stability

IRI: https://spec.industrialontologies.org/ontology/construct/Stability

Defined In: https://spec.industrialontologies.org/ontology/biopharma/BiopharmaReferenceOntologyAttributes/

SubClass Of: capability

Class Hierarchy

owl:Thing › bfo:entity › bfo:continuant › bfo:specifically dependent continuant › bfo:realizable entity › bfo:disposition › capability › stability

Direct subclasses:

• photostability
• thermal stability

Definition

capability of a material entity to resist change in one or more of its attributes during a particular process

Examples

• Stability of a drug substance batch during refrigerated storage; Stability of a formulated drug product during accelerated stability testing; Stability of a cell culture medium lot during storage at 2–8 °C; Stability of a buffer preparation during a defined hold interval;

Adapted From

• https://database.ich.org/sites/default/files/Q1A%28R2%29%20Guideline.pdf and https://goldbook.iupac.org/terms/view/08027

Primitive Class

This class is declared primitive and it does not have necessary and sufficient condiftions defined.

Primitive Rationale

There are insufficient constructs to create a set of necessary and sufficient conditions.

Formal Axioms

First-Order Logic Axioms

Stability(x) → Capability(x) ∧ ∃m (MaterialEntity(m) ∧ capabilityOf(x, m))

Semi-Formal Natural Language Axioms

if x is a ‘stability’ then x is a ‘capability’ that is the ‘capability of’ some ‘material entity’

Description Logic

constr:Stability ⊑ constr:Capability

constr:Stability ⊑ ∃ constr:capabilityOf .bfo:material_entity

SubClassOf: constr:Capability

SubClassOf: constr:capabilityOf some bfo:material_entity