A Nitrite Excipient Database - Risk Assessment

If you haven’t, I encourage you to read the recent publication " A Nitrite Excipient Database: A Useful Tool to Support N- Nitrosamine Risk Assessments for Drug Products" by Boetzel et al.

A fantastic update on the data-sharing consortium, maintained by Lhasa Limited. The goal of the initiative is to provide a common framework to contextualize and estimate the risk posed by the presence of nitrites to contribute to the formation of nitrosamines in drug products.

Key takes aways:

  1. Average nitrite content and batch to batch variance differ among excipients
  2. For solid dosage forms, the nitrite contribution is dominated by the highest formula % excipients, e.g., the fillers (diluents), which are typically used in larger proportion, and are characterized by low nitrite levels and low variability, leading to an average value of 1 µg/g nitrite in a typical formulation
  3. Substantial differences in average nitrite content in batches from different excipient vendors potentially reflecting differences in source materials or processing methods for excipient manufacturing

Our community members: @schlinjo1975 @giorgio @MarkWH @leonardo.allain are also contributors.

For access click here


where can i get A Nitrite Excipient Database from Lhasa? please share if available.

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I’m sure that @Carolina.MA should be able to help you navigate to learn more about the initiative.

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is it necessary to become a member of lhasa vitic to access this nitrite excipient database? or we can have these database on FOC base?

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Hey @Chirag
To join the Nitrites in Excipients Initiative, is required to be a Lhasa member.
We will be happy to discuss this further with you by e-mail or call.

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Thanks @Carolina.MA Can you please share with us what it takes to become contributor/member?


Hey @Naiffer_Host
We will be happy to discuss this further by e-mail or call. Please send us a message Info@lhasalimited.org

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