We recently had the pleasure of hosting the second Lhasa/IPEC Nitrites in Excipients Collaborative Meeting at our Head Office in Leeds. Following on from the success of last year, this day served as a vital, in-person platform to bring together members from the Lhasa Nitrites data sharing consortium, IPEC Europe – European Excipients Association, excipient manufacturers, and the wider pharmaceutical industry.

Dr Ulrich Reichert, Head of CDMO and Bioprocess Materials, Merck, reflected on the progress made after the meeting:

“The Lhasa and IPEC Nitrites Collaborative Meeting provided a valuable platform for exchanging best practices on nitrite management in excipients. The advances since the previous session are impressive. Continued focus on root causes will help us more effectively manage nitrosamine risks in drug products.”

The challenge of managing nitrosamine risk in drug products, particularly concerning nitrite impurities in excipients, is a global concern that requires harmonised approaches and continuous scientific exchange. The meeting was dedicated to insightful discussions and presentations aimed at advancing our collective understanding and establishing best practices for risk mitigation. The collaborative atmosphere underscored the industry’s commitment to patient safety and the development of robust, reliable testing methods.

Here are the five key takeaways which emerged from the day’s discussions:

1.     Collaboration drives progress on nitrite control

 

Collaboration remains key to tackling nitrite levels in excipients, reagents and solvents. The ever-expanding Lhasa Nitrites database facilitates improved industry decision-making by providing a richer foundation for scientific analysis and trend identification.

2.     Lhasa Nitrites data sharing initiative strengthens global response

 

The remains a cornerstone of the global response to the nitrosamine challenge. Now containing 2,570 results for 132 products (including excipients, reagents and solvents), the database demonstrates significant industry engagement and is critical for facilitating the sharing of scientific knowledge and data for risk mitigation strategies.

3.     Evolving analytical techniques for nitrite testing

 

Analytical techniques for measuring nitrites in excipients has rapidly evolved, shifting from two techniques upon inception of the Lhasa Nitrites database in 2020 to a comprehensive suite of modern methods by 2025. This trend demonstrates that industry has adopted a product-dependent analytical approach rather than a single universal technique which was highlighted in the consortiums latest publication (Nitrite testing in excipients – Industry best practices – ScienceDirect).

4.     Increasing sensitivity in nitrosamine detection

 

To effectively control limits of nitrosamines, analytical methods are becoming increasingly sensitive, facilitating the detection of trace amounts of nitrite.

5.     Collaboration and networking for lasting impact

 

The Lhasa/IPEC collaborative meeting offered a valuable platform not only for high-quality scientific knowledge sharing and regulatory exchanges but also for facilitating lasting professional connections. This emphasis on networking and meaningful partnership ensures that the benefits of the collaboration will be on going and help to facilitate ongoing efforts in nitrosamine risk management.

Anne Garnier, Scientific Programme Manager at EDQM, praised the environment for meaningful partnership:

“The Nitrite collaborative meeting offered high-quality scientific, technical, and regulatory exchanges. In addition to the rich and constructive exchanges, this meeting helped build lasting professional connections around the topic, which will continue to bear fruit well beyond the event itself. A heartfelt thank you to Lhasa in Leeds for their warm welcome and impeccable organisation, which created an ideal environment for meaningful collaboration.”

Continuing to advance Nitrite understanding

 

The Lhasa Nitrites data sharing initiative remains a cornerstone of the global response to the nitrosamine challenge. By facilitating the sharing of scientific knowledge and data, we continue to work towards harmonising testing methods and standards for nitrite in excipients, ultimately striving to ensure the quality and safety of drug products worldwide.

If you would like to find out more about joining the Lhasa Nitrites data sharing initiative, please get in touch.

Last Updated on January 9, 2026 by lhasalimited