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ForumsCompounding & FormulationCompounded semaglutide stability: accelerated degradation study results — November 2025 Page 2

Compounded semaglutide stability: accelerated degradation study results — November 2025

pat_auckland Mon, Oct 20, 2025 at 6:54 AM 24 replies 1,352 viewsPage 2 of 5
FDA_TrackerJim
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Oct 20, 2025 at 4:31 PM#6
Dr.SleepRoch said:
Albumin binding above 99% is the whole reason weekly dosing works, and it is also why the trough matters more than the peak.

I will push back on the "any working dose is fine" framing. The maintenance evidence sits overwhelmingly at the top studied dose, and the extension data shows regain tracking dose reduction rather than tracking stopping. Holding low is reasonable; pretending it is evidentially equivalent is not.

Last edited: Oct 20, 2025 at 7:31 PM
25 3Dr.Martinez, mike_mod, SarahChen_PharmD and 22 others
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PeptideSynthNJ
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Princeton, NJ
Oct 20, 2025 at 8:18 PM#7

The figures, for anyone assembling their own picture. For anyone assembling their own picture: Tmax is one to three days, terminal half-life about 165 to 170 hours, steady state at four to five weeks, and subcutaneous bioavailability near 89%. Those four numbers explain most of the questions people ask about timing.

Last edited: Oct 21, 2025 at 12:18 AM
26 4NurseAsh_DET, BenResearch_OR, MikeKY_noInsulin and 23 others
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hyun_seoul
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Seoul, KR
Oct 21, 2025 at 12:05 AM#8
FDA_TrackerJim said:
I will push back on the "any working dose is fine" framing.

There is a second half to this that has not been said yet. Resolution therefore closed the doors unevenly, and the asymmetry follows from the bulks lists. For 503B the shortage clause was the only route to these molecules, so that route shut completely. A 503A pharmacy can still argue a doorway via "component of an approved drug" — but only for the substance in the form present in the approved product, which is exactly where the base-versus-salt argument lives, and it does nothing about the copy restriction, which came back into force on resolution.

Last edited: Oct 21, 2025 at 4:05 AM
27 5MASHdoc_SA, GenomicsKate, Dr.ObesityMed and 24 others
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tane_welly
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Oct 21, 2025 at 3:52 AM#9

A narrower follow-up, since the general answer is now clear:

What actually distinguishes 503A from 503B, in terms of what each may make and from what starting material?

28 6marco_milano, pam_columbus, nick_SD_fit and 25 others
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pat_auckland
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Oct 21, 2025 at 10:04 PM#10

Reporting back.

Following this thread I went back and re-read the extension data properly. The point about trough rather than peak explains the pattern I was seeing on day six, which I had been blaming on the vial.

38 11dan_philly, MeganSA_TX, LarryQC_SD and 35 others
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