Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
2.0.0 - STU2 United States of America flag

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Resource Profile: ImpuritySubstance - Mappings

Page standards status: Trial-use Maturity Level: 2

Mappings for the pqcmc-drug-product-substance-impurity resource profile.

Mappings to Structures in this Implementation Guide

No Mappings Found

Mappings to other Structures

No Mappings Found

Other Mappings

NameFiveWs Pattern MappingIDMP Mapping (Substance)RIM Mappingdoco
.. SubstanceDefinition
administrative.medication
  • Chemical
  • Polymer
  • Protein
  • Nucleic_Acid
  • Structurally_Diverse)
  • Entity
  • Role
  • or Act
... id
... meta
... implicitRules
... language
... text
Act.text?
... contained
N/A
... extension
N/A
... modifierExtension
N/A
... identifier
Substance.Substance_Id
... version
Version.Version_Number
... status
n/a
... classification
Substance_Classification.Substance_Classification and Substance_classification.Substance_Classification_Subtype
... domain
Substance_Classification.Substance_Classification (and Code and Type) and Substance_Classification.Substance_Classification_Subtype
... grade
Substance_Specified_Substance_Group_3.Grade
... description
Substance.Comment
... informationSource
Substance.Reference_Source
... note
n/a
... manufacturer
n/a
... supplier
n/a
... moiety
Substance.Moiety
.... id
n/a
.... extension
n/a
.... modifierExtension
N/A
.... role
Moiety.Moiety_Role
.... identifier
Moiety.Moiety_Id
.... name
Moiety.Moiety_Name
.... stereochemistry
Moiety.Stereochemistry
.... opticalActivity
Moiety.Optical_Activity
.... molecularFormula
Moiety.Molecular_Formula
.... amount[x]
Moiety.Amount
.... measurementType
Amount.Amount_Type
... characterization
n/a
.... id
n/a
.... extension
n/a
.... modifierExtension
N/A
.... technique
n/a
.... form
n/a
.... description
n/a
.... Slices for file
n/a
..... file:AnalysisGraphic
n/a
..... file:AnalyticalInstrumentData
n/a
... property
Substance.Property
.... id
n/a
.... extension
n/a
.... modifierExtension
N/A
.... type
Property.Property_Type
.... value[x]
  • Physical Characteristics
  • attribute's value
... referenceInformation
Reference_Information
... molecularWeight
.... id
n/a
.... extension
n/a
.... modifierExtension
N/A
.... method
Molecular_Weight.Molecular_Weight_Method
.... type
Molecular_Weight.Molecular_Weight_Type
.... amount
Molecular_Weight.Amount
... structure
Substance.Structure
.... id
n/a
.... extension
n/a
.... modifierExtension
N/A
.... stereochemistry
Structure.Stereochemistry
.... opticalActivity
Structure.Optical_Activity
.... molecularFormula
Structure.Molecular_Formula
.... molecularFormulaByMoiety
Structure.Molecular_Formula_By_Moiety
.... molecularWeight
Structure.Molecular_Weight
.... technique
n/a
.... sourceDocument
Structure.Reference_Source
.... Slices for representation
Structure.Structural_Representation
..... representation:All Slices
...... id
n/a
...... extension
n/a
...... modifierExtension
N/A
...... type
Structural_Representation.Structural_Representation_Type
...... representation
Structural_Representation.Structural_Representation
...... format
n/a
...... document
Structural_Representation.Structural_Representation_Attachment
..... representation:graphic
Structure.Structural_Representation
...... id
n/a
...... extension
n/a
...... modifierExtension
N/A
...... type
Structural_Representation.Structural_Representation_Type
...... representation
Structural_Representation.Structural_Representation
...... format
n/a
...... document
Structural_Representation.Structural_Representation_Attachment
..... representation:structureFile
Structure.Structural_Representation
...... id
n/a
...... extension
n/a
...... modifierExtension
N/A
...... type
Structural_Representation.Structural_Representation_Type
...... representation
Structural_Representation.Structural_Representation
...... format
n/a
...... document
Structural_Representation.Structural_Representation_Attachment
..... representation:structureString
Structure.Structural_Representation
...... id
n/a
...... extension
n/a
...... modifierExtension
N/A
...... type
Structural_Representation.Structural_Representation_Type
...... representation
Structural_Representation.Structural_Representation
...... format
n/a
...... document
Structural_Representation.Structural_Representation_Attachment
... Slices for code
Substance.Substance_Code
.... code:All Slices
..... id
n/a
..... extension
n/a
..... modifierExtension
N/A
..... code
  • Substance_Code.Code
  • Substance_Code.Code_System
  • Substance_Code.Code_System_Id
..... status
Substance_Code.Code_System_Status
..... statusDate
Substance_Code.Code_Change_Date
..... note
Substance_Code.Comment
..... source
Substance_Code.Reference_Source
.... code:unii
Substance.Substance_Code
..... id
n/a
..... extension
n/a
..... modifierExtension
N/A
..... code
  • Substance_Code.Code
  • Substance_Code.Code_System
  • Substance_Code.Code_System_Id
...... id
n/a
...... extension
n/a
...... coding
  • union(.
  • ./translation)
....... id
n/a
....... extension
n/a
....... system
./codeSystem
....... version
./codeSystemVersion
....... code
./code
....... display
CV.displayName
....... userSelected
CD.codingRationale
...... text
./originalText[mediaType/code="text/plain"]/data
..... status
Substance_Code.Code_System_Status
..... statusDate
Substance_Code.Code_Change_Date
..... note
Substance_Code.Comment
