Skip to main content

Table 2 Percentage maximum actual levels of lumefantrine related impurities observed(1)

From: Stability-indicating HPLC-DAD/UV-ESI/MS impurity profiling of the anti-malarial drug lumefantrine

# Compound API FPP
   Unstressed Stressed Release Accelerated Stressed
1 Desbenzylketo N-oxide   1.39    0.60
2 Monodesbutyl derivative   0.56 0.11   
3 Lumefantrine N-oxide   21.32   0.12 0.86
4 Desbenzylketo derivative     0.34 4.26
5 Desbenzyl derivative      
6 Lumefantrine oxide (RRT ~ 0.49)      
7 Lumefantrine oxide (RRT ~ 0.52)      
8 Impurity A      
9 Lumefantrine oxide (RRT ~ 0.59)      
  1. (1) RT: reporting threshold = 0.10%