Hi everyone,
It is safe to assume that Mesochem make batches of several Kg at at time and no doubt they have their own quality control procedures just like any other large industrial manufacturer. So once they know that they are producing pure API, there is no reason to suppose they will suddenly start producing junk.
Since the fixHepC team test every batch they receive, which is probably just a small fraction of each Mesochem batch, it is extremely unlikely that anything bought from Mesochem will be less than top quality.
The only doubt could be if someone buys what they believe to be Mesochem product through an unknown agency.
Still, this is not to say that fixHepC should stop testing. This extra level of confidence is invaluable for anyone sourcing through fixHepC, and also for defusing the Big Pharma myth that there could be a risk associated with "generic" APIs.
If a molecule from Mesochem, or Beacon, or Incepta, or anywhere else, is provably the same molecule as a "brand-name" molecule, then it is the same API as the brand-name API with precisely the same pharmaceutical properties.
Water is water is H20, or whatever else you want to call it.
Same thing for sofosbuvir if you can prove it using mass spectroscopy and NMR.
Technical note for chemists:
In fact, it is not absolutely as clear-cut is this if a molecule contains chiral centres (which is the case for sofosbuvir) because it is possible for a molecule with the same chemical formula to have different stereo-isomers, and sometimes only one of the stereo-isomers is biologically active. But even stereo-isomers can normally be differentiated by NMR (one of Jame's tests:
fixhepc.com/blog/item/16-testing-provisions-patient-safety.html).
According to a detailed report by the European Medicines agency
www.ema.europa.eu/docs/en_GB/document_li...2798/WC500160600.pdf
Sofosbuvir has 6 stereogenic centres, which "are well controlled by the synthetic process and the specifications of the raw materials." (page 14) "... and the manufacturing process consistently produces Sofosbuvir as the most thermodynamically stable polymorphic form... Other polymorphic forms are excluded by the manufacturing process and their absence is confirmed by DSC."
(DSC = differential scanning calorimetry).
End of technical note.
So if James has a good reference NMR spectrum (and there is every reason to believe that he does), then the generic APIs sourced on our behalf by fixHepC can safely be assumed to be nothing less than the genuine product...