Linagliptin N-Acetyl Impurity
| CAS No. | : 1803079-49-3 |
| Mol F. | : C27H30N8O3 |
| Mol W. | : 514.58 |
| Cat No. | : SA49901 |
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Description
| Product Name | Linagliptin N-Acetyl Impurity |
| Synonyms | (R)-N-(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)acetamide |
| Related API | Linagliptin |
| Category | Impurities |
Linagliptin N-Acetyl Impurity product with CAS: 1803079-49-3 is also known as (R)-N-(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)acetamide. 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 N-Acetyl Impurity is generally used for Quality Control (QC), Quality Assurance (QA) during commercial production of Linagliptin and its related formulations. Moreover,(R)-N-(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)acetamide 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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