Profile Comparison between http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-excipient vs http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-excipient

Left:Excipient Drug Substance (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-excipient)
Right:Excipient Drug Substance (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-excipient)

Messages

ErrorStructureDefinition.versionValues for version differ: '1.0.0-ballot' vs '1.0.0'
InformationStructureDefinition.dateValues for date differ: '2024-04-08T17:51:06+00:00' vs '2024-12-11T13:47:08+00:00'
InformationSubstanceDefinition.classificationElement maximum cardinalities differ: '2147483647' vs '1'
InformationSubstanceDefinition.gradeElement maximum cardinalities differ: '1' vs '2147483647'
InformationSubstanceDefinition.manufacturerElement maximum cardinalities differ: '1' vs '2147483647'
InformationStructureDefinition.definitionValues for definition differ: ' Implementation Note: the cardinality represents the business rule for unii, uniprot, or some other code being required' vs 'Codes associated with the substance.'
WarningSubstanceDefinition.code.codeElements differ in definition for mustSupport: 'true' vs 'false'
InformationSubstanceDefinition.code.codeElement minimum cardinalities differ: '1' vs '0'
InformationStructureDefinition.shortValues for short differ: 'The genus of an organism e.g. the Latin epithet of the plant/animal scientific name' vs 'Source Organism Genus'
InformationStructureDefinition.definitionValues for definition differ: 'The genus of an organism, typically referring to the Latin epithet of the genus element of the plant/animal scientific name.' vs 'The name, genus or genus and species of the organism from which the material is derived. [Source: SME Defined] Examples: human or Homo Sapiens, chicken, dog or canine, cow or bovine, rat or rattus.'
InformationStructureDefinition.shortValues for short differ: 'Source Organism' vs 'Source Organism Species'
InformationStructureDefinition.definitionValues for definition differ: 'A fragment of the source organism. [Source: SME Defined] Examples: secretions, material from a specific organ, tissue or portion of the organism such as liver, pancreas, blood or from bark or seed of a plant. IDMP 11238 definition & examples: Entity of anatomical origin of source material within an organism. Cartilage, Root and Stolon, whole plant is considered as a part, Aerial part of the plant, Leaf, Tuberous Root, whole animal ' vs 'A fragment of the source organism. [Source: SME Defined] Examples: secretions, material from a specific organ, tissue or portion of the organism such as liver, pancreas, blood or from bark or seed of a plant. IDMP 11238 definition & examples: Entity of anatomical origin of source material within an organism. Cartilage, Root and Stolon, whole plant is considered as a part, Aerial part of the plant, Leaf, Tuberous Root, whole animal'

Metadata

NameValueComments
.abstractfalse
    .baseDefinitionhttp://hl7.org/fhir/StructureDefinition/SubstanceDefinition
      .copyright
        .date2024-04-08T17:51:06+00:002024-12-11T13:47:08+00:00
        • Values Differ
        .descriptionProvides sufficient information to identify an inactive substance and raw materials and its source when stability data is required in the submission.
          .experimental
            .fhirVersion5.0.0
              .jurisdiction
                ..jurisdiction[0]urn:iso:std:iso:3166#US
                  .kindresource
                    .nameExcipientRaw
                      .publisherHL7 International / Biomedical Research and Regulation
                        .purpose
                          .statusactive
                            .titleExcipient Drug Substance
                              .typeSubstanceDefinition
                                .urlhttp://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-excipient
                                  .version1.0.0-ballot1.0.0
                                  • Values Differ

                                  Structure

                                  NameL FlagsL Card.L TypeL Description & ConstraintsR FlagsR Card.R TypeR Description & ConstraintsCommentsdoco
                                  .. SubstanceDefinition C0..*SubstanceDefinitionThe 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','Protein'.
                                  cmc-name-isbt: Name.type ISBT 128 required for blood products.
                                  cmc-source-material: IF raw material source type equals Microbial, Animal, Plant, Insect or Human THEN the 4 source related attributes are required and the manufacturer and supplier information is highly desirable.
                                  C0..*SubstanceDefinitionThe 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-source-material: IF raw material source type equals Microbial, Animal, Plant, Insect or Human THEN the 4 source related attributes are required and the manufacturer and supplier information is highly desirable.
                                    ... id Σ0..1idLogical id of this artifactΣ0..1idLogical id of this artifact
                                      ... meta Σ0..1MetaMetadata about the resourceΣ0..1MetaMetadata about the resource
                                        .... id 0..1idUnique id for inter-element referencing
                                        • Removed this element
                                        .... Slices for extension 0..*ExtensionAdditional content defined by implementations
                                        Slice: Unordered, Open by value:url
                                        • Removed this element
                                        .... versionId Σ0..1idVersion specific identifier
                                        • Removed this element
                                        .... lastUpdated Σ0..1instantWhen the resource version last changed
                                        • Removed this element
                                        .... source Σ0..1uriIdentifies where the resource comes from
                                        • Removed this element
                                        .... profile SΣ1..1canonical(StructureDefinition)Profiles this resource claims to conform to
                                        • Removed this element
                                        .... security Σ0..*CodingSecurity Labels applied to this resource
                                        Binding: ?? (extensible): Security Labels from the Healthcare Privacy and Security Classification System.


