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

Asked 19 Apr 2024Modified 2.1 years agoViewed 67k times
36

Conditions: 37 °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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BN
askedbridget_nyathi12k1519 Apr 2024
What temperature, and for how long? Both are needed before anyone can say anything useful. – kirsi_lahtinen 9 months ago
8Do you know the residual moisture? It predicts this better than any date does. – tri_gly_ala 8 months ago
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4 Answers

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40

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.

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.

Reported and extrapolated stability by condition

StateConditionUsable windowBasis
Lyophilised solid−20 °C, sealed, dry24–36 monthsSupplier guidance
Lyophilised solid2–8 °C, sealed12–24 monthsSupplier guidance
Lyophilised solid25 °C, sealed4–8 weeksExtrapolated (Arrhenius)
Lyophilised solid40 °C, sealed1–2 weeksExtrapolated
Solution, preserved2–8 °C28 daysUSP microbiological convention
Solution, preserved25 °C3–7 daysExtrapolated
Solution, unpreserved2–8 °C24 hoursUSP microbiological convention

Windows for the solid state are chemical; windows for solution are microbiological and usually shorter than the chemical limit.

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.

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

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answeredforty_two_c66k5813 May 2024
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25

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

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

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.

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

edited 17 Jun 2024 by leonid_marchuk — reworded for clarity after a comment

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LM
answeredleonid_marchuk19k2724 May 2024
18

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.

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.

Residual moisture is the dominant determinant of solid-state stability, which is why desiccants accompany lyophilised material.

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

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

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DV
answereddead_volume56k4820 Apr 2024
6This should be linked from the help pages. – Dr_Nadia_Farsi 6 months ago
5Small correction: it is the number of cycles rather than the freezer temperature that does the damage. – rhian_prydderch 4 months ago
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14

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.

Equilibrate before opening or you condense water into the cake.

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MV
answeredmala_venkatesh22k372 May 2024
4Does the same reasoning apply to material already in solution, or is that a different curve? – Dr_Colm_Fitzhenry 37 days 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.