Progress in the control concepts and determination methods of residual solvents in pharmaceuticals
LIU Ying
WANG Zhi-jun
DONG Xin
WANG Yan
ZHU Feng-chang
HU Chang-qin
Abstract：Objective:To introduce the residual solvents determination methods in different pharmacopoeias and their applications.Methods:Determination of the residual solvents in cefamandole nafate was taken as an example to indicate how to establish the correct method using the residual solvents determination methods in general chapter 0861 of Chinese pharmacopoeia 2015 edition.Results:The residual solvents in cefamandole nafate from different manufactures were determined accurately using the methods in general chapter 0861 of Chinese pharmacopoeia 2015 edition.Conclusion:The control concepts and determination methods of residual solvents in pharmaceuticals are different in different pharmacopoeias.The residual solvents determination methods in general chapter 0861 of Chinese pharmacopoeia 2015 can be used to screening and confirm the unknown peaks using two opposite polar columns system.
Keywords：pharmaceuticalresidual solventspharmacopeiadetermination methodapplication
Publication Date：2017-01-01
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：6( 2040-2045 )