                                        • Removed this element
                                        .... tag Σ0..*CodingTags applied to this resource
                                        Binding: ?? (example): Codes that represent various types of tags, commonly workflow-related; e.g. "Needs review by Dr. Jones".


                                        • Removed this element
                                        ... implicitRules ?!Σ0..1uriA set of rules under which this content was created?!Σ0..1uriA set of rules under which this content was created
                                          ... language 0..1codeLanguage of the resource content
                                          Binding: ?? (required): IETF language tag for a human language

                                          Additional BindingsPurpose
                                          ??Starter Set
                                          0..1codeLanguage of the resource content
                                          Binding: ?? (required): IETF language tag for a human language

                                          Additional BindingsPurpose
                                          ??Starter Set
                                            ... text 0..1NarrativeText summary of the resource, for human interpretation0..1NarrativeText summary of the resource, for human interpretation
                                              ... contained 0..*ResourceContained, inline Resources
                                              0..*ResourceContained, inline Resources
                                                ... extension 0..*ExtensionAdditional content defined by implementations
                                                0..*ExtensionAdditional content defined by implementations
                                                  ... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored
                                                  ?!Σ0..*ExtensionExtensions that cannot be ignored
                                                    ... identifier Σ0..1Identifieroptional user designated identifier
                                                    Σ0..1Identifieroptional user designated identifier
                                                      ... version Σ0..1stringA business level version identifier of the substanceΣ0..1stringA business level version identifier of the substance
                                                        ... status Σ0..1CodeableConceptStatus of substance within the catalogue e.g. active, retired
                                                        Binding: ?? (preferred): The lifecycle status of an artifact.

                                                        Σ0..1CodeableConceptStatus of substance within the catalogue e.g. active, retired
                                                        Binding: ?? (preferred): The lifecycle status of an artifact.

                                                          ... classification SΣ1..*CodeableConceptSubstance Type
                                                          Binding: ?? (required)
                                                          SΣ1..1CodeableConceptSubstance Type
                                                          Binding: ?? (required)
                                                          • Element maximum cardinalities differ: '2147483647' vs '1'
                                                          ... domain Σ0..1CodeableConceptIf the substance applies to human or veterinary use
                                                          Binding: ?? (example): Applicable domain for this product (e.g. human, veterinary).

                                                          Σ0..1CodeableConceptIf the substance applies to human or veterinary use
                                                          Binding: ?? (example): Applicable domain for this product (e.g. human, veterinary).

                                                            ... grade Σ1..1CodeableConceptQuality Standard
                                                            Binding: ?? (example): The quality standard, established benchmark, to which a substance complies


                                                            Σ1..*CodeableConceptQuality Standard
                                                            Binding: ?? (required)
                                                            • Element maximum cardinalities differ: '1' vs '2147483647'
                                                            .... id 0..1idUnique id for inter-element referencing
                                                            • Removed this element
                                                            .... Slices for extension 0..*ExtensionAdditional content defined by implementations
                                                            Slice: Unordered, Open by value:url
                                                            • Removed this element
                                                            .... coding Σ0..*CodingCode defined by a terminology system
                                                            Binding: ?? (required)
                                                            • Removed this element
                                                            .... text Σ0..1stringPlain text representation of the concept
                                                            • Removed this element
                                                            ... description Σ0..1markdownTextual description of the substanceΣ0..1markdownTextual description of the substance
                                                              ... informationSource Σ0..*Reference(Citation)Supporting literature
                                                              Σ0..*Reference(Citation)Supporting literature
                                                                ... note Σ0..*AnnotationTextual comment about the substance's catalogue or registry record
                                                                Σ0..*AnnotationTextual comment about the substance's catalogue or registry record
                                                                  ... manufacturer SΣ0..1Reference(Manufacturing and/or Test Site Organization)The entity that creates, makes, produces or fabricates the substance
                                                                  SΣ0..*LiteralReference(Basic Organization) {b}The entity that creates, makes, produces or fabricates the substance
                                                                  • Element maximum cardinalities differ: '1' vs '2147483647'
                                                                  ... supplier SΣ0..1Reference(Supplier Organization)An entity that is the source for the substance. It may be different from the manufacturer
                                                                  SΣ0..1LiteralReference(Basic Organization) {b}An entity that is the source for the substance. It may be different from the manufacturer
                                                                    ... moiety Σ0..*BackboneElementMoiety, for structural modifications
                                                                    Σ0..*BackboneElementMoiety, for structural modifications
                                                                      .... id 0..1stringUnique id for inter-element referencing0..1stringUnique id for inter-element referencing
                                                                        .... extension 0..*ExtensionAdditional content defined by implementations
                                                                        0..*ExtensionAdditional content defined by implementations
                                                                          .... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
                                                                          ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
                                                                            .... role Σ0..1CodeableConceptRole that the moiety is playingΣ0..1CodeableConceptRole that the moiety is playing
                                                                              .... identifier Σ0..1IdentifierIdentifier by which this moiety substance is knownΣ0..1IdentifierIdentifier by which this moiety substance is known
                                                                                .... name Σ0..1stringTextual name for this moiety substanceΣ0..1stringTextual name for this moiety substance
                                                                                  .... stereochemistry Σ0..1CodeableConceptStereochemistry type
                                                                                  Binding: ?? (example): The optical rotation type of a substance.

