Vildagliptin Impurity 47

Identification, isolation and characterization of potential process-related impurity and its degradation product in vildagliptin
Neeraj Kumar, Subba Rao Devineni, Gurmeet Singh, A.Kadirappa, Shailendra Kumar, Dubey, Pramod Kumar
Journal of Pharmaceutical and Biomedical Analysis Volume 119, 5 February 2016, Pages 114-121
 
Development and validation of a cyclodextrin‐modified capillary electrophoresis method for the enantiomeric separation of vildagliptin enantiomers
Adrienn Kazsoki  Ida Fejős  Tamás Sohajda  Wei Zhou  Wenhui Hu  Lajos Szente  Szabolcs Béni
Electrophoresis Volume37, Issue10 May 2016 Pages 1318-1325
 
New forced degradation products of vildagliptin: Identification and structural elucidation using LC-MS, with proposed formation mechanisms
Sharif Arar,Enas Al-Qudah,Muhammad Alzweiri &Kamal Sweidan
Journal of Liquid Chromatography & Related Technologies  Volume 43, 2020 - Issue 15-16 Pages 633-644

Vildagliptin Impurity 47 is chemically (5aS,10aS)-Octahydro-5H,10H-dipyrrolo[1,2-a:1',2'-d]pyrazine-5,10-dione. It is also known as Cyclo(L-Pro-L-Pro) ; Cyclo(prolylproline) ; Cyclo-L-prolyl-L-proline ; Cis-Cyclo(Pro-Pro). Vildagliptin Impurity 47 is supplied with detailed characterization data compliant with regulatory guideline. Vildagliptin Impurity 47 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 Vildagliptin.

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.