Preferred Label : Unspecified Product Impurity below ICH Identification Threshold;
NCIt related terms : Identified Impurity under IT, Monitored as Unspecified;
NCIt definition : Identified unspecified impurities which are below the ICH (International Council for
Harmonisation) identification threshold in a pharmacologic product.;
Alternative definition : PQCMC: Identification (chemical name and/or UNII code) of all the identified (known)
impurities that are being controlled as unspecified impurities rather than Specified
Identified Impurity due to the level being consistently below the ICH identification
threshold (IT) value. Note: this includes degradation products for tests conducted
on drug products.;
NCI Metathesaurus CUI : CL1927119;
Origin ID : C205051;
concept_is_in_subset
