Acalabrutinib Nitroso Impurity 1 is a structurally defined nitrosamine related to acalabrutinib, with molecular formula C22H20N8O2 and molecular weight 428.45 g/mol. The nitrogenous nitroso functionality places this impurity within a class of compounds evaluated for mutagenic and potentially carcinogenic risk under ICH M7 frameworks. Its occurrence is typically associated with nitrosating conditions during synthesis, purification, or storage, especially where secondary amine precursors and nitrite sources coexist. Determination generally requires orthogonal high-sensitivity methods such as LC-MS/MS and high-resolution LC-MS, often supported by GC-MS when volatility and stability permit.
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