Release 5 Preview #3
Biomedical Research and Regulation Work GroupMaturity Level: 1 Trial UseSecurity Category: Anonymous Compartments: Not linked to any defined compartments

Detailed Descriptions for the elements in the Ingredient resource.

Ingredient
Element IdIngredient
Definition

An ingredient of a manufactured item or pharmaceutical product.

Cardinality0..*
TypeDomainResource
Summarytrue
Ingredient.identifier
Element IdIngredient.identifier
Definition

The identifier(s) of this Ingredient that are assigned by business processes and/or used to refer to it when a direct URL reference to the resource itself is not appropriate.

NoteThis is a business identifier, not a resource identifier (see discussion)
Cardinality0..1
TypeIdentifier
Summarytrue
Ingredient.role
Element IdIngredient.role
Definition

A classification of the ingredient identifying its purpose within the product, e.g. active, inactive.

Cardinality1..1
TypeCodeableConcept
Summarytrue
Ingredient.function
Element IdIngredient.function
Definition

A classification of the ingredient identifying its precise purpose(s) in the drug product. This extends the Ingredient.role to add more detail. Example: Antioxidant, Alkalizing Agent.

Cardinality0..*
TypeCodeableConcept
Summarytrue
Ingredient.description
Element IdIngredient.description
Definition

A general description of the ingredient, or any supporting text. May be used for an unstructured list of excipients.

Cardinality0..1
Typemarkdown
Summarytrue
Ingredient.allergenicIndicator
Element IdIngredient.allergenicIndicator
Definition

If the ingredient is a known or suspected allergen.

Cardinality0..1
Typeboolean
Summarytrue
Ingredient.manufacturer
Element IdIngredient.manufacturer
Definition

The organization that manufactures this ingredient.

Cardinality0..*
TypeReference(Organization)
Summarytrue
Ingredient.substance
Element IdIngredient.substance
Definition

The substance that comprises this ingredient.

Cardinality0..1
Summarytrue
Ingredient.substance.code
Element IdIngredient.substance.code
Definition

A code or full resource that represents the ingredient substance.

Cardinality1..1
TypeCodeableReference(SubstanceDefinition | Substance)
PatternsCodeableReference(SubstanceDefinition,Substance): No common pattern
Summarytrue
Ingredient.substance.strength
Element IdIngredient.substance.strength
Definition

The quantity of substance in the unit of presentation, or in the volume (or mass) of the single pharmaceutical product or manufactured item. When there is a range of strengths, this represents the lower limit.

Cardinality0..*
Summarytrue
Ingredient.substance.strength.presentation
Element IdIngredient.substance.strength.presentation
Definition

The quantity of substance in the unit of presentation, or in the volume (or mass) of the single pharmaceutical product or manufactured item.

Cardinality0..1
TypeRatio
Summarytrue
Ingredient.substance.strength.presentationHighLimit
Element IdIngredient.substance.strength.presentationHighLimit
Definition

An upper limit for the quantity of substance in the unit of presentation. When there is a range of strengths, this represents the upper limit.

Cardinality0..1
TypeRatio
Is Modifiertrue (Reason: If this is present it implies that the whole strength is expressed as a range, due to uncertainty or variation)
Summarytrue
Ingredient.substance.strength.presentationText
Element IdIngredient.substance.strength.presentationText
Definition

A textual represention of either the whole of the presentation strength or a part of it - with the rest being in Strength.presentation as a ratio.

Cardinality0..1
Typestring
Summarytrue
Ingredient.substance.strength.concentration
Element IdIngredient.substance.strength.concentration
Definition

The strength per unitary volume (or mass).

Cardinality0..1
TypeRatio
Summarytrue
Ingredient.substance.strength.concentrationHighLimit
Element IdIngredient.substance.strength.concentrationHighLimit
Definition

An upper limit for the strength per unitary volume (or mass), for when there is a range. The concentration attribute then becomes the lower limit.

Cardinality0..1
TypeRatio
Is Modifiertrue (Reason: If this is present it implies that the whole strength is expressed as a range, due to uncertainty or variation)
Summarytrue
Ingredient.substance.strength.concentrationText
Element IdIngredient.substance.strength.concentrationText
Definition

A textual represention of either the whole of the concentration strength or a part of it - with the rest being in Strength.concentration as a ratio.

Cardinality0..1
Typestring
Summarytrue
Ingredient.substance.strength.measurementPoint
Element IdIngredient.substance.strength.measurementPoint
Definition

For when strength is measured at a particular point or distance.

Cardinality0..1
Typestring
Summarytrue
Ingredient.substance.strength.country
Element IdIngredient.substance.strength.country
Definition

The country or countries for which the strength range applies.

Cardinality0..*
TypeCodeableConcept
Summarytrue
Ingredient.substance.strength.referenceStrength
Element IdIngredient.substance.strength.referenceStrength
Definition

Strength expressed in terms of a reference substance.

Cardinality0..*
Summarytrue
Ingredient.substance.strength.referenceStrength.substance
Element IdIngredient.substance.strength.referenceStrength.substance
Definition

Relevant reference substance.

Cardinality0..1
TypeCodeableReference(SubstanceDefinition | Substance)
PatternsCodeableReference(SubstanceDefinition,Substance): No common pattern
Summarytrue
Ingredient.substance.strength.referenceStrength.strength
Element IdIngredient.substance.strength.referenceStrength.strength
Definition

Strength expressed in terms of a reference substance. When there is a range of strengths, this represents the lower limit.

Cardinality1..1
TypeRatio
Summarytrue
Ingredient.substance.strength.referenceStrength.strengthHighLimit
Element IdIngredient.substance.strength.referenceStrength.strengthHighLimit
Definition

Strength expressed in terms of a reference substance. When there is a range of strengths, this represents the upper limit.

Cardinality0..1
TypeRatio
Summarytrue
Ingredient.substance.strength.referenceStrength.measurementPoint
Element IdIngredient.substance.strength.referenceStrength.measurementPoint
Definition

For when strength is measured at a particular point or distance.

Cardinality0..1
Typestring
Summarytrue
Ingredient.substance.strength.referenceStrength.country
Element IdIngredient.substance.strength.referenceStrength.country
Definition

The country or countries for which the strength range applies.

Cardinality0..*
TypeCodeableConcept
Summarytrue
Ingredient.specifiedSubstance
Element IdIngredient.specifiedSubstance
Definition

A specified substance that comprises this ingredient.

Cardinality0..*
Summarytrue
Ingredient.specifiedSubstance.code
Element IdIngredient.specifiedSubstance.code
Definition

Substance as a 'specified substance', implying extra substance related characteristics.

Cardinality1..1
TypeCodeableReference(SubstanceDefinition | Substance)
PatternsCodeableReference(SubstanceDefinition,Substance): No common pattern
Summarytrue
Ingredient.specifiedSubstance.group
Element IdIngredient.specifiedSubstance.group
Definition

The group of specified substance, e.g. group 1 to 4, where the group categorises the level of description of the substance according to standardised sets of properties.

Cardinality1..1
TypeCodeableConcept
Summarytrue
Ingredient.specifiedSubstance.confidentiality
Element IdIngredient.specifiedSubstance.confidentiality
Definition

Confidentiality level of the specified substance as the ingredient.

Cardinality0..1
TypeCodeableConcept
Summarytrue
Ingredient.specifiedSubstance.strength
Element IdIngredient.specifiedSubstance.strength
Definition

Quantity of the substance or specified substance present in the manufactured item or pharmaceutical product.

Cardinality0..*
TypeSee Ingredient.substance.strength
Summarytrue