Accepted answer
The underlying point is that evaluate a supplier on the documentation they cannot fabricate cheaply, which in practice means lot-specific certificates from a laboratory that hosts its own reports and a testing history that spans more than one lot.
The diagnostic red flags, in rough order of how much they tell you: a certificate whose lot number does not match the vial; a certificate with no method section; a purity figure quoted to two decimal places with no chromatogram; a testing date that precedes the stated manufacturing date; identical certificates across nominally different lots; and "sterile filtered" offered in place of a sterility test. Each of those is a specific inference, not a vibe.
The part that matters: cost per milligram, worked honestly: a 10 mg vial at £34 is £3.40 per nominal milligram. If the content assay says 9.2 mg, that is £3.70 per actual milligram. If you then lose 4 µL of dead space per draw from a 2 mL fill across twenty draws, that is 80 µL or four per cent of the fill, taking you to £3.85. Add a £110 content assay amortised across the vial and it is £14.85 per milligram for the first vial of a new lot and £3.85 thereafter. The testing dominates, which is the actual argument for buying larger lots.
Independent testing costs have been stable enough over the past two years that amortisation arithmetic across a lot is worth doing before choosing a lot size, and the numbers usually favour a larger lot tested once over several small lots tested never.
The evidence you want is boring: the same result, from an independent laboratory, across more than one lot, over more than one year.
edited 1 Jul 2025 by jo_vandeberg — fixed an arithmetic slip in the third paragraph
6Thank you — the worked example is what makes this usable. – tandem_gradient 8 months ago 5Related: the same reasoning applies to the counter-ion question. – n_takahashi 6 months ago add a comment