Assertion: impurity | /r/HasProperty | characterized by its molecular structure
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text: The most up-to-date thinking is that when a new impurity from a degradation product appears, this impurity should be characterized by its molecular structure, following by an in silico evaluation, and a review of the dossier expert, and if a doubt still remains, the impurity should be synthetized and evaluated in an Ames test, the gold standard test to detect mutagenic potential (ICH M7 guideline).