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- Synonyms:Sitagliptin 4-Desfluoro Impurity;(3R)-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;2,5-Difluoro Sitagliptin
- Chemical Name:(3R)-3-amino-4-(2,5-difluorophenyl)-1-[3-(trifluoromethyl)-6,8-dihydro-5H-[1,2,4]triazolo[4,3-a]pyrazin-7-yl]butan-1-one
- Product Category:Sitagliptin Impurities
Sitagliptin EP Impurity B is identified by CAS No. 486460-31-5 and is chemically known as Sitagliptin 4-Desfluoro Impurity;(3R)-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;2,5-Difluoro Sitagliptin, IUPAC Name: (3R)-3-amino-4-(2,5-difluorophenyl)-1-[3-(trifluoromethyl)-6,8-dihydro-5H-[1,2,4]triazolo[4,3-a]pyrazin-7-yl]butan-1-one.
Sitagliptin EP Impurity B is provided with comprehensive characterization data in accordance with regulatory guidelines. It is suitable for use in analytical method development, method validation (AMV), Quality Control (QC) applications for Abbreviated New Drug Applications (ANDA) and commercial production of Sitagliptin.
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Sitagliptin EP Impurity B
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