Accepted answer
Start with the physical state, because it changes the answer completely and is the first thing to establish.
Anything shipped in solution is a different risk category, because hydrolysis and deamidation proceed in the aqueous phase and are strongly temperature-dependent.
Reported and extrapolated stability by condition
| State | Condition | Usable window | Basis |
|---|
| Lyophilised solid | −20 °C, sealed, dry | 24–36 months | Supplier guidance |
| Lyophilised solid | 2–8 °C, sealed | 12–24 months | Supplier guidance |
| Lyophilised solid | 25 °C, sealed | 4–8 weeks | Extrapolated (Arrhenius) |
| Lyophilised solid | 40 °C, sealed | 1–2 weeks | Extrapolated |
| Solution, preserved | 2–8 °C | 28 days | USP microbiological convention |
| Solution, preserved | 25 °C | 3–7 days | Extrapolated |
| Solution, unpreserved | 2–8 °C | 24 hours | USP microbiological convention |
Windows for the solid state are chemical; windows for solution are microbiological and usually shorter than the chemical limit.
Put another way, a pack that arrived hard tells you about the last day of transit only, since it will have melted and, if the ambient dropped, partially refrozen.
Solid-state stability of lyophilised peptides at ambient temperature is documented in formulation studies with residual moisture as the dominant variable.
A liquefied pack is expected. It is not evidence of a problem.
3I have kept vials both ways for a year and this matches what I saw. – t_oyelaran 10 months ago add a comment