Preliminary identification and quantification of residual solvents in pharmaceuticals using the parallel dual-column system.
A database for preliminary identification and quantification of residual solvents in pharmaceuticals has been established using the parallel dual-column system. Two columns with different polarities, SPB-1 and HP-INNOWAX, connected with a 'Y' splitter, constituted the dual pathways system. Fifty-two solvents were studied according to the guidelines for residual solvents regulated by the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) on this system. Through a single run, preliminary identification and quantification can be performed using the database. An important advantage of the database is that the residual solvents in the pharmaceuticals can be prescreened without using reference organic solvents.
Liu
Ying
Y
National Institute for the Control of Pharmaceutical and Biological Products, Beijing 100050, China.
Hu
Chang-Qin
CQ
D002849:Chromatography, Gas / Q000379:methods*; D016208:Databases, Factual; D004364:Pharmaceutical Preparations / Q000737:chemistry*; D012997:Solvents / Q000032:analysis*
D004364:Pharmaceutical Preparations; D012997:Solvents