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.
On declarations: the accurate description of a research reference material is a research reference material, and accuracy is both the legal position and the practical one. A declaration that misdescribes the contents converts a customs question into a different kind of question, and it does so on a document with your name on it.
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.
Regulatory positions on personal importation are published: the relevant frameworks are the US FDA’s personal importation policy in its Regulatory Procedures Manual, the UK MHRA’s guidance on importing medicines for personal use, and the equivalent national provisions in the EU member states and Australia’s Therapeutic Goods Administration personal importation scheme. They differ materially from each other.
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The evidence you want is boring: the same result, from an independent laboratory, across more than one lot, over more than one year.
6Have you seen anything published on this, or is it inference from the mechanism? – tobias_maartens 3 months ago 7Useful. I have added the accept threshold suggestion to my own notes. – vial_five 4 months ago add a comment