pharmaceutical impurity analysis solutions - Lcms-connect.com

Improve profiling productivityfor the identification of tracelevelimpurities using AgilentLC/Q-TOF solutionsThe Agilent 6540 Q-TOF delivers sensitive MS and MS/MS analysis of trace levelimpurities in drug substances with sub-ppm mass accuracy. The workfl ow shown inFigure 13 uses advanced MassHunter data analysis features like molecular featureextraction (MFE) and molecular formula generation (MFG), along with molecularstructure correlator (MSC) software.The effective use of this novel workfl ow for impurity profi ling is demonstrated bythe rapid identifi cation and structural elucidation of atenolol and eight impurities(present at > 0.01 % relative to the API’s UV detection area) as shown in Figure 14.A unique feature of MSC software helps elucidate the structure of impurities in aneffi cient manner. This workfl ow is streamlined to provide high confi dence, accurateidentifi cation and faster structure elucidation compared to conventional impurityprofi ling which requires multiple platforms and spreads analysis over multiple days.If the method isMS compatibleHPLC SeparationLC/MS analysis usingAgilent 6540 Q-TOF withfull MS scan followed byauto MS/MS1If the method is notMS compatibleResult Ex.m/z: 268.1543Develop equivalentMS Compatible LC methodFind and identifyimpurities by MFEand MFG based onthe accurate massMS data2C 14H 21NO 4MSC facilitatesthe structureelucidation of theimpurities3Figure 13. Software-assisted workflow for impurity identification and profiling of pharmaceuticals onthe Agilent 1200 Infinity Series LC combined with an accurate mass Q-TOF, and MassHunter QualitativeAnalysis and MSC software. Agilent publication in development.20