Linagliptin Dimer impurity (N-C-C-C Dimer)
| CAS No. | : 2463617-49-2 |
| Mol F. | : C51H56N16O4 |
| Mol W. | : 957.1 |
| Cat No. | : SA49908 |
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Description
| Product Name | Linagliptin Dimer impurity (N-C-C-C Dimer) |
| Synonyms | 8-((R)-3-aminopiperidin-1-yl)-7-(but-2-ynyl)-1-((4-(2-((R)-1-(7-(but-2-ynyl)-3-methyl-1-((4-methylquinazolin-2-yl)methyl)-2,6-dioxo-2,3,6,7-tetrahydro-1H-purin-8-yl)piperidin-3-ylamino)ethyl)quinazolin-2-yl)methyl)-3-methyl-1H-purine-2,6(3H,7H)-dione |
| Related API | Linagliptin |
| Category | Impurities |
Linagliptin Dimer impurity (N-C-C-C Dimer) product with CAS: 2463617-49-2 is also known as 8-((R)-3-aminopiperidin-1-yl)-7-(but-2-ynyl)-1-((4-(2-((R)-1-(7-(but-2-ynyl)-3-methyl-1-((4-methylquinazolin-2-yl)methyl)-2,6-dioxo-2,3,6,7-tetrahydro-1H-purin-8-yl)piperidin-3-ylamino)ethyl)quinazolin-2-yl)methyl)-3-methyl-1H-purine-2,6(3H,7H)-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 (N-C-C-C Dimer) is generally used for Quality Control (QC), Quality Assurance (QA) during commercial production of Linagliptin and its related formulations. Moreover,8-((R)-3-aminopiperidin-1-yl)-7-(but-2-ynyl)-1-((4-(2-((R)-1-(7-(but-2-ynyl)-3-methyl-1-((4-methylquinazolin-2-yl)methyl)-2,6-dioxo-2,3,6,7-tetrahydro-1H-purin-8-yl)piperidin-3-ylamino)ethyl)quinazolin-2-yl)methyl)-3-methyl-1H-purine-2,6(3H,7H)-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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