why does nobody talk about stability
why does nobody talk about stability. I would rather ask a basic question now than get this wrong quietly for two months. Put a logger in three consecutive orders. Two never went above the range at all and the third spent four hours warm on a Friday. Cost me almost nothing to stop wondering. Gel pack fully liquid on…
You cannot infer potency from a temperature record. The record tells you what happened to the box; only a test tells you what happened to the material.
Push back: you cannot infer degradation from a temperature excursion alone. That is what testing is for.
Correction: that stability figure covers the lyophilised powder, not the reconstituted solution. Different claim entirely.
ask what storage condition the stability statement was written against
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How many days in transit, and which month?