Lacosamide EP Impurity B (R-Isomer)

Identification and characterization of stress degradants of lacosamide by LC–MS and ESI-Q-TOF-MS/MS:Development and validation of a stability indicating RP-HPLC method
NageswaraRaoRamisettia,∗,RamakrishnaKuntamukkalaa,SridharLakshettib,PrabhakarSripadi
JournalofPharmaceuticalandBiomedicalAnalysis95(2014)256–264

Lacosamide EP Impurity B (R-Isomer) is chemically (2R)-2-(Acetylamino)-3-(acetyloxy)-N-(phenylmethyl)-propanamide. It is also known as Lacosamide O-Acetyl Impurity. Lacosamide EP Impurity B (R-Isomer) is supplied with detailed characterization data compliant with regulatory guideline. Lacosamide EP Impurity B (R-Isomer) 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 Lacosamide.

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.