5-nitroso-4H,5H,6H,7H-thieno[3,2-c]pyridine, also known as Clopidogrel Nitroso Impurity, is a nitroso heterocyclic impurity associated with clopidogrel manufacture and storage. With CAS 2460755-43-3, molecular formula C7H8N2OS, and molecular weight 168.22 g/mol, it reflects N-nitrosation of the thienopyridine scaffold under nitrosating conditions or from residual nitrite chemistry. As a potential genotoxic impurity, it is evaluated within the regulatory framework of ICH M7. Trace-level determination typically requires LC-MS/MS, high-resolution LC-MS, and, where volatility permits, GC-MS, due to low abundance and structural similarity to process-related species.
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