Analysis of Genotoxic Impurities in Pharmaceuticals

The U.S. Food and Drug Administration (FDA) has published a liquid chromatography-high resolution mass spectrometry (LC-HRMS) method for the quantitative determination of N-nitrosodimethylamine (NDMA) in ranitidine APIs and formulations using the Q Exactive combined quadrupole-Orbitrap mass spectrometer.

Highly reliable results, fast

HRAM and full-scan capabilities capture all sample data from start to finish, enabling retrospective data analysis without the need to rescan samples
Resolution of up to 140,000 FWHM eliminates interference from isomeric compounds in the same amount and order, increasing the reliability of results when analyzing samples in complex matrices
Mass accuracy better than 1 ppm in both full-scan and all-ion cleavage (AIF) modes ensures reliable compound identification
Rapid 12 hz scanning and spectral multiplexing technologies are particularly well suited for UHPLC applications
Rapid polarity switching to obtain as much information as possible
AIF and a variety of dissociation techniques - in-source CID and HCD - to assist in compound identification
Extended mass number range up to 6000 m/z for improved detection of singly charged small molecules and biomolecules
More than four orders of magnitude of scanning dynamic range and femtogram-level sensitivity for simultaneous detection of trace and high-abundance compounds in a single scan
More reliable for drug discovery and metabolomics research

Quantitative capabilities comparable to Triple Quadrupole Mass Spectrometry not only for quantitative analysis of parent compounds and metabolites, but also for higher throughput in identifying defined compounds
Rapid HRAM Orbitrap technology eliminates interferences for highly reliable metabolite structure identification and enables large-scale profiling of metabolomics and lipidomics samples
Fast "scan-to-scan" polarity switching now available in both MS and MS/MS modes, enabling the detection and identification of as many metabolites as possible in a single sample injection
Gain more proteomics information

HCD performs better cleavage and produces higher quality MS/MS spectra than CID, resulting in improved identification capabilities.
High spectral quality and wide dynamic range enable identification and quantification of proteins not found on other instruments.
Quantitative/quantitative analysis capability allows proteomics discovery experiments to be easily converted to quantitative analysis of target proteins
Highly specific environmental and food safety analysis

The mass spectrometer's specificity exceeds that of a triple quadrupole Q-TOF or Q-Trap, making it the quantitative/qualitative screening platform of choice
Data-dependent full-scan MS/MS capability and HRAM data ensures high reliability in every identification
Provides high reliability for quantitative confirmation in clinical studies and forensic toxicology

The combination of SRM and HRAM capabilities makes it easy to quantify endogenous steroids, illicit drugs and analgesics with high reliability.
Application-specific software for improved throughput

Thermo Scientific™ ExactFinder™, LCQuan™, Mass Frontier™, MetQuest™, MetWorks™, SIEVE™ and TraceFinder™ software is available to accelerate data analysis.