[Discussion] can we stop arguing about excursion until somebody posts a number
can we stop arguing about excursion until somebody posts a number. If this has been answered properly somewhere, link me and I will delete. Regional stock changes the question rather than answering it: shorter lanes mean less exposure and fewer variables, which is why the warehouse question is worth asking before…
Careful. "The cold chain failed" is a strong claim and the evidence you have is a warm box.
I would not freeze it in solution. That is a different failure mode and a worse one.
A transit temperature logger records a distribution, and time above a threshold matters as much as peak temperature. That is the argument for logging rather than guessing.
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Right, and asking what the stability statement was written against is one line of email that reframes everything.
ask which lines are held in regional stock before you order in July
Once in solution, the relevant risks are hydrolysis, aggregation and, for some sequences, oxidation. Refrigeration slows all three; freezing a solution introduces a separate risk at the ice interface.
Lyophilisation removes the water that drives most degradation pathways. That is why the dry cake is comparatively robust and the reconstituted solution is not.
ask what storage condition the stability statement was written against