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Is 4 °C an acceptable storage condition for lyophilised liraglutide?

Asked 13 Nov 2024Modified 18 months agoViewed 33k times
38

The case in front of me: 4 °C · liraglutide.

I want to know whether there is evidence behind this or only repetition.

I have checked the obvious registries and monographs without success.

Has anyone verified this independently?

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SS
askedswirl_dont_shake10k1413 Nov 2024
6Same question here after a warm delivery, so I am following this. – tobias_maartens 3 months ago
5Worth saying whether the vial has been opened, because that starts a different clock. – Dr_Fatima_Belkacem 2 months ago
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5 Answers

Accepted answer first, then by votes
20

Accepted answer

4 °C is inside or near the refrigerated band. 4 °C is the condition the rule of thumb is anchored to, so it is the baseline rather than a multiplier: everything else in this thread is quoted relative to it. That is the condition most lyophilised peptide is specified at, so the useful question moves to what happens after reconstitution, where the same temperature buys far less. 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.

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.

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

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HP
answered · acceptedh_pergande71k1582 Jan 2025
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6

The relevant practical failure is not chemical at all: it is losing the link between a vial and its certificate when the box gets thrown away.

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.

On the detail: let a refrigerated or frozen vial equilibrate to room temperature before opening, so humid air does not condense water onto a cold cake.

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

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

edited 3 Dec 2024 by h_pergande — fixed an arithmetic slip in the third paragraph

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HP
answeredh_pergande71k15819 Nov 2024
2This should be linked from the help pages. – nkem_obiora 9 months ago
3Same experience here, different supplier. – gradient_slope 20 days ago
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5

Keep the paperwork with the material, or the material becomes anonymous.

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.

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.

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

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SC
answeredstopper_core28k12714 Jan 2025
Two lots stored differently, reassayed at a year — the difference was smaller than I expected. – sian_llewellyn 7 months ago
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3

It helps to be literal here: 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.

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.

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

Equilibrate before opening or you condense water into the cake.

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FV
answeredfill_volume22k3811 Dec 2024
2

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

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.

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

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

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MV
answeredmala_venkatesh22k3723 Dec 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.