sitagliptin and its Impurities
Sitagliptin impurity B is also known as Defluoro Sitagliptin, an impurity of Sitagliptan, an dipeptidyl peptidase-4 (DPP-4) inhibitor for treatment of diabetes mellitus type 2. Reference standards of Sitagliptin API,and its pharmacopeial, non pharmacopeial impurities, and stable isotopes are listed below.


(2Z)-1-[5,6-Dihydro-3-(trifluoromethyl)-1,2,4-triazolo[4,3-a]pyrazin-7(8H)-yl]-4-(2,4,5-trifluorophenyl)-2-buten-1-one
(2Z)-1-[5,6-Dihydro-3-(trifluoromethyl)-1,2,4-triazolo[4,3-a]pyrazin-7(8H)-yl]-4-(2,4,5-trifluorophenyl)-2-buten-1-one
Catalogue No.:PA 19 48740
CAS :
1803026-54-1
Molecular Formula : C16H12F6N4O
Molecular Weight : 390.28


(R,E)-3-Amino-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)-4-(2,4,5-trifluorophenyl)but-2-enamide
(R,E)-3-Amino-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)-4-(2,4,5-trifluorophenyl)but-2-enamide
Catalogue No.:PA 19 48810
CAS :
NA
Molecular Formula : C26H21F9N6O2
Molecular Weight : 620.47


(S)-3-Amino-1-(3-(trifluoromethyl)-5,6-dihydro-[1,2,4]triazolo[4,3-a]pyrazin-7(8H)-yl)-4-(2,4,5-trifluorophenyl)butan-1-one (2R,3R)-2,3-bis(benzoyloxy)succinate
(S)-3-Amino-1-(3-(trifluoromethyl)-5,6-dihydro-[1,2,4]triazolo[4,3-a]pyrazin-7(8H)-yl)-4-(2,4,5-trifluorophenyl)butan-1-one (2R,3R)-2,3-bis(benzoyloxy)succinate
Catalogue No.:PA 19 48890
CAS :
1219440-27-3
Molecular Formula : C34H29F6N5O9
Molecular Weight : 765.61

![4-Oxo-4-[3-(trifluoromethyl)-5,6-dihydro-[1,2,4]tr PA STI 070760](https://www.pharmaffiliates.com/pimages/PASTI070760.jpg)
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-one-d4
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-one-d4
Catalogue No.:PA STI 070760
CAS :
NA
Molecular Formula : C16H8D4F6N4O2
Molecular Weight : 410.31


(2Z)-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-amine-d4
(2Z)-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-amine-d4
Catalogue No.:PA STI 070770
CAS :
1620233-76-2
Molecular Formula : C16H9D4F6N5O
Molecular Weight : 409.32


(3R)-3-Amino-4-(2,3,6-trifluorophenyl)-1-[3-(trifluoromethyl)-5,6-dihydro[1,2,4] triazolo[4,3-a]pyrazin-7(8H)-yl]butan-1-one
(3R)-3-Amino-4-(2,3,6-trifluorophenyl)-1-[3-(trifluoromethyl)-5,6-dihydro[1,2,4] triazolo[4,3-a]pyrazin-7(8H)-yl]butan-1-one
Catalogue No.:PA 19 48900
CAS :
945261-50-7
Molecular Formula : C16H15F6N5O
Molecular Weight : 407.32


(3R)-3-Amino-4-(3,4-difluorophenyl)-1-(3-(trifluoromethyl)-5,6-dihydro-[1,2,4]triazolo[4,3-a]pyrazin-7(8H)-yl)butan-1-one
(3R)-3-Amino-4-(3,4-difluorophenyl)-1-(3-(trifluoromethyl)-5,6-dihydro-[1,2,4]triazolo[4,3-a]pyrazin-7(8H)-yl)butan-1-one
Catalogue No.:PA 19 48910
CAS :
486459-88-5
Molecular Formula : C16H16F5N5O
Molecular Weight : 389.33


Sitagliptin System Suitability Mixture (Sitagliptin Phosphate containing about 0.2% of S-enantiomer (1612914)
Sitagliptin System Suitability Mixture (Sitagliptin Phosphate containing about 0.2% of S-enantiomer (1612914)
Catalogue No.:PA USP1612914
CAS :
NA
Molecular Formula : NA
Molecular Weight : NA


