Robustness Calculator
Show that small, deliberate changes to the method do not change the result, with resolution and tailing checked for each condition.
- ICH Q2(R2) and Q14
- Any number of conditions
- Resolution and tailing
- No sign-up
Four steps, or fewer
- Enter the nominal method as the first row.
- Add one row per varied condition, e.g. flow rate ±10%, column temperature ±5 °C or pH ±0.2.
- Check the difference from nominal and the system suitability results for each condition.
Not sure what to enter? Press Load example to see the calculator with realistic data. Your inputs are saved in this browser, so they are still there when you come back.
How robustness is evaluated
Robustness is studied during development (ICH Q14) by deliberately varying method parameters within a realistic range. Each condition should still meet system suitability and the result should stay close to nominal. Parameters that matter become part of the method’s system suitability or control strategy.
References
- ICH Q2(R2) Validation of analytical procedures
- ICH Q14 Analytical procedure development
These calculators are decision support for orientation and training. They are not validated GMP software, and results must be checked against your approved method, SOP and the current pharmacopoeia or guideline before use in GMP records. Your data is processed in your browser and is not sent to Molgenium.