This is the set of resources that conform to both Drug Substance Impurity (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-drug-product-substance-impurity) and Drug Substance Impurity (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-drug-product-substance-impurity).
Name Flags Card. Type Description & Constraints Filter: Bindings
SubstanceDefinition C 0..* The detailed description of a substance, typically at a level beyond what is used for prescribingConstraints: cmc-impurity-unii-required meta Σ 0..1 Meta Metadata about the resource implicitRules ?! Σ 0..1 uri A set of rules under which this content was created language 0..1 code Language of the resource contentBinding: ?? ( required ) : IETF language tag for a human language text 0..1 Narrative Text summary of the resource, for human interpretationThis profile does not constrain the narrative in regard to content, language, or traceability to data elements contained 0..* Resource Contained, inline Resources extension 0..* Extension Additional content defined by implementations modifierExtension ?! Σ 0..* Extension Extensions that cannot be ignored identifier S Σ 0..1 Identifier optional user designated identifier version Σ 0..1 string A business level version identifier of the substance status Σ 0..1 CodeableConcept Status of substance within the catalogue e.g. active, retiredBinding: ?? ( preferred ) : The lifecycle status of an artifact. classification S Σ 1..* CodeableConcept Impurity ClassificationBinding: ?? ( required ) domain Σ 0..1 CodeableConcept If the substance applies to human or veterinary useBinding: ?? ( example ) : Applicable domain for this product (e.g. human, veterinary). grade Σ 0..* CodeableConcept The quality standard, established benchmark, to which substance complies (e.g. USP/NF, BP)Binding: ?? ( example ) : The quality standard, established benchmark, to which a substance complies description Σ 0..1 markdown Textual description of the substance informationSource Σ 0..* Reference (Citation )Supporting literature note Σ 0..* Annotation Textual comment about the substance's catalogue or registry record manufacturer Σ 0..* Reference (Organization )The entity that creates, makes, produces or fabricates the substance supplier Σ 0..* Reference (Organization )An entity that is the source for the substance. It may be different from the manufacturer moiety Σ 0..* BackboneElement Moiety, for structural modifications extension 0..* Extension Additional content defined by implementations modifierExtension ?! Σ 0..* Extension Extensions that cannot be ignored even if unrecognized role Σ 0..1 CodeableConcept Role that the moiety is playing identifier Σ 0..1 Identifier Identifier by which this moiety substance is known name Σ 0..1 string Textual name for this moiety substance stereochemistry Σ 0..1 CodeableConcept Stereochemistry typeBinding: ?? ( example ) : The optical rotation type of a substance. opticalActivity Σ 0..1 CodeableConcept Optical activity typeBinding: ?? ( example ) : The optical rotation type of a substance. molecularFormula Σ 0..1 string Molecular formula for this moiety (e.g. with the Hill system) amount[x] Σ 0..1 Quantitative value for this moiety amountQuantity Quantity amountString string measurementType Σ 0..1 CodeableConcept The measurement type of the quantitative valueBinding: ?? ( example ) : The relationship between two substance types. characterization S Σ 0..* BackboneElement General specifications for this substance extension 0..* Extension Additional content defined by implementations modifierExtension ?! Σ 0..* Extension Extensions that cannot be ignored even if unrecognized technique S 0..1 ?? , ?? Substance Characterisation TechniqueBinding: ?? ( example ) : The method used to elucidate the characterization of the drug substance. form Σ 0..1 CodeableConcept Describes the nature of the chemical entity and explains, for instance, whether this is a base or a salt formBinding: ?? ( example ) description S Σ 0..1 markdown Analysis Narrative Text and Table file S Σ 0..* Attachment Impurity Analysis Graphic | Impurity Analytical Instrument Data File property Σ 0..* BackboneElement General specifications for this substance extension 0..* Extension Additional content defined by implementations modifierExtension ?! Σ 0..