Nitrosamines and Impurities Resource Hub

Over four years ago, the nitrosamine crisis shook the pharmaceutical world, and it still remains a hot topic. Since then, in an ever-changing regulatory landscape, more stringent regulations have been put in place.  

According to the EMA guidelines:

Confirmatory testing should now be completed in the identified active substances and finished products at risk of N-nitrosamine formation or (cross-)contamination. Submission of any changes should include confirmatory testing. 

Keep up to date with the latest guidelines here and access the nitrosamine and impurities resource kit and learn how to comply with the given regulations.

Resource hub includes:  

• Resources to help you in assessing your risk
• Learn about the regulations and how to update your methods
• Authority (FDA, EMA, USP) information  
• Product Demonstrations
• Plus much more...

Webinars and Educational Resources

To keep professionals informed about the latest developments and best practices, the hub features a series of on-demand webinars presented by industry experts.

• Comprehensive Solutions for Risk Evaluation, Test and Control of N-Nitrosamines in Pharmaceuticals
  • Presenter: Amy Bartlett (Principal Pharma Market Dev Manager)
  • RECORD
• Technologies for Optimising Performance, Minimising Risk and preparing for the Future in Trace Impurity Quantification
  • Presenter: Antonia Wierzbicki (Marketing Manager, Waters)
  • RECORD
• Waters Virtual Pharma Day - Analytical Challenges and Workflows in Pharma Analysis

Waters Virtual Pharma Day - Analytical Challenges and Workflows in Pharma Analysis

• N-Nitrosamines: ​ Facing the challenge of effective control 
  • Presenter: Dr. Andrew Teasdale
  • RECORD
• Genotoxic Impurities: Nitrosamines LC-MS TOF screening analysis with automated sample preparation
• Analytical Strategies for Improved Sensitivity, Selectivity, and Quantitation of Genotoxic Impurities
• Nitrosamine Impurities: USP’s Compendial Response - Tools & Resources
• Streamlined Development of Analytical Methods for Trace Level Genotoxic Impurities: Simplifying Workflows, Optimizing Performance and Mitigating Analytical Risk
• Mass Spectrometry Fundamentals Webinar Series Part 1: Ion Sources
• Mass Spectrometry Fundamentals Webinar Series Part 2: Mass Analyzers and Detectors
• Mass Spectrometry Fundamentals Webinar Series Part 3: Advanced Topics in Mass Spectrometry (RECORD)
• Be ready for Nitrosamines Analysis (Step 2): Confirmatory testing
• Suitability of a Walk-Up Time of Flight System in a Pharma Lab (RECORD)

Analytical Solutions and Application Notes

The resource hub offers detailed information on advanced analytical solutions designed to detect and quantify nitrosamine impurities. These solutions encompass various methodologies, including:

• Nitrosamines Analysis with LC/MS-MS Ensuring Safety and Quality in Pharmaceutical Manufacturing
  • Full PDF for download
• Xevo TQ Absolute Triple Quadrupole Mass Spectrometry
  • Achieve absolute confidence to reach lower limits of quantitation even for challenging negative ionizing compounds.
  • Full PDF for download
• Suggested Approaches for Minimizing Background Chemical Noise in Low Mass MRM Transitions for Trace Level Quantification of N-Nitrosamines
  • Full PDF for download
• High Sensitivity Analysis of Potential Mutagenic Boronic Acids Using Xevo™ TQ Absolute Tandem Quadrupole Mass Spectrometer with an ACQUITY™ Premier System
  • Full PDF for download
• High Sensitivity Quantification of Nitrosamines in Metformin Using Xevo™ TQ Absolute Tandem Quadrupole Mass Spectrometer With an ACQUITY™ Premier System
  • Full PDF for download
• Xevo G3 QTof
  • Maximize sample information for your analytes from detailed characterization to accurate quantitation with the Xevo G3 QTof, which enables complete confidence...
  • Full PDF for download
• Xevo G3 QTof - Demonstration (video)
  • Xevo G3 QTof - Product Demonstration by Isabel Riba, Principal Applications Chemist, Waters
• Improving the Transmission of Nitrosamine Impurities with the Waters Xevo G3 QTof Mass Spectrometer
  • Demonstrating improved transmission of nitrosamines when utilizing the soft ionization transmission mode on a Waters Xevo™ G3 QTof mass spectrometer compared...
  • Full PDF for download
• Andrew+ the Pipetting Robot (video)
  • Andrew+ pipetting robot offers fully automated liquid handling using Andrew Alliance electronic pipettes and labware holders called Dominos.
  • Click here to see the video
• Demonstration of LC-MS Nitrosamine Impurity Quantification Performance using Automated Sample Preparation with the Andrew+ Pipetting Robot
  • Full PDF for download
• Application Note: Development of a Sensitive High Resolution Mass Spectrometry Method
  • Full PDF for download
• ACQUITY RDa Detector
  • Waters’ ACQUITY RDa Detector is a bench-top High-Resolution LC-MS system accessible to MS Experts and novices alike. Compact, compliance-ready.
• ACQUITY RDa detector Product Overview
  • Watch how the ACQUITY RDa Detector can enhance your laboratory workflows
  • Click here to see the video
• ACQUITY RDa Detector
  • The ACQUITY RDa Detector: Delivering SmartMS to the Masses
  • Full PDF for download
• CDMO Partnership Sai Life Sciences
  • Learn how this CDRO have implemented the RDa
  • Click here to see the video
• Xevo TQ-S cronos Triple Quadrupole Mass Spectrometry
  • Check out the many NDSRI applications already developed on our Xevo TQ-S cronos platform
• NDSRI application examples with XEVO TQ-S Cronos
  • A Robust and Sensitive Instrument for Quantification of N-Nitroso Argatroban impurity at 0.3 ppm in Argatroban Drug Product.
  • Full PDF for download

Regulatory Updates and Guidelines

Staying abreast of regulatory changes is crucial for maintaining compliance. The resource hub offers updates on guidelines from major regulatory bodies, including:

• *NEW* Updated - EMA / CMDh
  • Are you prepared for the latest guidelines for Nitrosamines? Read the latest update to the EMA guidelines updated in July 2023.
• Recommended Acceptable Intake Limits for (NDSRIs)
  • This guidance is for immediate implementation.
• EMA Risk Assessment Update
• USP General Chapter
  • General Chapter Prospectus: <1469> Nitrosamine Impurities
• Nitrosamine Contamination EDQM Response
  • EDQM's responses to nitrosamine contamination
• EMA Lessons Learnt Document
  • Lessons learnt from presence of N-nitrosamine impurities in sartan medicines
• Health Canada
  • Health Canada: Guidance on nitrosamine impurities in medications
• Case Study
  • Waters Mass Spectrometry enables contract testing lab to quickly respond to increased customer requests for nitrosamines services
• Case Study
  • Forward-thinking CDMO Tackles the Dynamic Challenge of N-nitrosamines Control with High Performance Analytical Instrumentation Case Study

For complete information, please visit the Nitrosamines and Impurities Resource Hub website