Nitrosamine Impurity Analysis | Thermo Fisher Scientific

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:

Liquid, gas, and ion chromatography for robust separation
High resolution, accurate mass (HRAM) mass spectrometry for ultimate confidence avoiding false positive results
Tandem mass spectrometry, the best tool in routine analysis
Single, compliance-ready software solution for all our technology solutions

Application Note: HRAM LC-MS method for the determination of nitrosamine impurities in drugs
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Case Study: What pharmaceutical QA/QC laboratories need to know for overcoming challenges of nitrosamine impurities in drugs
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Application Note: High-resolution accurate-mass liquid chromatography mass spectrometry (HRAM LC-MS) methodology for the determination and quantitation of nitrosamine impurities in drug products
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Case Study: EUROLAB adopts Orbitrap high-resolution accurate-mass (HRAM) solution for both targeted and untargeted contaminant analysis
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Application Note: A validated method for the rapid determination of fifteen nitrosamines in metformin drug substance
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Application Note: Determination of genotoxic nitrosamines in Valsartan with gas chromatography and mass spectrometry
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Case Study: What pharmaceutical QA/QC laboratories need to know for cGMP for nitrosamine testing
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Application Note: Determination of Dimethylamine in Metformin HCl drug product using IC with Suppressed Conductivity detection
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Application Note: Determination of nitrite in pharmaceuticals
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Technical Note: Designing ion chromatography methods for determining amines in pharmaceuticals
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LCMS