Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
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This page is part of the Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA (v1.0.0-ballot: STU1 Ballot 1) based on FHIR (HL7® FHIR® Standard) v5.0.0. . For a full list of available versions, see the Directory of published versions

Extension: Strength Extension

Official URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/strength-extension Version: 1.0.0-ballot
Active as of 2024-04-08 Computable Name: StrengthExtension
Other Identifiers: OID:2.16.840.1.113883.4.642.40.36.42.33

Values required in Ingredient.substance.strength

Context of Use

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

  • Element ID Ingredient.substance.strength

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

Complex Extension: Values required in Ingredient.substance.strength

  • strengthType: CodeableConcept: A physical (content) or activity measurement of the strength of the ingredient. [Source: SME Defined] Example: Mass, Activity
  • contentPercent: decimal: The percentage of the component in the drug product. [Source: SME Defined] Example: Product Total Weight = 1200 mg and Product Ingredient Amount = 325 mg, so Product Ingredient Content Percent = 27.08
  • strengthOperator: CodeableConcept: A mathematical symbol that denotes equality or inequality between two values Note: This is typically applicable to biologics

This structure is derived from Extension

NameFlagsCard.TypeDescription & Constraintsdoco
.. Extension 0..* Extension Strength Extension
... extension 2..* Extension Extension
... extension:strengthType S 1..1 Extension Strength Type (for API)
.... extension 0..0
.... url 1..1 uri "strengthType"
.... value[x] 0..1 CodeableConcept Value of extension
Binding: Strength Type Terminology (required)
... extension:contentPercent S 1..1 Extension Product Ingredient Content Percent
.... extension 0..0
.... url 1..1 uri "contentPercent"
.... value[x] 0..1 decimal Value of extension
.... extension 0..0
.... url 1..1 uri "strengthOperator"
.... value[x] 0..1 CodeableConcept Value of extension
Binding: Strength Operator Terminology (required)
... url 1..1 uri "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/strength-extension"
... value[x] 0..0

doco Documentation for this format
NameFlagsCard.TypeDescription & Constraintsdoco
.. Extension 0..* Extension Strength Extension
... id 0..1 id Unique id for inter-element referencing
... Slices for extension 2..* Extension Extension
Slice: Unordered, Open by value:url
... extension:strengthType S 1..1 Extension Strength Type (for API)
.... id 0..1 id Unique id for inter-element referencing
.... extension 0..0
.... url 1..1 uri "strengthType"
.... value[x] 0..1 CodeableConcept Value of extension
Binding: Strength Type Terminology (required)
.... id 0..1 id Unique id for inter-element referencing
.... extension 0..0
.... url 1..1 uri "contentPercent"
.... value[x] 0..1 decimal Value of extension
... extension:strengthOperator S 0..1 Extension Strength Operator
.... id 0..1 id Unique id for inter-element referencing
.... extension 0..0
.... url 1..1 uri "strengthOperator"
.... value[x] 0..1 CodeableConcept Value of extension
Binding: Strength Operator Terminology (required)
... url 1..1 uri "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/strength-extension"

doco Documentation for this format

This structure is derived from Extension

Summary

Complex Extension: Values required in Ingredient.substance.strength

  • strengthType: CodeableConcept: A physical (content) or activity measurement of the strength of the ingredient. [Source: SME Defined] Example: Mass, Activity
  • contentPercent: decimal: The percentage of the component in the drug product. [Source: SME Defined] Example: Product Total Weight = 1200 mg and Product Ingredient Amount = 325 mg, so Product Ingredient Content Percent = 27.08
  • strengthOperator: CodeableConcept: A mathematical symbol that denotes equality or inequality between two values Note: This is typically applicable to biologics

Differential View

This structure is derived from Extension

NameFlagsCard.TypeDescription & Constraintsdoco
.. Extension 0..* Extension Strength Extension
... extension 2..* Extension Extension
... extension:strengthType S 1..1 Extension Strength Type (for API)
.... extension 0..0
.... url 1..1 uri "strengthType"
.... value[x] 0..1 CodeableConcept Value of extension
Binding: Strength Type Terminology (required)
... extension:contentPercent S 1..1 Extension Product Ingredient Content Percent
.... extension 0..0
.... url 1..1 uri "contentPercent"
.... value[x] 0..1 decimal Value of extension
.... extension 0..0
.... url 1..1 uri "strengthOperator"
.... value[x] 0..1 CodeableConcept Value of extension
Binding: Strength Operator Terminology (required)
... url 1..1 uri "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/strength-extension"
... value[x] 0..0

doco Documentation for this format

Snapshot View

NameFlagsCard.TypeDescription & Constraintsdoco
.. Extension 0..* Extension Strength Extension
... id 0..1 id Unique id for inter-element referencing
... Slices for extension 2..* Extension Extension
Slice: Unordered, Open by value:url
... extension:strengthType S 1..1 Extension Strength Type (for API)
.... id 0..1 id Unique id for inter-element referencing
.... extension 0..0
.... url 1..1 uri "strengthType"
.... value[x] 0..1 CodeableConcept Value of extension
Binding: Strength Type Terminology (required)
.... id 0..1 id Unique id for inter-element referencing
.... extension 0..0
.... url 1..1 uri "contentPercent"
.... value[x] 0..1 decimal Value of extension
... extension:strengthOperator S 0..1 Extension Strength Operator
.... id 0..1 id Unique id for inter-element referencing
.... extension 0..0
.... url 1..1 uri "strengthOperator"
.... value[x] 0..1 CodeableConcept Value of extension
Binding: Strength Operator Terminology (required)
... url 1..1 uri "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/strength-extension"

doco Documentation for this format

 

Other representations of profile: CSV, Excel, Schematron

Terminology Bindings

PathConformanceValueSetURI
Extension.extension:strengthType.value[x]requiredPqcmcStrengthTypeTerminology
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-strength-type-terminology
from this IG
Extension.extension:strengthOperator.value[x]requiredPqcmcStrengthOperatorTerminology
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-strength-operator-terminology
from this IG

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()