                                                                                  Σ0..1CodeableConceptStereochemistry type
                                                                                  Binding: ?? (example): The optical rotation type of a substance.

                                                                                    .... opticalActivity Σ0..1CodeableConceptOptical activity type
                                                                                    Binding: ?? (example): The optical rotation type of a substance.

                                                                                    Σ0..1CodeableConceptOptical activity type
                                                                                    Binding: ?? (example): The optical rotation type of a substance.

                                                                                      .... molecularFormula Σ0..1stringMolecular formula for this moiety (e.g. with the Hill system)Σ0..1stringMolecular formula for this moiety (e.g. with the Hill system)
                                                                                        .... amount[x] Σ0..1Quantity, stringQuantitative value for this moietyΣ0..1Quantity, stringQuantitative value for this moiety
                                                                                          .... measurementType Σ0..1CodeableConceptThe measurement type of the quantitative value
                                                                                          Binding: ?? (example): The relationship between two substance types.

                                                                                          Σ0..1CodeableConceptThe measurement type of the quantitative value
                                                                                          Binding: ?? (example): The relationship between two substance types.

                                                                                            ... characterization Σ0..*BackboneElementGeneral specifications for this substance
                                                                                            Σ0..*BackboneElementGeneral specifications for this substance
                                                                                              .... id 0..1stringUnique id for inter-element referencing0..1stringUnique id for inter-element referencing
                                                                                                .... extension 0..*ExtensionAdditional content defined by implementations
                                                                                                0..*ExtensionAdditional content defined by implementations
                                                                                                  .... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
                                                                                                  ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
                                                                                                    .... technique Σ0..1CodeableConceptThe method used to find the characterization e.g. HPLC
                                                                                                    Binding: ?? (example): The method used to elucidate the characterization of the drug substance.

                                                                                                    Σ0..1CodeableConceptThe method used to find the characterization e.g. HPLC
                                                                                                    Binding: ?? (example): The method used to elucidate the characterization of the drug substance.

                                                                                                      .... form Σ0..1CodeableConceptDescribes the nature of the chemical entity and explains, for instance, whether this is a base or a salt form
                                                                                                      Binding: ?? (example)
                                                                                                      Σ0..1CodeableConceptDescribes the nature of the chemical entity and explains, for instance, whether this is a base or a salt form
                                                                                                      Binding: ?? (example)
                                                                                                        .... description Σ0..1markdownThe description or justification in support of the interpretation of the data fileΣ0..1markdownThe description or justification in support of the interpretation of the data file
                                                                                                          .... file Σ0..*AttachmentThe 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
                                                                                                          Σ0..*AttachmentThe 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 Σ0..*BackboneElementGeneral specifications for this substance
                                                                                                            Σ0..*BackboneElementGeneral specifications for this substance
                                                                                                              .... id 0..1stringUnique id for inter-element referencing0..1stringUnique id for inter-element referencing
                                                                                                                .... extension 0..*ExtensionAdditional content defined by implementations
                                                                                                                0..*ExtensionAdditional content defined by implementations
                                                                                                                  .... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
                                                                                                                  ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
                                                                                                                    .... type Σ1..1CodeableConceptA 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.

