Sitagliptin Impurity M

SZ CAT No:	SZ-S009058
CAS No	218608-98-1
Mol.F.	C15H20FNO4
Mol.Wt.	297.3
Inv. Status	Custom Synthesis

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Chemical Name: Benzenebutanoic acid, β-[[(1,1-dimethylethoxy)carbonyl]amino]-2-fluoro-, (βR)-; (βR)-β-[[(1,1-Dimethylethoxy)carbonyl]amino]-2-fluorobenzenebutanoic acid ;(3R)-3-[(tert-Butoxycarbonyl)amino]-4-(2-fluorophenyl)butanoic acid ;(3R)-[(tert-Butoxycarbonyl)amino]-4-(2-fluorophenyl)butanoic acid; (R)-3-[(tert-Butoxycarbonyl)amino]-4-(2-fluorophenyl)butanoic acid

Shipping Temperature: Ambient

HSN Code: 38229010

Country of Origin: India

Smiles: O=C(OC(C)(C)C)N[C@@H](CC(O)=O)CC(C=CC=C1)=C1F

Determination of chemical stability of sitagliptin by LC-UV, LC-MS and FT-IR methods
Anna Gumieniczek, Anna Berecka, Tomasz Mroczek, Krzysztof Wojtanowski, Kinga Dąbrowska, Katarzyna Stępień
Journal of Pharmaceutical and Biomedical Analysis Volume 164, 5 February 2019, Pages 789-807

Development and validation of stability indicating assay method by HPLC for the analysis of sitagliptin phospahte in bulk drug substances
Meher Vijay Dalawai , Paul Douglas Sanasi and Hemant Kumar Sharma
Journal of Chemical and Pharmaceutical Research, 2015, 7(10):781-787

Enantiometric separation of sitagliptin in a fixed dose combination formula of sitagliptin and metformin by a chiral liquid chromatographic method
nagadeep jaishetty*, kamaraj palanisamy, arthanareeswari maruthapillai
Int J Pharm Pharm Sci, Vol 11, Issue 6, 66-71

Sitagliptin Impurity M is chemically Benzenebutanoic acid, β-[[(1,1-dimethylethoxy)carbonyl]amino]-2-fluoro-, (βR)-; (βR)-β-[[(1,1-Dimethylethoxy)carbonyl]amino]-2-fluorobenzenebutanoic acid ;(3R)-3-[(tert-Butoxycarbonyl)amino]-4-(2-fluorophenyl)butanoic acid ;(3R)-[(tert-Butoxycarbonyl)amino]-4-(2-fluorophenyl)butanoic acid; (R)-3-[(tert-Butoxycarbonyl)amino]-4-(2-fluorophenyl)butanoic acid. Sitagliptin Impurity M is supplied with detailed characterization data compliant with regulatory guideline. Sitagliptin Impurity M can be used for the analytical method development, method validation (AMV), Quality Controlled (QC) application for Abbreviated New Drug Application (ANDA) or during commercial production of Sitagliptin.

The product can be used as reference standards and further traceability against pharmacopeial standards (USP or EP) can be provided based on feasibility. SynZeal products are for analytical purpose only and not for human use.

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Sitagliptin Hydrochloride

SZ CAT No:	: SZ-S009001
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Mol.F.	: C16H15F6N5O : HCl
Mol.Wt.	: 407.3 : 36.5
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Sitagliptin EP Impurity A

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Mol.F.	: C16H15F6N5O
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Sitagliptin EP Impurity B

SZ CAT No:	: SZ-S009003
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Mol.F.	: C16H16F5N5O
Mol.Wt.	: 389.3
Inv. Status	: In Stock

Sitagliptin EP Impurity C

SZ CAT No:	: SZ-S009004
CAS No	: 945261-48-3
Mol.F.	: C16H16F5N5O
Mol.Wt.	: 389.3
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Sitagliptin FP Impurity A

SZ CAT No:	: SZ-S009005
CAS No	: 2088771-60-0
Mol.F.	: C20H19F6N5O5
Mol.Wt.	: 523.4
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Sitagliptin FP Impurity B

