what does a certificate of analysis actually tell you?

read_the_labelSenior Analyst

COAs get cited like they settle things and I'm slowly realising they're narrower than people think.

What one typically reports: identity (often mass spec, confirms the molecular weight matches) and purity (usually HPLC, what fraction of the material is the target compound). Sometimes water content.

What that establishes: a tested sample was mostly the stated compound.

What it doesn't: that your specific vial came from that batch, what the impurities actually are (98% pure says nothing about the other 2%), sterility or endotoxin, or that the analysis was independent.

The identity vs purity distinction is the one I'd underline. Deliberately not getting into who provides what, that's a different topic and not one for this thread. Have I got this right?

7 replies6 upvotesBeginner Questions

7 replies

  • ShowMeTheDataSenior Analyst

    "What's the other 2%" is the question nobody asks. A purity figure without an impurity profile is much less informative than it looks. Truncated sequences for example.

    6 upvotes

    • read_the_labelSenior Analyst

      Truncated sequences hadn't occurred to me.

      2 upvotes

  • newvialwhodisSenior Analyst

    what does hplc stand for?

    2 upvotes

  • quick_qSenior Analyst

    whats endotoxin

    1 upvote

  • in_vitro_caveatSenior Analyst

    A COA is a document. Documents can be reused, edited, or correspond to nothing.

    4 upvotes

  • same_tbhSenior Analyst

    the other 2% question is a good one

    2 upvotes

  • anecdote_flagSenior Analyst

    Good call keeping sources out of it. That always eats the thread.

    3 upvotes

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