Sodium 1-(2,2-dimethyl-4,6-dioxo-1,3-dioxan-5-ylidene)-2-(2,4,5-trifluorophenyl)ethan-1-olate
Sodium 1-(2,2-dimethyl-4,6-dioxo-1,3-dioxan-5-ylidene)-2-(2,4,5-trifluorophenyl)ethan-1-olate
Catalogue No.:PA 19 48515
CAS :
1253055-91-2
Molecular Formula : C14H10F3NaO5
Molecular Weight : 338.21


(R)-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)formamide
(R)-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)formamide
Catalogue No.:PA 19 48535
CAS :
NA
Molecular Formula : C17H15F6N5O2
Molecular Weight : 435.33


(R)-7-(3-Amino-4-(2,4,5-trifluorophenyl)butanoyl)-3-(trifluoromethyl)-5,6,7,8-tetrahydro-[1,2,4]triazolo[4,3-a]pyrazine 2-oxide
(R)-7-(3-Amino-4-(2,4,5-trifluorophenyl)butanoyl)-3-(trifluoromethyl)-5,6,7,8-tetrahydro-[1,2,4]triazolo[4,3-a]pyrazine 2-oxide
Catalogue No.:PA 19 48960
CAS :
NA
Molecular Formula : C16H15F6N5O2
Molecular Weight : 423.32


(R)-7-(3-Amino-4-(2,4,5-trifluorophenyl)butanoyl)-3-(trifluoromethyl)-5,6,7,8-tetrahydro-[1,2,4]triazolo[4,3-a]pyrazine 1-oxide
(R)-7-(3-Amino-4-(2,4,5-trifluorophenyl)butanoyl)-3-(trifluoromethyl)-5,6,7,8-tetrahydro-[1,2,4]triazolo[4,3-a]pyrazine 1-oxide
Catalogue No.:PA 19 48970
CAS :
NA
Molecular Formula : C16H15F6N5O2
Molecular Weight : 423.32


7-(3-Amino-4-(2,4,5-trifluorophenyl)butanoyl)-3-(trifluoromethyl)-6,7-dihydro-[1,2,4]triazolo[4,3-a]pyrazin-8(5H)-one
7-(3-Amino-4-(2,4,5-trifluorophenyl)butanoyl)-3-(trifluoromethyl)-6,7-dihydro-[1,2,4]triazolo[4,3-a]pyrazin-8(5H)-one
Catalogue No.:PA 19 48555
CAS :
NA
Molecular Formula : C16H13F6N5O2
Molecular Weight : 421.3


1-[5,6-Dihydro-3-(trifluoromethyl)-1,2,4-triazolo[4,3-a]pyrazin-7(8H)-yl]-3-hydroxy-4-(2,4,5-trifluorophenyl)-1-butanone
1-[5,6-Dihydro-3-(trifluoromethyl)-1,2,4-triazolo[4,3-a]pyrazin-7(8H)-yl]-3-hydroxy-4-(2,4,5-trifluorophenyl)-1-butanone
Catalogue No.:PAI 19 009020
CAS :
1253056-01-7
Molecular Formula : C16H14F6N4O2
Molecular Weight : 408.30


(R)-7-(3-Amino-4-(2,3,5-trifluorophenyl)butanoyl)-3-(trifluoromethyl)-5,6,7,8-tetrahydro-[1,2,4]triazolo[4,3-a]pyrazine 1-Oxide
(R)-7-(3-Amino-4-(2,3,5-trifluorophenyl)butanoyl)-3-(trifluoromethyl)-5,6,7,8-tetrahydro-[1,2,4]triazolo[4,3-a]pyrazine 1-Oxide
Catalogue No.:PA 19 48575
CAS :
NA
Molecular Formula : C16H15F6N5O2
Molecular Weight : 423.32


(R)-3-Amino-N-((R)-4-oxo-4-(3-(trifluoromethyl)-5,6-dihydro-[1,2,4]triazolo[4,3-a]pyrazin-7(8H)-yl)-1-(2,3,5-trifluorophenyl)butan-2-yl)-4-(2,3,5-trifluorophenyl)butanamide
(R)-3-Amino-N-((R)-4-oxo-4-(3-(trifluoromethyl)-5,6-dihydro-[1,2,4]triazolo[4,3-a]pyrazin-7(8H)-yl)-1-(2,3,5-trifluorophenyl)butan-2-yl)-4-(2,3,5-trifluorophenyl)butanamide
Catalogue No.:PA 19 48585
CAS :
NA
Molecular Formula : C26H23F9N6O2
Molecular Weight : 622.5


tert-Butyl (R)-(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)carbamate
tert-Butyl (R)-(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)carbamate
Catalogue No.:PA 19 48595
CAS :
486460-23-5
Molecular Formula : C21H23F6N5O3
Molecular Weight : 507.44


