Article ID | Journal | Published Year | Pages | File Type |
---|---|---|---|---|
1223203 | Journal of Pharmaceutical and Biomedical Analysis | 2010 | 6 Pages |
Abstract
A major process-related impurity associated with the synthesis of ezetimibe was detected by LC–MS. The isolated impurity was found not to have been previously reported. Based on LC/MS/MS studies and accurate mass data, the structure of that impurity was proposed to be 2-(4-hydroxybenzyl)-N,5-bis-(4-fluorophenyl)-5-hydroxypentanamide. The postulated structure was unambiguously confirmed with the help of the NMR and IR analyses of a synthetically obtained sample. The chemical shift of the labile proton of that new entity was assigned by a 2D-NOESY NMR experiment. A rationalization for the formation of this impurity is provided.
Related Topics
Physical Sciences and Engineering
Chemistry
Analytical Chemistry
Authors
Bhanu Raman, Brajesh A. Sharma, Rahul Butala, Pradeep D. Ghugare, Ashok Kumar,