| 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 ) |
|
manufacturer
|
S | 1..1 | Reference (Manufacturing and/or Test Site Organization) | |
|
supplier
|
S | ..1 | Reference (Supplier Organization) | |
|
characterization
|
S | |||
|
technique
|
||||
|
text
|
S | 1.. | ||
|
form
|
||||
|
text
|
S | Form | ||
|
description
|
S | Analytical Instrument Data File Narrative Text | ||
|
file
|
S | ..1 | Anlaysis Graphic | |
data
|
S | 1.. | ||
|
title
|
S | 1.. | ||
|
molecularWeight
|
S | ..1 | Molecular Weight | |
|
amount
|
S | |||
|
unit
|
Molecular Weight UOM | |||
|
code
|
S | 1.. | Binding: Units Of Measure Terminology ( required ) | |
|
structure
|
S | 1.. | ||
|
molecularFormula
|
S | Molecular Formula | Biopolymer Sequence | ||
|
technique
|
S | 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, Open 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 | |||
|
relationship
|
S | |||
|
Slices for substanceDefinition[x]
|
Slice: Unordered, Open by type:$this | |||
|
substanceDefinition[x]:substanceDefinitionReference
|
0..1 | Reference (Drug Substance Impurity | Polymorphic Form | Component Substance) | ||
|
type
|
||||
|
text
|
Values: 'Polymorph', 'Raw Material', and 'Impurity' | |||
|
Documentation for this format
|
||||