7-(3-Amino-4-(2,4,5-trifluorophenyl)butanoyl)-3-(trifluoromethyl)-6,7-dihydro-[1,2,4]triazolo[4,3-a]pyrazin-8(5H)-one
7-(3-Amino-4-(2,4,5-trifluorophenyl)butanoyl)-3-(trifluoromethyl)-6,7-dihydro-[1,2,4]triazolo[4,3-a]pyrazin-8(5H)-one
Catalogue No.:PA 19 48605
CAS :
NA
Molecular Formula : C16H13F6N5O2
Molecular Weight : 421.3


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)pivalamide
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)pivalamide
Catalogue No.:PA 19 48615
CAS :
1351498-33-3
Molecular Formula : C21H23F6N5O2
Molecular Weight : 491.44


3-Amino-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)-4-(2,4,5-trifluorophenyl)butanamide
3-Amino-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)-4-(2,4,5-trifluorophenyl)butanamide
Catalogue No.:PA 19 48625
CAS :
NA
Molecular Formula : C26H23F9N6O2
Molecular Weight : 622.5

![3-Amino-1-(3-(trifluoromethyl)-5,6-dihydro-[1,2,4] PA 19 48635](https://www.pharmaffiliates.com/pimages/PA1948635.jpg)
3-Amino-1-(3-(trifluoromethyl)-5,6-dihydro-[1,2,4]triazolo[4,3-a]pyrazin-7(8H)-yl)-4-(2,4,5-trifluorophenyl)butan-1-one
3-Amino-1-(3-(trifluoromethyl)-5,6-dihydro-[1,2,4]triazolo[4,3-a]pyrazin-7(8H)-yl)-4-(2,4,5-trifluorophenyl)butan-1-one
Catalogue No.:PA 19 48635
CAS :
NA
Molecular Formula : C16H15F6N5O
Molecular Weight : 407.32


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 Phosphate Hydrate
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 Phosphate Hydrate
Catalogue No.:PA 19 57530
CAS :
NA
Molecular Formula : C16H21F5N5O6P
Molecular Weight : 505.34


3-Amino-4-(2,4-difluorophenyl)-1-(3-(trifluoromethyl)-5,6-dihydro-[1,2,4]triazolo[4,3-a]pyrazin-7(8H)-yl)butan-1-one Phosphate Hydrate
3-Amino-4-(2,4-difluorophenyl)-1-(3-(trifluoromethyl)-5,6-dihydro-[1,2,4]triazolo[4,3-a]pyrazin-7(8H)-yl)butan-1-one Phosphate Hydrate
Catalogue No.:PA 19 57540
CAS :
NA
Molecular Formula : C16H21F5N5O6P
Molecular Weight : 505.34


3-Amino-4-(3,4-difluorophenyl)-1-(3-(trifluoromethyl)-5,6-dihydro-[1,2,4]triazolo[4,3-a]pyrazin-7(8H)-yl)butan-1-one Phosphate Hydrate
3-Amino-4-(3,4-difluorophenyl)-1-(3-(trifluoromethyl)-5,6-dihydro-[1,2,4]triazolo[4,3-a]pyrazin-7(8H)-yl)butan-1-one Phosphate Hydrate
Catalogue No.:PA 19 57550
CAS :
NA
Molecular Formula : C16H21F5N5O6P
Molecular Weight : 505.34


(R)-10-(2,4,5-Trifluorobenzyl)-3-(trifluoromethyl)-6,7,10,11-tetrahydro-[1,2,4]triazolo[3,4-c][1,4,7]triazecine-8,12(5H,9H)-dione
(R)-10-(2,4,5-Trifluorobenzyl)-3-(trifluoromethyl)-6,7,10,11-tetrahydro-[1,2,4]triazolo[3,4-c][1,4,7]triazecine-8,12(5H,9H)-dione
Catalogue No.:PA 19 0481000
CAS :
2088771-61-1
Molecular Formula : C16H13F6N5O2
Molecular Weight : 421.3


10-(2,4,5-Trifluorobenzyl)-3-(trifluoromethyl)-6,7,10,11-tetrahydro-[1,2,4]triazolo[3,4-c][1,4,7]triazecine-8,12(5H,9H)-dione
10-(2,4,5-Trifluorobenzyl)-3-(trifluoromethyl)-6,7,10,11-tetrahydro-[1,2,4]triazolo[3,4-c][1,4,7]triazecine-8,12(5H,9H)-dione
Catalogue No.:PA 19 0481002
CAS :
2805078-75-3
Molecular Formula : C16H13F6N5O2
Molecular Weight : 421.3


