Bioequivalence and Bioavailability Forum

Hi all,

❝ So world has gone crazy, anyways.

Agreed. I wonder what the use of the products from EDQM is at all? If they don't come with a CoA they aren't useful for anything quantitative in a regulated manner such as medicines. Perhaps they'd be useful for qualitative purposes - identification and such. You do an IR spectrum or whatever on it and hope it contains more than trace amounts of the stuff you are interested in - I mean that the spectrum you get is not too influenced by whatever is also in the sample in amounts you have no clue about and of which EDQM is silent. While I do not like to resort to any degree of harsh words, yes, I must say it does seem to be a kind of clusterf#ck this one.

Will we in the future be expressing our concentrations as 30P ng/mL where P is an unknown purity coefficient?

Come on, EDQM, you can do better than that. You value, first and foremost, public health, scientific competence, integrity, objectivity and respect for the fundamental principles of the Council of Europe, so perhaps you can offer to use a tiny bit of that competence to give your costumers a CoA?

At USP they must be having a great laugh.

Now if you'll excuse me I'll go back to my living room and tell my tv some deep secrets.