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Mean kinetic temperature (MKT) calculator
Paste logger readings and get MKT per ICH Q1A(R2) alongside min, max, mean and out-of-limit runs with durations.
Summary
Paste data or load the example to see MKT and excursion statistics.
MKT characterises the thermal exposure of a period; whether an excursion is acceptable depends on product-specific stability data, not on MKT staying below the label condition. This quick check does no data-quality gating — for a mapping study use the full workflow.
How the calculation works
- 01MKT (K) = (ΔH/R) / −ln[ Σ e^(−ΔH/(R T_i)) / n ], with T_i in kelvin and ΔH/R = 10 000 K (ΔH = 83.144 kJ/mol, R = 8.3144 J/(mol·K)).
- 02Excursions are consecutive readings outside the limits; duration = time from the first to the last reading in the run plus one sampling interval (median spacing).
Limitations
- MKT summarises thermal exposure for storage assessment. It does not justify an excursion above a product's limit — product-specific stability data do that.
- This is a quick check, not a mapping analysis: no data-quality gating for gaps, flatlines or unit ambiguity.
- Readings are assumed to be in °C.
Frequently asked questions
- Why is MKT higher than the average temperature?
- Because degradation rates rise exponentially with temperature (Arrhenius), warmer periods are weighted more heavily. MKT equals the mean only for a constant temperature.
- Can MKT be used to release a product after an excursion?
- Only if the product's stability documentation explicitly allows it. Regulators expect excursion assessments to rest on product-specific data; MKT is for characterising storage conditions over a period.
- What format does the paste box accept?
- One reading per line; commas, semicolons, tabs or spaces as separators; the last number on each line is the temperature and anything before it is read as a timestamp if it parses (ISO 8601 works best). Header lines are skipped.
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Mean kinetic temperature (MKT): what it is and when to use it
MKT is a single temperature that represents the cumulative thermal stress of a varying temperature history, weighted by the Arrhenius relationship. It is useful for storage assessment, not for hiding excursions.
Handling temperature excursions in storage and distribution
An excursion is a deviation: contain, record, assess product impact against stability data, decide, and learn. The record must show all five steps.
Storage condition labels explained: 2–8 °C, 15–25 °C, 'do not freeze'
Label storage conditions derive from stability studies under ICH conditions. Each phrase has a defined meaning that sets the limits for mapping, monitoring and excursion assessment.
Data-quality checks before analysing mapping data
Statistics computed on bad data are precise and wrong. Check the data first.