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Nitrosamine impurity analysis requires robust and sensitive analytical methods to ensure confidence in the obtained results. The wide Thermo Scientific portfolio is proven to be excellent for nitrosamine analysis, ensuring your exploratory and routine methods are performed as accurately and reliably as possible while maintaining requirements from regulatory bodies worldwide. Our major products for the analysis of nitrosamines include:
All the tools you need for nitrosamine impurity analysis
The use of some common solvents, such as DMF, in the manufacturing process can lead to false-positive results if the interfering compounds cannot be sufficiently separated chromatographically. Orbitrap technology is the gold standard mass spectrometry technique for fast and confident nitrosamine impurity screening, or for piece-of-mind confirmation analysis, which is critical to eliminate false-positive results through interferences. Here are two workflows demonstrating this application:
Routine batch monitoring for specifically identified nitrosamines (as per regulatory recommendations, or by internal risk assessments) requires set methods that may last for years. Tandem MS has long been the method of choice for applications with challenging sensitivity requirements. Combined with proven method robustness, simplicity of use and the ability to easily achieve. Here are two workflows demonstrating this application:
All Thermo Scientific nitrosamine solutions are controlled and operated by Chromeleon CDS software. Built with both the lab and IT in mind, this software delivers superior compliance tools, networking capabilities, instrument control, automation, and data processing. It's a full enterprise solution designed for tracking, accountability, and QA/QC that is incredibly easy to use, with fewer mouse clicks, and more "right-first-time" results. It's also designed to scale globally and provide strong, reliable return on investment.
The use of some common solvents, such as DMF, in the manufacturing process can lead to false-positive results if the interfering compounds cannot be sufficiently separated chromatographically. Orbitrap technology is the gold standard mass spectrometry technique for fast and confident nitrosamine impurity screening, or for piece-of-mind confirmation analysis, which is critical to eliminate false-positive results through interferences. Here are two workflows demonstrating this application:
Routine batch monitoring for specifically identified nitrosamines (as per regulatory recommendations, or by internal risk assessments) requires set methods that may last for years. Tandem MS has long been the method of choice for applications with challenging sensitivity requirements. Combined with proven method robustness, simplicity of use and the ability to easily achieve. Here are two workflows demonstrating this application:
All Thermo Scientific nitrosamine solutions are controlled and operated by Chromeleon CDS software. Built with both the lab and IT in mind, this software delivers superior compliance tools, networking capabilities, instrument control, automation, and data processing. It's a full enterprise solution designed for tracking, accountability, and QA/QC that is incredibly easy to use, with fewer mouse clicks, and more "right-first-time" results. It's also designed to scale globally and provide strong, reliable return on investment.
Nitrosamines, or more correctly N-nitrosoamines, refer to any molecule containing the nitroso functional group. These molecules are of concern because nitrosamine impurities are probable human carcinogens. The unexpected finding of nitrosamine impurities in drugs such as angiotensin II receptor blockers (ARBs), ranitidine, nizatidine, and metformin, has made clear the need for a risk assessment strategy for potential nitrosamines in any pharmaceutical product at risk for their presence. Stringent regulatory guidance’s are not only helping to make drugs safer, but through the method requirements are helping laboratories to identify the appropriate tools needed for accurate and confident 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.
Nitrosamine Analysis | LC-MS | GC-MS | IC |
---|---|---|---|
| Orbitrap Exploris 120 LC-HRAM | Orbitrap Exploris GC-HRAM | - |
| TSQ Quantis LC-MS/MS | TSQ 9610 GC-MS | - |
| TriPlus RSH SMART | TriPlus RSH SMART | - |
| Chromeleon CDS Software | Chromeleon CDS Software | Chromeleon CDS Software |
| - | - | HPIC system |
Obtain new benchmarks in accuracy, precision, and sensitivity with the Thermo Scientific Vanquish HPLC and UHPLC systems. With state-of-the-art quaternary or binary high-pressure solvent blending, these ultra-high-performance liquid chromatography systems share all Vanquish values, such as a design focused on uptime, robustness and reliability.
Succeed with flexibility. Vanquish Flex UHPLC systems excel from method development to routine analyses. With binary and quaternary pump options, the Vanquish Flex UHPLC systems offer outstanding performance for LC and LC-MS based nitrosamine workflows.
Eliminate disruptions to your routine analytical work with the Vanquish Core HPLC system. Switching to Vanquish Core is simple and seamless. A full suite of method transfer tools, including tune-able gradient delay volume, makes adoption easy. Like all members of our Vanquish product line, Vanquish Core HPLC systems offer hardware precision and simplicity of operation. Ideal for routine nitrosamine impurity analysis.