SZ CAT No:	: SZ-S009006
CAS No	: 2088771-61-1
Mol.F.	: C16H13F6N5O2
Mol.Wt.	: 421.3
Inv. Status	: In Stock

Sitagliptin FP Impurity C

SZ CAT No:	: SZ-S009007
CAS No	: 1803026-58-5
Mol.F.	: C16H12F6N4O
Mol.Wt.	: 390.3
Inv. Status	: In Stock

Sitagliptin FP Impurity D

SZ CAT No:	: SZ-S009008
CAS No	: 1253056-18-6
Mol.F.	: C16H12F6N4O
Mol.Wt.	: 390.3
Inv. Status	: In Stock

Sitagliptin FP Impurity E (HCl salt)

SZ CAT No:	: SZ-S009009
CAS No	: 1204818-19-8
Mol.F.	: C10H10F3NO2 : HCl
Mol.Wt.	: 233.2 : 36.5
Inv. Status	: In Stock

Sitagliptin 2-Desfluoro Impurity

SZ CAT No:	: SZ-S009010
CAS No	: 486459-88-5
Mol.F.	: C16H16F5N5O
Mol.Wt.	: 389.3
Inv. Status	: In Stock

Sitagliptin Desfluorobenzene Analog

SZ CAT No:	: SZ-S009011
CAS No	: NA
Mol.F.	: C16H18F3N5O
Mol.Wt.	: 353.3
Inv. Status	: Custom Synthesis

Sitagliptin Enamine Impurity

SZ CAT No:	: SZ-S009012
CAS No	: 767340-03-4
Mol.F.	: C16H13F6N5O
Mol.Wt.	: 405.3
Inv. Status	: In Stock

Sitagliptin Hydroxy Amide Impurity

SZ CAT No:	: SZ-S009013
CAS No	: 1253056-01-7
Mol.F.	: C16H14F6N4O2
Mol.Wt.	: 408.3
Inv. Status	: In Stock

Sitagliptin Ketoamide Impurity

SZ CAT No:	: SZ-S009014
CAS No	: 764667-65-4
Mol.F.	: C16H12F6N4O2
Mol.Wt.	: 406.3
Inv. Status	: In Stock

Sitagliptin N-Acetyl Impurity

SZ CAT No:	: SZ-S009015
CAS No	: 1379666-94-0
Mol.F.	: C18H17F6N5O2
Mol.Wt.	: 449.4
Inv. Status	: In Stock

Sitagliptin Triazole Hydrochloride

SZ CAT No:	: SZ-S009017
CAS No	: 762240-92-6
Mol.F.	: C6H7F3N4 : HCl
Mol.Wt.	: 192.1 : 36.5
Inv. Status	: In Stock

Sitagliptin-N-sulfate

SZ CAT No:	: SZ-S009018
CAS No	: 940002-57-3
Mol.F.	: C16H15F6N5O4S
Mol.Wt.	: 487.4
Inv. Status	: Custom Synthesis

Sitagliptin Carbamoyl Glucuronide

SZ CAT No:	: SZ-S009019
CAS No	: 940002-59-5
Mol.F.	: C23H23F6N5O9
Mol.Wt.	: 627.5
Inv. Status	: Custom Synthesis

Sitagliptin Phosphate Monohydrate

SZ CAT No:	: SZ-S009020
CAS No	: 654671-77-9
Mol.F.	: C16H15F6N5O : H3O4P : H2O
Mol.Wt.	: 407.3 : 98.0 :18.0
Inv. Status	: In Stock

Sitagliptin Defluoro Impurity 1

SZ CAT No:	: SZ-S009023
CAS No	: NA
Mol.F.	: C16H20F3N5O
Mol.Wt.	: 355.3
Inv. Status	: Custom Synthesis

Sitagliptin Defluoro Impurity 2

SZ CAT No:	: SZ-S009024
CAS No	: NA
Mol.F.	: C16H20F3N5O
Mol.Wt.	: 355.3
Inv. Status	: Custom Synthesis

