DI(4-CHLORO-PHENYLDIGUANIDO) DERIVATIVE WHICH IS FREE OF POTENTIAL GENOTOXICITY AND A PROCESS FOR REDUCING THE RESIDUAL AMOUNT OF P-CHLOROANILINE IN SAID DI(4-CHLORO-PHENYLDIGUANIDO) DERIVATIVE
Laura Sanchez Salguero,Raquel Bou Bosch,Jordi Bosch I Lladó
申请号：
US13510668
公开号：
US20130065965A1
申请日:
2010.11.18
申请国别(地区):
US
年份:
2013
代理人:
摘要：
The invention relates to a process for reducing the residual amount of p-chloroaniline in chlorhexidine. Also, the invention relates to a process for preparing chlorhexidine, or a pharmaceutically acceptable salt thereof, which is free of potential genotoxicity. In addition, the invention refers to the said chlorhexidine, or a pharmaceutically acceptable salt thereof, which is free of potential genotoxicity. Further, the invention relates to an analytical HPLC method for the determination of potentially genotoxic impurities in samples of chlorhexidine, or of a pharmaceutically acceptable salt thereof. The invention also relates to stabilized chlorhexidine digluconate salt free of potential genotoxicity in aqueous solution, and to a method for stabilizing chlorhexidine digluconate salt free of potential genotoxicity in aqueous solution.