* Extension Extensions that cannot be ignored even if unrecognized type Σ 1..1 CodeableConcept A code expressing the type of propertyBinding: ?? ( example ) : This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. value[x] Σ 0..1 A value for the property valueCodeableConcept CodeableConcept valueQuantity Quantity valueDate date valueBoolean boolean valueAttachment Attachment referenceInformation Σ 0..1 Reference (SubstanceReferenceInformation )General information detailing this substance molecularWeight Σ 0..* BackboneElement The average mass of a molecule of a compound extension 0..* Extension Additional content defined by implementations modifierExtension ?! Σ 0..* Extension Extensions that cannot be ignored even if unrecognized method Σ 0..1 CodeableConcept The method by which the weight was determinedBinding: ?? ( example ) : The method by which the substance weight was measured. type Σ 0..1 CodeableConcept Type of molecular weight e.g. exact, average, weight averageBinding: ?? ( example ) : The type of substance weight measurement. amount Σ 1..1 Quantity Used to capture quantitative values for a variety of elements structure S Σ 0..1 BackboneElement Structural information extension 0..* Extension Additional content defined by implementations modifierExtension ?! Σ 0..* Extension Extensions that cannot be ignored even if unrecognized stereochemistry Σ 0..1 CodeableConcept Stereochemistry typeBinding: ?? ( example ) : The optical rotation type of a substance. opticalActivity Σ 0..1 CodeableConcept Optical activity typeBinding: ?? ( example ) : The optical rotation type of a substance. molecularFormula Σ 0..1 string An expression which states the number and type of atoms present in a molecule of a substance molecularFormulaByMoiety Σ 0..1 string Specified per moiety according to the Hill system molecularWeight Σ 0..1 The molecular weight or weight range technique S 0..* ?? , ?? Impurity Substance Characterisation TechniqueBinding: ?? ( example ) : The method used to elucidate the structure of the drug substance. sourceDocument Σ 0..* Reference (DocumentReference )Source of information for the structure representation S Σ 0..* BackboneElement Impurity Structure Graphic | Impurity Structure Data File extension 0..* Extension Additional content defined by implementations modifierExtension ?! Σ 0..* Extension Extensions that cannot be ignored even if unrecognized type S Σ 1..1 CodeableConcept The kind of structural representation (e.g. full, partial)Binding: ?? ( required ) representation Σ 0..1 string The structural representation as a text string in a standard format format Σ 0..1 CodeableConcept The format of the representation e.g. InChI, SMILES, MOLFILE (note: not the physical file format)Binding: ?? ( example ) : A format of a substance representation. document Σ 0..1 Reference (DocumentReference )An attachment with the structural representation e.g. a structure graphic or AnIML file code S Σ 0..* BackboneElement Codes associated with the substance extension 0..* Extension Additional content defined by implementations modifierExtension ?! Σ 0..* Extension Extensions that cannot be ignored even if unrecognized code Σ 0..1 CodeableConcept The specific code status Σ 0..1 CodeableConcept Status of the code assignment, for example 'provisional', 'approved'Binding: ?? ( preferred ) : The lifecycle status of an artifact. statusDate Σ 0..1 dateTime The date at which the code status was changed note Σ 0..* Annotation Any comment can be provided in this field source Σ 0..* Reference (DocumentReference )Supporting literature name S Σ C 1..* BackboneElement Substance NameConstraints: cmc-name-preferred extension 0..* Extension Additional content defined by implementations modifierExtension ?! Σ 0..* Extension Extensions that cannot be ignored even if unrecognized name Σ 1..1 string The actual name type Σ 0..1 CodeableConcept Name type e.g. 'systematic', 'scientific, 'brand'Binding: ?? ( required ) status Σ 0..1 CodeableConcept The status of the name e.g. 'current', 'proposed'Binding: ?? ( preferred ) : The lifecycle status of an artifact. preferred S Σ 0..1 boolean True when the name type is Substance Name language Σ 0..