Batch consistency is in part another way of saying what I posted...

Batch consistency is in part another way of saying what I posted about above. Bene is capable of producing consistently the particular mix of pentosan sulfate with minor structural variations that consistently produce the same trace on whatever tests are part of the product description with FDA, be it Gel Permeation Chromatography (GPC), FTIR, mass spectroscopy, NMR, etc.

Once you get your head around the fact that PPS is not a single molecule, but a mixture of close structural variants, and that testing the material is more a fingerprinting exercise than simply verifying the structure of a simple molecule, like aspirin, it should help explain the difficulties of copying.

Another aspect of batch consistency is not just what’s in the product, but what is excluded. So the batch analyses are probably also characterized but components with “must not exceed” levels. These would be things like toxic byproducts from the synthesis steps, but also likely common natural materials from the beech bark extraction that are difficult to remove, or allergenic, etc.

I emphasize that I do not know what Bene’s process looks like. But it would go something like solvent extraction of the bark, purification processes to pull out the soluble polysaccharides, fractionation by chromatography to zero in on the pentosan in the right molecular weight range, cleanup of that fraction, sulfonation to add the sulfate groups, perhaps further fractionation to get the fully sulfonated component. It would be something along those lines, and that all produces a product mix with a particular fingerprint.