Wish list (0)Genotoxic Impurity Reference Standards
This classification focuses on genotoxic impurities (GTIs) with high carcinogenic risks in drugs, encompassing Class 1 to Class 3 impurities as defined by the ICH M7 guidelines. These impurities, even in trace amounts, can damage DNA and constitute a "zero tolerance" red line in drug registration applications. We provide key GTI reference standards such as nitrosamines (NDMA/NDEA), sulfonates, haloalkanes, aromatic amines, and epoxides. All products are accompanied by comprehensive structural confirmation reports (NMR, LC-MS), with precise purity and reliable assay values, supporting your (Q)SAR assessments, Ames test verifications, and TTC limit control studies. The products strictly comply with ICH M7(R2) regulatory requirements, assisting you in managing the entire process from source identification, process control to finished product release, thereby mitigating carcinogenic risks associated with drugs and ensuring patient medication safety and international registration compliance.
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