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Nitrites in Excipients data release: Supporting more scientifically driven nitrosamine risk assessments

Lhasa Limited is pleased to announce the release of the 2022.1.0 Nitrites in Excipients database.

The Nitrites in Excipients data sharing consortium is a collaborative data sharing initiative for assessing the levels of nitrites in excipients. The consortium allows members to access shared proprietary data to support the risk assessment of nitrosamines.

Using the Vitic database, members of the consortium regularly share analytical data with Lhasa Limited. With regular member contributions, the database is continuing to grow.

The 2022.1.0 database contains the following new data:

  • New Excipient results records = 127
  • New Excipient summary records = 10*
  • New Excipient records = 5

The 2022.1.0 database marks the 7th data release since the initiatives inception in 2020 bringing the total database records to:

  • 804 data records in the Excipients Results table
  • 127* data records in the Excipient Summary table
  • This data covers 84 excipients

In April 2022, the consortium released its first publication. Discussing major findings from the database, the publication ‘A Nitrite Excipient Database: A Useful Tool to Support N-Nitrosamine Risk Assessments for Drug Products’ offers a great insight into the database and how it constitutes a central platform to hold the data donated by the pharmaceutical company members on the nitrite concentrations in common excipients measured with validated analytical procedures.

Find out more about the Nitrites in Excipients data sharing initiative or enquire about getting involved.

* The Excipient summary table has been updated to consider the new and modified records in the Excipient results table. This may have led to additional records and/or changes to existing records.