@ZachShurtleff This is an area where the federal government should take over regulation and oversight
Having 50 know-nothing SBoP regulators in your business (literally and figuratively) each with their own asinine state regs is a disaster
It’s worse than the EU
@rorynotsorry Unsurprising.
You also hit me as the type that wouldn’t participate in the 🦆 thing. Although maybe with your fam…
Have you tried doing the same with side by sides?
I ordered 100 RT10s from China.
Going to run a full set of testing on them, including USP <905> Uniformity of Dosage Units (10 vial assay for statistics).
I just want to have a single COA with every test we offer on it.
Will be something like 78 vials vials left over after
There is a push to move lyophilization to the US
It’s all fun and games until the State Board of Pharmacy and local police show up and seize all of your infrastructure
I think they are more likely to go after filling lines in their state than the random online resellers
@rorynotsorry Ordered from @Luna7sale
We’ll see 🤷🏻♂️
I’m just pumped to see a single COA with content uniformity, heavy metals, endotoxin, sterility, etc
@KevinPomaski@rorynotsorry And we could even obfuscate the weight by adding a random amount of trehalose to each vial, so the labs couldn’t get close by weight alone
@KevinPomaski@rorynotsorry This approach doesn’t account for issues with fill
Need to have someone hand-fill the vials with a semi-micro balance and record the weight loaded into each
Then send them out for testing, keeping the labs blind to actual content
We could create the vials…
@NDMFlyHigh@padreresearch You forget that the entire market exists because of inaccessibility, caused by gatekeeping MDs or Lilly charging $1400/mo
They lower the price to $50 or $100 per month and watch the market evaporate