Used primarily as a reference standard in pharmaceutical quality control and analytical testing during the manufacturing of linagliptin, this impurity helps ensure the purity and consistency of the final drug product. It is essential in method development and validation for detecting and quantifying trace impurities in linagliptin formulations. Its presence is monitored to comply with regulatory requirements, particularly in assessing the stability and degradation profile of the active pharmaceutical ingredient. This compound supports the identification of potential degradation pathways, aiding in the optimization of formulation and storage conditions to enhance drug shelf life and safety.