                                                                                                                    Σ1..1CodeableConceptA 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] Σ0..1CodeableConcept, Quantity, date, boolean, AttachmentA value for the propertyΣ0..1CodeableConcept, Quantity, date, boolean, AttachmentA value for the property
                                                                                                                        ... referenceInformation Σ0..1Reference(SubstanceReferenceInformation)General information detailing this substanceΣ0..1Reference(SubstanceReferenceInformation)General information detailing this substance
                                                                                                                          ... molecularWeight Σ0..*BackboneElementThe average mass of a molecule of a compound
                                                                                                                          Σ0..*BackboneElementThe average mass of a molecule of a compound
                                                                                                                            .... id 0..1stringUnique id for inter-element referencing0..1stringUnique id for inter-element referencing
                                                                                                                              .... extension 0..*ExtensionAdditional content defined by implementations
                                                                                                                              0..*ExtensionAdditional content defined by implementations
                                                                                                                                .... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
                                                                                                                                ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
                                                                                                                                  .... method Σ0..1CodeableConceptThe method by which the weight was determined
                                                                                                                                  Binding: ?? (example): The method by which the substance weight was measured.

                                                                                                                                  Σ0..1CodeableConceptThe method by which the weight was determined
                                                                                                                                  Binding: ?? (example): The method by which the substance weight was measured.

                                                                                                                                    .... type Σ0..1CodeableConceptType of molecular weight e.g. exact, average, weight average
                                                                                                                                    Binding: ?? (example): The type of substance weight measurement.

                                                                                                                                    Σ0..1CodeableConceptType of molecular weight e.g. exact, average, weight average
                                                                                                                                    Binding: ?? (example): The type of substance weight measurement.

                                                                                                                                      .... amount Σ1..1QuantityUsed to capture quantitative values for a variety of elementsΣ1..1QuantityUsed to capture quantitative values for a variety of elements
                                                                                                                                        ... structure Σ0..1BackboneElementStructural informationΣ0..1BackboneElementStructural information
                                                                                                                                          .... id 0..1stringUnique id for inter-element referencing0..1stringUnique id for inter-element referencing
                                                                                                                                            .... extension 0..*ExtensionAdditional content defined by implementations
                                                                                                                                            0..*ExtensionAdditional content defined by implementations
                                                                                                                                              .... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
                                                                                                                                              ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
                                                                                                                                                .... stereochemistry Σ0..1CodeableConceptStereochemistry type
                                                                                                                                                Binding: ?? (example): The optical rotation type of a substance.

                                                                                                                                                Σ0..1CodeableConceptStereochemistry type
                                                                                                                                                Binding: ?? (example): The optical rotation type of a substance.

                                                                                                                                                  .... opticalActivity Σ0..1CodeableConceptOptical activity type
                                                                                                                                                  Binding: ?? (example): The optical rotation type of a substance.

                                                                                                                                                  Σ0..1CodeableConceptOptical activity type
                                                                                                                                                  Binding: ?? (example): The optical rotation type of a substance.

                                                                                                                                                    .... molecularFormula Σ0..1stringAn expression which states the number and type of atoms present in a molecule of a substanceΣ0..1stringAn expression which states the number and type of atoms present in a molecule of a substance
                                                                                                                                                      .... molecularFormulaByMoiety Σ0..1stringSpecified per moiety according to the Hill systemΣ0..1stringSpecified per moiety according to the Hill system
                                                                                                                                                        .... molecularWeight Σ0..1See molecularWeight (SubstanceDefinition)The molecular weight or weight rangeΣ0..1See molecularWeight (SubstanceDefinition)The molecular weight or weight range
                                                                                                                                                          .... technique Σ0..*CodeableConceptThe method used to find the structure e.g. X-ray, NMR
                                                                                                                                                          Binding: ?? (example): The method used to elucidate the structure of the drug substance.


                                                                                                                                                          Σ0..*CodeableConceptThe method used to find the structure e.g. X-ray, NMR
                                                                                                                                                          Binding: ?? (example): The method used to elucidate the structure of the drug substance.


                                                                                                                                                            .... sourceDocument Σ0..*Reference(DocumentReference)Source of information for the structure
                                                                                                                                                            Σ0..*Reference(DocumentReference)Source of information for the structure
                                                                                                                                                              .... representation Σ0..*BackboneElementA depiction of the structure of the substance
                                                                                                                                                              Σ0..*BackboneElementA depiction of the structure of the substance
                                                                                                                                                                ..... id 0..1stringUnique id for inter-element referencing0..1stringUnique id for inter-element referencing
                                                                                                                                                                  ..... extension 0..*ExtensionAdditional content defined by implementations
                                                                                                                                                                  0..*ExtensionAdditional content defined by implementations
                                                                                                                                                                    ..... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
                                                                                                                                                                    ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
                                                                                                                                                                      ..... type Σ0..1CodeableConceptThe kind of structural representation (e.g. full, partial)
                                                                                                                                                                      Binding: ?? (example): A format of a substance representation.

                                                                                                                                                                      Σ0..1CodeableConceptThe kind of structural representation (e.g. full, partial)
                                                                                                                                                                      Binding: ?? (example): A format of a substance representation.

