Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
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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 1.0.0-ballot 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

Extension: Content Percent

Official URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/content-percent Version: 1.0.0-ballot
Active as of 2024-04-04 Computable Name: ContentPercent
Other Identifiers: OID:2.16.840.1.113883.4.642.40.36.42.7

constituent content percent

Context of Use

This extension may be used on the following element(s):

  • Element ID ManufacturedItemDefinition.component.constituent

Usage info

Usage:

Formal Views of Extension Content

Description of Profiles, Differentials, Snapshots, and how the XML and JSON presentations work.

This structure is derived from Extension

Summary

Simple Extension of type decimal: constituent content percent

This structure is derived from Extension

NameFlagsCard.TypeDescription & Constraintsdoco
.. Extension 0..* Extension Constituent Content Percent
... extension 0..0
... url 1..1 uri "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/content-percent"
... value[x] C 1..1 decimal Value of extension
cmc-decimal-format: Content percent must be in the format of leading zero, decimal point, any number of digits up to 17 places.

doco Documentation for this format
NameFlagsCard.TypeDescription & Constraintsdoco
.. Extension 0..* Extension Constituent Content Percent
... id 0..1 id Unique id for inter-element referencing
... extension 0..0
... url 1..1 uri "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/content-percent"

doco Documentation for this format

This structure is derived from Extension

Summary

Simple Extension of type decimal: constituent content percent

Differential View

This structure is derived from Extension

NameFlagsCard.TypeDescription & Constraintsdoco
.. Extension 0..* Extension Constituent Content Percent
... extension 0..0
... url 1..1 uri "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/content-percent"
... value[x] C 1..1 decimal Value of extension
cmc-decimal-format: Content percent must be in the format of leading zero, decimal point, any number of digits up to 17 places.

doco Documentation for this format

Snapshot View

NameFlagsCard.TypeDescription & Constraintsdoco
.. Extension 0..* Extension Constituent Content Percent
... id 0..1 id Unique id for inter-element referencing
... extension 0..0
... url 1..1 uri "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/content-percent"

doco Documentation for this format

 

Other representations of profile: CSV, Excel, Schematron

Constraints

IdGradePath(s)DetailsRequirements
cmc-decimal-formaterrorExtension.value[x]Content percent must be in the format of leading zero, decimal point, any number of digits up to 17 places.
: value.toString().matches('^(1([.]0{1,17})?|0([.][0-9]{1,17})?)$') = true
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()