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Includes: HPLC, MASS/LC-MS, 1H NMR, FT-IR, Potency, Structure Elucidation Report (SER), and additional analytical data depending on the product.

2088771-60-0Sitagliptin Fumarate Adduct

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Catalogue No.:	VL201021
CAS No.:	2088771-60-0
Mol. Formula:	C₂₀H₁₉F₆N₅O₅
Mol. Weight:	523.39 g/mol

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Additional information on CAS 2088771-60-0

Parent drug

Sitagliptin

IUPAC Name

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-ylamino)succinic acid

Pharmacopoeial Synonyms

Sitagliptin FP Impurity A

Other Synonyms

Sitagliptin Maleate adduct; N-Succinyl Sitagliptin

Smiles

O=C(O)C(N[C@@H](CC(N1CC2=NN=C(C(F)(F)F)N2CC1)=O)CC3=CC(F)=C(F)C=C3F)CC(O)=O

InChI

InChI=1S/C20H19F6N5O5/c21-11-6-13(23)12(22)4-9(11)3-10(27-14(18(35)36)7-17(33)34)5-16(32)30-1-2-31-15(8-30)28-29-19(31)20(24,25)26/h4,6,10,14,27H,1-3,5,7-8H2,(H,33,34)(H,35,36)/t10-,14?/m1/s1

Characterization Data (Included)

HPLC, MASS/LC-MS, 1H NMR, FT-IR, Potency, and Structure Elucidation Report (SER).

Additional Characterization Data

QNMR, D2O Exchange, 13C NMR, 13C APT, COSY NMR, NOESY NMR, 15N NMR, HSQC NMR, HMQC NMR, and HMBC NMR. These are available upon request and may be free or subject to additional charges.

Description

Sitagliptin Fumarate Adduct also known as Sitagliptin FP Impurity A, in various pharmacopoeias, is a highly characterized standard. It meets strict regulatory requirements set by USP, EMA, JP, and BP, making it a crucial component in Abbreviated New Drug Applications (ANDA), New Drug Applications (NDA), and the commercial production of Sitagliptin.

References

By Katherine A Lyseng-Williamson Container: Drugs Year: 2007 Volume: 67 Issue: 4 DOI: 10.2165/00003495-200767040-00007 URL: https://link.springer.com/article/10.2165/00003495-200767040-00007