                                                                                                                                                                        ..... representation Σ0..1stringThe structural representation as a text string in a standard formatΣ0..1stringThe structural representation as a text string in a standard format
                                                                                                                                                                          ..... format Σ0..1CodeableConceptThe format of the representation e.g. InChI, SMILES, MOLFILE (note: not the physical file format)
                                                                                                                                                                          Binding: ?? (example): A format of a substance representation.

                                                                                                                                                                          Σ0..1CodeableConceptThe format of the representation e.g. InChI, SMILES, MOLFILE (note: not the physical file format)
                                                                                                                                                                          Binding: ?? (example): A format of a substance representation.

                                                                                                                                                                            ..... document Σ0..1Reference(DocumentReference)An attachment with the structural representation e.g. a structure graphic or AnIML fileΣ0..1Reference(DocumentReference)An attachment with the structural representation e.g. a structure graphic or AnIML file
                                                                                                                                                                              ... code SΣ1..*BackboneElementCodes associated with the substance
                                                                                                                                                                              SΣ1..*BackboneElementCodes associated with the substance
                                                                                                                                                                              Slice: Unordered, Open by value:code.coding.system
                                                                                                                                                                                .... id 0..1stringUnique id for inter-element referencing0..1stringUnique id for inter-element referencing
                                                                                                                                                                                  .... extension 0..*ExtensionAdditional content defined by implementations
                                                                                                                                                                                  0..*ExtensionAdditional content defined by implementations
                                                                                                                                                                                    .... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
                                                                                                                                                                                    ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
                                                                                                                                                                                      .... code SΣ1..1CodeableConceptThe specific codeΣ0..1CodeableConceptThe specific code
                                                                                                                                                                                      • Elements differ in definition for mustSupport: 'true' vs 'false'
                                                                                                                                                                                      • Element minimum cardinalities differ: '1' vs '0'
                                                                                                                                                                                      ..... id 0..1idUnique id for inter-element referencing
                                                                                                                                                                                      • Removed this element
                                                                                                                                                                                      ..... Slices for extension 0..*ExtensionAdditional content defined by implementations
                                                                                                                                                                                      Slice: Unordered, Open by value:url
                                                                                                                                                                                      • Removed this element
                                                                                                                                                                                      ..... Slices for coding Σ0..*CodingCode defined by a terminology system
                                                                                                                                                                                      Slice: Unordered, Open by value:system
                                                                                                                                                                                      • Removed this element
                                                                                                                                                                                      ..... text Σ0..1stringPlain text representation of the concept
                                                                                                                                                                                      • Removed this element
                                                                                                                                                                                      .... status Σ0..1CodeableConceptStatus of the code assignment, for example 'provisional', 'approved'
                                                                                                                                                                                      Binding: ?? (preferred): The lifecycle status of an artifact.

                                                                                                                                                                                      Σ0..1CodeableConceptStatus of the code assignment, for example 'provisional', 'approved'
                                                                                                                                                                                      Binding: ?? (preferred): The lifecycle status of an artifact.

                                                                                                                                                                                        .... statusDate Σ0..1dateTimeThe date at which the code status was changedΣ0..1dateTimeThe date at which the code status was changed
                                                                                                                                                                                          .... note Σ0..*AnnotationAny comment can be provided in this field
                                                                                                                                                                                          Σ0..*AnnotationAny comment can be provided in this field
                                                                                                                                                                                            .... source Σ0..*Reference(DocumentReference)Supporting literature
                                                                                                                                                                                            Σ0..*Reference(DocumentReference)Supporting literature
                                                                                                                                                                                              ... Slices for name SΣC1..*BackboneElementSubstance Name
                                                                                                                                                                                              Slice: Unordered, Closed by value:type.coding
                                                                                                                                                                                              cmc-name-preferred: Name.preferred: at most one = true
                                                                                                                                                                                              SΣC1..*BackboneElementSubstance Name
                                                                                                                                                                                              Slice: Unordered, Closed by value:type
                                                                                                                                                                                              cmc-name-preferred: Name.preferred: at most one = true
                                                                                                                                                                                                .... id 0..1stringUnique id for inter-element referencing0..1stringUnique id for inter-element referencing
                                                                                                                                                                                                  .... extension 0..*ExtensionAdditional content defined by implementations
                                                                                                                                                                                                  0..*ExtensionAdditional content defined by implementations
                                                                                                                                                                                                    .... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
                                                                                                                                                                                                    ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
                                                                                                                                                                                                      .... name Σ1..1stringThe actual nameΣ1..1stringThe actual name
                                                                                                                                                                                                        .... type Σ0..1CodeableConceptName type e.g. 'systematic', 'scientific, 'brand'
                                                                                                                                                                                                        Binding: ?? (example): The type of a name given to a substance.

