Diamide Sitagliptin impurity
| CAS No. | : NA |
| Mol F. | : C20H19F6N5O3 |
| Mol W. | : 491.39 |
| Cat No. | : SA10420 |
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Description
| Product Name | Diamide Sitagliptin impurity |
| Synonyms | (S)-N-acetyl-N-(4-oxo-4-(3-(trifluoromethyl)-5,6-dihydro-[1,2,4]triazolo[4,3-a]pyrazin-7(8H)-yl)-1-(2,4,5-trifluorophenyl)butan-2-yl)acetamide |
| Related API | Sitagliptin |
| Category | Impurities |
Diamide Sitagliptin impurity product with CAS: NA is also known as (S)-N-acetyl-N-(4-oxo-4-(3-(trifluoromethyl)-5,6-dihydro-[1,2,4]triazolo[4,3-a]pyrazin-7(8H)-yl)-1-(2,4,5-trifluorophenyl)butan-2-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. Diamide Sitagliptin impurity is generally used for Quality Control (QC), Quality Assurance (QA) during commercial production of Sitagliptin and its related formulations. Moreover, (S)-N-acetyl-N-(4-oxo-4-(3-(trifluoromethyl)-5,6-dihydro-[1,2,4]triazolo[4,3-a]pyrazin-7(8H)-yl)-1-(2,4,5-trifluorophenyl)butan-2-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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