Neratinib Impurities

Neratinib is a potent oral tyrosine kinase inhibitor primarily used to treat HER2-positive breast cancer. It works as a prolonged adjuvant therapy after trastuzumab, lowering the chance of cancer recurrence by irreversibly blocking the HER1, HER2, and HER4 receptors. This activity affects signaling pathways required for tumor development and proliferation. Monitoring Neratinib-related impurities, such as synthesis byproducts, degradation products, and residual solvents, is critical in pharmaceutical research and development to ensure the drug's purity, efficacy, and patient safety. Isotopically labeled Neratinib molecules are commonly employed to explore these contaminants and metabolic pathways, resulting in a better understanding of its pharmacokinetics and therapeutic potential.