1.
J Pharm Biomed Anal
; 114: 441-6, 2015 Oct 10.
Article
in English
| MEDLINE
| ID: mdl-26133102
ABSTRACT
Two new potential impurities of antiarrhythmic drug substance Dronedarone Hydrochloride together with debutyldronedarone were detected by LC-MS analysis during process development. A successful synthetic strategy for the synthesis of these potential impurities was developed facilitating the access to new impurity reference standards. Their synthesis and characterization are discussed in detail. The availability of these impurity standards allowed cost reduction through the increase of process control.