Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
2.0.0 - STU2 United States of America flag

This page is part of the Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA (v2.0.0: STU2) based on FHIR (HL7® FHIR® Standard) v5.0.0. This is the current published version. For a full list of available versions, see the Directory of published versions

Extension: Product Batch Strength Textual Extension

Official URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-product-batch-strength-textual-extension Version: 2.0.0
Standards status: Trial-use Maturity Level: 2 Computable Name: ProductBatchStrengthTextualExtension
Other Identifiers: OID:2.16.840.1.113883.4.642.40.36.42.64

Extension for strength as a string for ingredients in the batch formula.

Context of Use

Usage info

Usages:

Formal Views of Extension Content

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

This structure is derived from Extension

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Extension 0..* Extension Product Batch Strength Textual Extension
... extension 0..0
... url 1..1 uri "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-product-batch-strength-textual-extension"
... value[x] S 1..1 string Strength Textual

doco Documentation for this format
NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Extension 0..* Extension Product Batch Strength Textual Extension
... 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/pq-product-batch-strength-textual-extension"

doco Documentation for this format

This structure is derived from Extension

Summary

Simple Extension with the type string: Extension for strength as a string for ingredients in the batch formula.

Maturity: 2

Differential View

This structure is derived from Extension

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Extension 0..* Extension Product Batch Strength Textual Extension
... extension 0..0
... url 1..1 uri "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-product-batch-strength-textual-extension"
... value[x] S 1..1 string Strength Textual

doco Documentation for this format

Snapshot View

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Extension 0..* Extension Product Batch Strength Textual Extension
... 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/pq-product-batch-strength-textual-extension"

doco Documentation for this format

This structure is derived from Extension

Summary

Simple Extension with the type string: Extension for strength as a string for ingredients in the batch formula.

Maturity: 2

 

Other representations of profile: CSV, Excel, Schematron

Constraints

IdGradePath(s)DetailsRequirements
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()