Quality and regulatory · Mutagenicity and nitrosamines (ICH M7)
The authority wants to see our nitrosamine assessment, and external reports take weeks.
The nitrosamine and M7 assessment as a reviewable draft for your toxicologist, with data basis and limits.
Who needs this in your company
What we can do
We assign impurities to classes 1 to 5 under ICH M7, check structural alerts and categorise nitrosamines using the CPCA approach. This works for single candidates as well as for a whole list from synthesis, formulation and packaging.
What you get
- Structure check and potency category
- Acceptable intake in ng per day
- Risk along synthesis, formulation and packaging
- A draft your toxicologist reviews and releases
Evaluated for you or done yourself
The same calculations, different ways to you. Which one fits, we work out in the intro call.
Free calculators
Calculate single values right in the browser, no account needed.
Free
Learn moreSketcher in the browser
Draw a molecule and run the evaluation yourself in the browser.
Free, Pro EUR 250, Max EUR 750 per user and month, net
Learn moreCovaSyn in your AI (MCP)
The same calculations directly in Claude, ChatGPT or your own AI.
Learn moreEvaluation report
You send the data, we deliver the reviewed report.
From EUR 1,490 net, typically 5 working days after complete data
Learn moreWorkshops
Your team learns it on its own data, online or in Leipzig.
EUR 490 to 1,990 per person, in-house EUR 3,500 to 9,900, net
Learn morePilot project
One question on your data, with a success criterion agreed in writing beforehand.
From EUR 1,490 net, fully creditable
Learn more
Limits of the result
- The limit is confirmed by an expert.
- The assessment does not replace a lab measurement.
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Next step
Which case is on your desk right now?
30 minutes on Microsoft Teams with the CovaSyn team. If it is not a fit, we will say so.