## Intersection of http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-drug-product-substance-impurity and http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-drug-product-substance-impurity

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).

### Structure

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
SubstanceDefinition | C | 0..* |  | The detailed description of a substance, typically at a level beyond what is used for prescribing Constraints: 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 content Binding: ?? (required): IETF language tag for a human language
text |  | 0..1 | Narrative | Text summary of the resource, for human interpretation This 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, retired Binding: ?? (preferred): The lifecycle status of an artifact.
classification | S Σ | 1..* | CodeableConcept | Impurity Classification Binding: ?? (required)
domain | Σ | 0..1 | CodeableConcept | If the substance applies to human or veterinary use Binding: ?? (example): Applicable domain for this product (e.g. human, veterinary).
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 type Binding: ?? (example): The optical rotation type of a substance.
opticalActivity | Σ | 0..1 | CodeableConcept | Optical activity type Binding: ?? (example): The optical rotation type of a substance.
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 value Binding: ?? (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 Technique Binding: ?? (example): The method used to elucidate the characterization of the drug substance.
form | Σ | 0..1 | CodeableConcept | Describes the nature of the chemical entity and explains, for instance, whether this is a base or a salt form Binding: ?? (example)
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 property Binding: ?? (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.
value[x] | Σ | 0..1 |  | 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 determined Binding: ?? (example): The method by which the substance weight was measured.
type | Σ | 0..1 | CodeableConcept | Type of molecular weight e.g. exact, average, weight average Binding: ?? (example): The type of substance weight measurement.
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 type Binding: ?? (example): The optical rotation type of a substance.
opticalActivity | Σ | 0..1 | CodeableConcept | Optical activity type Binding: ?? (example): The optical rotation type of a substance.
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 Technique Binding: ?? (example): The method used to elucidate the structure of the drug substance.
sourceDocument | Σ | 0..* | Reference(DocumentReference) | Source of information for the structure
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 Name Constraints: 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 in Binding: ?? (required): IETF language tag for a human language
domain | Σ | 0..* | CodeableConcept | The use context of this name e.g. as an active ingredient or as a food colour additive Binding: ?? (example): The use context of a substance name for example if there is a different name when used as a drug active ingredient as opposed to a food colour additive.
jurisdiction | Σ | 0..* | CodeableConcept | The jurisdiction where this name applies Binding: ?? (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 name Binding: ?? (preferred): An authority that officates substance names.
status | Σ | 0..1 | CodeableConcept | The status of the official name, for example 'draft', 'active' Binding: ?? (preferred): The lifecycle status of an artifact.
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
substanceDefinitionReference |  |  | 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 type Binding: ?? (example): A classification that provides the origin of the substance raw material.
genus | Σ | 0..1 | CodeableConcept | The genus of an organism e.g. the Latin epithet of the plant/animal scientific name Binding: ?? (example): The genus of an organism, typically referring to the Latin epithet of the genus element of the plant/animal scientific name.
species | Σ | 0..1 | CodeableConcept | The species of an organism e.g. the Latin epithet of the species of the plant/animal Binding: ?? (example): A species of origin a substance raw material.
part | Σ | 0..1 | CodeableConcept | An anatomical origin of the source material within an organism Binding: ?? (example): An anatomical origin of the source material within an organism.
countryOfOrigin | Σ | 0..* | CodeableConcept | The country or countries where the material is harvested Binding: ?? (required): Jurisdiction codes
Documentation for this format