Hi Stabilitarians,
We have drug product labelled per CRT : "Store at 25°C excursions permitted 15°C to 30°C".
An inspector requested to see our stability data to support 15°C.
We have stability data at 30°C but not at 15°C.
Our thermal cycling data (-10°C) has no aging.

Has anyone else faced questions supporting 15°C on product label?
Based on our 25/60 data, does Mean Kinetic Temperature idea not support "excursions 15C to 30C" or is there other guidance?
Thank You
John




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