Comment · Fri, May 1, 2020 · Natrium Health & Nootropics Depot
FDA's Letter to Tailor Made Compounding Pharmacy
What they were answering
charlesbukowksi · 8 points
FWIW, having tested peptides from Chinese vendors, I have concluded:
* they do not use sterile equipment, nothing we tested was sterile
* aliquots in the same lot often contain wildly varying amounts of the active peptide
* aliquots often contain less than half of the expected active peptide
* they frequently use much more counterion (TFA, acetate, HCl) than is actually needed e.g. a ratio of 3:1 counterion to peptide when only 1:1 is needed
* due to the nature of HPLC/UPLC, we cannot be 100% sure of assay results because the larger the molecule is, the harder it is to detect a permutation in molecular structure
* they are not using the highest quality reagents (≥98% L amino acids) and therefore there is a lot of chirally impure peptide
u/MisterYouAreSoDumb · Natrium Health & Nootropics Depot
Most Chinese companies just don't give a shit about quality. They just don't. No matter how much you try to beat it into their heads, it never connects. They respond to money. They produce quality things if, and only if, you have financial power over them. Even then, they are doing it because that is what you require. If you don't make it VERY clear exactly what you want, and exactly what you will not accept, they will just go the path of least resistance. They know almost nobody is properly testing any of this shit, and that almost nobody will catch it if they cut a few corners. They know that because time has proven them right. When they do produce a good quality end result that meets stringent specs, most of the time there is no real emotion there. They don't get excited about producing the best thing they can. It's very rigid and robotic. They met your specs, which they think are ridiculous. However, they met them because they know you will hold them accountable if they didn't. That's it.
I am not saying the US suppliers are better, either. I still have to hold them accountable, too. However, at least the ones in the US can resonate with the passion to be the best you can be. But it is a constant struggle with people that are either incompetent, or are willfully trying to deceive everyone. You know how many US labs I have found, and PROVEN, to be faking analytical testing results? Dude, it's bad. It's a web of incompetence and lies from sea to shining sea. It's way way worse than anyone here knows. I won't go so far as to say the entire system is built on lies, incompetence, and deceit. However, some days it feels like it. There are some good guys out there peppered into the sea of bad ones. So it is not all bad. However, the system needs changing.