Linagliptin Impurity 36
| CAS No. | : 2074688-82-5 |
| Mol F. | : C58H58N16O6 |
| Mol W. | : 1075.2 |
| Cat No. | : SA49927 |
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Description
| Product Name | Linagliptin Impurity 36 |
| Synonyms | N,N’-bis((R)-1-(7-(but-2-yn-1-yl)-3-methyl-1-((4-methylquinazolin-2-yl)methyl)-2,6-dioxo-2,3,6,7-tetrahydro-1Hpurin-8-yl)piperidin-3-yl)phthalamide |
| Related API | Linagliptin |
| Category | Impurities |
Linagliptin Impurity 36 product with CAS: 2074688-82-5 is also known as N,N’-bis((R)-1-(7-(but-2-yn-1-yl)-3-methyl-1-((4-methylquinazolin-2-yl)methyl)-2,6-dioxo-2,3,6,7-tetrahydro-1Hpurin-8-yl)piperidin-3-yl)phthalamide. 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 Impurity 36 is generally used for Quality Control (QC), Quality Assurance (QA) during commercial production of Linagliptin and its related formulations. Moreover,N,N’-bis((R)-1-(7-(but-2-yn-1-yl)-3-methyl-1-((4-methylquinazolin-2-yl)methyl)-2,6-dioxo-2,3,6,7-tetrahydro-1Hpurin-8-yl)piperidin-3-yl)phthalamide 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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