Accepted answer
minus 20 °C is colder than anything a lyophilised cake needs. minus 20 °C is 25 kelvin below a refrigerator, and below the glass transition of a lyophilised cake the ten-degree rule of thumb stops applying at all — solid-state chemistry is not slow liquid chemistry, it is a different regime, and the failure modes that survive it are mechanical rather than chemical. A dry cake has no solvent to react in, so the marginal benefit below a domestic freezer is small and the marginal risk is not: freeze-thaw on the way in and out, and condensation on a cold stopper when you open it, are the failure modes that actually happen at minus 20 °C. Nothing here is medical advice, and research-use-only material is not approved for human use.
The short version: powder in the freezer or fridge, reconstituted in the fridge for weeks, and never anything on a windowsill.
Label the vial at reconstitution with the date, the concentration and the resulting units per dose. This is the single most useful thirty seconds in the whole process.
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.
Store with the desiccant sachet if one was supplied, inside the secondary container rather than loose in a drawer. Residual moisture is the dominant variable in solid-state stability.
Residual moisture is the dominant determinant of solid-state stability, which is why desiccants accompany lyophilised material.
Keep the desiccant with the vial and the certificate with the lot code.