N-Nitrosamines Analysis

N-Nitrosamines Analysis

Detect, quantify, and control N-Nitrosamines (nitrosamines) with unparalleled precision with Waters LC/MS-MS solutions, tailored to overcome the complexities of nitrosamine analysis in pharmaceuticals. With Waters as your trusted analytical sidekick, dive into the heart of regulatory challenges and emerge victorious.

Detect, quantify, and control N-Nitrosamines (nitrosamines) with unparalleled precision with Waters LC/MS-MS solutions, tailored to overcome the complexities of nitrosamine analysis in pharmaceuticals. With Waters as your trusted analytical sidekick, dive into the heart of regulatory challenges and emerge victorious.
White and blue pills in blister packs
White and blue pills in blister packs

Overview

To control and mitigate the potential presence of mutagenic impurities like nitrosamines in medicines, pharmaceutical companies face strict regulatory guidelines. Scientists need to have robust and precise analytical methodologies to accurately detect and quantify the presence of nitrosamines and their precursors. Waters delivers accessible LC-MS and MS/MS solutions to resolve these challenges and help you confidently take mitigating action against nitrosamines and make critical decisions.

From the inception of drug development to the rigors of manufacturing quality control (QC), partnering with Waters means you can leverage powerful technologies to navigate regulatory guidelines, ensure patient safety, and support an ongoing supply of critical medicines.

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Applications

Global regulatory bodies require that pharmaceutical manufacturers control and strive to mitigate the presence of nitrosamines in their products. Learn how advanced technologies like the Xevo Mass Spectrometer family and ACQUITY Premier System ensure high-performance detection of nitrosamine impurities, with compliance, in pharmaceuticals.

Global regulatory bodies require that pharmaceutical manufacturers control and strive to mitigate the presence of nitrosamines in their products. Learn how advanced technologies like the Xevo Mass Spectrometer family and ACQUITY Premier System ensure high-performance detection of nitrosamine impurities, with compliance, in pharmaceuticals.

Application Notes

Application Notes

When faced with the risk of a new nitrosamine, the focus rapidly shifts to developing new analytical methods. Discover advanced sample preparation techniques and method optimization for nitrosamine analysis. Explore automated solutions like the Andrew+ Pipetting Robot and strategies for reducing background noise in trace detection in these application notes.

When faced with the risk of a new nitrosamine, the focus rapidly shifts to developing new analytical methods. Discover advanced sample preparation techniques and method optimization for nitrosamine analysis. Explore automated solutions like the Andrew+ Pipetting Robot and strategies for reducing background noise in trace detection in these application notes.

Application Notes

Application Notes

Whether you are working with small nitrosamines or NDSRI’s in a wide range of drug products, Waters has solutions for all your testing needs. The ACQUITY Premier System with Xevo family of Tandem Quadrupole Mass Spectrometers provide sensitivity beyond regulatory requirements. The Xevo TQ Absolute routinely provides parts per billion (ppb) and lower levels of quantitation in drug products.

Whether you are working with small nitrosamines or NDSRI’s in a wide range of drug products, Waters has solutions for all your testing needs. The ACQUITY Premier System with Xevo family of Tandem Quadrupole Mass Spectrometers provide sensitivity beyond regulatory requirements. The Xevo TQ Absolute routinely provides parts per billion (ppb) and lower levels of quantitation in drug products.

Application Notes

Application Notes

eBook: Nitrosamines Analysis with LC-MS/MS

Pharmaceutical manufacturers strive to control or mitigate the presence of potentially harmful nitrosamines in their drug products. Discover how Waters can support you as your analytical sidekick providing comprehensive end-to-end workflows for sensitive and robust quantitative measurements of nitrosamines.

Download this eBook to learn how you can support drug safety and quality testing through comprehensive nitrosamine analysis solutions.

Pharmaceutical manufacturers strive to control or mitigate the presence of potentially harmful nitrosamines in their drug products. Discover how Waters can support you as your analytical sidekick providing comprehensive end-to-end workflows for sensitive and robust quantitative measurements of nitrosamines.

Download this eBook to learn how you can support drug safety and quality testing through comprehensive nitrosamine analysis solutions.

