Alogliptin Impurity 1 is a critical reference standard for the pharmaceutical synthesis of the dipeptidyl peptidase-4 inhibitor. It serves as an essential control substance in quality assurance protocols to ensure the purity and safety of the final API. The chemical structure corresponds to N-(2-cyanoethyl)-N-methyl-4-[2-(5,6-dihydro-2H-pyran-4-yl)ethyl]benzamide. Its molecular formula is C19H26N2O3, with CAS Registry Number 1078437-46-9.
This substance is intended strictly for laboratory research and analytical calibration; it is not approved for direct clinical administration. Personnel must handle the material using appropriate PPE to avoid skin contact or inhalation. Store in a cool, dry place away from light and moisture, typically at temperatures between 2°C and 8°C, sealed in inert atmosphere containers.