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

Asked 19 Nov 2024Modified 17 months agoViewed 42k times
25

Setup, so nobody has to ask: dulaglutide · minus 80 °C · forty-two days.

I am trying to build something sustainable rather than something thorough that I will abandon.

I have already decided the broad direction; this is about the specifics.

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

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askedfresh_bac9.7k1619 Nov 2024
5How many freeze-thaw cycles are we talking about? One and ten are different questions. – esther_vandeVelde 5 months ago
4Add the diluent — a preservative changes the in-use period entirely. – Dr_Ilse_Vandenberg 4 months ago
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5 Answers

Accepted answer first, then by votes
67

Accepted answer

Forty-two 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: forty-two days at one stable temperature is gentler than a single uncontrolled transition. Either way, record the forty-two days and the temperature now, while you still know them; an excursion you did not write down is an excursion you cannot interpret later.

On the detail: the domestic leg after arrival is the part most often left in a warm hallway and least often worried about.

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

Specifically, once the parcel arrives, the domestic leg is the controllable part: get it into the refrigerator promptly rather than leaving it in a warm hallway for a day.

Solid-state stability of lyophilised peptides at ambient temperature is documented in formulation studies with residual moisture as the dominant variable.

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

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

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MO
answered · acceptedmarta_okonkwo190k25823 Dec 2024
8I would add a sentence about light, since tryptophan-containing sequences care. – Dr_Bram_Verhoeven 3 months ago
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60

The relevant physics is latent heat: a phase-change pack holds temperature only while it is changing phase, and once it has melted it is a warm mass.

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.

Stated carefully, a pack that arrived hard tells you about the last day of transit only, since it will have melted and, if the ambient dropped, partially refrozen.

Single-use temperature loggers are standard practice in supply chains where temperature genuinely matters and are inexpensive at parcel scale.

The domestic leg is the part you control. Refrigerate it promptly.

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LB
answeredlaminar_bench69k5712 Dec 2024
32

The relevant detail is that this is where the anxiety in this hobby is most out of proportion to the chemistry.

Asking a supplier to hold a shipment during a heatwave is reasonable and the better ones agree; the cost is a week and the benefit is a shorter warm exposure for anything in solution.

Specifically, a single phase-change pack in a thin-walled box holds below ten degrees for roughly one to two days at twenty-five degrees ambient, and under a day at thirty-five. On a nine-to-fourteen-day lane the material is at ambient for most of the journey whatever was packed with it.

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

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HP
answeredh_pergande71k1583 Jan 2025
4Two lots stored differently, reassayed at a year — the difference was smaller than I expected. – fiadh_cronin 16 days ago
3I have kept vials both ways for a year and this matches what I saw. – Dr_Colm_Fitzhenry 9 months ago
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25

If temperature history matters to you, buy a data logger. It is the only way to know.

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.

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

Solutions are a different question and deserve the worry the solids get.

edited 27 Jan 2025 by s_kalniete — corrected a unit error in the worked example

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SK
answereds_kalniete57k3814 Jan 2025
Small correction: it is the number of cycles rather than the freezer temperature that does the damage. – Dr_Hanne_Solberg 6 months ago
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23

Answering this needs the transit duration and the ambient temperature, and then the arithmetic is straightforward.

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.

The caveat is that a warm transit is survivable for a solid and materially different for a solution.

Lyophilised tolerates the lane. That is the answer for almost every order.

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GH
answeredgreta_holzmann23k2725 Feb 2025
4Adding a vote because this deserves more of them. – ruaidhri_o_shea 7 months ago
3The doubling-per-ten-degrees rule is the part I did not know and now use constantly. – kwn_analytical 5 months ago
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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.