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Is 25 °C an acceptable storage condition for lyophilised liraglutide?

Asked 5 Aug 2024Modified 19 months agoViewed 15k times
5

The case in front of me: 25 °C · liraglutide.

The claim is plausible, which is exactly why I want to check it.

I am able to read a paper if someone points me at one.

Has anyone verified this independently?

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askedpip_okonjo13k275 Aug 2024

5 Answers

Accepted answer first, then by votes
74

Accepted answer

25 °C is above the refrigerated band, and how far above is the whole answer. 25 °C is 20 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 — makes that about 4 times the refrigerated rate, which is an order-of-magnitude statement and not a shelf life. 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.

Start with the physical state, because lyophilised and reconstituted material have completely different storage answers.

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

StateConditionUsable windowBasis
Lyophilised solid−20 °C, sealed, dry24–36 monthsSupplier guidance
Lyophilised solid2–8 °C, sealed12–24 monthsSupplier guidance
Lyophilised solid25 °C, sealed4–8 weeksExtrapolated (Arrhenius)
Lyophilised solid40 °C, sealed1–2 weeksExtrapolated
Solution, preserved2–8 °C28 daysUSP microbiological convention
Solution, preserved25 °C3–7 daysExtrapolated
Solution, unpreserved2–8 °C24 hoursUSP microbiological convention

Windows for the solid state are chemical; windows for solution are microbiological and usually shorter than the chemical limit.

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.

Photodegradation of tryptophan-containing peptides is documented and is the basis for light-protected storage recommendations.

Nothing here is medical advice, and research-use compounds are not approved for human use.

Label the vial at reconstitution with date, concentration and units per dose.

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answered · acceptedone_ml_bac18k2714 Oct 2024
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67

Answering this needs the intended duration, since a fortnight and two years call for different arrangements.

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.

Lyophilised powder: refrigerated at two to eight degrees for months, frozen at minus twenty for longer. The gain from minus eighty over minus twenty is small for a dry solid and is not usually worth the arrangement.

Appearance does not indicate stability; a normal-looking cake can be substantially degraded.

Dry, cold, dark, still. Four words and you have the answer.

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ED
answerede_dziedzic51k1473 Oct 2024
32

The relevant detail is that this is the tag where the advice is cheapest to follow and most often ignored.

Keep vials in their original carton or in an opaque box. Light exposure matters for tryptophan-containing sequences and for anything with a chromophore, and a closed box is free.

Keep the certificate with the vial, physically or as a photograph filed under the lot code. A vial without a traceable certificate is an anonymous vial regardless of where it came from.

Two-to-eight-degree refrigeration and minus-twenty freezing are the standard storage conditions for lyophilised peptides in supplier documentation across the market.

Keep the desiccant with the vial and the certificate with the lot code.

edited 4 Oct 2024 by pierce_count — updated for the 2026 guidance change

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PC
answeredpierce_count24k3811 Sept 2024
6Adding for future readers: the domestic leg after delivery is the part you control. – u100_marks 3 months ago
7Is there a reason to prefer minus eighty here, or is minus twenty genuinely enough? – zainab_mustafa 4 months ago
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25

Worth being precise here: desiccant matters more than the last few degrees of cold for a lyophilised powder.

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.

Minus eighty buys very little over minus twenty for a dry solid.

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DV
answeredDr_Bram_Verhoeven84k24822 Sept 2024
21

Answer first: dry, cold, dark and still, with the lot code where you can still read it in a year.

Let a refrigerated or frozen vial equilibrate to room temperature before opening, so humid air does not condense water onto a cold cake.

A printed expiry on research-grade material has no stability programme behind it.

Equilibrate before opening or you condense water into the cake.

edited 16 Dec 2024 by forty_two_c — fixed an arithmetic slip in the third paragraph

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answeredforty_two_c66k5817 Nov 2024

Your answer

Ask PeptideStack is a static archive. Posting is closed, but the norms are worth stating: answer the question that was asked, show your working, cite the trial or the certificate, and say plainly where the evidence runs out.

Not medical advice. Research-use-only compounds are not approved for human use.