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Calcimator

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
  1. Enter the product launch date or first batch date.
  2. Set required stability study conditions (ICH Zone I, II, III, IV) for your target markets.
  3. Input planned testing intervals (0, 3, 6, 12, 18, 24 months).
  4. Review the complete testing schedule with dates for each condition and interval.
  5. 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)
331.7413.8
413.037.9
505.664.2
579.192.6

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

  1. Identify Input Parameters
    4 parameters
    Target shelf life (months) = 24, Accelerated temp (°C) = 40, Storage temp (°C) = 25, Q10 factor = 2 = 7 input(s) provided
  2. Calculate Acceleration factor
    Acceleration factor = pow(q10Factor, tempDiffOver10)
    2.83 = 2.83
  3. Calculate Accelerated test duration
    Accelerated test duration = targetShelfLifeMonths / accelerationFactor
    8.5 = 8.5
  4. Calculate Estimated shelf life
    Estimated shelf life = accelDurationMonths * accelerationFactor
    24 = 24
  5. Calculate Real-time pull points
    Real-time pull points
    9 = 9

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