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 analyzing 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.

Speak to a specialist  Join our community

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 at our virtual seminar

  • Session 1: June 16 | Introduction to impurity testing, European regulations and the importance of compliance
  • Session 2: June 17 | Solutions for nitrosamine analysis by GC-MS
  • Session 3: June 18 | Solutions for Nitrosamine analysis including NDMA by LC-MS

Each session will begin at 11:00 Central European Summer Time (CEST) / 10:00 British Summer Time, (BST), and last 20 - 30 minutes, but you can join just for the presentations relevant to you.

Learn more about the sessions and register ›

Popular products for nitrosamines analysis

Q Exactive Plus Hybrid Quadrupole-Orbitrap Mass Spectrometer
 Chromeleon Chromatography Data System (CDS) Software
Vanquish Core HPLC System

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.


Analytical methods for nitrosamines in drugs

Q Exactive Plus

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 ›

Vanquish Core

The Thermo Scientific Vanquish Core is ideal for routine analysis requirements and can be seamlessly coupled to a mass spectrometer (MS), allows the users in the QC labs to obtain new benchmarks in accuracy, precision and sensitivity while delivering reproducibly consistent results. New enhancements such as System Health Monitoring and the Vanquish Solvent Monitor, provide increased productive time for your system.

Hypersil Gold Phenyl liquid chromatography column

Hypersil Gold Phenyl liquid chromatography column offers good retention of NDMA and other nitrosamines, allowing them to be effectively separated from the main API component. It is moderately hydrophobic, has enhanced pi-pi interaction with aromatic compounds, and an excellent peak pattern and sensitivity.

Accucore PFP liquid chromatography column

Accucore PFP liquid chromatography column is L43 (USP) designation and is based on Core Enhanced Technology, Thermo Scientific Accucore HPLC and UHPLC columns provide ultimate core performance, allowing you to maximize your investment. Solid core particles make for fast separations with superb resolution. A wide range of phases help meet all your separation needs, while our columns are exceptionally rugged and easy to use.

TSQ Fortis Triple Quadrupole Mass Spectrometer

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.

TSQ Altis Triple Quadrupole Mass Spectrometer

The Thermo Scientific TSQ Altis Triple Quadrupole Mass Spectrometer will with its improved Active Ion Management (AIM™) technology, segmented quadrupoles, novel electron multipliers, and enhanced ion transmission tubes will support  you to achieve unprecedented experimental sensitivity for nitrosamine impurities in complex matrices without sacrificing robustness.

Vanquish Flex Binary UHPLC system

The Thermo Scientific Vanquish Flex Binary UHPLC system is ideal for high-throughput analyses and can be seamlessly coupled to a mass spectrometer (MS), allows the users in the QC labs to obtain new benchmarks in accuracy, precision and sensitivity while delivering reproducibly consistent results.

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.

ISQ 7000 GC-MS system

The ISQ 7000 GC-MS system delivers highest sensitivity amongst single quadruple systems, being able to reach detection limits appropriate and needed for nitrosamine analysis. Whether you run in selected ion monitoring (SIM) or full scan modes, you consistently achieve the required response as you analyze samples. Achieving low detection limits requires breaking noise-reduction boundaries. The ISQ 7000 GC-MS system does so with pre-filters having a unique ion path that neutrals cannot navigate.

TriPlus 500 GC Headspace Autosampler

Whether you need headspace sample introduction or direct liquid injection we have a solution for you.

The Thermo Scientific TriPlus 500 GC Headspace Autosampler delivers the trusted reliability and robustness for testing laboratories performing nitrosamine analysis.

Read more ›

AS1310 Liquid Autosampler

Thermo Scientific AS1310 Liquid Autosampler developed to serve the demands of any busy QA/QC or high-throughput lab.

Q Exactive Plus

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 ›

Vanquish Core

The Thermo Scientific Vanquish Core is ideal for routine analysis requirements and can be seamlessly coupled to a mass spectrometer (MS), allows the users in the QC labs to obtain new benchmarks in accuracy, precision and sensitivity while delivering reproducibly consistent results. New enhancements such as System Health Monitoring and the Vanquish Solvent Monitor, provide increased productive time for your system.

Hypersil Gold Phenyl liquid chromatography column

Hypersil Gold Phenyl liquid chromatography column offers good retention of NDMA and other nitrosamines, allowing them to be effectively separated from the main API component. It is moderately hydrophobic, has enhanced pi-pi interaction with aromatic compounds, and an excellent peak pattern and sensitivity.

Accucore PFP liquid chromatography column

Accucore PFP liquid chromatography column is L43 (USP) designation and is based on Core Enhanced Technology, Thermo Scientific Accucore HPLC and UHPLC columns provide ultimate core performance, allowing you to maximize your investment. Solid core particles make for fast separations with superb resolution. A wide range of phases help meet all your separation needs, while our columns are exceptionally rugged and easy to use.

TSQ Fortis Triple Quadrupole Mass Spectrometer

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.

TSQ Altis Triple Quadrupole Mass Spectrometer

The Thermo Scientific TSQ Altis Triple Quadrupole Mass Spectrometer will with its improved Active Ion Management (AIM™) technology, segmented quadrupoles, novel electron multipliers, and enhanced ion transmission tubes will support  you to achieve unprecedented experimental sensitivity for nitrosamine impurities in complex matrices without sacrificing robustness.

Vanquish Flex Binary UHPLC system

The Thermo Scientific Vanquish Flex Binary UHPLC system is ideal for high-throughput analyses and can be seamlessly coupled to a mass spectrometer (MS), allows the users in the QC labs to obtain new benchmarks in accuracy, precision and sensitivity while delivering reproducibly consistent results.

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.

ISQ 7000 GC-MS system

The ISQ 7000 GC-MS system delivers highest sensitivity amongst single quadruple systems, being able to reach detection limits appropriate and needed for nitrosamine analysis. Whether you run in selected ion monitoring (SIM) or full scan modes, you consistently achieve the required response as you analyze samples. Achieving low detection limits requires breaking noise-reduction boundaries. The ISQ 7000 GC-MS system does so with pre-filters having a unique ion path that neutrals cannot navigate.

TriPlus 500 GC Headspace Autosampler

Whether you need headspace sample introduction or direct liquid injection we have a solution for you.

The Thermo Scientific TriPlus 500 GC Headspace Autosampler delivers the trusted reliability and robustness for testing laboratories performing nitrosamine analysis.

Read more ›

AS1310 Liquid Autosampler

Thermo Scientific AS1310 Liquid Autosampler developed to serve the demands of any busy QA/QC or high-throughput lab.

FDA method links


Compliant software controlling your MS instrument and data analysis for impurity analysis in a GMP environment

Streamline your laboratory workflow using Thermo Scientific Chromeleon Chromatography Data System (CDS) software. Run your routine GC-MS or LC-MS nitrosamine analyses in an enterprise environment—from method creation to final reporting. Download eWorkflows directly from our Thermo Scientific AppsLab Library . Your complete method and consumables shopping list in one click. Chromeleon software then delivers superior instrument control, automation, and data processing for compliant GxP pharmaceutical manufacturing and QA/QC environments.


Confidence and compliance
Confidence and compliance

Accurate and targeted analyses for known GTIs.

  • Highly selective methods
  • Robust system performance
  • Fully compliant ready CDS
  • Meets FDA method specifications

Read more ›