We are excited to announce our latest collaborative data-sharing initiative. The data sharing initiative is part of our efforts to support nitrosamine risk assessment and will see consortium members share data on the level of nitrites in excipients.
There is now a greater need to understand the potential sources of nitrosamines, as the presence of this carcinogen class of compound has recently been detected in various drug products. The Nitrites in Excipients database aims to generate a comprehensive and robust dataset which supports more scientifically driven risk assessments, aiding data sharing among pharmaceutical companies and enabling more informed decision making.
The consortium is made up of several companies that meet regularly to discuss topics such as potential sources of nitrosamines within drug products and review the validation approach and data entry guidance. The sharing of data will allow consortium members to assess the likelihood that a nitrate or nitrite will react to form a nitrosamine. Used in this way, the Nitrites in Excipients database will allow members to understand the risk posed by nitrosamines in the drug product.
The first release of Nitrites in Excipients contains:
- 23 excipients
- 130 data records in the Excipients Results table
- 41 data records in the Excipients Summary table
Read more about the Nitrites in Excipients data sharing initiative. Alternatively, if you would like to know more about this data sharing initiative or other nitrosamine related work at Lhasa, please get in touch.