Accepted answer
Answer first: for a lyophilised solid the cold chain matters far less than people believe, and for a solution it matters far more than they act as though it does.
A single-use temperature logger costs a few pounds, records the whole journey and converts an argument into a record. If the history matters, this is the answer.
Degradation pathway by condition
| Pathway | Dominant when | Detected by |
|---|
| Deamidation | Solution, neutral to alkaline pH | RP-HPLC, +1 Da on MS |
| Oxidation | Light, trace metals, peroxides | RP-HPLC, +16 Da on MS |
| Hydrolysis | Solution, extremes of pH | RP-HPLC, fragment masses |
| Aggregation | Agitation, interfaces, high concentration | SEC, visual haze; often invisible on RP-HPLC |
| Freeze-concentration damage | Freeze-thaw of buffered solution | SEC, loss of recovered content |
More usefully, anything shipped in solution is a different risk category, because hydrolysis and deamidation proceed in the aqueous phase and are strongly temperature-dependent.
Solid-state stability of lyophilised peptides at ambient temperature is documented in formulation studies with residual moisture as the dominant variable.
A cold pack tells you nothing about the eleven days before the last one.
Solutions are a different question and deserve the worry the solids get.
Adding for future readers: the domestic leg after delivery is the part you control. – u100_marks 3 months ago add a comment