What I have: room temperature · dulaglutide.
I am asking for verification rather than opinion, ideally with something I can read myself.
It is possible the evidence exists and I am searching for the wrong term.
Is this actually true, and what is the evidence?
room temperature is above the refrigerated band, and how far above is the whole answer. Room temperature is not a number, so take the pharmacopoeial 20–25 °C and its 22.5 °C midpoint: 17.5 kelvin above the 5 °C middle of a 2–8 °C refrigerator. The ten-degree rule of thumb — degradation rate roughly doubling per 10 K — puts that at about 3.4 times the refrigerated rate. It is an order-of-magnitude statement about a rate, not a shelf life, and the top of the 20–25 °C band runs about 1.4 times faster than the bottom of it. Lyophilised material tolerates this far better than solution does, which is why it is shipped that way, but "tolerates" is a statement about weeks and the vial is being asked about months. Log the excursion rather than guess at it. Nothing here is medical advice, and research-use-only material is not approved for human use.
Answer first: dry, cold, dark and still, with the lot code where you can still read it in a year.
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.
| 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, let a refrigerated or frozen vial equilibrate to room temperature before opening, so humid air does not condense water onto a cold cake.
The 28-day in-use period for preservative-containing multi-dose preparations is printed on the diluent labelling and is a long-standing pharmacy convention.
The caveat is that storage conditions preserve what you have and cannot improve it.
Dry, cold, dark, still. Four words and you have the answer.
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