| Linagliptin Nitroso Dimer Impurity 4 is chemically N,N’-methylenebis(N-((R)-1-(7-(but-2-yn-1-yl)-3-methyl-1-((4-methylquinazolin-2-yl)methyl)-2,6-dioxo-2,3,6,7-tetrahydro-1H-purin-8-yl)piperidin-3-yl)nitrous amide). Linagliptin Nitroso Dimer Impurity 4 is supplied with detailed characterization data compliant with regulatory guideline. Linagliptin Nitroso Dimer Impurity 4 can be used for the analytical method development, method validation (AMV), Quality Controlled (QC) application for Abbreviated New Drug Application (ANDA) or during commercial production of Linagliptin. The product can be used as reference standards and further traceability against pharmacopeial standards (USP or EP) can be provided based on feasibility. ChemWhat products are for analytical purpose only and not for human use. |