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ForumsCompounding & FormulationHas anyone dealt with lyophilization process for peptides? Page 3

Has anyone dealt with lyophilization process for peptides?

Dr.AddMedPHL Mon, Jul 22, 2024 at 12:05 PM 34 replies 2,498 viewsPage 3 of 7
DanielChem_CHI
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Mar 2024
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Jul 24, 2024 at 10:08 PM#11
Dr.ObesityMed said:
503A vs 503B compounding pharmacies for compounded supply — this distinction matters enormously: Feature 503A 503B Regulation State Board of Pharmacy…

Regarding compounded supply compounding legality: compounding pharmacies can legally produce semaglutide and tirzepatide while these drugs remain on the FDA shortage list. If/when the shortage resolves, the legal landscape may change.

Stay informed. The FDA shortage list is updated regularly. Current status as of my last check: semaglutide shortage ongoing, tirzepatide partially resolved. This directly impacts compounding availability.

13 13fiona_VT, denise_HTX, raj_cambridge and 10 others
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PharmHunterJen
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Jul 26, 2024 at 6:19 AM#12
LarryQC_SD said:
Agreed, and the enforcement dates were staggered by category — 503A first, 503B a few weeks later — because outsourcing facilities have manufactured…

Saving this. It is the first explanation that did not require me to already understand it. Sending this to two other people who asked me the same thing last week.

12 12alex_tucson, kevin_tulsa, Dr.PainCLE and 9 others
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fiona_glasgow
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Jul 27, 2024 at 2:31 PM#13
Dr.ObesityMed said:
503A vs 503B compounding pharmacies for compounded supply — this distinction matters enormously: Feature 503A 503B Regulation State Board of Pharmacy…

Price comparison for compounded supply across sources I've used:

SourceMonthly CostTypePurity Verified
Brand (Ozempic)$978FDA-approvedN/A (pharma)
503B Compounding$158cGMP compoundedYes (in-house)
503A Compounding$128Patient-specificVaries
Research peptide$43Not for human useOften Janoshik

I use the 503B option — best balance of quality, cost, and legality. The brand price is insane but insurance can help if you qualify.

11 11KevinCompounds, TirzTom, TrialTracker_MD and 8 others
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Sigma-Aldrich — Research-Grade Standards

Certified reference materials, analytical reagents, and research-grade standards for peptide verification. Trusted by laboratories worldwide.

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FDA_TrackerJim
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Jul 28, 2024 at 10:43 PM#14
Dr.AddMedPHL said:
Two pharmacies quoted me last year, one describing itself as 503A and one as 503B, and I assumed 503B just meant bigger until both stopped within…

Compounded has been just as effective for me. If compounded supply is the concern, the COA from my 503B pharmacy shows 99.1% purity. Verified by Janoshik.

10 10Dr.LeslieOBGYN, MikeNYC_runner and 7 others
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Admin
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Jul 30, 2024 at 6:56 AM#15

Moderator note: the sourcing question belongs in the vendor section and has been split out. No action needed from anybody.

Last edited: Jul 30, 2024 at 10:56 AM
9 9PeptideSynthNJ, Dr.KarenChen, Dr.NateNeph and 6 others
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