PeptideStack
5.2kquestions
20kanswers
220users

My dulaglutide vial sat at minus 80 °C for ten days — is testing worth it before use?

Asked 29 Jan 2026Modified 2 months agoViewed 5.9k times
5

Stated plainly: dulaglutide · minus 80 °C · ten days.

I would like to set this up properly once, rather than adjust it repeatedly.

My budget is real but not tight, and my tolerance for uncertainty is low.

What should I decide now, and what should I defer?

cold-chain
cold-chain

Keeping material within a temperature window from manufacture to use: phase-change packs versus dry ice, thermal mass, transit-lane temperature…

578 questions
peptide-stability
peptide-stability

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

908 questions
batch-testing
batch-testing

Testing at the batch or lot level: sampling plans, how many vials from a lot need testing to say anything about the lot, and the difference…

910 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
DB
askedDr_Aoife_Brennan20k2729 Jan 2026

2 Answers

Accepted answer first, then by votes
89

Accepted answer

Ten days at minus 80 °C. minus 80 °C is 85 kelvin below a refrigerator, and below the glass transition of a lyophilised cake the ten-degree rule of thumb stops applying at all — solid-state chemistry is not slow liquid chemistry, it is a different regime, and the failure modes that survive it are mechanical rather than chemical. The thing to establish is how many times it froze and thawed, not how long it sat: ten days at one stable temperature is gentler than a single uncontrolled transition. Either way, record the ten days and the temperature now, while you still know them; an excursion you did not write down is an excursion you cannot interpret later.

Start with the physical state, because it changes the answer completely and is the first thing to establish.

That is the argument for shipping lyophilised rather than for shipping colder. A dry powder with low residual moisture is stable at ambient for months; the pathways that matter need water.

A single-use temperature logger costs a few pounds, records the whole journey and converts an argument into a record. If the history matters, this is the answer.

Arrhenius kinetics predict approximately a doubling of degradation rate per ten-degree rise and are the standard basis for cold-chain design.

Reconstituted material has a genuine cold-chain requirement and it starts the moment water is added.

A liquefied pack is expected. It is not evidence of a problem.

shareimprove this answerflag
EL
answered · acceptedesben_lykke84k15829 May 2026
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 short version: a spent cold pack on arrival is expected, the solid does not mind, and the pack was never going to last twelve days.

Anything shipped in solution is a different risk category, because hydrolysis and deamidation proceed in the aqueous phase and are strongly temperature-dependent.

Stated carefully, arrhenius behaviour means the degradation rate roughly doubles per ten degrees. A week at thirty degrees is therefore a meaningful exposure for a solution and an immaterial one for a dry solid.

Buy a logger if you actually want to know. Everything else is inference.

edited 14 Feb 2026 by marta_okonkwo — removed a claim I could not source

shareimprove this answerflag
MO
answeredmarta_okonkwo190k2589 Feb 2026
7Thank you — this is the answer I was looking for. – rukhsana_iqbal 5 months ago
add a comment

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.