Source | hl7.fhir.us.pq-cmc#current:PQ/CMC FHIR Implementation Guide (v5.0.0) |
resourceType | StructureDefinition |
id | pqcmc-drug-substance-molecular-structure |
canonical | http://hl7.org/fhir/us/pq-cmc/StructureDefinition/pqcmc-drug-substance-molecular-structure |
version | 0.1.15 |
status | draft |
publisher | HL7 International - Biomedical Research and Regulatory WG |
name | DrugSubstanceMolecularStructure |
title | Drug Substance Molecular Structure |
date | 2023-07-17T03:00:13+00:00 |
description | Drug Substance (Active Ingredient) molecular structure. Profile on Drug Substance profile. |
jurisdictions | us |
fhirVersion | 5.0.0 |
kind | resource |
abstract | false |
sdTtype | SubstanceDefinition |
derivation | constraint |
base | http://hl7.org/fhir/StructureDefinition/SubstanceDefinition |
Usages |
|
Name | Flags | Card. | Type | Description & Constraints |
---|---|---|---|---|
SubstanceDefinition | C | SubstanceDefinition |
cmc-structure-required:
A structure is required in code for any of these categories: 'Chemical', 'Mixture', 'Nucleic Acid','Polymer','Protein - Other'. cmc-when-unii-required: A UNII is required in code for any of these categories: 'Chemical', 'Mixture', 'Nucleic Acid','Polymer','Protein - Other'. cmc-substance-structure-graphic-required: A Substance Structure Graphic is required Required for Small Molecules. Equivalent to classification code equals 'Chemical'. cmc-name-isbt: Name.type ISBT 128 requried for blood products. |
|
meta | ||||
profile | S | ..1 | ||
identifier | S | ..1 | optional user designated identifier | |
classification | S | 1.. |
Substance Type Binding: EVMPD Substance Classification ( required ) |
|
structure | S | 1.. | ||
molecularFormula | S | Molecular Formula | Biopolymer Sequence | ||
technique | S | 1..1 | Substance Structure Technique | |
text | S | 1.. | ||
representation | S | 1.. | ||
representation | S | Drug Substance Structural Representation | ||
format | S | Structural Representation Type | ||
coding | Binding: Chemical Structure Data File Type Terminology ( required ) | |||
document | S | Reference (Document Reference Attachment) | Structure Graphic | |
code | S | |||
code | ||||
Slices for coding | Slice: Unordered, Closed by pattern:system | |||
coding:unii | 0..1 | UNII | ||
system | 1.. | Required Pattern: https://gsrs.ncats.nih.gov | ||
coding:uniProt | 0..1 | UniProt ID | ||
system | 1.. | Required Pattern: https://www.uniprot.org | ||
Slices for name | S C | 1 .. |
Only one name required
Slice: Unordered, Closed by value:type.coding cmc-name-preferred: Name.preferred: at most one = true |
|
name:All Slices | Content/Rules for all slices | |||
preferred | S | True when the name type is Substance Name | ||
name:sys | S | 0..1 | ||
name | S | Systematic | ||
type | S | 1.. | ||
coding | S | 1..1 | Required Pattern: At least the following | |
system | 1..1 | uri |
Identity of the terminology system Fixed Value: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl |
|
code | 1..1 | code |
Symbol in syntax defined by the system Fixed Value: 145 |
|
display | 1..1 | string |
Representation defined by the system Fixed Value: Systematic |
|
preferred | S | |||
name:sub | S | 0..1 | ||
name | S | Generic | ||
type | S | 1.. | ||
coding | S | 1..1 | Required Pattern: At least the following | |
system | 1..1 | uri |
Identity of the terminology system Fixed Value: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl |
|
code | 1..1 | code |
Symbol in syntax defined by the system Fixed Value: 138 |
|
display | 1..1 | string |
Representation defined by the system Fixed Value: Generic |
|
preferred | S | |||
name:brand | S | 0..1 | ||
name | S | Brand | ||
type | S | 1.. | ||
coding | S | 1..1 | Required Pattern: At least the following | |
system | 1..1 | uri |
Identity of the terminology system Fixed Value: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl |
|
code | 1..1 | code |
Symbol in syntax defined by the system Fixed Value: 137 |
|
display | 1..1 | string |
Representation defined by the system Fixed Value: Brand |
|
preferred | S | |||
name:comn | S | 0..1 | ||
