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565453-39-6Vildagliptin IP Impurity B

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Catalogue No.:	VL3490003
CAS No.:	565453-39-6
Mol. Formula:	C17H27N3O3
Mol. Weight:	321.41 g/mol

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Additional information on CAS 565453-39-6

Parent drug

Viladagliptin

IUPAC Name

1-[(3-Hydroxyadamant-1-ylamino-acetyl)]-(2S)-prolinamide

Pharmacopoeial Synonyms

N/A

Other Synonyms

Vildagliptin Amide Impurity; N-(3-Hydroxytricyclo[3.3.1.13,7]dec-1-yl)glycyl-L-prolinamide; 1-[2-[(3-hydroxy-1-adamantyl)amino]acetyl]pyrrolidine-2-carboxamide

Smiles

C1CC(N(C1)C(=O)CNC23CC4CC(C2)CC(C4)(C3)O)C(=O)N

InChI

InChI=1S/C17H27N3O3/c18-15(22)13-2-1-3-20(13)14(21)9-19-16-5-11-4-12(6-16)8-17(23,7-11)10-16/h11-13,19,23H,1-10H2,(H2,18,22)

Description

Vildagliptin IP Impurity B, also known as Vildagliptin Amide Impurity, CAS 565453-39-6, is a process-related related substance associated with over-acylation or amidation during manufacture of vildagliptin. With molecular formula C17H27N3O3 and molecular weight 321.41 g/mol, it represents a structurally defined amide derivative rather than a nitrosamine or simple hydrolytic degradant. Its occurrence is typically monitored in accordance with impurity control expectations under ICH Q3A and ICH Q3B, with trace-level characterization commonly requiring reversed-phase LC-MS/MS, high-resolution LC-MS, and confirmatory LC-UV methods. Solid-state isolation and spectroscopic assignment support distinction from the API and other synthetic byproducts.

References

Vildagliptin: the evidence for its place in the treatment of type 2 diabetes mellitus By Louise Profit, Paul Chrisp, Carole Nadin Container: Core evidence Publisher: Dove Medical Press Year: 2008 Volume: 3 Issue: 1 DOI: 10.3355/ce.2008.009 URL: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2899806/