* CodeableConcept Human language that the name is written inBinding: ?? ( required ) : IETF language tag for a human language domain Σ 0..* CodeableConcept The use context of this name e.g. as an active ingredient or as a food colour additiveBinding: ?? ( example ) : The use context of a substance name for example if there is a different name when used as a drug active ingredient as opposed to a food colour additive. jurisdiction Σ 0..* CodeableConcept The jurisdiction where this name appliesBinding: ?? ( example ) : Jurisdiction codes synonym Σ 0..* A synonym of this particular name, by which the substance is also known translation Σ 0..* A translation for this name into another human language official Σ 0..* BackboneElement Details of the official nature of this name extension 0..* Extension Additional content defined by implementations modifierExtension ?! Σ 0..* Extension Extensions that cannot be ignored even if unrecognized authority Σ 0..1 CodeableConcept Which authority uses this official nameBinding: ?? ( preferred ) : An authority that officates substance names. status Σ 0..1 CodeableConcept The status of the official name, for example 'draft', 'active'Binding: ?? ( preferred ) : The lifecycle status of an artifact. date Σ 0..1 dateTime Date of official name change source Σ 0..* Reference (DocumentReference )Supporting literature relationship Σ 0..* BackboneElement A link between this substance and another extension 0..* Extension Additional content defined by implementations modifierExtension ?! Σ 0..* Extension Extensions that cannot be ignored even if unrecognized substanceDefinition[x] Σ 0..1 A pointer to another substance, as a resource or a representational code Reference (SubstanceDefinition )substanceDefinitionCodeableConcept CodeableConcept type Σ 1..1 CodeableConcept For example "salt to parent", "active moiety"Binding: ?? ( example ) : The relationship between two substance types. isDefining Σ 0..1 boolean For example where an enzyme strongly bonds with a particular substance, this is a defining relationship for that enzyme, out of several possible relationships amount[x] Σ 0..1 A numeric factor for the relationship, e.g. that a substance salt has some percentage of active substance in relation to some other amountQuantity Quantity amountRatio Ratio amountString string ratioHighLimitAmount Σ 0..1 Ratio For use when the numeric has an uncertain range comparator Σ 0..1 CodeableConcept An operator for the amount, for example "average", "approximately", "less than"Binding: ?? ( example ) : The relationship between two substance types. source Σ 0..* Reference (DocumentReference )Supporting literature nucleicAcid Σ 0..1 Reference (SubstanceNucleicAcid )Data items specific to nucleic acids polymer Σ 0..1 Reference (SubstancePolymer )Data items specific to polymers protein Σ 0..1 Reference (SubstanceProtein )Data items specific to proteins sourceMaterial Σ 0..1 BackboneElement Material or taxonomic/anatomical source extension 0..* Extension Additional content defined by implementations modifierExtension ?! Σ 0..* Extension Extensions that cannot be ignored even if unrecognized type Σ 0..1 CodeableConcept Classification of the origin of the raw material. e.g. cat hair is an Animal source typeBinding: ?? ( example ) : A classification that provides the origin of the substance raw material. genus Σ 0..1 CodeableConcept The genus of an organism e.g. the Latin epithet of the plant/animal scientific nameBinding: ?? ( example ) : The genus of an organism, typically referring to the Latin epithet of the genus element of the plant/animal scientific name. species Σ 0..1 CodeableConcept The species of an organism e.g. the Latin epithet of the species of the plant/animalBinding: ?? ( example ) : A species of origin a substance raw material. part Σ 0..1 CodeableConcept An anatomical origin of the source material within an organismBinding: ?? ( example ) : An anatomical origin of the source material within an organism. countryOfOrigin Σ 0..* CodeableConcept The country or countries where the material is harvestedBinding: ?? ( required ) : Jurisdiction codes
SubstanceDefinition 
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implicitRules 
contained 
extension 
modifierExtension 
informationSource 
amount[x] 
