Quality and regulatory · Stability, degradation, forced degradation
One result in our stability study looks different, and we do not know whether it is a trend or scatter.
Shelf life, trends and degradation pathways evaluated robustly, so studies and releases hold.
Who needs this in your company
What we can do
We evaluate stability data per ICH Q1E, check batch poolability and spot out-of-trend results. We design studies per Q1A, matrixing per Q1D and photostability per Q1B, predict degradation products and close gaps in the mass balance after forced degradation.
What you get
- Shelf life with the 95 % limit and the limiting batch
- OOT finding for each batch
- Degradation pathways
- Causes of gaps in the mass balance
Typical cases
Stability data evaluation: detect OOT and estimate shelf life
One result in our stability study looks different from the earlier ones, and we don't know whether it's a trend or just scatter.
See solutionForced degradation study: degradation products and mass balance
The mass balance in our stress study doesn't close, and we don't know where the missing part went.
See solution
Evaluated for you or done yourself
The same calculations, different ways to you. Which one fits, we work out in the intro call.
CovaSyn 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 morePartners and academic
For software and instrument partners and for research.
Terms per partner, academic free on application
Learn more
Limits of the result
- Few time points mean wide limits.
- Arrhenius extrapolation only holds for the same degradation mechanism.
More from this area
Mutagenicity and nitrosamines (ICH M7)
The authority wants to see our nitrosamine assessment, and external reports take weeks.
Learn moreOOS, control charts, release data
An OOS result is holding the batch, and the investigation has been stuck for weeks.
Learn moreChange and comparability
The column is discontinued, the instrument is new, the supplier has changed: can we do this without revalidation?
Learn moreCleaning validation
For our multi-product facility we have to justify the worst-case marker and the limit.
Learn moreEcotox and product safety
We are missing environmental data for registration and the safety data sheet.
Learn more
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.