Dapoxetine Impurity 8

Structure elucidation of a process-related impurity of dapoxetine
Andras Darcsi Gerg ´ o T˝ oth J ´ ozsef K ´ ok¨ osi Szabolcs ¨ Beni
Journal of Pharmaceutical and Biomedical Analysis Volume 96, 5 August 2014, Pages 272-277
 
Identification and characterization of a new dapoxetine impurity by NMR: Transformation of N-oxide by Cope elimination
Andras Darcsi ´ Akos R ´ acz Szabolcs B ´ eni
J Pharm Biomed Anal. 2017 Feb 5;134:187-194.

Dapoxetine Impurity 8 is chemically 1-(3-Chloro-3-phenylpropoxy)naphthalene. Dapoxetine Impurity 8 is supplied with detailed characterization data compliant with regulatory guideline. Dapoxetine Impurity 8 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 Dapoxetine .

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.