4-Desfluoro Sitagliptin; Sitagliptin EP Impurity B; 2,5-Difluoro Sitagliptin (
Price : $295 – $1,095
| CAS No. | : 1345822-87-8; 486460-31-5 |
| Mol F. | : C16H16F5N5O |
| Mol W. | : 389.32 |
| Cat No. | : SA10411 |
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Description
| Product Name | 4-Desfluoro Sitagliptin; Sitagliptin EP Impurity B |
| Synonyms | (R)-3-amino-4-(2,5-difluorophenyl)-1-(3-(trifluoromethyl)-5,6-dihydro-[1,2,4]triazolo[4,3-a]pyrazin-7(8H)-yl)butan-1-one |
| Related API | Sitagliptin |
| Category | Impurities |
4-Desfluoro Sitagliptin; Sitagliptin EP Impurity B product with CAS: 1345822-87-8; 486460-31-5 is also known as (R)-3-amino-4-(2,5-difluorophenyl)-1-(3-(trifluoromethyl)-5,6-dihydro-[1,2,4]triazolo[4,3-a]pyrazin-7(8H)-yl)butan-1-one. This product can be used as a working standard or secondary reference standard. Additional internal validation as per respective FDA regulations/guidelines may require. 4-Desfluoro Sitagliptin; Sitagliptin EP Impurity B is generally used for Quality Control (QC), Quality Assurance (QA) during commercial production of Sitagliptin and its related formulations. Moreover, (R)-3-amino-4-(2,5-difluorophenyl)-1-(3-(trifluoromethyl)-5,6-dihydro-[1,2,4]triazolo[4,3-a]pyrazin-7(8H)-yl)butan-1-one 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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