Development of reference substances for series impurities of lacosamide
SUN Chang-ying
MA Xun
PENG Yu-shuai
YIN Li-hui
Abstract：Objective:To calibrate and develop the system suitability impuritiesⅠ,Ⅱ,Ⅲ,Ⅳ,Ⅴ,andⅥ in the related substances inspection of national drug standards of lacosamide and its preparations in China to meet the needs of quality control.Methods:Techniques such as MS,IR,UV and NMR were used to confirm the structures of impuritiesⅠ,Ⅱ,Ⅲ,Ⅳ,Ⅴ,andⅥ.Purity analysis was performed using two HPLC methods,and quantitative nuclear magnetic resonance was used for value determination.Results:The structures of impuritiesⅠ,Ⅱ,Ⅲ,Ⅳ,Ⅴ,and Ⅵ were confirmed.Conclusion:The first batch of reference substances for lacosamide impurities Ⅰ,Ⅱ,Ⅲ,Ⅳ,Ⅴ,and Ⅵ were established,providing an accurate reference basis for the quality control of lacosamide and its preparations.
Keywords：lacosamide series impuritiesstandard substancesstructure confirmquantitative nuclear magnetic resonance
Publication Date：2026-02-28
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：9( 406-414 )