Vildagliptin Impurity 43

Vildagliptin Impurity 43 is chemically 2-((1S,3R,5R)-3-Hydroxyadamantan-1-yl)-2,3,6,7-tetrahydropyrrolo[1,2-a]pyrazine-1,4-dione. Vildagliptin Impurity 43 is supplied with detailed characterization data compliant with regulatory guideline. Vildagliptin Impurity 43 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.

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

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Delivery time:

• In Stock product will dispatch in 24 h after receipt of purchase order. It usually take 2-3 days to receive products in India and 5-6 working days for export customer depending on destination.
• The custom synthesis products would be dispatched as per quoted timeline.

Shipping:

• There will be 100 USD towards logistic charges per shipment if we used our FedEx. There will not be any charge if we use your FedEx/DHL Account. Depending on part shipment logistic charges will be added.
• For countries dispatch by courier is not allowed where product would be dispatched in cargo mode as per agreed Inco term.

Additional Charges:

• Controlled substance charges need to follow as per quotation. The specific inputs are required for controlled substance because regulatory status will differ based on destination.
• Cold Shipment Charges needs to be considered as per quotation.
• For ice pack there are no additional charges.

Technical Queries:

• All technical queries need to raise within 15 days of product receipt. Thereafter it will be our resolved at our discretion.

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• All communication will be addressed to standards@synzeal.com
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