3,3'-Oxybis(1-(3-(trifluoromethyl)-5,6-dihydro-[1,2,4]triazolo[4,3-a]pyrazin-7(8H)-yl)-4-(2,4,5-trifluorophenyl)butan-1-one)
3,3'-Oxybis(1-(3-(trifluoromethyl)-5,6-dihydro-[1,2,4]triazolo[4,3-a]pyrazin-7(8H)-yl)-4-(2,4,5-trifluorophenyl)butan-1-one)
Catalogue No.:PA 19 0481004
CAS :
NA
Molecular Formula : C32H26F12N8O3
Molecular Weight : 798.59

![1-(3-(Trifluoromethyl)-5,6-dihydro-[1,2,4]triazolo PA 19 0481007](https://www.pharmaffiliates.com/pimages/PA190481007.jpg)
1-(3-(Trifluoromethyl)-5,6-dihydro-[1,2,4]triazolo[4,3-a]pyrazin-7(8H)-yl)-4-(2,4,5-trifluorophenyl)but-3-en-1-one
1-(3-(Trifluoromethyl)-5,6-dihydro-[1,2,4]triazolo[4,3-a]pyrazin-7(8H)-yl)-4-(2,4,5-trifluorophenyl)but-3-en-1-one
Catalogue No.:PA 19 0481007
CAS :
1675201-14-5
Molecular Formula : C16H12F6N4O
Molecular Weight : 390.29


(R)-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
(R)-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
Catalogue No.:PA 19 0481008
CAS :
1379666-94-0
Molecular Formula : C18H17F6N5O2
Molecular Weight : 449.36


(S)-2-(((R)-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)amino)-2-phenylacetamide
(S)-2-(((R)-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)amino)-2-phenylacetamide
Catalogue No.:PA 19 0481010
CAS :
769195-20-2
Molecular Formula : C24H22F6N6O2
Molecular Weight : 540.47


(R)-4-Oxo-4-[3-(trifluoromethyl)-5,6-dihydro[1,2,4]triazolo[4,3-a]pyrazin-7(8H)-yl]-1-phenylbutan-2-amine
(R)-4-Oxo-4-[3-(trifluoromethyl)-5,6-dihydro[1,2,4]triazolo[4,3-a]pyrazin-7(8H)-yl]-1-phenylbutan-2-amine
Catalogue No.:PA 19 0481011
CAS :
NA
Molecular Formula : C16H18F3N5O
Molecular Weight : 353.35


(R)-(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)sulfamic acid
(R)-(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)sulfamic acid
Catalogue No.:PA 19 0481012
CAS :
940002-57-3
Molecular Formula : C16H15F6N5O4SÂ
Molecular Weight : 487.38


(2S,3S,4S,5R,6S)-3,4,5-Trihydroxy-6-[[(2R)-4-oxo-4-[3-(trifluoromethyl)-6,8-dihydro-5H-[1,2,4]triazolo[4,3-a]pyrazin-7-yl]-1-(2,4,5-trifluorophenyl)butan-2-yl]carbamoyloxy]oxane-2-carboxylic Acid
(2S,3S,4S,5R,6S)-3,4,5-Trihydroxy-6-[[(2R)-4-oxo-4-[3-(trifluoromethyl)-6,8-dihydro-5H-[1,2,4]triazolo[4,3-a]pyrazin-7-yl]-1-(2,4,5-trifluorophenyl)butan-2-yl]carbamoyloxy]oxane-2-carboxylic Acid
Catalogue No.:PA 19 0481013
CAS :
940002-59-5
Molecular Formula : C23H23F6N5O9
Molecular Weight : 627.45


(3R)-3-Amino-1-(3-methyl-5,6,8,8a-tetrahydro-[1,2,4]triazolo[4,3-a]pyrazin-7(3H)-yl)-4-(2,4,5-trifluorophenyl)butan-1-one
(3R)-3-Amino-1-(3-methyl-5,6,8,8a-tetrahydro-[1,2,4]triazolo[4,3-a]pyrazin-7(3H)-yl)-4-(2,4,5-trifluorophenyl)butan-1-one
Catalogue No.:PA 19 0481015
CAS :
NA
Molecular Formula : C16H20F3N5O
Molecular Weight : 355.37


(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
(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
Catalogue No.:PA 19 0481017
CAS :
NA
Molecular Formula : C18H15F6N5O2
Molecular Weight : 447.34