Quantity, Ratio, string | A numeric factor for the relationship, e.g. that a substance salt has some percentage of active substance in relation to some other | |||||||||
| ratioHighLimitAmount | Σ | 0..1 | Ratio | For use when the numeric has an uncertain range | 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: ?? (example): The relationship between two substance types. | Σ | 0..1 | CodeableConcept | An operator for the amount, for example "average", "approximately", "less than" Binding: ?? (example): The relationship between two substance types. | |||||||||
| source | Σ | 0..* | Reference(DocumentReference) | Supporting literature | Σ | 0..* | Reference(DocumentReference) | Supporting literature | |||||||||
| nucleicAcid | Σ | 0..1 | Reference(SubstanceNucleicAcid) | Data items specific to nucleic acids | Σ | 0..1 | Reference(SubstanceNucleicAcid) | Data items specific to nucleic acids | |||||||||
| polymer | Σ | 0..1 | Reference(SubstancePolymer) | Data items specific to polymers | Σ | 0..1 | Reference(SubstancePolymer) | Data items specific to polymers | |||||||||
| protein | Σ | 0..1 | Reference(SubstanceProtein) | Data items specific to proteins | Σ | 0..1 | Reference(SubstanceProtein) | Data items specific to proteins | |||||||||
| sourceMaterial | Σ | 0..1 | BackboneElement | Material or taxonomic/anatomical source | Σ | 0..1 | BackboneElement | Material or taxonomic/anatomical source | |||||||||
| id | 0..1 | string | Unique id for inter-element referencing | 0..1 | string | Unique id for inter-element referencing | |||||||||||
| extension | 0..* | Extension | Additional content defined by implementations | 0..* | Extension | Additional content defined by implementations | |||||||||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ?!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: ?? (example): A classification that provides the origin of the substance raw material. | Σ | 0..1 | CodeableConcept | Classification of the origin of the raw material. e.g. cat hair is an Animal source type Binding: ?? (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: ?? (example): The genus of an organism, typically referring to the Latin epithet of the genus element of the plant/animal scientific name. | Σ | 0..1 | CodeableConcept | The genus of an organism e.g. the Latin epithet of the plant/animal scientific name Binding: ?? (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: ?? (example): A species of origin a substance raw material. | Σ | 0..1 | CodeableConcept | The species of an organism e.g. the Latin epithet of the species of the plant/animal Binding: ?? (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: ?? (example): An anatomical origin of the source material within an organism. | Σ | 0..1 | CodeableConcept | An anatomical origin of the source material within an organism Binding: ?? (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: ?? (required): Jurisdiction codes | Σ | 0..* | CodeableConcept | The country or countries where the material is harvested Binding: ?? (required): Jurisdiction codes | |||||||||
| Documentation for this format | |||||||||||||||||