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

Asked 8 Oct 2024Modified 19 months agoViewed 50k times
This question was marked as a duplicate of How long does liraglutide stay within specification at 25 °C once reconstituted?Closed 13 Oct 2024. It remains here because the answers below are specific to how it was asked.
40

Concretely: 37 °C · tirzepatide.

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.

Is there data behind this, or is it received wisdom?

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askedoona_kekkonen13k178 Oct 2024

4 Answers

Accepted answer first, then by votes
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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.

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

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.

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.

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

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answered · acceptedmarta_okonkwo190k25813 Dec 2024
4Worth adding that residual moisture predicts this better than any printed date. – Dr_Priya_Raghunathan 10 months ago
5The doubling-per-ten-degrees rule is the part I did not know and now use constantly. – dermot_kiely 44 days ago
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55

Desiccant matters more than the last few degrees of cold for a lyophilised powder.

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.

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

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answeredhalvard_ness69k4725 Dec 2024
The desiccant point is under-appreciated and costs nothing to act on. – k_szabo 3 months ago
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41

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

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.

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.

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

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

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answeredgrainne_ahearn50k3821 Nov 2024
33

Put another way, 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.

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

Equilibrate before opening or you condense water into the cake.

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answeredDr_Rosalind_Achebe69k1472 Dec 2024
8Same experience here, different supplier. – tabular_nums 6 days ago
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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.