Lansoprazole Impurity 4

Analytical Quality by Design (AQbD)-oriented RPUFLC method for quantification of lansoprazole with superior method robustness
Sagar Suman Panda, Venkata Varaha Ravi Kumar Bera, Sarwar Beg & Omkar Mandal
Journal of Liquid Chromatography & Related Technologies  Volume 40, 2017 - Issue 9 Pages 479-485
 
Identification, isolation and characterization of potential degradation product in lansoprazole drug substance
K.Ramulu1 , B.M. Rao2* and N.Someswara Rao
Rasayan J. Chem. Vol. 6 | No.4 | 274 - 283 | October- December| 2013
 
Development and validation of an enantioselective and chemoselective HPLC method using a Chiralpak IA column to simultaneously quantify (R)-(+)- and (S)-(−)-lansoprazole enantiomers and related impurities
Roberto Cirilli, Rosella Ferretti ∗, Bruno Gallinella, Luciana Turchetto, Leo Zanitti, Francesco La Torre
Journal of Pharmaceutical and Biomedical Analysis 50 (2009) 9–14

Lansoprazole Impurity 4 is chemically 12-(((1H-Benzo[d]imidazol-2-yl)thio)(3-methyl-4-(2,2,2-trifluoroethoxy)pyridin-2-yl)methyl)-1-methyl-2-(2,2,2-trifluoroethoxy)benzo[4',5']imidazo[2',1':2,3]imidazo[1,5-a]pyridine. Lansoprazole Impurity 4 is supplied with detailed characterization data compliant with regulatory guideline. Lansoprazole Impurity 4 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 Lansoprazole.

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.