The Medicine Maker / White Papers / 2017 / Achieve confident impurity detection with the Thermo Scientific ISQ EC single quadrupole mass spectrometer

Achieve confident impurity detection with the Thermo Scientific ISQ EC single quadrupole mass spectrometer

12/06/2017

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Goal

Demonstrate quantitative impurity analysis with the Thermo Scientific™ ISQ™ EC™ single quadrupole mass spectrometer and show its benefit for pharmaceutical development and quality control.

Introduction

Impurity analysis of produced chemicals is essential for small molecule pharmaceutical development or quality control. According to guidelines from the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), all side products above a certain threshold need to be first characterized and later monitored. Identification and qualification thresholds depend on the daily dose and range between 0.1% and 1.0%.1 Analysis is often done by an array of different detection methods. In quality control, UV-based detection is still the standard, but MS detection is gaining acceptance because of its clear advantages. Besides its lower detection limit, it also allows immediate analyte identification based on its respective mass and straightforward peak purity analysis based on its mass spectrum. UV-based identification, on the other hand, is often ambiguous since analyte identities are inferred based on their retention time and UV absorption. 

Modern single quadrupole mass spectrometers, such as the ISQ EC single quadrupole mass spectrometer (ISQ EC MS), are reliable workhorses designed for routine applications. The ISQ EC MS can operate in Full Scan or Single Ion Monitoring (SIM) mode, to either scan a mass range for all detectable analytes or focus on a specific compound. It can run at scan rates suitable for fast UHPLC applications while delivering picogram detection limits. The new orthogonal source design provides high levels of instrument robustness, even with challenging matrices. Full integration into the Thermo Scientific™ Chromeleon™ 7.2 chromatography data system (CDS) and the Thermo Scientific™ AutoSpray™ smart method set-up make LC-MS operation and data analysis straightforward and intuitive.
>> Download the full Application Note as PDF

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