Mass Spectrometry

PPD’s mass spectrometry (MS) team works closely with our method development, stability and synthesis teams to identify critical degradation products that emerge over the course of the development cycle. We use state-of-the-art instrumentation to identify and characterize active components as well as process impurities during the early phases of development for both small and large molecules.

Key mass spectrometry instrumentation includes:

• Waters Q-Tof Premier® coupled with HPLC
• Waters ACQUITY® TQ Detector coupled with UPLC
• Applied Biosystems/MDS Sciex 4000 QTRAP® System coupled with HPLC
• Applied Biosystems/MDS Sciex API 3000™ System
• Applied Biosystems/MDS Sciex API 2000™ System
• Agilent Single Quad

Iso-LC/MS System

We have also developed an in-house 2-D HPLC/MS system that uses a Sciex 4000 Q-Trap for online separation and detection of compounds. This Iso-LC/MS system is for compounds observed in mobile phases not compatible with traditional LC/MS.

Advantages of the Iso-LC/MS include:

• Cost and time savings since there is no need to redevelop an MS-compatible method
• Significantly reduced chance for secondary degradation of impurity compounds
• Confidence in the peak assignment
• Concentrating effect of the compound (three to five times with multiple injections)
• Secondary separation to resolve co-eluting components from the primary separation
• Full control through Applied Biosystems Analyst™ v.1.4.2 software