Propafenone EP Impurity B (oxalate salt)

Stability‐indicating methods applied in the separation and characterization of the main degradation product of propafenone
Heitor Oliveira de Almeida Leite  Nájla Mohamad Kassab  Maria Segunda Aurora Prado  Anil Kumar Singh
SSC Plus Volume1, Issue7 July 2018 Pages 490-497

Propafenone EP Impurity B (oxalate salt) is chemically ((2E)-1-[2-[(2RS)-2-hydroxy-3-(propylamino)propoxy]phenyl]-3-phenylprop-2-en-1-one oxalate. It is also known as Propafenone USP Related Compound B ; Propafenone Didehydro Impurity. Propafenone EP Impurity B (oxalate salt) is supplied with detailed characterization data compliant with regulatory guideline. Propafenone EP Impurity B (oxalate salt) 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 Propafenone.

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.