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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.
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
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.
The proven Thermo Scientific Orbitrap technology in the Thermo Scientific Orbitrap Exploris 120 mass spectrometer accelerates your route to qualitative and quantitative confidence for both method development and everyday testing purposes. With its unique ability to provide consistently accurate data and a design made for operational simplicity, it sets the new standard in instrument productivity and ruggedness
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 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 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.
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.
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.
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.
Simplify everyday quantitation with the Thermo Scientific TSQ QuantisTriple Quadrupole Mass Spectrometer, which offers outstanding robustness and sensitivity. With its segmented quadrupoles, an enhanced dual-mode discrete-dynode electron multiplier detector, and high-resolution SRM (0.4 FWHM), the TSQ Quantis meets every targeted quantitation workflow requirement, with an ease-of-use that ensures quality data from every user, every molecule, and every analytical lab.
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.
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
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 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.
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.
Thermo Scientific AS1310 Liquid Autosampler developed to serve the demands of any busy QA/QC or high-throughput lab.
The proven Thermo Scientific Orbitrap technology in the Thermo Scientific Orbitrap Exploris 120 mass spectrometer accelerates your route to qualitative and quantitative confidence for both method development and everyday testing purposes. With its unique ability to provide consistently accurate data and a design made for operational simplicity, it sets the new standard in instrument productivity and ruggedness
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 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 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.
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.
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.
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.
Simplify everyday quantitation with the Thermo Scientific TSQ QuantisTriple Quadrupole Mass Spectrometer, which offers outstanding robustness and sensitivity. With its segmented quadrupoles, an enhanced dual-mode discrete-dynode electron multiplier detector, and high-resolution SRM (0.4 FWHM), the TSQ Quantis meets every targeted quantitation workflow requirement, with an ease-of-use that ensures quality data from every user, every molecule, and every analytical lab.
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.
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
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 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.
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.
Thermo Scientific AS1310 Liquid Autosampler developed to serve the demands of any busy QA/QC or high-throughput lab.
Regulatory guidance for nitrosamine impurity analysis
Stay up to date on what regulatory agencies are saying about nitrosamines impurities and learn more about what they are asking the pharmaceutical industry to do to prevent unacceptable levels.
FDA method links
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
Anticipating future regulatory requirements with:
- Increased sensitivity
- Improved analytical precision
- Highly selective methods
- Robust platforms
- Fully compliant software
Lab ideas for medicine makers – current topics for pharma – biopharma analytical labs!
Lab ideas for people – like yourself– in analytical labs making medicines, directed by topics, ideas and thoughts from your fellow medicine makers. Each month, a new theme addresses challenges and solutions around technology and workflows.