PeptideStack
5.2kquestions
20kanswers
220users

Is 37 °C an acceptable storage condition for lyophilised dulaglutide?

Asked 18 May 2024Modified 23 months agoViewed 16k times
14

Numbers first: 37 °C · 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.

How well supported is this claim?

storage
storage

Storage conditions and their evidence base: minus twenty degrees for powder, refrigerated for solution, protection from light, and what the…

701 questions
peptide-stability
peptide-stability

The chemistry of peptide degradation: deamidation, oxidation, hydrolysis, aggregation and fibrillation, and how temperature, pH, ionic strength,…

908 questions
shelf-life
shelf-life

How long a preparation remains within specification: labelled expiry for a sealed lyophilised vial, beyond-use dating after reconstitution, and…

327 questions
dulaglutide
dulaglutide

A once-weekly GLP-1 receptor agonist built on an Fc fusion rather than fatty-acid acylation. Use this tag for questions about the fusion-protein…

200 questions
shareeditfollowflag
CO
askedcoldbox941k13818 May 2024
5Worth saying whether the vial has been opened, because that starts a different clock. – loss_on_drying 3 months ago
add a comment

5 Answers

Accepted answer first, then by votes
34

Accepted answer

37 °C is above the refrigerated band, and how far above is the whole answer. 37 °C is 32 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 9.2 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.

The short version: powder in the freezer or fridge, reconstituted in the fridge for weeks, and never anything on a windowsill.

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.

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

shareimprove this answerflag
TV
answered · acceptedten_mg_vial31k13814 Sept 2024
Sponsored

Sigma-Aldrich - Certified Reference Materials

Analytical standards and reagents with traceable certificates. Every quantitative result you read inherits the accuracy of the standard behind it.

Shop standards
34

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.

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.

Mechanically, 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.

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.

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

edited 25 Aug 2024 by marta_okonkwo — tightened the wording; no substantive change

shareimprove this answerflag
MO
answeredmarta_okonkwo190k25823 Aug 2024
24

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

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.

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.

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

edited 25 Aug 2024 by esben_lykke — updated for the 2026 guidance change

shareimprove this answerflag
EL
answeredesben_lykke84k15812 Aug 2024
6Adding for future readers: the domestic leg after delivery is the part you control. – ilaria_bertone 4 months ago
5Small correction: it is the number of cycles rather than the freezer temperature that does the damage. – seven_day_half 3 months ago
add a comment
16

The honest answer is that ordinary refrigeration handles almost every case people ask about.

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

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

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

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

shareimprove this answerflag
IB
answeredines_brandt113k2573 Sept 2024
14

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

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.

Deamidation kinetics for asparagine in peptides are well characterised and strongly sequence-dependent: the residue following the asparagine dominates the rate, with glycine and serine at the n+1 position accelerating it by an order of magnitude relative to bulkier residues. That is why two peptides in the same buffer at the same temperature can have quite different shelf lives.

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

Equilibrate before opening or you condense water into the cake.

shareimprove this answerflag
LC
answeredlyoph_cake78k26710 Jul 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.