lyophilised vs reconstituted storage are two completely different problems

lyophilised_or_notSenior Analyst

Short version of something that keeps getting mixed up.

Storage advice for the powder does not transfer to the solution and vice versa. Different physical states, different failure modes.

Powder: no water, hydrolysis risk low, microbial risk basically none, freezing generally fine, timescale months plus.

Solution: water present, hydrolysis happening, microbial risk real, freezing usually harmful, timescale days to weeks.

When someone says "this is stable at room temperature" the first question is which state. The answer is usually the powder, and it's usually being repeated about the solution.

6 replies

  • cold_chainSenior Analyst

    The room temp claim drift is real. I've seen manufacturer powder data quoted about a vial someone mixed two weeks ago.

    5 upvotes

  • same_tbhSenior Analyst

    which state. always ask which state?

    2 upvotes

  • read_the_labelSenior Analyst

    Two states makes the whole topic much easier to hold. Saving this.

    3 upvotes

  • newvialwhodisSenior Analyst

    so powder in the freezer is fine?

    2 upvotes

  • quick_qSenior Analyst

    so which state is the shipping one?

    2 upvotes

    • lyophilised_or_notSenior Analyst

      Powder. That's why shipping works at all.

      3 upvotes

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