name | S | Common | ||
type | S | 1.. | ||
coding | S | 1..1 | Required Pattern: At least the following | |
system | 1..1 | uri |
Identity of the terminology system Fixed Value: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl |
|
code | 1..1 | code |
Symbol in syntax defined by the system Fixed Value: 139 |
|
display | 1..1 | string |
Representation defined by the system Fixed Value: Common |
|
preferred | S | |||
name:gsrs | S | 0..1 | ||
name | S | GSRS Preferred | ||
type | S | 1.. | ||
coding | S | 1..1 | Required Pattern: At least the following | |
system | 1..1 | uri |
Identity of the terminology system Fixed Value: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl |
|
code | 1..1 | code |
Symbol in syntax defined by the system Fixed Value: 141 |
|
display | 1..1 | string |
Representation defined by the system Fixed Value: GSRS Preferred |
|
preferred | S | |||
name:usp | S | 0..1 | ||
name | S | USP/NF | ||
type | S | 1.. | ||
coding | S | 1..1 | Required Pattern: At least the following | |
system | 1..1 | uri |
Identity of the terminology system Fixed Value: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl |
|
code | 1..1 | code |
Symbol in syntax defined by the system Fixed Value: 147 |
|
display | 1..1 | string |
Representation defined by the system Fixed Value: USP/NF |
|
preferred | S | |||
name:comp | S | 0..1 | ||
name | S | Company Code | ||
type | S | 1.. | ||
coding | 1..1 | Required Pattern: At least the following | ||
system | 1..1 | uri |
Identity of the terminology system Fixed Value: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl |
|
code | 1..1 | code |
Symbol in syntax defined by the system Fixed Value: Company |
|
display | 1..1 | string |
Representation defined by the system Fixed Value: Company ID/Code |
|
preferred | S | |||
name:cas | S | 0..1 | ||
name | S | CAS Number | ||
type | S | 1.. | ||
coding | S | 1..1 | Required Pattern: At least the following | |
system | 1..1 | uri |
Identity of the terminology system Fixed Value: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl |
|
code | 1..1 | code |
Symbol in syntax defined by the system Fixed Value: 222 |
|
display | 1..1 | string |
Representation defined by the system Fixed Value: CAS Number |
|
preferred | S | |||
name:inn | S | 0..1 | ||
name | S | INN | ||
type | S | 1.. | ||
coding | S | 1..1 | Required Pattern: At least the following | |
system | 1..1 | uri |
Identity of the terminology system Fixed Value: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl |
|
code | 1..1 | code |
Symbol in syntax defined by the system Fixed Value: 223 |
|
display | 1..1 | string |
Representation defined by the system Fixed Value: INN |
|
preferred | S | |||
name:usan | S | 0..1 | ||
name | S | USAN | ||
type | S | 1.. | ||
coding | S | 1..1 | Required Pattern: At least the following | |
system | 1..1 | uri |
Identity of the terminology system Fixed Value: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl |
|
code | 1..1 | code |
Symbol in syntax defined by the system Fixed Value: 224 |
|
display | 1..1 | string |
Representation defined by the system Fixed Value: USAN |
|
preferred | S | |||
name:iupac | S | 0..1 | ||
name | S | IUPAC | ||
type | S | 1.. | ||
coding | S | 1..1 | Required Pattern: At least the following | |
system | 1..1 | uri |
Identity of the terminology system Fixed Value: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl |
|
code | 1..1 | code |
Symbol in syntax defined by the system Fixed Value: 225 |
|
display | 1..1 | string |
Representation defined by the system Fixed Value: IUPAC |
|
preferred | S | |||
name:isbt | S | 0..1 | ||
name | S | ISBT 128 | ||
type | S | 1.. | ||
coding | S | 1..1 | Required Pattern: At least the following | |
system | 1..1 | uri |
Identity of the terminology system Fixed Value: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl |
|
code | 1..1 | code |
Symbol in syntax defined by the system Fixed Value: 226 |
|
display | 1..1 | string |
Representation defined by the system Fixed Value: ISBT 128 |
|
preferred | S | |||
Documentation for this format |
Produced 08 Sep 2023