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ForumsCompounding & FormulationCompounded peptide reconstitution water — looking for input Page 2

Compounded peptide reconstitution water — looking for input

maria_elpaso Fri, Oct 18, 2024 at 11:14 PM 33 replies 2,392 viewsPage 2 of 7
stefan_berlin
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Oct 19, 2024 at 12:58 AM#6

One concrete data point for the thread. Two things anyone can check: a state licence number for a 503A, and an FDA outsourcing-facility registration for a 503B. Both are publicly searchable, and a pharmacy unwilling to give you either has answered the question.

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tony_orlando
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Oct 19, 2024 at 1:38 AM#7

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

How much material I am losing to dead space, and whether that explains why a 10mg vial gives me nine usable draws rather than ten?

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TrialNerd_Beth
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Oct 19, 2024 at 2:18 AM#8
stefan_berlin said:
Two things anyone can check: a state licence number for a 503A, and an FDA outsourcing-facility registration for a 503B.

Adding the part of the answer the thread has not reached. 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.

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maria_elpaso
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Oct 19, 2024 at 2:58 AM#9

OP back with an update, since a thread like this is useless without one.

My error was treating units as a mass. Once I wrote mg/ml on the vial in marker and worked in millilitres first, the two of us got the same answer.

Last edited: Oct 19, 2024 at 8:58 AM
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pete_manc_UK
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Oct 19, 2024 at 6:10 AM#10
TrialNerd_Beth said:
Resolution therefore closed the doors unevenly, and the asymmetry follows from the bulks lists.

Agreeing with TrialNerd_Beth, and the qualification matters more than the agreement. The arithmetic is right and one caveat matters: a U-40 syringe changes the markings, not the volumes. If someone hands you U-40 and you read it as U-100 you will be 2.5 times out, and that error has a direction — it is always an overdose.

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