Stability Testing Schedule Calculator
Accelerated and real-time stability test design.
Inputs
Results
Acceleration factor (×)
2.83
Accelerated test duration (months)
8.5
Estimated shelf life (months)24
Real-time pull points9
Accelerated pull points5
Storage conditions3
Total pull points16
Total samples needed48
Total tests to perform288
Study duration (months)24
How to Use This Calculator
- Enter the product launch date or first batch date.
- Set required stability study conditions (ICH Zone I, II, III, IV) for your target markets.
- Input planned testing intervals (0, 3, 6, 12, 18, 24 months).
- Review the complete testing schedule with dates for each condition and interval.
- Use the calendar to book testing lab capacity and schedule product release decisions.
How the result changes with Accelerated temp (°C)
| Accelerated temp (°C) | Acceleration factor (×) | Accelerated test duration (months) |
|---|---|---|
| 33 | 1.74 | 13.8 |
| 41 | 3.03 | 7.9 |
| 50 | 5.66 | 4.2 |
| 57 | 9.19 | 2.6 |
What each input means
- Target shelf life (months)
- Desired product shelf life in months. Typical: 12-36 months for cosmetics.
- Accelerated temp (°C)
- Temperature for accelerated stability testing. Standard: 40°C per ICH guidelines.
- Storage temp (°C)
- Normal storage/shelf temperature. Standard: 25°C (room temperature).
- Q10 factor
- Rate acceleration per 10°C increase. Typical: 2 for most cosmetics, 3-4 for sensitive formulas.
- Samples per pull point
- Number of samples tested at each time point (triplicates recommended).
- Tests per sample
- Number of tests per sample: pH, viscosity, appearance, color, odor, microbial, etc.
- Freeze-thaw cycles
- Number of freeze-thaw cycles (-10°C to 45°C). Standard: 5 cycles.
What each result means
- Acceleration factor (×)
- How many times faster aging occurs at accelerated temperature vs storage temperature.
- Accelerated test duration (months)
- How long to run the accelerated test to simulate your target shelf life.
- Estimated shelf life (months)
- Shelf life estimate if accelerated testing passes at the specified duration.
- Real-time pull points
- Number of testing time points for the real-time stability study.
- Accelerated pull points
- Number of testing time points for the accelerated study.
- Storage conditions
- Number of different storage conditions (real-time + accelerated + freeze-thaw).
- Total pull points
- Total number of pull/testing events across all conditions.
- Total samples needed
- Total individual samples needed for the entire study.
- Total tests to perform
- Total number of individual tests across all samples and time points.
- Study duration (months)
- Total calendar time for the complete stability study (real-time leg).
How this is calculated
Worked example, using the default values
- Identify Input Parameters4 parametersTarget shelf life (months) = 24, Accelerated temp (°C) = 40, Storage temp (°C) = 25, Q10 factor = 2 = 7 input(s) provided
- Calculate Acceleration factorAcceleration factor = pow(q10Factor, tempDiffOver10)2.83 = 2.83
- Calculate Accelerated test durationAccelerated test duration = targetShelfLifeMonths / accelerationFactor8.5 = 8.5
- Calculate Estimated shelf lifeEstimated shelf life = accelDurationMonths * accelerationFactor24 = 24
- Calculate Real-time pull pointsReal-time pull points9 = 9
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