                                                                                                                                                                                                        Σ0..1CodeableConceptName type e.g. 'systematic', 'scientific, 'brand'
                                                                                                                                                                                                        Binding: ?? (required)
                                                                                                                                                                                                          .... status Σ0..1CodeableConceptThe status of the name e.g. 'current', 'proposed'
                                                                                                                                                                                                          Binding: ?? (preferred): The lifecycle status of an artifact.

                                                                                                                                                                                                          Σ0..1CodeableConceptThe status of the name e.g. 'current', 'proposed'
                                                                                                                                                                                                          Binding: ?? (preferred): The lifecycle status of an artifact.

                                                                                                                                                                                                            .... preferred SΣ0..1booleanTrue when the name type is Substance NameSΣ0..1booleanTrue when the name type is Substance Name
                                                                                                                                                                                                              .... language Σ0..*CodeableConceptHuman language that the name is written in
                                                                                                                                                                                                              Binding: ?? (required): IETF language tag for a human language

                                                                                                                                                                                                              Additional BindingsPurpose
                                                                                                                                                                                                              ??Starter Set

                                                                                                                                                                                                              Σ0..*CodeableConceptHuman language that the name is written in
                                                                                                                                                                                                              Binding: ?? (required): IETF language tag for a human language

                                                                                                                                                                                                              Additional BindingsPurpose
                                                                                                                                                                                                              ??Starter Set

                                                                                                                                                                                                                .... domain Σ0..*CodeableConceptThe 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.


                                                                                                                                                                                                                Σ0..*CodeableConceptThe 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 Σ0..*CodeableConceptThe jurisdiction where this name applies
                                                                                                                                                                                                                  Binding: ?? (example): Jurisdiction codes


                                                                                                                                                                                                                  Σ0..*CodeableConceptThe jurisdiction where this name applies
                                                                                                                                                                                                                  Binding: ?? (example): Jurisdiction codes


                                                                                                                                                                                                                    .... synonym Σ0..*See name (SubstanceDefinition)A synonym of this particular name, by which the substance is also known
                                                                                                                                                                                                                    Σ0..*See name (SubstanceDefinition)A synonym of this particular name, by which the substance is also known
                                                                                                                                                                                                                      .... translation Σ0..*See name (SubstanceDefinition)A translation for this name into another human language
                                                                                                                                                                                                                      Σ0..*See name (SubstanceDefinition)A translation for this name into another human language
                                                                                                                                                                                                                        .... official Σ0..*BackboneElementDetails of the official nature of this name
                                                                                                                                                                                                                        Σ0..*BackboneElementDetails of the official nature of this name
                                                                                                                                                                                                                          ..... id 0..1stringUnique id for inter-element referencing0..1stringUnique id for inter-element referencing
                                                                                                                                                                                                                            ..... extension 0..*ExtensionAdditional content defined by implementations
                                                                                                                                                                                                                            0..*ExtensionAdditional content defined by implementations
                                                                                                                                                                                                                              ..... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
                                                                                                                                                                                                                              ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
                                                                                                                                                                                                                                ..... authority Σ0..1CodeableConceptWhich authority uses this official name
                                                                                                                                                                                                                                Binding: ?? (preferred): An authority that officates substance names.

                                                                                                                                                                                                                                Σ0..1CodeableConceptWhich authority uses this official name
                                                                                                                                                                                                                                Binding: ?? (preferred): An authority that officates substance names.

                                                                                                                                                                                                                                  ..... status Σ0..1CodeableConceptThe status of the official name, for example 'draft', 'active'
                                                                                                                                                                                                                                  Binding: ?? (preferred): The lifecycle status of an artifact.

                                                                                                                                                                                                                                  Σ0..1CodeableConceptThe status of the official name, for example 'draft', 'active'
                                                                                                                                                                                                                                  Binding: ?? (preferred): The lifecycle status of an artifact.

                                                                                                                                                                                                                                    ..... date Σ0..1dateTimeDate of official name changeΣ0..1dateTimeDate of official name change
                                                                                                                                                                                                                                      .... source Σ0..*Reference(DocumentReference)Supporting literature
                                                                                                                                                                                                                                      Σ0..*Reference(DocumentReference)Supporting literature
                                                                                                                                                                                                                                        ... relationship Σ0..*BackboneElementA link between this substance and another
                                                                                                                                                                                                                                        Σ0..*BackboneElementA link between this substance and another
                                                                                                                                                                                                                                          .... id 0..1stringUnique id for inter-element referencing0..1stringUnique id for inter-element referencing
                                                                                                                                                                                                                                            .... extension 0..*ExtensionAdditional content defined by implementations
                                                                                                                                                                                                                                            0..*ExtensionAdditional content defined by implementations
                                                                                                                                                                                                                                              .... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
                                                                                                                                                                                                                                              ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
                                                                                                                                                                                                                                                .... substanceDefinition[x] Σ0..1Reference(SubstanceDefinition), CodeableConceptA pointer to another substance, as a resource or a representational codeΣ0..1Reference(SubstanceDefinition), CodeableConceptA pointer to another substance, as a resource or a representational code
                                                                                                                                                                                                                                                  .... type Σ1..1CodeableConceptFor example "salt to parent", "active moiety"
                                                                                                                                                                                                                                                  Binding: ?? (example): The relationship between two substance types.