Sitagliptin Defluoro Impurity 3

SZ CAT No:	: SZ-S009025
CAS No	: 851307-12-5
Mol.F.	: C15H19F2NO4
Mol.Wt.	: 315.3
Inv. Status	: In Stock

Sitagliptin Defluoro Impurity 4

SZ CAT No:	: SZ-S009026
CAS No	: 1271773-97-7
Mol.F.	: C15H19F2NO4
Mol.Wt.	: 315.3
Inv. Status	: Custom Synthesis

(S)-Sitagliptin N-Boc-Acid Impurity

SZ CAT No:	: SZ-S009027
CAS No	: 922178-94-7
Mol.F.	: C15H18F3NO4
Mol.Wt.	: 333.3
Inv. Status	: In Stock

(R)-Sitagliptin N-Boc-Methyl-Ester Impurity

SZ CAT No:	: SZ-S009028
CAS No	: 881995-73-9
Mol.F.	: C16H20F3NO4
Mol.Wt.	: 347.3
Inv. Status	: In Stock

(R)-Sitagliptin Methyl-Ester Impurity HCl salt

SZ CAT No:	: SZ-S009029
CAS No	: 1374985-05-3
Mol.F.	: C11H12F3NO2 : HCl
Mol.Wt.	: 247.2 : 36.5
Inv. Status	: In Stock

Sitagliptin N-Phoshate Impurity

SZ CAT No:	: SZ-S009030
CAS No	: NA
Mol.F.	: C16H16F6N5O4P
Mol.Wt.	: 487.3
Inv. Status	: Custom Synthesis

Sitagliptin Impurity 19 ((R)-Sitagliptin N-Boc-Acid Impurity)

SZ CAT No:	: SZ-S009031
CAS No	: 486460-00-8
Mol.F.	: C15H18F3NO4
Mol.Wt.	: 333.3
Inv. Status	: In Stock

Sitagliptin Impurity 18 (Sitagliptin N-Boc Impurity)

SZ CAT No:	: SZ-S009032
CAS No	: 486460-23-5
Mol.F.	: C21H23F6N5O3
Mol.Wt.	: 507.4
Inv. Status	: In Stock

Sitagliptin Impurity 6

SZ CAT No:	: SZ-S009033
CAS No	: NA
Mol.F.	: C17H15F6N5O2
Mol.Wt.	: 435.3
Inv. Status	: In Stock

Sitagliptin impurity F

SZ CAT No:	: SZ-S009034
CAS No	: 1608491-98-0
Mol.F.	: C22H24F6N4O2
Mol.Wt.	: 490.5
Inv. Status	: In Stock

Sitagliptin Desfluoro Impurity HCl

SZ CAT No:	: SZ-S009035
CAS No	: NA
Mol.F.	: C16H17F4N5O : HCl
Mol.Wt.	: 371.3 : 36.5
Inv. Status	: Custom Synthesis

Sitagliptin Related compound 1

SZ CAT No:	: SZ-S009036
CAS No	: 331763-66-7
Mol.F.	: C15H20FNO4
Mol.Wt.	: 297.3
Inv. Status	: Custom Synthesis

Sitagliptin Impurity P HCl

SZ CAT No:	: SZ-S009037
CAS No	: NA
Mol.F.	: C16H17F4N5O : HCl
Mol.Wt.	: 371.3 : 36.5
Inv. Status	: Custom Synthesis

Sitagliptin Impurity B

SZ CAT No:	: SZ-S009038
CAS No	: 2955636-26-5
Mol.F.	: C32H25F12N9O2
Mol.Wt.	: 795.6
Inv. Status	: In Stock

Sitagliptin Diamide impurity

SZ CAT No:	: SZ-S009039
CAS No	: NA
Mol.F.	: C20H19F6N5O3
Mol.Wt.	: 491.4
Inv. Status	: Custom Synthesis