Spend less time questioning your results with the unique ability of Thermo Scientific Orbitrap high-resolution, accurate-mass (HRAM) mass spectrometers to provide accurate results and reduce false positives or negatives.
The proven 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.
Also see: Looking for Thermo Scientific Q Exactive plus Hybrid Quadrupole-Orbitrap Mass Spectrometer?
Easily answer critical analytical challenges during targeted quantitation workflows in your laboratory. With its segmented quadrupoles, faster rod drivers, and improved electron multipliers, the Thermo Scientific TSQ Quantis Triple Quadrupole Mass Spectrometer delivers unprecedented robustness with best-in-class sensitivity for everyday use and for every user.
Get excellent retention and unique selectivity for aromatic and moderately polar analytes.
Thermo Scientific Hypersil GOLD Phenyl RP HPLC columns utilizes a butyl (C4) linker in the phenyl bonded phase allows for superior alignment of the phenyl ring with aromatic molecules, while providing the stationary phase with moderate hydrophobicity, making it ideal for the separation of analyte mixtures with varying polarity and aromaticity.
Simplify analytical workflows with the compact Thermo Scientific Orbitrap Exploris GC mass spectrometer, which brings the versatility of full-scan, high-resolution accurate-mass data to screening and quantitation.
Reduce time spent evaluating data and increase confidence with exceptional levels of selectivity, sensitivity, and linear dynamic range that come together to deliver accurate results, in all sample matrices. Full-scan, high-resolution MS data allows multipoint compound identification with spectral matching, isotope patterns, retention indices, and elemental compositions to reduce time to results
For high-throughput analytical laboratories, the TSQ 9610 GC-MS/MS system provides sensitive, specific quantitation of target compounds.
Delivering attogram-level sensitivity and best-in-class selected reaction monitoring (SRM) performance, the TSQ 9610 GC-MS/MS system consistently meets required detection limits as you run samples. Choose the rugged Thermo Scientific ExtractaBrite ion source or the ultra-sensitive, ultra-robust Thermo Scientific Advanced Electron Ionization (AEI) ion source, depending on your sensitivity needs.
Get ahead of the curve by determining nitrite in pharmaceuticals to assess the likelihood of nitrosamine formation before they do.
Obtain high performance, convenience, and flexibility by using our top-of-the-line IC platform optimized for capillary flow rates. The Thermo Scientific Dionex ICS-6000 Capillary HPIC System enables you to scale down column size, injection volumes, and flow rates by a factor of 25 to 100. With a capillary configuration, your system is always ready and able to run samples 24/7 with minimal calibration and equilibration time.
Achieve high resolution separations of trace inorganic anions in using the Thermo Scientific Dionex IonPac AS19-4µm hydroxide-selective anion-exchange column. Its high resolution, high capacity and selectivity allow the determination of analytes at low concentrations.
Minimize environmental contamination and improve laboratory productivity by automating the sample preparation for nitrosamine impurity analysis
Sample preparation steps, which can account for more than 60% of the time spent on chromatographic analysis, generally include extraction, clean-up, dilution, standard addition, derivatization, mixing and heating. The Thermo Scientific TriPlus RSH SMART Autosampler can eliminate the sample preparation bottleneck for both online automation for GC-MS, and off-line automation for GC-MS and LC-MS.
Compliance-ready operation and data processing for every Thermo Scientific nitrosamine solution, enabling confidence in data generation and result reporting
Built with both the lab and IT in mind, this software delivers superior compliance tools, networking capabilities, instrument control, automation, data processing, and much more. It's a full enterprise solution designed for tracking, accountability, and QA/QC that is incredibly easy to use, with fewer mouse clicks, and more "right-first-time" results. It is also designed to scale globally and provide strong, reliable return on investment.
All Thermo Scientific systems for nitrosamine impurity analysis can be operated by Chromeleon CDS software, giving confidence in results which ever direction your laboratory takes.
Nitrite impurities are found in a range of commonly used excipients, which may lead to nitrosamine impurities forming in drug products during the drug product manufacturing process and shelf-life storage. Therefore, it is important to limit the nitrite and amine levels in drug substances and drug products. Reagent-Free™ (RFIC™) ion chromatography coupled with high capacity IC column allows for assessment and quantitation of nitrite levels even in the presence of high concentration counterions such as chloride.