Analytics · Unknown peaks, impurities, extractables and leachables
A peak above the identification threshold is blocking release, a stability study or a submission.
We narrow down the unknown peak, classify it under ICH M7 and name the confirming measurement.
Who needs this in your company
What we can do
We profile impurities per ICH Q3A and Q3B, match them against the degradation and by-products you would expect and assess extractables and leachables. We check residual solvents in the NMR against the Q3C limits.
What you get
- Molecular formula and fragment annotation
- Ranked structure proposals with the M7 class for each candidate
- Correlation of extractables to leachables
- The measurement that confirms the proposal
Typical cases
Identify an unknown impurity by LC-MS
A peak has appeared above the identification threshold, and we do not know what it is.
See solutionExtractables and leachables assessment: identification to toxicology
The extractables study produced a long peak list, and for most peaks we have neither a name nor an assessment.
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.
Evaluation report
You send the data, we deliver the reviewed report.
From EUR 1,490 net, typically 5 working days after complete data
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 morePilot project
One question on your data, with a success criterion agreed in writing beforehand.
From EUR 1,490 net, fully creditable
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 morePartners and academic
For software and instrument partners and for research.
Terms per partner, academic free on application
Learn more
Limits of the result
- Without a reference substance the structure remains provisional.
- The assessment does not replace your toxicologist's judgement.
More from this area
Structure elucidation and identity
The spectra have been sitting there for days, and nobody has time to assign them properly.
Learn moreAssay, purity, qNMR, dissolution
We need assay and purity, but we do not have a suitable reference standard.
Learn moreBioanalytics: peptides, proteins, oligos, metal binding
Our small-molecule workflows cannot cleanly evaluate peptide and oligo identity, modifications and metal binding.
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.