Accepted answer
Keep the paperwork with the material, or the material becomes anonymous.
Reconstituted with a preservative-containing diluent: refrigerated, conventionally treated as usable for about 28 days from first entry. Without a preservative, single use and discard.
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.
Position matters less than people think: upright or on its side makes no difference to a lyophilised powder, and upright is marginally better for a reconstituted vial because it keeps the stopper dry.
Residual moisture is the dominant determinant of solid-state stability, which is why desiccants accompany lyophilised material.
Appearance does not indicate stability; a normal-looking cake can be substantially degraded.
Equilibrate before opening or you condense water into the cake.
This should be linked from the help pages. – Dr_Tomas_Kral 6 months ago add a comment