The Lhasa Nitrites Data Sharing Initiative involves exclusively shared proprietary data, sourced from our consortium members formed from various leading pharmaceutical organisations and excipient manufacturers.
In order to understand the potential risk of nitrosamine formation, the level of nitrites in excipients, solvents and reagents must be assessed.
With this, the Lhasa nitrites database supports expanded knowledge of nitrite levels without the requirement to conduct time consuming in-house analytical testing.
Lhasa Limited is pleased to announce the further expansion of our nitrites shared database in 2026, as Lhasa welcomes a 22% increase in high quality data compared to last year’s release.
Hear more from Senior Scientist, and Scientific Lead of the Nitrite initiative at Lhasa Limited, Dr Gemma Packer, alongside Application Scientist, Lucy O’Dwyer.
Lhasa Nitrites shared data release
Acting as a central source of reference across the pharmaceutical industry, for determining the levels of nitrites in , the Lhasa Nitrites 2026.1 release represents continued progression.
This year, the Nitrites 2026.1 release cumulates 22% more precompetitive shared data:
- Increasing the total number of results to 3132 results for 152 products
All donations are aligned with a consortium-approved validation criteria and reviewed by Lhasa Scientists.
Lhasa Limited is pleased to provide value to our consortium members through supporting confident regulatory submissions, the Nitrites 2026.1 release facilitates this by:
- Supporting defensible strategies using complete data that spans excipients, reagents and solvents
- Further reducing the need for analytical testing with a further 20 new products covered in 2026.1 release
- Reliably determining risk using the most conservative threshold as schema updates included the 95th and 98th percentile (where applicable)
To access the latest records in Vitic Nitrites, you must be a member of the Vitic solution and participant in the consortium.
Consortium members will automatically see the updated dataset housed and powered by Vitic Nitrites.
Harnessing regulatory robustness and global alliance
Joining the initiative also enables members to be a part of an industry consortium, focused on the current landscape and the challenges that nitrites pose. Discussions actively shape the scientific direction of the initiative. This has led to several significant milestones. These include:
- Establishing best practice standards through a recent co-authored publication on nitrite testing in excipients .
- Conducting a multi-laboratory comparative study showing the high reliability of the results within the database and outlining the need for standardised testing methods and validation to assess nitrosamine risk.
- Strengthening expertise across a community following in-person consortium meetings and expanding regulatory harmony through collaboration with IPEC Europe ((International Pharmaceutical Excipients Council Europe) at 2025’s meeting.
By practicing shared knowledge, the Lhasa Nitrite Data sharing Initiative has moved beyond existing data to shared problem-solving, and shared industry progression.
Enhanced nitrosamine risk assessment workflows
The Lhasa Nitrite shared dataset is a crucial aspect of the nitrosamine risk assessment workflow.
Through immediate access to high quality nitrite level data, Lhasa enables more accurate calculations for formation and control.
Justification of acceptable intake (AI) limits and wider control strategies benefit from the data-driven approach – particularly when pre-existing study data is contributed by leading organisations working collaboratively to enhance in silico assessments.
Joining the consortium
Ready to share and access a suite of >3000 nitrite level results? Get in touch with Lhasa Limited.
By joining, members will unlock proprietary, shared data for 152 products, including excipients, reagents and solvents. All now available in the Nitrite 2026.1.0 release!
We’re also pleased to be discussing the Lhasa Nitrite data sharing initiative alongside our in silico solutions in our upcoming webinar, N-Nitrosamine formation and clearance: in silico tools and data sharing strategies.