Achieve LC-MS/MS Sensitivity Beyond Regulatory Thresholds for Nitrosamines

Faced with the challenge of quantifying trace levels of small alkyl nitrosamines or nitrosamine drug substance related impurities (NDSRIs)? Waters ACQUITY Premier UPLC paired with Xevo Tandem Quadrupole Mass Spectrometers stands at the forefront of quantitative analytical technologies for nitrosamine detection, confirmation and control. Our comprehensive LC-MS/MS solutions support every stage of nitrosamines control: from risk evaluations during development to routine testing in manufacturing. The Waters Xevo range of tandem quadrupole MS solutions provide sensitivity beyond regulatory-recommended thresholds, ensuring accurate detection and quantification. An integral part of our solution, MassLynx security supports companies globally with compliant-ready software specifically designed for quantitative analytical workflows.

Elevate the Precision and Effectiveness of Your Nitrosamine Analysis Methods with Comprehensive Chemistry Solutions

Selective chromatography and sample extraction are the foundation of robust nitrosamine methods. However, the introduction of a new drug or formulation often requires the development of a new nitrosamine method. Waters offers a diverse range of column chemistries, including the ACQUITY Premier Columns, to ensure that achieving robustness, reliability, and effective method development is straightforward through the delivery of high-quality chromatographic separation.

In handling more challenging samples, Waters' selective Solid-Phase Extraction (SPE) extraction technologies simplify selective sample preparation and aid in achieving even lower limits of quantification.

Maximize Productivity and Minimize Error With Automated Sample Preparation

Optimize day-to-day assay efficiencies and reduce the risk of errors in your laboratories by implementing automated nitrosamines assay sample preparation with the Andrew + Robot. Robotic liquid handling supports a more seamless transition to QC with the traceability necessary for regulatory compliance provided through OneLab software. Learn from the demonstration of LC-MS Nitrosamine Impurity Quantification Performance using Automated Sample Preparation with the Andrew+ Pipetting Robot.

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Unlock the Power to Screen and Characterize Unknown Impurities with Confidence​

When suspicions arise regarding the presence of new nitrosamines in API or drug products, comprehensive High Resolution Mass Spectrometry (HRMS) screening workflows support robust identification. The ACQUITY Premier, Xevo G3 QTof and waters_connect software platform provide a versatile solution for both targeted and screening approaches to nitrosamines control. Combining the selectivity and sensitivity of the LC-MS system with the powerful screening workflow within the software platform provides the tools needed for confident identification and quantification of nitrosamines.

Explore how you can improve the transmission of Nitrosamine impurities with the Waters Xevo G3 QTof Mass Spectrometer.

Evaluate Raw Materials and Excipients to Mitigate the Formation of Nitrosamines

Support the mitigation of Nitrosamines formation by implementing regular monitoring of Nitrite contaminants. Leverage the capabilities of the ACQUITY ARC UPLC coupled with ACQUITY QDa mass detection to track nitrite levels within common excipients helping to minimise challenges associated with downstream nitrosamines control. Integration of the Empower Chromatography data system ensures seamless alignment with stringent regulatory demands of routine use in a manufacturing environment.