Sitagliptin Enamine Diamide Impurity
| CAS No. | : NA |
| Mol F. | : C18H15F6N5O2 |
| Mol W. | : 447.33 |
| Cat No. | : SA10425 |
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Description
| Product Name | Enamine Diamide Impurity |
| Synonyms | (Z)-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)but-2-en-2-yl)acetamide |
| Related API | Sitagliptin |
| Category | Impurities |
Enamine Diamide Impurity product with CAS: NA is also known as (Z)-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)but-2-en-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. Enamine Diamide Impurity is generally used for Quality Control (QC), Quality Assurance (QA) during commercial production of Sitagliptin and its related formulations. Moreover, (Z)-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)but-2-en-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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