Preferred Label : Specified Identified Impurity Test;
NCIt related terms : Specified Identified 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 for which a
structured characterization has been achieved.;
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 for
which a structured characterization has been achieved. Note: this includes degradation
products for tests conducted on drug products.;
NCI Metathesaurus CUI : CL1927160;
Origin ID : C205039;
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