Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
2.0.0-ballot - 2025Jan United States of America flag

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 2.0.0-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: Amount Ratio

Official URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-amount-ratio Version: 2.0.0-ballot
Active as of 2024-12-04 Computable Name: AmountRatio
Other Identifiers: OID:2.16.840.1.113883.4.642.40.36.42.60

represent an amount as a ratio in ManufacturedItemDefinition

Context of Use

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

  • Element ID ManufacturedItemDefinition.component
  • 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 Ratio: represent an amount as a ratio in ManufacturedItemDefinition

This structure is derived from Extension

NameFlagsCard.TypeDescription & Constraintsdoco
.. Extension ?! 0..* Extension Amount Ratio
... extension 0..0
... url 1..1 uri "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-amount-ratio"
... value[x] S 1..1 Ratio Value of extension
.... numerator S 1..1 Quantity Amount Numeric Numerator
..... value S 1..1 decimal Numerical value (with implicit precision)
.... denominator S 1..1 SimpleQuantity Amount Numeric Denominator
Binding: Non-Percentage Units (required)
..... value S 1..1 decimal Numerical value (with implicit precision)
..... unit S 1..1 string Unit representation
..... code S 1..1 code Coded form of the unit

doco Documentation for this format
NameFlagsCard.TypeDescription & Constraintsdoco
.. Extension ?! 0..* Extension Amount Ratio
... 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-amount-ratio"
.... id 0..1 id Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... numerator SΣC 1..1 Quantity Amount Numeric Numerator
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... value SΣ 1..1 decimal Numerical value (with implicit precision)
..... comparator ?!Σ 0..1 code < | <= | >= | > | ad - how to understand the value
Binding: QuantityComparator (required): How the Quantity should be understood and represented.

..... unit Σ 0..1 string Unit representation
..... system ΣC 0..1 uri System that defines coded unit form
..... code ΣC 0..1 code Coded form of the unit
.... denominator SΣC 1..1 SimpleQuantity Amount Numeric Denominator
Binding: Non-Percentage Units (required)
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... value SΣ 1..1 decimal Numerical value (with implicit precision)
..... unit SΣ 1..1 string Unit representation
..... system ΣC 0..1 uri System that defines coded unit form
..... code SΣC 1..1 code Coded form of the unit

doco Documentation for this format

This structure is derived from Extension

Summary

Simple Extension of type Ratio: represent an amount as a ratio in ManufacturedItemDefinition

Differential View

This structure is derived from Extension

NameFlagsCard.TypeDescription & Constraintsdoco
.. Extension ?! 0..* Extension Amount Ratio
... extension 0..0
... url 1..1 uri "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-amount-ratio"
... value[x] S 1..1 Ratio Value of extension
.... numerator S 1..1 Quantity Amount Numeric Numerator
..... value S 1..1 decimal Numerical value (with implicit precision)
.... denominator S 1..1 SimpleQuantity Amount Numeric Denominator
Binding: Non-Percentage Units (required)
..... value S 1..1 decimal Numerical value (with implicit precision)
..... unit S 1..1 string Unit representation
..... code S 1..1 code Coded form of the unit

doco Documentation for this format

Snapshot View

NameFlagsCard.TypeDescription & Constraintsdoco
.. Extension ?! 0..* Extension Amount Ratio
... 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-amount-ratio"
.... id 0..1 id Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... numerator SΣC 1..1 Quantity Amount Numeric Numerator
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... value SΣ 1..1 decimal Numerical value (with implicit precision)
..... comparator ?!Σ 0..1 code < | <= | >= | > | ad - how to understand the value
Binding: QuantityComparator (required): How the Quantity should be understood and represented.

..... unit Σ 0..1 string Unit representation
..... system ΣC 0..1 uri System that defines coded unit form
..... code ΣC 0..1 code Coded form of the unit
.... denominator SΣC 1..1 SimpleQuantity Amount Numeric Denominator
Binding: Non-Percentage Units (required)
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... value SΣ 1..1 decimal Numerical value (with implicit precision)
..... unit SΣ 1..1 string Unit representation
..... system ΣC 0..1 uri System that defines coded unit form
..... code SΣC 1..1 code Coded form of the unit

doco Documentation for this format

 

Other representations of profile: CSV, Excel, Schematron

Terminology Bindings

PathConformanceValueSetURI
Extension.value[x].numerator.comparatorrequiredQuantityComparator
http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0
from the FHIR Standard
Extension.value[x].denominatorrequiredPqcmcNonPercentageUnits
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-units
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()