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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%
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Malaria Journal

ISSN: 1475-2875

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