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Lhasa Limited continues to support the global challenge of nitrosamine impurity assessment

With 164 new nitrite results, bringing the total number to 440 nitrite results for 64 common excipients, Lhasa Limited is pleased to announce the release of the 2021.1 Nitrites in Excipients database.

The Nitrites in Excipients database is part of Lhasa’s overall efforts to support the global challenge of nitrosamine impurity assessment. The Nitrites in Excipients project aims to generate a comprehensive and robust dataset to support more scientifically driven risk assessments, aiding data sharing among pharmaceutical companies and enabling more informed decision making.

Marking our continued commitment to increasing knowledge in the area of nitrosamines and nitrosamine formation, the 2021.1 release is the third update to the database since the project was established in November 2020, enabling partners of the initiative to make use of additional data to inform their nitrosamine risk assessments

The 2021.1 database contains the following data:

  • New Excipient result records = 164
  • Total Excipient result records = 440
  • New Excipient summary records = 12
  • Total Excipient summary records = 104
  • New Excipients = 10
  • Total Excipients = 64

The continued sharing of data by the Nitrites in Excipients consortium members is allowing scientists to confidently assess the likelihood that a nitrate or nitrite will react to form a nitrosamine based on the levels found in excipients. Used in this way, the Nitrites in Excipients database allows users to understand the risk posed by nitrosamines in the drug product.

The Nitrites in Excipients project offers an extension to the Vitic 2020.1 database which contains 518 nitrosamines: 411 with Ames test data, 234 with rodent carcinogenicity data and 184 with both Ames and rodent carcinogenicity data.

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.