Genotoxic Impurities: An Overview | Veeprho
Genotoxic Impurities: An Overview
Genotoxic Impurities (GTIs) in pharmaceutical products at trace levels are of concern due to human carcinogen and their detection at trace levels are of increasing concern to pharmaceutical industries and regulatory agencies. Pharmaceutical regulatory agencies Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have raised concerns about the presence of low levels of genotoxic impurities (GTIs) in APIs or in drug products.
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