Saxagliptin Impurity 53

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 Impurity 53 is chemically 1-(Tert-butyl) 2-ethyl (S)-5-oxopyrrolidine-1,2-dicarboxylate. Saxagliptin Impurity 53 is supplied with detailed characterization data compliant with regulatory guideline. Saxagliptin Impurity 53 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.