Specificity Calculator
Show that blank, placebo, impurities and degradants do not interfere with the analyte peak and are resolved from it.
- ICH Q2(R2)
- Interference %
- Resolution
- No sign-up
Four steps, or fewer
- Enter the mean standard response at the 100% level.
- Add each solution you injected with the response at the analyte retention time (0 if no peak).
- Add the resolution of the nearest peak from the analyte where relevant.
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 specificity is evaluated
Specificity shows that the method measures the analyte unequivocally in the presence of expected components. Inject diluent blank, placebo, known impurities and stressed samples. Typical criteria are no significant interference at the analyte retention time and adequate resolution from neighbouring peaks. Peak purity from a diode-array or mass detector supports the conclusion.
References
- ICH Q2(R2) Validation of analytical procedures
- USP General Chapter <1225>
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.