Assertion: genotoxic impurity | /r/HasProperty | identified
Facets:
Source sentences:
text: According to the ICH guidelines, when genotoxic impurities are identified, an appropriate control strategy leveraging process understanding and/or analytical controls should be developed to ensure that the mutagenic impurity is at or below the acceptable cancer risk level.
text: ICH guidelines indicate that all the genotoxic impurity present in drug substance should be identified if present at or above a certain limit which is called as identification threshold .