Sitagliptin Enamine Amide Impurity

SZ CAT No:	: SZ-S009040
CAS No	: NA
Mol.F.	: C18H15F6N5O2
Mol.Wt.	: 447.3
Inv. Status	: Custom Synthesis

Sitagliptin Impurity Related compound N

SZ CAT No:	: SZ-S009041
CAS No	: NA
Mol.F.	: C16H10F6N4O
Mol.Wt.	: 388.3
Inv. Status	: Custom Synthesis

Sitagliptin Impurity Related compound O

SZ CAT No:	: SZ-S009042
CAS No	: NA
Mol.F.	: C26H21F9N6O2
Mol.Wt.	: 620.5
Inv. Status	: Custom Synthesis

Sitagliptin Impurity N

SZ CAT No:	: SZ-S009043
CAS No	: 2409985-39-1
Mol.F.	: C16H14F6N4O
Mol.Wt.	: 392.3
Inv. Status	: In Stock

Sitagliptin Impurity O

SZ CAT No:	: SZ-S009044
CAS No	: 2072867-07-1
Mol.F.	: C26H23F9N6O2
Mol.Wt.	: 622.5
Inv. Status	: In Stock

Sitagliptin Impurity 7

SZ CAT No:	: SZ-S009045
CAS No	: NA
Mol.F.	: C15H17F2N5O
Mol.Wt.	: 321.3
Inv. Status	: Custom Synthesis

Sitagliptin Impurity 8

SZ CAT No:	: SZ-S009046
CAS No	: NA
Mol.F.	: C15H17F2N5O
Mol.Wt.	: 321.3
Inv. Status	: Custom Synthesis

Sitagliptin Impurity 9

SZ CAT No:	: SZ-S009047
CAS No	: 1234321-81-3
Mol.F.	: C13H12F3NO3
Mol.Wt.	: 287.2
Inv. Status	: Custom Synthesis

Sitagliptin Impurity 10

SZ CAT No:	: SZ-S009048
CAS No	: 837430-15-6
Mol.F.	: C6H5F3N4O
Mol.Wt.	: 206.1
Inv. Status	: Custom Synthesis

Sitagliptin impurity 11

SZ CAT No:	: SZ-S009049
CAS No	: 764667-63-2
Mol.F.	: C6H9F3N4O
Mol.Wt.	: 210.2
Inv. Status	: In Stock

Sitagliptin Impurity 12

SZ CAT No:	: SZ-S009050
CAS No	: 1234321-83-5
Mol.F.	: C13H14F3NO3
Mol.Wt.	: 289.3
Inv. Status	: In Stock

Sitagliptin Related Compound (1-(4-Methylphenyl)-4,4,4-Trifluorobutano-1,3-dione)

SZ CAT No:	: SZ-S009051
CAS No	: 720-94-5
Mol.F.	: C11H9F3O2
Mol.Wt.	: 230.2
Inv. Status	: In Stock

Sitagliptin Impurity 14

SZ CAT No:	: SZ-S009052
CAS No	: 1151240-91-3
Mol.F.	: C12H14F3NO2
Mol.Wt.	: 261.3
Inv. Status	: Custom Synthesis

Sitagliptin Impurity 15

SZ CAT No:	: SZ-S009053
CAS No	: 2114308-71-1
Mol.F.	: C18H17F3N2O3
Mol.Wt.	: 366.3
Inv. Status	: Custom Synthesis

Sitagliptin Impurity 16

SZ CAT No:	: SZ-S009054
CAS No	: 769195-20-2
Mol.F.	: C24H22F6N6O2
Mol.Wt.	: 540.5
Inv. Status	: In Stock

Sitagliptin Impurity G

SZ CAT No:	: SZ-S009056
CAS No	: 269396-59-0
Mol.F.	: C15H19F2NO4
Mol.Wt.	: 315.3
Inv. Status	: Custom Synthesis

Sitagliptin Impurity H HCl

SZ CAT No:	: SZ-S009057
CAS No	: NA
Mol.F.	: C16H16F5N5O : HCl
Mol.Wt.	: 389.3 : 36.5
Inv. Status	: Custom Synthesis