KUWABE, SHIN-ITSU,YANAGIMACHI, TAKEHIKO,YOSHIYAMA, HIDEYUKI,PINES, SEEMON,DE GROOT, ELEANOR,GARCIA RUBIO, SILVINA,MANINI, PETER
申请号：
PE0016242014
公开号：
PE00842015A1
申请日:
2013.04.18
申请国别(地区):
PE
年份:
2015
代理人:
摘要：
Referring to the monohydrochloride anamorelin isolated in Amorphous State, which has a Content of chloride in a range from 5.8% to 6.2% by weight, and contains less than 0.5% by weight of impurities such as Pollutants, degradation products and residual solvents. The residual Solvent is Butyl acetate, Isopropyl acetate, Methyl acetate, Methyl ethyl ketone, among others.It also relates to a preparation method and a Pharmaceutical compositionREFERIDA AL MONOCLORHIDRATO DE ANAMORELINA AISLADO, EN ESTADO AMORFO, QUE TIENE UN CONTENIDO DE CLORURO EN UN RANGO DE ENTRE 5,8% A 6,2% POR PESO Y COMPRENDE MENOS DE 0,5% POR PESO DE IMPUREZAS TALES COMO CONTAMINANTES, PRODUCTOS DE DEGRADACION Y SOLVENTES RESIDUALES. EL SOLVENTE RESIDUAL ES ACETATO DE BUTILO, ACETATO DE ISOPROPILO, ACETATO DE METILO, METILETILCETONA, ENTRE OTROS. TAMBIEN ESTA REFERIDA A UN PROCEDIMIENTO DE PREPARACION Y A UNA COMPOSICION FARMACEUTICA
