Well, the FDA allows 100EU per dose. But everybody tries to stay far below
this value.
My protein purification group has a 'smaller than 50EU/mg' rule for all
proteins used in pre-clinical (in vivo) experiments (mice, rats). For our
clinical material we try to stay below 10EU/mg.
Cheers,
Achim
Maggy Mitra <maggy73x at worldnet.fr> wrote in message
news:37826216.9FA43A9D at worldnet.fr...
> hi everybody,
> would you have an idea concerning the highest rate of bacterial
> endotoxines (UI/mg of protein) accepted in a iv injectable human
> vaccin ?
> thanks for your help
> MM
>
