Canagliflozin Dimer Impurity

Development and validation of HPLC method for determination of trace level potential genotoxic hydroperoxide impurity in canagliflozin
By Gosar, Amit; Shaikh, Tabrez; Botkondle, Suresh; Mahadik, Neelam; Tole, Rahul
From International Journal of Pharma Research and Health Sciences (2019), 7(5), 3068-3071
 
Bioanalytical method development and validation of canagliflozin in human plasma by liquid chromatography-​tandem mass spectrometry
By Deepan, T.; Rao, M. V. Basaveswara; Dhanaraju, M. D.
From Asian Journal of Pharmaceutical and Clinical Research (2019), 12(8), 46-51

Analytical method development and validation of canagliflozin and metformin HCl by using RP - HPLC
By Bakshi, Anjali; Reddy, Ns; Bhutada, Shweta; Raju, M. Bhagvan
From International Journal of Pharmacy and Pharmaceutical Research (2018), 12(4), 122-130

Canagliflozin Dimer Impurity is chemically (3S,4R,5R)-1-(2-Fluoro-5-(5-(2-methyl-5-((2S,3R,4R,5R,6S)-3,4,5-trihydroxy-6-(hydroxymethyl)tetrahydro-2H-pyran-2-yl)benzyl)thiophen-2-yl)phenyl)-1-(3-((5-(4-fluorophenyl)thiophen-2yl)methyl)-4-methylphenyl)hexan-1,2,3,4,5,6-hexaol. Canagliflozin Dimer Impurity is supplied with detailed characterization data compliant with regulatory guideline. Canagliflozin Dimer 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 Canagliflozin.

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.