Skip to main content
Calcimator

Stability Study Design Calculator

Calculate total sample count from time points, conditions, tests, replicates, and batches per ICH Q1A(R2).

Inputs

%

Results

Total samples needed

594

Test samples540
Retain samples54
Samples per pull10
Total sampling events54
Estimated total volume (L)3
How to Use This Calculator
  1. Enter the number of sampling time points and storage conditions in the study.
  2. Set tests per pull, replicates per test, number of batches, and retain sample percentage.
  3. Review Total Samples Needed, Test Samples, Retain Samples, and Total Sampling Events.
  4. Use Estimated Total Volume (L) to plan bulk drug substance or drug product requirements for the study.
Ad Placeholder
Ad Placeholder