Download eBook

Solutions

Waters LC-MS systems offer absolute performance in separation and sensitivity for nitrosamine analysis.

Waters LC-MS systems offer absolute performance in separation and sensitivity for nitrosamine analysis.

Achieve LC-MS/MS sensitivity beyond regulatory thresholds for nitrosamines

Achieve LC-MS/MS sensitivity beyond regulatory thresholds for nitrosamines
Xevo Tandem Quadrupole Mass Spectrometers

Quantify trace levels of small alkyl nitrosamines or nitrosamine drug substance-related impurities with Waters ACQUITY Premier System paired with Xevo tandem quadrupole mass spectrometers for sensitivity beyond regulatory-recommended thresholds. Waters comprehensive LC-MS/MS solutions support every processing stage– from risk evaluations during development to routine testing in manufacturing– for accurate detection, confirmation, and control.

  • Nitrosamines
  • Pharma and Impurity Analysis

The next evolution in separation science is here

The next evolution in separation science is here
ACQUITY Premier System

Maximize the sensitivity, repeatability, and robustness of your LC and LC-MS applications with the ACQUITY Premier System that features MaxPeak High Performance Surfaces (HPS) Technology for improvements in the separation and detection of metal-sensitive analytes.

  • Nitrosamines
  • Pharma and Impurity Analysis

Unlock the power to screen and characterize unknown impurities with confidence

Unlock the power to screen and characterize unknown impurities with confidence
Xevo G3 QTof

Address concerns about new nitrosamines in API or drug products with Waters High Resolution Mass Spectrometry (HRMS) screening workflows. Waters ACQUITY Premier System and Xevo G3 QTof and waters_connect Software offer a robust and versatile solution for both targeted and screening approaches for confident nitrosamines identification, quantification, and control.

  • Nitrosamines
  • Pharma and Impurity Analysis

Evaluate raw materials and excipients to mitigate the formation of nitrosamines

Evaluate raw materials and excipients to mitigate the formation of nitrosamines
ACQUITY QDa II Mass Detector

Mitigate the risk of nitrosamines formation with regular monitoring of nitrite contaminants using the ACQUITY Arc System coupled with ACQUITY QDa II Mass Detector. Tracking nitrite levels within common excipients helps minimize the challenges associated with downstream nitrosamine control.

  • Nitrosamines
  • Pharma and Impurity Analysis

Effortlessly minimize errors and transfer methods using lab automation solutions from Waters

Effortlessly minimize errors and transfer methods using lab automation solutions from Waters

Maximize productivity and minimize error with automated sample preparation

Maximize productivity and minimize error with automated sample preparation
Andrew+ Pipetting Robot

Robotic liquid handling supports a more seamless transition to QC with the traceability necessary for regulatory compliance provided through OneLab software.

  • Nitrosamines
  • Pharma and Impurity Analysis

Waters compliance- enabled LC-MS/MS software streamlines nitrosamines assays from method development to processing and reporting

Waters compliance- enabled LC-MS/MS software streamlines nitrosamines assays from method development to processing and reporting

Dominate your data 

Dominate your data 
waters_connect for Quantitation

Enable end to end analytical efficiency and regulatory compliance for nitrosamines analysis workflows with waters_connect for Quantitation software. Built to enable 21 CFR Part 11 and EMA Annex 11 regulatory compliance, this software ensures data security, and traceability through deep and extensive audit trails. The secure relational database fosters a compliance-driven and data integrity focused ecosystem, enhanced by mixed MS system networks and LIMS connectivity.

  • Nitrosamines
  • Pharma and Impurity Analysis

Simplify data acquisition, processing, and reporting

Simplify data acquisition, processing, and reporting
Empower Chromatography Data System (CDS)

Gain advanced data management for your nitrosamines analyses including acquisition, processing, and reporting for liquid and gas chromatography instruments with Empower Chromatography Data System (CDS) and ensure seamless alignment with manufacturing environment regulatory demands.

  • Nitrosamines
  • Pharma and Impurity Analysis

Elevate the precision and effectiveness of your nitrosamine analysis methods with Waters robust and reliable chemistry solutions.

