- A collaborative data sharing project for assessing the levels of nitrites in excipients, reagents and solvents
- Become a member to join regular and evolving consortium discussions
The Nitrites project is part of Lhasa's efforts to support nitrosamine risk assessment. By sharing data on the level of nitrites in excipients, reagents, and solvents, consortium members will be able to assess the likelihood that a nitrate or nitrite will react to form a nitrosamine. Used in this way, the Nitrites database will allow members to understand the risk posed by nitrosamines in the drug product.
Using the Vitic database, members of the consortium will regularly share analytical data with Lhasa Limited. As the honest broker, Lhasa will then expertly curate the data from participating organisations. This allows a level of anonymity, whereby the submitting companies are known to each other, but who submitted what is known to Lhasa Limited only.
The most recent Nitrites database (Nitrites 2023.1.0) contains:
- 162 new results records
- 966 total results records
* The Excipient summary table has been updated to take into account the new and modified records in the Excipient results table. This may have led to additional records and/or changes to existing records. A copy of the Excipient summary table from the previous release is available from Lhasa Limited upon request.
Figures 1 and 2 illustrate the growth of the database so far.
Figure 1: Recorded number of studies in the database
Figure 2: Recorded number of products in the database.
In April 2022, the consortium released its first publication. Published in the 'Journal of Pharmaceutical Sciences', ‘A Nitrite Excipient Database: A Useful Tool to Support N-Nitrosamine Risk Assessments for Drug Products’ discusses major findings from the database, and offers a great insight into how it constitutes a central platform to hold the data donated by pharmaceutical company members on the nitrite concentrations in common excipients measured with validated analytical procedures.
The benefits that can be achieved by joining this data sharing consortium include:
- Support Nitrosamine Risk Assessment: The project uses high-quality data from proprietary sources, which will aid in nitrosamine risk assessment,
- Utilise Proprietary Data: Expand your knowledge of nitrite levels present in a wide range of excipients.
- Save Time: Data in the Nitrites in Excipients database can support multiple risk assessments; it can help to establish the risk of nitrosamine formation, to confirm conclusions of risk and ensure that appropriate controls have been established. It is expected that this database will reduce the requirement for drug product testing, by helping to establish the level of risk posed by nitrosamines.
- Continually Expanding Database: Consistent member contributions mean that the database will constantly grow and therefore provide a better indication of risk.
The consortium consists of pharmaceutical companies that contribute analytical data on the level of nitrites in excipients. As the consortium takes quality of data seriously, all shared data conforms to predefined quality standards and a validation approach (developed by Lhasa Limited and experts from the consortium).
To ensure the continued success of the project, the consortium comprises of an elected chairperson and has regular meetings to:
- Discuss and agree upon the scientific direction of the project
- Contribute expertise and share knowledge
- Develop and regularly review a validation approach
- Discuss cross-laboratory testing
- Recommend priorities for the consortium and the database
Lhasa Limited - an honest broker and trusted holder of data
Lhasa is a not-for-profit organisation and believes that shared knowledge can lead to shared progress. Recognised as the original "Honest Broker", Lhasa Limited has repeatedly been trusted with proprietary data and this can be seen with our involvement in other collaborative data sharing projects.
To find out more about data sharing opportunities at Lhasa Limited, please get in touch.
A Nitrite Excipient Database: A useful Tool to Support N-Nitrosamine Risk Assessments for Drug Products, Journal of Pharmaceutical Sciences, April 2022
- Wu, Y et al. (2011) 'Reactive impurities in excipients: profiling, identification and mitigation of drug-excipient incompatibility', AAPS PharmSciTech, December 2011, Volume 12, Issue 4, Pages 1248 - 1263.