Nitrosamine Impurity Analysis

Screen and quantify nitrosamine impurities with confidence

Certain pharmaceutical manufacturing processes can result in the production of genotoxic impurities (GTIs), such as N-nitrosodimethylamine (NDMA) and other nitrosamines, many of which are potentially carcinogenic.

Whether you are analysing these impurities in finished drug products, active pharmaceutical ingredients, intermediates, or raw materials you will benefit from the robustness and accuracy provided by high resolution accurate mass detection and quantitation or equally reliable quantitation by triple quadrupole technology. Our mass spectrometers will be the platforms for highly robust advanced analytical methods to answer your questions with high confidence.

Confident quantitation can be provided by our GC or HPLC separation systems coupled to Quadrupole and Orbitrap-based mass spectrometry systems together with advanced informatics capabilities.

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Virtual seminar

Hear from our experts as well as our customers on how they are rising to the challenge of analyzing nitrosamines by LC-MS and GC-MS

  • Session 1: Introduction to impurity testing, European regulations and the importance of compliance
  • Session 2: Solutions for nitrosamine analysis by GC-MS
  • Session 3: Solutions for nitrosamine analysis including NDMA by LC-MS

Learn more and view the sessions ›

Popular products for nitrosamines analysis

There are a variety of ways MS-based methods can be leveraged to provide confident and reliable quantitation of nitrosamine impurities, as has also been shown by official methods advocated by regulatory agencies.

The Thermo Scientific TSQ Fortis Triple Quadrupole Mass Spectrometer allows you to increase productivity, with reliability and robustness for targeted quantitation of nitrosamine impurities. This system makes it easier to achieve reproducible results. Coupling it to the Thermo Scientific Vanquish Flex Binary UHPLC system makes it ideal for analyses leveraging high-throughput selected reaction monitoring-based approaches for low level analyte quantitation.

Since GC-MS methods cannot yet directly detect one of the common nitrosamine impurities (N-nitroso-N-methyl-4-aminobutyric acid (NMBA)) as derivatization is required, laboratories may prefer an LC-MS approach. The exceptional high-resolution accurate mass (HRAM) selectivity of the Thermo Scientific Q Exactive Plus allows high-resolution (R>140,000) to remove interferences without the need for fragmentation, MS analysis can be performed in full scan mode and data can be interrogated post run for any ions of interested through extracted ion chromatograms. For targeted ion scans more ions are detected, resulting in easy to detect and integrate peaks, even at the limit of detection (LOD) allowing to take advantage of a simple and fast method, for the quantitative analysis of the most common nitrosamines in drug product formulations and  active pharmaceutical ingredient.

Read more ›

Bring the power of the first-ever combination of high-resolution gas chromatography (GC) and high-resolution/accurate-mass (HRAM) Orbitrap mass spectrometry to your laboratory. The Thermo Scientific™ Q Exactive™ GC Orbitrap™ GC-MS/MS system provides comprehensive characterization of samples in a single analysis for the highest confidence in compound discovery, identification, and quantitation. This system offers the quantitative power of a GC triple quadrupole MS combined with the high precision, full-scan HRAM capabilities only available in combination with Thermo Scientific™ Orbitrap™ technology.

TSQ 9000 Triple Quadrupole GC-MS/MS and TriPlus RSH Liquid Autosampler
TSQ 9000 Triple Quadrupole GC-MS/MS and TriPlus RSH Liquid Autosampler

Thermo Scientific TSQ 9000 Triple Quadrupole GC-MS/MS combined with the Thermo Scientific TriPlus RSH Liquid Autosampler assures the sensitivity level required by official methods and in many pharma laboratories ensuring the safety of products. A dedicated configuration for maximum performance may be provided which combines headspace and the liquid injection capability on the same GC deliver exceptional precision, unprecedented sample handling flexibility. Accurate and repeatable sample preparation and introduction are essential to achieving the highest quality GC-MS results and also support the needs for the required productivity for QC testing laboratories.

The TSQ 9000 GC-MS/MS system is able to deliver sensitivity into the attogram range and best-in-class selected-reaction-monitoring (SRM) performance to consistently meet required detection limits for nitrosamine analysis as you test samples.

The power of multi-award winning Orbitrap™ GC-MS technology has so far allowed research scientists to break new ground in gaining a broader and deeper understanding of their samples through the use of high-resolution, accurate-mass (HRAM) analysis. The introduction of the Thermo Scientific™ Exactive™ GC Orbitrap™ GC-MS system brings that power into the routine environment for the first time. This system allows scientists working in fields like food safety, environmental, industrial, forensics and anti-doping to revolutionize their workflows by taking their analytical capability to the next level.

Since GC-MS methods cannot yet directly detect one of the common nitrosamine impurities (N-nitroso-N-methyl-4-aminobutyric acid (NMBA)) as derivatization is required, laboratories may prefer an LC-MS approach. The exceptional high-resolution accurate mass (HRAM) selectivity of the Thermo Scientific Q Exactive Plus allows high-resolution (R>140,000) to remove interferences without the need for fragmentation, MS analysis can be performed in full scan mode and data can be interrogated post run for any ions of interested through extracted ion chromatograms. For targeted ion scans more ions are detected, resulting in easy to detect and integrate peaks, even at the limit of detection (LOD) allowing to take advantage of a simple and fast method, for the quantitative analysis of the most common nitrosamines in drug product formulations and  active pharmaceutical ingredient.

Read more ›

Bring the power of the first-ever combination of high-resolution gas chromatography (GC) and high-resolution/accurate-mass (HRAM) Orbitrap mass spectrometry to your laboratory. The Thermo Scientific™ Q Exactive™ GC Orbitrap™ GC-MS/MS system provides comprehensive characterization of samples in a single analysis for the highest confidence in compound discovery, identification, and quantitation. This system offers the quantitative power of a GC triple quadrupole MS combined with the high precision, full-scan HRAM capabilities only available in combination with Thermo Scientific™ Orbitrap™ technology.

TSQ 9000 Triple Quadrupole GC-MS/MS and TriPlus RSH Liquid Autosampler
TSQ 9000 Triple Quadrupole GC-MS/MS and TriPlus RSH Liquid Autosampler

Thermo Scientific TSQ 9000 Triple Quadrupole GC-MS/MS combined with the Thermo Scientific TriPlus RSH Liquid Autosampler assures the sensitivity level required by official methods and in many pharma laboratories ensuring the safety of products. A dedicated configuration for maximum performance may be provided which combines headspace and the liquid injection capability on the same GC deliver exceptional precision, unprecedented sample handling flexibility. Accurate and repeatable sample preparation and introduction are essential to achieving the highest quality GC-MS results and also support the needs for the required productivity for QC testing laboratories.

The TSQ 9000 GC-MS/MS system is able to deliver sensitivity into the attogram range and best-in-class selected-reaction-monitoring (SRM) performance to consistently meet required detection limits for nitrosamine analysis as you test samples.

The power of multi-award winning Orbitrap™ GC-MS technology has so far allowed research scientists to break new ground in gaining a broader and deeper understanding of their samples through the use of high-resolution, accurate-mass (HRAM) analysis. The introduction of the Thermo Scientific™ Exactive™ GC Orbitrap™ GC-MS system brings that power into the routine environment for the first time. This system allows scientists working in fields like food safety, environmental, industrial, forensics and anti-doping to revolutionize their workflows by taking their analytical capability to the next level.

FDA method links