Sertraline EP Impurity B

Separation of stereoisomers of sertraline and its related enantiomeric impurities on a dimethylated β-cyclodextrin stationary phase by HPLC
R. Nageswara Rao M.V.N. KumarTalluri Pawan K.Maurya
Journal of Pharmaceutical and Biomedical Analysis Volume 50, Issue 3, 15 October 2009, Pages 281-286
 
Development and validation of a HPLC method for the determination of sertraline and three non-chiral related impurities
Alessia Ferrarini , Angel Luis Huidobro, Federica Pellati, Coral Barbas
J Pharm Biomed Anal. 2010 Oct 10;53(2):122-9
 
UHPLC Determination of Enantiomeric Purity of Sertraline in the Presence of its Production Impurities
M. L. Reyes-Reyes, Gabriela Roa-Morales, Roberto Melgar-Fernández, Horacio Reyes-Pérez & Patricia Balderas-Hernández
Chromatographia volume 77, pages1315–1321(2014)

Sertraline EP Impurity B is chemically Cis-4-Phenyl-1,2,3,4-tetrahydro-N-methyl -1-naphthalen amine hydrochloride ; . It is also known as 3,4-Dideschloro Sertraline HCl (USP) ; cis-3,4-Dideschloro Sertraline HCl ; Sertraline Phenyl Impurity ; . Sertraline EP Impurity B is supplied with detailed characterization data compliant with regulatory guideline. Sertraline EP Impurity B 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 Sertraline.

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.