Saxagliptin EP Impurity B

SZ CAT No:	SZ-S005016
CAS No	1496712-39-0
Mol.F.	C18H27N3O3
Mol.Wt.	333.4
Inv. Status	In Stock
Rel. CAS No	2173146-02-4 (HCl salt)

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Chemical Name: (1S,3S,5S)-2-[(S)-amino(3-hydroxyadamantan-1-yl)acetyl]-2-azabicyclo[3.1.0]hexane-3-carboxamide (as per EP)

Synonym: 3-Descarbonitrile 3-Acetamido Saxagliptin

Shipping Temperature: Ambient

HSN Code: 38229010

Country of Origin: India

Smiles: N[C@@H]([C@](C[C@H](C1)C2)(C[C@@H]1C3)C[C@]23O)C(N([C@H](C(N)=O)C4)[C@@H]5[C@H]4C5)=O

Development and validation of RP-HPLC method for simultaneous estimation of saxagliptin and dapagliflozin
By Desai, Charmy P.; Chaudhary, Ankit B.; Patel, Bhoomi D.
From World Journal of Pharmacy and Pharmaceutical Sciences (2018), 7(5), 803-812

Gradient elution RP-HPLC method for the determination of related substances in saxagliptin
By Li, Xiaoyan; Liu, Fei
From Zhongguo Yaopin Biaozhun (2015), 16(1), 16-19

Development and validation of simple stability indicating RP-HPLC method for analysis of saxagliptin and its forced degradation impurities in bulk drug and pharmaceutical dosage form
By Chhabda, Pawanjeet J.; Balaji, M.; Srinivasarao, V.; Ramakrishna, K.; Apparao, K. M. Ch.
From International Journal of Research and Development in Pharmacy & Life Sciences (2014), 3(3), 993-1003, 11 pp..

Saxagliptin EP Impurity B is chemically (1S,3S,5S)-2-[(S)-amino(3-hydroxyadamantan-1-yl)acetyl]-2-azabicyclo[3.1.0]hexane-3-carboxamide (as per EP). It is also known as 3-Descarbonitrile 3-Acetamido Saxagliptin. Saxagliptin EP Impurity B is supplied with detailed characterization data compliant with regulatory guideline. Saxagliptin EP Impurity B 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 Saxagliptin.

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.

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