pharmaceutical degradation product impurity role
IRI: https://spec.industrialontologies.org/ontology/construct/PharmaceuticalDegradationProductImpurityRole
Defined In: https://spec.industrialontologies.org/ontology/biopharma/BiopharmaMaterial/
SubClass Of: pharmaceutical product related impurity role
Class Hierarchy
owl:Thing › bfo:entity › bfo:continuant › bfo:specifically dependent continuant › bfo:realizable entity › bfo:role › material impurity role › pharmaceutical product related impurity role › pharmaceutical degradation product impurity role
Definition
pharmaceutical product related impurity role held by a material entity that differs from the targeted drug substance or drug product as a result of chemical change occurring during manufacture or storage
Explanatory Notes
Chemical change may be caused by light, temperature, pH, water, oxygen, process conditions, storage conditions, or reaction with an excipient or the immediate container closure system. Degradation product impurity role is used for product-related material that arises through degradation of the targeted drug substance or drug product, rather than through adventitious introduction or carryover of process materials.
Examples
- the degradation product impurity role of oxidized protein species formed during storage; the degradation product impurity role of deamidated protein variants formed under formulation pH conditions; the degradation product impurity role of hydrolyzed drug substance material formed during storage;
Adapted From
- https://database.ich.org/sites/default/files/Q3B%28R2%29%20Guideline.pdf
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 necessary and sufficient conditions.
Formal Axioms
First-Order Logic Axioms
PharmaceuticalDegradationProductImpurityRole(x) → PharmaceuticalProductRelatedImpurityRole(x)
Semi-Formal Natural Language Axioms
if x is a ‘pharmaceutical degradation product impurity role’ then x is a ‘pharmaceutical product related impurity role’