Clinical Trial MKT Excursion Calculator
Determine whether thermal spikes during investigational medicinal product (IMP) transit result in product compromise or remain salvageable under Arrhenius kinetic degradation models.
01 Storage Regime & Excursion Profile
Arrhenius Mean Kinetic Temperature Output
USP <1079> MODELMean Kinetic Temperature (MKT) Mathematics & Stability Salvage Strategy
Chemical reactions accelerate exponentially as temperature rises (Arrhenius rate law). A single 4-hour excursion to -30°C causes far more molecular degradation than 40 hours at -75°C. Arithmetic means dangerously underestimate stability decay.
MKT calculates the single isothermal temperature that would produce the same total thermal degradation as the actual fluctuating temperature history over the shipment timeframe.
When an excursion occurs, rather than automatically destroying multi-million-dollar investigational drug supplies, MKT modeling demonstrates to the FDA/EMA that the effective thermal dose did not exceed stability claim limits.
| Storage Regime | Permitted MKT Cap | Max Spike Allowance | Action On MKT Exceedance |
|---|---|---|---|
| Ultra-Cold (-80°C) | < -60.0°C MKT | < -20.0°C (Max 4 hrs) | Bioassay potency check required |
| Frozen (-20°C) | < -15.0°C MKT | < 0.0°C (No Thaw) | Enzyme activity titration |
| Refrigerated (+2 to +8°C) | < +8.0°C MKT | < +15.0°C (Max 12 hrs) | Turbidity & aggregation scan |
| Controlled Room (+15 to +25°C) | < +25.0°C MKT | < +30.0°C (Max 24 hrs) | Dissolution rate testing |
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