Dinitroso Potassium Clavulanate EP Impurity L, also designated N,N'-(ethane-1,2-diyl)bis(N-isopropylnitrous amide), CAS 56134-72-6, is a nitrosamine-related impurity associated with clavulanate manufacturing chemistry. Its molecular formula, C8H18N4O2, and molecular weight, 202.25 g/mol, are consistent with a discrete N-nitroso species that may arise from nitrosating conditions involving secondary amine precursors or nitrite contamination during synthesis or storage. As a structural class, such compounds are treated under ICH M7 as potential mutagenic impurities because of DNA-alkylating risk. Trace analysis typically requires LC-MS/MS or GC-MS, often with selective ion monitoring and rigorous sample handling to suppress artefactual nitrosation.
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