neratinib maleate and its Impurities

Neratinib Maleate is used as an adjuvant therapy in people with early stage breast cancer in which HER2 is overexpressed, after the person receives treatment with trastuzumab. It is a tyrosine kinase inhibitor anticancer drug. Reference standards of Neratinib Maleate API,and its pharmacopeial, non pharmacopeial impurities, and stable isotopes are listed below.