Mixture of Lumefantrine Impurity 7 & 8

Stability-indicating HPLC-DAD/UV-ESI/MS impurity profiling of the anti-malarial drug lumefantrine
Mathieu Verbeken1† , Sultan Suleman1,3† , Bram Baert1 , Elien Vangheluwe1 , Sylvia Van Dorpe1 , Christian Burvenich2 , Luc Duchateau2 , Frans H Jansen4 , Bart De Spiegeleer
Verbeken et al. Malaria Journal 2011, 10:51 Page 2 of 9
 
Analytical Method Development and Validation for Estimation of Lumifantrine in Pharmaceutical Dosage Forms by HPLC
Naveen S Kotur *1 ,Singaravel Sivasamy2 , S.Srinivasan
J. Pharm. Sci. & Res. Vol.4(1), 2012,1672-1675
 
A Modified Method for Determination of Lumefantrine in Human Plasma by HPLC-UV and Combination of Protein Precipitation and Solid-Phase Extraction: Application to a Pharmacokinetic Study
Liusheng Huang, Patricia S. Lizak, Anura L. Jayewardene, Florence Marzan, Ming-Na Tina Lee and Francesca T. Aweeka
Analytical Chemistry Insights 2010:5 15–23

Mixture of Lumefantrine Impurity 7 & 8 is chemically 2,7-Dichloro-9-(4-chlorobenzyl)-4-(2-(dibutylamino)-1-hydroxyethyl)-9H-fluoren-9-ol compound with 2-(dibutylamino)-1-(2,7-dichloro-9-((4-chlorophenyl)(hydroxy)methyl)-9H-fluoren-4-yl)ethan-1-ol (1:1). Mixture of Lumefantrine Impurity 7 & 8 is supplied with detailed characterization data compliant with regulatory guideline. Mixture of Lumefantrine Impurity 7 & 8 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 Lumefantrine.

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.