..... source
Substance_Code.Reference_Source
.... code:uniProt
Substance.Substance_Code
..... id
n/a
..... extension
n/a
..... modifierExtension
N/A
..... code
  • Substance_Code.Code
  • Substance_Code.Code_System
  • Substance_Code.Code_System_Id
...... id
n/a
...... extension
n/a
...... coding
  • union(.
  • ./translation)
....... id
n/a
....... extension
n/a
....... system
./codeSystem
....... version
./codeSystemVersion
....... code
./code
....... display
CV.displayName
....... userSelected
CD.codingRationale
...... text
./originalText[mediaType/code="text/plain"]/data
..... status
Substance_Code.Code_System_Status
..... statusDate
Substance_Code.Code_Change_Date
..... note
Substance_Code.Comment
..... source
Substance_Code.Reference_Source
... Slices for name
Substance.Substance_Name
.... name:All Slices
..... id
n/a
..... extension
n/a
..... modifierExtension
N/A
..... name
Substance_Name.Substance_Name
..... type
Substance_Name.Substance_Name_Type
..... status
n/a
..... preferred
n/a
..... language
Substance_Name.Language
..... domain
Substance_Name.Substance_Name_Domain
..... jurisdiction
Substance_Name.Jurisdiction
..... synonym
n/a
..... translation
n/a
..... official
Substance_Name.Official_Name
...... id
n/a
...... extension
n/a
...... modifierExtension
N/A
...... authority
Official_Name.Official_Name_Type
...... status
Official_Name.Official_Name_Status
...... date
Official_Name.Official_Name_Status_Change_Date
..... source
Substance_Name.Reference_Source
.... name:sub
Substance.Substance_Name
..... id
n/a
..... extension
n/a
..... modifierExtension
N/A
..... name
Substance_Name.Substance_Name
..... type
Substance_Name.Substance_Name_Type
..... status
n/a
..... preferred
n/a
..... language
Substance_Name.Language
..... domain
Substance_Name.Substance_Name_Domain
..... jurisdiction
Substance_Name.Jurisdiction
..... synonym
n/a
..... translation
n/a
..... official
Substance_Name.Official_Name
...... id
n/a
...... extension
n/a
...... modifierExtension
N/A
...... authority
Official_Name.Official_Name_Type
...... status
Official_Name.Official_Name_Status
...... date
Official_Name.Official_Name_Status_Change_Date
..... source
Substance_Name.Reference_Source
.... name:gsrs
Substance.Substance_Name
..... id
n/a
..... extension
n/a
..... modifierExtension
N/A
..... name
Substance_Name.Substance_Name
..... type
Substance_Name.Substance_Name_Type
..... status
n/a
..... preferred
n/a
..... language
Substance_Name.Language
..... domain
Substance_Name.Substance_Name_Domain
..... jurisdiction
Substance_Name.Jurisdiction
..... synonym
n/a
..... translation
n/a
..... official
Substance_Name.Official_Name
...... id
n/a
...... extension
n/a
...... modifierExtension
N/A
...... authority
Official_Name.Official_Name_Type
...... status
Official_Name.Official_Name_Status
...... date
Official_Name.Official_Name_Status_Change_Date
..... source
Substance_Name.Reference_Source
.... name:isbt
Substance.Substance_Name
..... id
n/a
..... extension
n/a
..... modifierExtension
N/A
..... name
Substance_Name.Substance_Name
..... type
Substance_Name.Substance_Name_Type
..... status
n/a
..... preferred
n/a
..... language
Substance_Name.Language
..... domain
Substance_Name.Substance_Name_Domain
..... jurisdiction
Substance_Name.Jurisdiction
..... synonym
n/a
..... translation
n/a
..... official
Substance_Name.Official_Name
...... id
n/a
...... extension
n/a
...... modifierExtension
N/A
...... authority
Official_Name.Official_Name_Type
...... status
Official_Name.Official_Name_Status
...... date
Official_Name.Official_Name_Status_Change_Date
..... source
Substance_Name.Reference_Source
.... name:comp
Substance.Substance_Name
..... id
n/a
..... extension
n/a
..... modifierExtension
N/A
..... name
Substance_Name.Substance_Name
..... type
Substance_Name.Substance_Name_Type
..... status
n/a
..... preferred
n/a
..... language
Substance_Name.Language
..... domain
Substance_Name.Substance_Name_Domain
..... jurisdiction
Substance_Name.Jurisdiction
..... synonym
n/a
..... translation
n/a
..... official
Substance_Name.Official_Name
...... id
n/a
...... extension
n/a
...... modifierExtension
N/A
...... authority
Official_Name.Official_Name_Type
...... status
Official_Name.Official_Name_Status
...... date
Official_Name.Official_Name_Status_Change_Date
..... source
Substance_Name.Reference_Source
... relationship
Substance.Reference_Information.Relationship
.... id
n/a
.... extension
n/a
.... modifierExtension
N/A
.... substanceDefinition[x]
Substance_Relationship.Related_Substance_Id
.... type
Substance_Relationship.Relationship_Type
.... isDefining
Substance_Relationship.Is_Defining
.... amount[x]
Substance_Relationship.Amount.Quantity
.... ratioHighLimitAmount
Substance_Relationship.Amount.Quantity.High_Limit
.... comparator
Substance_Relationship.Amount_Type
.... source
Substance_Relationship.Reference_Source
... nucleicAcid
(used to add specifics of Nucleic Acids to Substances)
... polymer
(used to add specifics of Polymers to Substances)
... protein
(used to add specifics of Proteins to Substances)
... sourceMaterial
Substance.Source_Material
.... id
n/a
.... extension
n/a
.... modifierExtension
N/A
.... type
Source_Material.Source_Material_Type
.... genus
Source_Material.Organism.Genus
.... species
Source_Material.Organism.Species
.... part
Source_Material.Part_Description.Part
.... countryOfOrigin
Source_Material.Country_Of_Origin

doco Documentation for this format