| 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'. | |
meta
|
||||
profile
|
S | ..1 | ||
|
identifier
|
S | ..1 | optional user designated identifier | |
|
classification
|
S | Impurity Classification | ||
|
coding
|
Binding: Impurity Classification Terminology ( required ) | |||
|
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.. | ||
|
structure
|
S | |||
|
technique
|
S | Substance Structure Technique | ||
|
text
|
S | 1.. | ||
|
representation
|
S | |||
|
representation
|
S | Impurity Analysis Graphic | Impurity Analytical Instrument Data File | Impurity Chemical Structure Data File | ||
|
format
|
S | Drug Substance Impurity Method Type| Drug Product Impurity Method Type | ||
|
coding
|
Binding: Chemical Structure Data File Type Terminology ( required ) | |||
document
|
S | Reference (Document Reference Attachment) | Impurity 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: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: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: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
|
||||