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ForumsCompounding & FormulationHas anyone dealt with lyophilization process for peptides? Page 2

Has anyone dealt with lyophilization process for peptides?

Dr.AddMedPHL Mon, Jul 22, 2024 at 12:05 PM 34 replies 2,498 viewsPage 2 of 7
DataDave
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Jul 22, 2024 at 6:26 PM#6
InsuranceTom said:
They are two different exemptions from the same federal requirements and they buy different things.

I read this differently from InsuranceTom, on substance rather than tone. A research-chemical supplier selling lyophilised powder labelled research use only is not compounding and is not claiming to. It is a different legal universe with no pharmacy oversight, no patient relationship and no content guarantee, and conflating the two in these threads helps nobody.

5 8VendorMark, COA_Karl, MikeFit_NJ and 2 others
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VendorMark
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Jul 22, 2024 at 8:56 PM#7
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…

GMP compliance checklist relevant to compounded supply compounding quality:

  • Clean room environment with HEPA filtration
  • Environmental monitoring (viable and non-viable)
  • Personnel training and competency assessment
  • Validated analytical methods for testing
  • Stability testing program
  • Complete batch records and traceability
  • Quality management system with deviation handling

A 503B pharmacy following cGMP should be able to answer questions about ALL of these if you ask. Don't be afraid to ask — it's your health.

Last edited: Jul 22, 2024 at 10:56 PM
6 9KristenIndy, MarkLI_maint, Dr.PeteFamMed and 3 others
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PharmHunterJen
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Jul 22, 2024 at 11:26 PM#8
DataDave said:
A research-chemical supplier selling lyophilised powder labelled research use only is not compounding and is not claiming to.

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.

7 10kevin_tulsa, Dr.PainCLE, mike_mealprep and 4 others
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Sigma-Aldrich — Research-Grade Standards

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steve_okc
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Jul 23, 2024 at 1:56 AM#9

One thing that is still open after CryptoCarl’s answer:

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

Last edited: Jul 23, 2024 at 5:56 AM
8 11CanadaChris, ZaraB_AL, JakeSmashed95 and 5 others
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Dr.AddMedPHL
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Jul 23, 2024 at 1:58 PM#10

Closing the loop on my own question.

The bulks-list asymmetry was the piece I had missed entirely. It explains why one of my two pharmacies is still arguing it can supply and the other simply stopped.

Last edited: Jul 23, 2024 at 3:58 PM
14 14JessicaM_2024, TomFromTexas, mike.trainer_LA and 11 others
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