                                                                                                                                                                                                                                                  Σ1..1CodeableConceptFor example "salt to parent", "active moiety"
                                                                                                                                                                                                                                                  Binding: ?? (example): The relationship between two substance types.

                                                                                                                                                                                                                                                    .... isDefining Σ0..1booleanFor example where an enzyme strongly bonds with a particular substance, this is a defining relationship for that enzyme, out of several possible relationshipsΣ0..1booleanFor 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] Σ0..1Quantity, Ratio, stringA numeric factor for the relationship, e.g. that a substance salt has some percentage of active substance in relation to some otherΣ0..1Quantity, Ratio, stringA numeric factor for the relationship, e.g. that a substance salt has some percentage of active substance in relation to some other
                                                                                                                                                                                                                                                        .... ratioHighLimitAmount Σ0..1RatioFor use when the numeric has an uncertain rangeΣ0..1RatioFor use when the numeric has an uncertain range
                                                                                                                                                                                                                                                          .... comparator Σ0..1CodeableConceptAn operator for the amount, for example "average", "approximately", "less than"
                                                                                                                                                                                                                                                          Binding: ?? (example): The relationship between two substance types.

                                                                                                                                                                                                                                                          Σ0..1CodeableConceptAn operator for the amount, for example "average", "approximately", "less than"
                                                                                                                                                                                                                                                          Binding: ?? (example): The relationship between two substance types.

                                                                                                                                                                                                                                                            .... source Σ0..*Reference(DocumentReference)Supporting literature
                                                                                                                                                                                                                                                            Σ0..*Reference(DocumentReference)Supporting literature
                                                                                                                                                                                                                                                              ... nucleicAcid Σ0..1Reference(SubstanceNucleicAcid)Data items specific to nucleic acidsΣ0..1Reference(SubstanceNucleicAcid)Data items specific to nucleic acids
                                                                                                                                                                                                                                                                ... polymer Σ0..1Reference(SubstancePolymer)Data items specific to polymersΣ0..1Reference(SubstancePolymer)Data items specific to polymers
                                                                                                                                                                                                                                                                  ... protein Σ0..1Reference(SubstanceProtein)Data items specific to proteinsΣ0..1Reference(SubstanceProtein)Data items specific to proteins
                                                                                                                                                                                                                                                                    ... sourceMaterial SΣ1..1BackboneElementMaterial or taxonomic/anatomical sourceSΣ1..1BackboneElementMaterial or taxonomic/anatomical source
                                                                                                                                                                                                                                                                      .... id 0..1stringUnique id for inter-element referencing0..1stringUnique id for inter-element referencing
                                                                                                                                                                                                                                                                        .... extension 0..*ExtensionAdditional content defined by implementations
                                                                                                                                                                                                                                                                        0..*ExtensionAdditional content defined by implementations
                                                                                                                                                                                                                                                                          .... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
                                                                                                                                                                                                                                                                          ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
                                                                                                                                                                                                                                                                            .... type Σ1..1CodeableConceptSource Type
                                                                                                                                                                                                                                                                            Binding: ?? (example): A classification that provides the origin of the substance raw material.

                                                                                                                                                                                                                                                                            Σ1..1CodeableConceptSource Type
                                                                                                                                                                                                                                                                            Binding: ?? (required)
                                                                                                                                                                                                                                                                              ..... id 0..1idUnique id for inter-element referencing
                                                                                                                                                                                                                                                                              • Removed this element
                                                                                                                                                                                                                                                                              ..... Slices for extension 0..*ExtensionAdditional content defined by implementations
                                                                                                                                                                                                                                                                              Slice: Unordered, Open by value:url
                                                                                                                                                                                                                                                                              • Removed this element
                                                                                                                                                                                                                                                                              ..... coding Σ0..*CodingCode defined by a terminology system
                                                                                                                                                                                                                                                                              Binding: ?? (required)
                                                                                                                                                                                                                                                                              • Removed this element
                                                                                                                                                                                                                                                                              ..... text Σ0..1stringPlain text representation of the concept
                                                                                                                                                                                                                                                                              • Removed this element
                                                                                                                                                                                                                                                                              .... genus SΣ0..1CodeableConceptThe 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.

