N-Nitroso-Apixaban Impurity B is primarily used as a pharmaceutical reference standardanalytical impurity standard for the development and validation of analytical methods such as HPLCLC-MS. It supports the detection identification and quantification of nitrosamine impurities in Apixaban drug substances and products.

Its main purpose is to monitor and control nitrosamine contamination associated with Apixaban manufacturing. It is used in impurity profiling method validation stability studies and regulatory compliance related to nitrosamine risk assessment.

N-Nitroso-Apixaban Impurity B is a nitrosamine-related impurity of Apixaban formed through nitrosation of an amine-containing structural moiety.