Description

Linagliptin Dimer Impurity product with CAS: 1418133-47-7 is also known as 8-[(3R)-3-Amino-1-piperidinyl]-1-[[4-[[2-[[8-[(3R)-3-amino-1-piperidinyl]-7-(2-butyn-1-yl)-2,3,6,7-tetrahydro-3-methyl-2,6-dioxo-1H-purin-1-yl]methyl]-1,4-dihydro-4-ethyl-4-quinazolinyl]methyl]-2-quinazolinyl]methyl]-7-(2-butyn-1-yl)-3,7-dihydro-3-methyl-1H-purine-2,6-dione. This product can be used as a working standard or secondary reference standard. Additional internal validation as per respective FDA regulations/guidelines may require. Linagliptin Dimer Impurity is generally used for Quality Control (QC), Quality Assurance (QA) during commercial production of Linagliptin and its related formulations. Moreover,8-[(3R)-3-Amino-1-piperidinyl]-1-[[4-[[2-[[8-[(3R)-3-amino-1-piperidinyl]-7-(2-butyn-1-yl)-2,3,6,7-tetrahydro-3-methyl-2,6-dioxo-1H-purin-1-yl]methyl]-1,4-dihydro-4-ethyl-4-quinazolinyl]methyl]-2-quinazolinyl]methyl]-7-(2-butyn-1-yl)-3,7-dihydro-3-methyl-1H-purine-2,6-dione is also used in the process of Abbreviated New Drug Application (ANDA) filing to FDA and toxicity study of respective drug formulation.

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