Estimate shelf life from stability data per ICH Q1E: a regression line for each batch, its confidence bound, and the time the bound reaches your limit.
| Month | ||||
|---|---|---|---|---|
A stability study estimates how long a product stays within its specification in storage. Enter the results of each batch at each time point (for example assay at 0, 3, 6, 9, 12, 18 and 24 months) with the storage condition; the tool decides whether the batches can be combined, estimates the shelf life from the data, and gives the shelf life you can claim, including how far you may go beyond the data.
The statistical evaluation and the limits on extrapolation follow ICH Q1E, with significant change as defined in ICH Q1A(R2). The calculation is tested against published worked examples.
The data behind “Try an example”: assay (%) of 3 batches from 0 to 24 months, lower limit 95.0%, long-term room temperature storage, no significant change at accelerated.
| Result | Value |
|---|---|
| Batches | Same rate of loss, different starting levels |
| Shelf life by batch | A2401 31.9 · A2402 34.6 · A2403 30.0 months |
| Most that ICH Q1E allows here | 36 months |
| Shelf life to claim | 30 months |
Batch A2403 starts lowest and reaches the limit first, at 30.0 months. That is beyond the 24 months of data but within what ICH Q1E allows for this case, so 30 months can be claimed.