                                                                                                                                                                                                                                                                              S0..1??Source Organism Genus
                                                                                                                                                                                                                                                                              Binding: ?? (example): The genus of an organism, typically referring to the Latin epithet of the genus element of the plant/animal scientific name.

                                                                                                                                                                                                                                                                                ..... id 0..1idUnique id for inter-element referencing
                                                                                                                                                                                                                                                                                • Removed this element
                                                                                                                                                                                                                                                                                ..... Slices for extension 0..*ExtensionAdditional content defined by implementations
                                                                                                                                                                                                                                                                                Slice: Unordered, Open by value:url
                                                                                                                                                                                                                                                                                • Removed this element
                                                                                                                                                                                                                                                                                ..... coding Σ0..0
                                                                                                                                                                                                                                                                                • Removed this element
                                                                                                                                                                                                                                                                                ..... text Σ1..1stringSource Organism
                                                                                                                                                                                                                                                                                • Removed this element
                                                                                                                                                                                                                                                                                .... species SΣ0..1CodeableConceptSource Organism
                                                                                                                                                                                                                                                                                Binding: ?? (example): A species of origin a substance raw material.

                                                                                                                                                                                                                                                                                S0..1??Source Organism Species
                                                                                                                                                                                                                                                                                Binding: ?? (example): A species of origin a substance raw material.

                                                                                                                                                                                                                                                                                  ..... id 0..1idUnique id for inter-element referencing
                                                                                                                                                                                                                                                                                  • Removed this element
                                                                                                                                                                                                                                                                                  ..... Slices for extension 0..*ExtensionAdditional content defined by implementations
                                                                                                                                                                                                                                                                                  Slice: Unordered, Open by value:url
                                                                                                                                                                                                                                                                                  • Removed this element
                                                                                                                                                                                                                                                                                  ..... coding Σ0..0
                                                                                                                                                                                                                                                                                  • Removed this element
                                                                                                                                                                                                                                                                                  ..... text Σ1..1stringPlain text representation of the concept
                                                                                                                                                                                                                                                                                  • Removed this element
                                                                                                                                                                                                                                                                                  .... part SΣ0..1CodeableConceptSource Organism Part
                                                                                                                                                                                                                                                                                  Binding: ?? (example): An anatomical origin of the source material within an organism.

                                                                                                                                                                                                                                                                                  S0..1??Source Organism Part
                                                                                                                                                                                                                                                                                  Binding: ?? (example): An anatomical origin of the source material within an organism.

                                                                                                                                                                                                                                                                                    ..... id 0..1idUnique id for inter-element referencing
                                                                                                                                                                                                                                                                                    • Removed this element
                                                                                                                                                                                                                                                                                    ..... Slices for extension 0..*ExtensionAdditional content defined by implementations
                                                                                                                                                                                                                                                                                    Slice: Unordered, Open by value:url
                                                                                                                                                                                                                                                                                    • Removed this element
                                                                                                                                                                                                                                                                                    ..... coding Σ0..0
                                                                                                                                                                                                                                                                                    • Removed this element
                                                                                                                                                                                                                                                                                    ..... text Σ1..1stringPlain text representation of the concept
                                                                                                                                                                                                                                                                                    • Removed this element
                                                                                                                                                                                                                                                                                    .... countryOfOrigin SΣC0..1CodeableConceptSource Organism Country of Origin
                                                                                                                                                                                                                                                                                    Binding: ?? (required): Jurisdiction codes


                                                                                                                                                                                                                                                                                    cmc-iso-genc-overlap: Only country codes that are also member of GENC can be used.
                                                                                                                                                                                                                                                                                    SΣ0..1CodeableConceptSource Organism Country of Origin
                                                                                                                                                                                                                                                                                    Binding: ?? (required)
                                                                                                                                                                                                                                                                                      ..... id 0..1idUnique id for inter-element referencing
                                                                                                                                                                                                                                                                                      • Removed this element
                                                                                                                                                                                                                                                                                      ..... Slices for extension 0..*ExtensionAdditional content defined by implementations
                                                                                                                                                                                                                                                                                      Slice: Unordered, Open by value:url
                                                                                                                                                                                                                                                                                      • Removed this element
                                                                                                                                                                                                                                                                                      ..... coding SΣ1..1CodingCode defined by a terminology system
                                                                                                                                                                                                                                                                                      • Removed this element
                                                                                                                                                                                                                                                                                      ..... text Σ0..1stringPlain text representation of the concept
                                                                                                                                                                                                                                                                                      • Removed this element

                                                                                                                                                                                                                                                                                      doco Documentation for this format