Table 2.

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

#	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) RT: reporting threshold = 0.10%