Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
2.0.0 - STU2

Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA, published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 2.0.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/FHIR-us-pq-cmc-fda/ and changes regularly. See the Directory of published versions

## Resource Profile: DrugSubstanceNomenclatureStructure - Mappings

Page standards status: Trial-use | Maturity Level: 2

Mappings for the pqcmc-drug-substance-nomenclature-structure resource profile.

#### Mappings to Structures in this Implementation Guide

No Mappings Found

#### Mappings to other Structures

No Mappings Found

#### Other Mappings

Name | FiveWs Pattern Mapping | IDMP Mapping (Substance) | RIM Mapping
--- | --- | --- | ---
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 |
file |  | 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 |
id |  |  | n/a
extension |  |  | n/a
value |  |  | PQ.value CO.value MO.value IVL.high or IVL.low depending on the value
comparator |  |  | IVL properties
unit |  |  | PQ.unit
system |  |  | CO.codeSystem PQ.translation.codeSystem
code |  |  | PQ.code MO.currency PQ.translation.code
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:sys |  | 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: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:brand |  | 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:usp |  | 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:cas |  | 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:inn |  | 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:usan |  | 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:iupac |  | 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 |
id |  |  | n/a
extension |  |  | n/a
coding |  |  | union(. ./translation)
text |  |  | ./originalText[mediaType/code="text/plain"]/data
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 |
Documentation for this format