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ForumsCompounding & FormulationHas anyone dealt with lyophilization process for peptides? Page 6

Has anyone dealt with lyophilization process for peptides?

Dr.AddMedPHL Mon, Jul 22, 2024 at 12:05 PM 34 replies 2,498 viewsPage 6 of 7
TrialNerd_Beth
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Sep 5, 2024 at 1:47 AM#26
Dr.PeteFamMed said:
GMP compliance checklist relevant to compounded supply compounding quality: Clean room environment with HEPA filtration Environmental monitoring…

Beyond-use dating (BUD) for compounded supply compounded products:

Lyophilized (unreconstituted): typically 9 months from compounding date
Reconstituted with BAC water: typically 28-30 days refrigerated
Reconstituted with sterile water: typically 7 days (no preservative!)

Always use BAC water for multi-dose vials. Sterile water has no preservative and supports bacterial growth after first puncture. This is a common and potentially dangerous mistake.

27 2RickReta_CO, PharmHunterJen, TomTeleRx and 24 others
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hans_munich
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Sep 10, 2024 at 7:46 PM#27
Dr.PeteFamMed said:
GMP compliance checklist relevant to compounded supply compounding quality: Clean room environment with HEPA filtration Environmental monitoring…

Thank you for spelling out the reasoning rather than just the conclusion. Adding it to my notes with a link back to this thread.

Last edited: Sep 11, 2024 at 1:46 AM
26 1alex_tucson, kevin_tulsa, Dr.PainCLE and 23 others
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Dr.RheumBOS
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Sep 16, 2024 at 1:48 PM#28

Adding the clinical framing, because it changes how the question reads.

Compounding pharmacy response time test for compounded supply: I email customer service at odd hours to test responsiveness. A pharmacy that can't answer questions promptly is a red flag.

My current pharmacy: average response time same day. They answered my questions about sterility testing thoroughly and professionally.

Communication quality is a proxy for operational quality. A pharmacy that communicates well is likely manufacturing well too.

25 0cory_ATX, lori_vegas, Dr.PulmRoch and 22 others
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kate.chem
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Sep 22, 2024 at 7:53 AM#29
Dr.RheumBOS said:
Compounding pharmacy response time test for compounded supply: I email customer service at odd hours to test responsiveness.

Same experience, arrived at from the opposite direction. Posting only so the count is not one.

24 24jennifer_SEA, tyler_CSCS, VanRx_Mike and 21 others
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Dr.AddMedPHL
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Sep 28, 2024 at 2:02 AM#30
Dr.RheumBOS said:
Compounding pharmacy response time test for compounded supply: I email customer service at odd hours to test responsiveness.

Compounding pharmacy red flag checklist for compounded supply — if ANY of these apply, find a different source:

  1. No verifiable physical address
  2. No pharmacist available for consultation
  3. COA not available or clearly template/fake
  4. Prices dramatically below market ($30-40/month = suspicious)
  5. No prescription required
  6. Ships without cold pack or temperature control
  7. No batch/lot numbers on product labeling
  8. Pushes "research use only" products for human injection

Your health depends on product quality. Don't cut corners on source verification.

Last edited: Sep 28, 2024 at 4:02 AM
2 2JessicaM_2024, TomFromTexas
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