INVESTIGADORES
GANDOLFI DONADIO Lucia
artículos
Título:
Synthesis and characterization of new related substances of the antiarrhythmic drug dronedarone hydrochloride
Autor/es:
MARINA SANTOS; CYNTHIA L., GARCÍA; CINTIA CHECURA; LUCÍA, GANDOLFI DONADÍO; CARLOS FERNANDEZ; HERNAN ORGUEIRA; M. JULIETA, COMIN
Revista:
JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS
Editorial:
ELSEVIER SCIENCE BV
Referencias:
Lugar: Amsterdam; Año: 2015 vol. 114 p. 441 - 446
ISSN:
0731-7085
Resumen:
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.
