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Practice · Storage & stability

Mean kinetic temperature explained without the mathematics

IT
impurity_tableTL3Analytical chemist12 Jul 2024#1

Posting this under the heading it deserves: Mean kinetic temperature explained without the mathematics Everything below is what sits behind that.

Practical question with the units stated, because I have seen how quickly these go wrong without them.

I have a 5 mg vial of retatrutide and I am working to a 0.5 mg step. My syringes are U-100 insulin syringes, 0.3 mL barrel.

I can do the arithmetic and I have done it twice, getting the same answer both times, but I would like someone to check the reasoning rather than the number — specifically whether I have thought about the residual volume correctly, and whether the graduation I am landing on is one a person can actually read.

14 likes 2y
VB
v.baptistaTL2 Moderator24 Jul 2024#2

On the opening post — agreed on the reasoning, with one qualification.

Freeze-thaw: some peptide solutions tolerate freezing poorly because ice crystals damage protein structure. Whether your specific solution tolerates it depends on the formulation and is not something to test empirically. The conservative position is not to freeze.

18 likes 2y
BN
bench_notesTL4 Moderator31 Jul 2024#3

I want to gently push back on the reply above about storage extrapolation. The advice is sound and the confidence is not.

We are extrapolating from stability data on a licensed formulation to a preparation that differs in concentration, diluent and container. That extrapolation is reasonable and it is still an extrapolation. Saying so does not weaken the practical recommendation; it just stops the recommendation from hardening into a fact that someone cites as certain.

0 likes 2y
Moved from Administration by bench_notes. Category placement is not obvious from outside and getting it wrong is expected. This topic will get better answers here. The move is recorded in the public log citing R7.

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