Preferred Label : Specified Unidentified Impurity Test;
NCIt related terms : Specified Unidentified Impurity;
NCIt definition : Testing for an impurity that is individually listed and limited with a specific acceptance
criterion in the new drug substance or drug product specification and that is defined
solely by qualitative analytical properties and lacks a structured characterization.;
Alternative definition : PQCMC: Testing for an impurity that is individually listed and limited with a specific
acceptance criterion in the new drug substance or drug product specification and that
is defined solely by qualitative analytical properties (e.g., chromatographic retention
time) due to the lack of achieving a structured characterization. Note: this includes
degradation products for tests conducted on drug products.;
NCI Metathesaurus CUI : CL1927159;
Origin ID : C205040;
concept_is_in_subset
