Gliclazide Impurity 1

Development and Validation of Spectrophotometric Methods for the Determination of Canagliflozin or Gliclazide and Metformin in the Presence of Metformin Impurity (1-Cyanoguanidine)
Sonia T Hassib, Elham A Taha, Ehab F Elkady, Ghada H Barakat
Journal of Aoac international, Volume 102, Issue 4, 1 July 2019, Pages 1112–1124
 
Stability indicating MEKC method for the determination of gliclazide and its specified impurities
Athiporn Doomkaew Brompoj Prutthiwanasan Leena Suntornsuk
Journal of Pharmaceutical and Biomedical Analysis Volume 102, 5 January 2015, Pages 119-128
 
Analytical methods for the determination of gliclazide in pharmaceutical formulations and biological fluids
Vipin Kumar Sharma , Bhaskar Mazumder
World Journal of Pharmaceutical Research Volume 3, Issue 9, 979-997.

Gliclazide Impurity 1 is chemically Hexahydrocyclopenta[c]pyrrol-2(1H)-amine hydrochloride ; 3-Amino-3-azabicyclo[3,3,0]octane Hydrochloride. Gliclazide Impurity 1 is supplied with detailed characterization data compliant with regulatory guideline. Gliclazide Impurity 1 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 Gliclazide.

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.