Nitrosamines: A solution for high sensitivity and robust analysis.

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The self-inspection regarding the contamination of nitrosamines in pharmaceuticals, notified by the Ministry of Health, Labour and Welfare in October 2021, has a deadline of August 1, 2025. By the deadline, it is necessary to measure the amount of nitrosamines contained in items at risk of contamination, and if the levels exceed the limit, risk reduction measures such as setting standard values must be taken. When setting standard values for nitrosamines, it is essential to use systems and analytical conditions that enable high-sensitivity analysis, and we also want the systems to have the robustness to withstand daily analysis. Waters supports high-sensitivity and robust analysis of nitrosamines with total solutions including high-sensitivity and robust mass spectrometers, LC systems and columns that achieve high separation, and informatics, as a specialized manufacturer of LC and mass spectrometry. By clicking [Submit], you are deemed to have agreed that Waters will use and process the information provided on this site in accordance with Waters' Terms of Use and Privacy Notice. Terms of Use and Privacy Notice www.waters.com/legalandprivacy

User Lecture: Shionogi & Co., Ltd. "Risk Assessment of Nitrosamines in Pharmaceuticals and Testing Methods" (35 minutes)

basic information

■ High-Sensitivity Tandem Quadrupole Mass Spectrometer Xevo TQ Absolute Significantly improved sensitivity with the new detector Removes neutral molecules and conducts analysis with high robustness Achieves highly sensitive analysis of nitrosamines with excellent quantification using MS/MS ■ Ultra-Fast High-Resolution Liquid Chromatography ACQUITY Premier System Enhances the efficiency of analytical methods using UPLC technology Improved separation and detection of analytes that easily adsorb to metals ■ High-Resolution Mass Spectrometer Xevo G3 QTof Addresses concerns regarding novel nitrosamines in APIs and pharmaceuticals ■ ACQUITY and XSelect HSS T3 Columns Achieves retention of highly polar compounds under reversed-phase conditions Columns suitable for the separation of a wide range of active pharmaceutical ingredients and nitrosamines ■ Atlantis Premier BEH C18 AX Column Uses reversed-phase/anion exchange mixed-mode packing material Columns demonstrate excellent retention performance for highly polar low molecular weight compounds like NDMA ■ waters_connect A platform that allows intuitive operation and improves lab productivity Compliant with regulations, ensuring data reliability and integrity

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Applications/Examples of results

■ Diverse Column Chemistry In many cases where new pharmaceuticals or formulations are introduced, the development of new nitrosamine analysis methods is necessary. The variety of columns, such as ACQUITY and XSelect HSS T3 columns and Atlantis Premier BEH C18 AX columns, allows for robust, reliable, and straightforward effective method development. ■ Xevo TQ Absolute Tandem Quadrupole Mass Spectrometer and ACQUITY Premier System This system quantifies trace levels of low molecular weight nitrosamines and nitrosamine-related impurities. It achieves sensitivity that exceeds the quantitation limits recommended by regulatory authorities. Waters' LC-MS/MS total solution supports all stages of analysis, from risk assessment during development to routine testing during manufacturing, enabling accurate detection, confirmation, and management. ■ Xevo G3 QTof and ACQUITY Premier System This provides a robust and versatile solution that accommodates both targeted and screening approaches for the reliable identification, quantification, and management of nitrosamines.