For QA and regulatory
ICH M7 assessments take weeks, and there is no quick first read on nitrosamine risk.
This is how it runs today, and how it runs with reproducibly calculated results and a report your expert signs off.
Today and with CovaSyn
Today
- The ICH M7 assessment passes through several hands and several weeks.
- Structural alerts get looked up, the rationale is written by hand.
- When a nitrosamine is suspected, there is no quick first assessment.
- For the inspection you must show how an assessment came about.
With CovaSyn
- ICH M7 mutagenicity screening returns a first classification including structural alerts.
- Suspect impurities are checked against mass spectra and fragment annotation.
- Triage says early what is harmless and what needs a real assessment.
- Input, method version, configuration and result are logged for every evaluation.
The assessment stays yours. CovaSyn provides the reasoned evaluation and the trail that keeps it traceable.
What we evaluate for you
Toxicological classification under ICH M7
ICH M7 mutagenicity screening, Tox21, CYP450, structural alerts, ADMET triage.
Molecular formula from accurate mass and impurity profile
Mass spectra, formula prediction, fragment annotation, impurity profiling.
Next step
Check it on your own case.
30 minutes on Microsoft Teams. Bring a real spectrum or a separation problem, and we tell you whether and how we can help.