Elevate the precision and effectiveness of your nitrosamine analysis methods with Waters robust and reliable chemistry solutions.

High-performance chemistry solutions

High-performance chemistry solutions
ACQUITY Premier Columns

The introduction of a new drug or formulation often requires the development of a new nitrosamine method. Tried-and-tested, Waters diverse range of column chemistries, including the ACQUITY Premier Columns, ensure robustness, reliability, and straightforward effective method development.

  • Nitrosamines
  • Pharma and Impurity Analysis

Faster, cleaner, and simpler SPE starts here

Faster, cleaner, and simpler SPE starts here
Oasis Solid-Phase Sample Extraction Products

For more challenging samples, Waters Solid-Phase Extraction (SPE) extraction technologies simplify selective sample preparation for achieving even lower limits of quantification.

  • Nitrosamines
  • Pharma and Impurity Analysis

Accelerate your success with industry-leading support.

Accelerate your success with industry-leading support.

Maintain peak performance, minimize downtime, address your application challenges

Maintain peak performance, minimize downtime, address your application challenges
Waters Global Services

Optimize laboratory productivity with Waters tailored application support nitrosamineservices. Waters delivers holistic and long-term approaches rather than quick fixes, addressing immediate requirements and future regulatory demands.

  • Nitrosamines
  • Pharma and Impurity Analysis

Make science more accessible

Make science more accessible
Payment Solutions

Maximize resources and minimize risk with payment options from Waters Capital, including upgrading aging equipment, getting customized support, and bundling services into one monthly payment.

  • Nitrosamines
  • Pharma and Impurity Analysis

The data speaks for itself

The data speaks for itself
Sensitivity Lowest limits of detection and quantitation for the most challenging of N-nitrosamines Acquity Premier / Xevo TQ Absolute.
Robustness 8% RSD on N-nitroso sertraline hydrochloride peak area detected in > 250 injections of extracted sertraline tablet over 4 days of analysis ACQUITY Premier/ Xevo TQ-S Micro.
Linearity Coefficient of determination R2 >0.999 for N-nitroso sertraline in sertraline hydrochloride (0.25-100 ppb) ACQUITY Premier / Xevo TQ-S Micro.
Nitrite monitoring Nitrite recovery (%) in lactose samples analyzed over 190 hours of continuous acquisition. The red lines mark the 70–120% tolerance interval, while the black line shows the total average recovery of 94%.

Webinars and Resources

  • Case Study

Forward- thinking CDMO Tackles the Dynamic Challenge of N-nitrosamines Control with High Performance Analytical Instrumentation

Forward- thinking CDMO Tackles the Dynamic Challenge of N-nitrosamines Control with High Performance Analytical Instrumentation
Download
  • Case Study

Evaluating the Risk of Nitrosamine Contamination with the ACQUITY UPLC I-Class PLUS and the Xevo TQ-XS Tandem Quadrupole Mass Spectrometer

Evaluating the Risk of Nitrosamine Contamination with the ACQUITY UPLC I-Class PLUS and the Xevo TQ-XS Tandem Quadrupole Mass Spectrometer
Download
  • Case Study

Waters Mass Spectrometry Enables Contract Testing Lab to Quickly Respond to Increased Customer Requests for Nitrosamine Services

Waters Mass Spectrometry Enables Contract Testing Lab to Quickly Respond to Increased Customer Requests for Nitrosamine Services
Download
  • White Paper

INCQS Employs Waters Mass Spectrometry Instrumentation to Support N-nitrosamines Testing in Brazil

INCQS Employs Waters Mass Spectrometry Instrumentation to Support N-nitrosamines Testing in Brazil
Download

Related

Impurity Analysis
Perform impurity analysis in pharmaceuticals throughout the supply chain and quantitate them easily with Waters solutions for drug impurity analysis.

Learn more about N-Nitrosamines Analysis Solutions.

Learn more about N-Nitrosamines Analysis Solutions.
Enhance the precision of your pharmaceutical analysis with Waters LC-MS/MS solutions, effectively reducing the risk of N-Nitrosamine contamination.
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