Linagliptin Impurity 97 is chemically (R,Z)-8-(3-aminopiperidin-1-yl)-7-(4-hydroxy-3-methylbut-2-en-1-yl)-3-methyl-1-((4-methylquinazolin-2-yl)methyl)-3,7-dihydro-1H-purine-2,6-dione. Linagliptin Impurity 97 is supplied with detailed characterization data compliant with regulatory guideline.