Used primarily as a reference standard in pharmaceutical quality control, this impurity plays a critical role in the analysis and validation of Linagliptin drug substances and formulations. It helps in identifying and quantifying degradation products during stability studies, ensuring product purity and shelf life. Its presence is monitored in manufacturing processes to optimize synthesis and purification steps, minimizing impurity levels in the final active pharmaceutical ingredient. Additionally, it supports method development and validation in HPLC and LC-MS techniques for accurate detection of related substances in diabetic medications.