Lyophilization process for peptides — how freeze-drying works

PeptideSynthNJ said:

Freezing is the one to avoid, and freeze-thaw more so.

Storage best practices for compounded storage and cold:

• Unreconstituted lyophilized powder: refrigerate (36-46°F), good for 12+ months
• Reconstituted vials: refrigerate, use within 28 days
• Pre-filled pens: refrigerate until first use, then room temp OK for 28 days
• Never freeze reconstituted peptides — ice crystals damage the protein
• Protect from light — store in original box or wrap in foil

When in doubt, refrigerate. Temperature abuse is the #1 cause of reduced potency in compounded peptides.

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

Did your prescriber agree with that reading, and if not what was their objection?

PharmacoVig_BOS said:

Storage best practices for compounded storage and cold: Unreconstituted lyophilized powder: refrigerate (36-46°F), good for 12+ months Reconstituted…

Coming at PharmacoVig_BOS’s question from a different direction. It is worth asking what the claim would look like if it were false. If nothing would look different, it is not a claim about the world and no amount of discussion will settle it.

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

Update: the excursion was survivable and the vial was fine. I now keep a cheap fridge thermometer, which costs nothing and ends the argument.

LipidDoc_ATL said:

It is worth asking what the claim would look like if it were false.

Fair, and it stops being fair at the extremes. The middle of the range is well understood; the ends are where the honest answer is that nobody knows.