Actives in pharmaceuticals

[tilly]

Hello all. I welcome ideas on what constitutes an active ingredient in a pharmaceutical product and what is important in their determination. I think of paracetomal as a pharma product with the active ingredient being paracetomal. Can anyone help me please with the terminology for the types eg.potency, impurity of tests that are important?

[Bruce Hamilton]

Yon can find most of the relevant information at a regulatory site. The most pervasive manufacturing standards globally are now the ICH quality guidelines.

You can start will Q7... GOOD MANUFACTURING PRACTICE GUIDE FOR ACTIVE PHARMACEUTICAL INGREDIENTS, which will also reference the various quality tests that are performed... p39 has their definition of API.

http://www.ich.org/LOB/media/MEDIA433.pdf

Bruce Hamilton

[krickos]

will add a few more that can be intresting from what tests to do.

http://www.ich.org/cache/compo/276-254-1.html from here you can acess:

ICH Q3A and C. Impurities and residual solvents

ICH Q6A specification and test methods

[tilly]

Thanks guys. I've managed to have a quick look and there's a wealth of information there. Thanks for pointing me in the right direction.