Sitagliptin Impurity M

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

Sitagliptin Impurity M is chemically Benzenebutanoic acid, β-​[[(1,​1-​dimethylethoxy)​carbonyl]​amino]​-​2-​fluoro-​, (βR)​-; (βR)-β-[[(1,1-Dimethylethoxy)carbonyl]amino]-2-fluorobenzenebutanoic acid ;(3R)-3-[(tert-Butoxycarbonyl)amino]-4-(2-fluorophenyl)butanoic acid ;(3R)-[(tert-Butoxycarbonyl)amino]-4-(2-fluorophenyl)butanoic acid; (R)-3-[(tert-Butoxycarbonyl)amino]-4-(2-fluorophenyl)butanoic acid. Sitagliptin Impurity M is supplied with detailed characterization data compliant with regulatory guideline. Sitagliptin Impurity M 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.