Adulteration

Adulteration is a status a product holds, not an event that happens to it. Under US drug law it covers a medicine whose strength, quality or purity differs from what it purports to possess, one containing a substance that should not be there, and one prepared or held under insanitary conditions or outside good manufacturing practice. It is distinct from misbranding, which concerns the labelling rather than the material. A vial can be adulterated while looking, dissolving and injecting exactly like a good one.

In consumer products the commonest documented pattern is the undeclared pharmaceutical: regulators have catalogued well over a thousand supplements sold as botanical or sports products that contained unlisted drug substances such as sildenafil analogues or banned stimulants. In synthetic peptides the adulterants are usually process residues rather than deliberate additions, and they are quantitatively large: trifluoroacetate counterion, residual water, truncated and deletion sequences, and endotoxin carried through from raw materials.

The consequence is that correctness of the active ingredient does not clear a product. A batch can contain the intended molecule at the intended amount and still be adulterated because a quarter of the powder mass is counterion and water, or because the room it was filled in was never qualified. Manufacturing provenance is therefore evidence in its own right.

The recurring misreading is that adulteration means contamination with something foreign. It equally covers sub-potency, super-potency, and process conditions with no chemical signature at all. The companion error is reading a purity figure as a completeness statement: chromatographic purity is a proportion of what eluted and absorbed at one wavelength, so it is silent about counterion mass, water content, endotoxin and sterility, all of which are adulteration questions.