Genotoxic impurity analysis in pharmaceutical products

The Food and Drug Administration (FDA) released a liquid chromatography-high resolution mass spectrometry (LC-HRMS) method for the quantitation of N-nitrosodimethylamine (NDMA) in Ranitidine drug substance and drug products using the Q Exactive hybrid quadrupole-Orbitrap mass spectrometer.

High-Confidence Results, Quickly

• HRAM and full-scan capabilities capture all sample data, all the time, enabling retrospective data analysis without need to re-run samples
• Resolving power up to 140,000 FWHM eliminates isobaric interferences, increasing confidence in results when analyzing samples in complex matrices
• Better than 1 ppm mass accuracy in full-scan and all-ion fragmentation (AIF) modes ensures confident compound identification
• Fast scanning at 12 hz and spectral multiplexing suited to UHPLC applications
• Rapid polarity switching maximizes information obtained
• AIF and multiple dissociation techniques—in-source CID and HCD—aid in compound identification
• Extended mass range to 6000 m/z enhances detection of singly charged small molecules and biomolecules
• More than four orders of magnitude intrascan dynamic range, along with femtogram-level sensitivity, allow detection of trace-level and high-abundance compounds in the same scan

Greater Confidence for Drug Discovery and Metabolism Studies

• Triple quadruple-equivalent ability to quantify parent compounds and metabolites along with identity confirmation provides greater throughput
• Fast HRAM Orbitrap technology eliminates interferences for high-confidence metabolite structural identification and large-scale profiling of metabolomics and lipidomics samples
• Fast scan-to-scan polarity switching in both MS and MS/MS modes maximizes metabolite detection and identification from a single injection

More Information for Superior Proteomics

• HCD yields superior fragmentation and higher-quality MS/MS spectra compared to CID, improving identifications
• High spectral quality and a wide dynamic range make it possible to identify and quantify proteins other instruments cannot find.
• Quan/qual capability make it easier to transition from proteomic discovery experiments to targeted protein quantification

Highly Specific Environmental and Food Safety Analyses

• Specificity exceeding triple quadruple Q-TOF or Q-Trap levels make this mass spectrometer the preferred quan/qual screening platform
• Data-dependent, full-scan MS/MS capabilities and HRAM data ensure the highest possible confidence in every identification

High-Confidence Quanfirmation for Clinical Research and Forensic Toxicology

• The combination of SRM and HRAM capabilities provides high-confidence quanfirmation of endogenous steroids, drugs of abuse and pain-management therapeutics with ease.

Application-Specific Software for Greater Throughput

• Thermo Scientific™ ExactFinder™, LCQuan™, Mass Frontier™, MetQuest™, MetWorks™, SIEVE™ and TraceFinder™ software are available to speed data analysis.