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

Sitagliptin Impurity 19 ((R)-Sitagliptin N-Boc-Acid Impurity) is chemically (R)-3-((Tert-butoxycarbonyl)amino)-4-(2,4,5-trifluorophenyl)butanoic acid. Sitagliptin Impurity 19 ((R)-Sitagliptin N-Boc-Acid Impurity) is supplied with detailed characterization data compliant with regulatory guideline. Sitagliptin Impurity 19 ((R)-Sitagliptin N-Boc-Acid Impurity) 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.

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

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• The quotation ID needs to be mentioned in the purchase order.
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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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