For CMC and formulation
Stability packages and shelf-life estimates take days, and DoE lives in Excel.
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 stability plan lives in Word, the evaluation in Excel.
- Arrhenius fit and shelf life are recomputed by whoever knows the sheet.
- DoE plans get copied from old projects, and statistical power is never checked.
- Solubility and salt form are tried out, not narrowed down first.
With CovaSyn
- Stability plan following ICH Q1A, Arrhenius fit and shelf-life estimate come from one evaluation.
- For the experiment you get an RSM design with power analysis before material is consumed.
- pH-solubility profiles, miscibility and antisolvent strategies narrow down the salt form and crystallisation route beforehand.
- Multi-objective optimisation and robustness checks continue on the same data.
The calculation is traceable instead of buried in a spreadsheet that has grown over the years. What goes into the dossier is still a human decision.
What we evaluate for you
Stability evaluation and shelf life under ICH
ICH stability models, Arrhenius fits, shelf-life predictions.
Experimental design with power analysis
Design of Experiments with RSM, power analysis, optimisation and ready-made templates.
Solubility, miscibility and antisolvent strategy
Solubility prediction, miscibility, pH curves and antisolvent strategies.
Multi-objective optimisation, robustness and drift
Multi-objective optimisation, robustness, drift detection, model training.
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.