Page 1 of 1

Dissolution Test Media Discarding

Posted: Thu Feb 11, 2016 6:10 pm
by Fernando
Hi All

is there anywhere in USA or Europe a requisite or regulation in the way a pharmaceutical laboratory has to discard a Test media?
Here in South America in QC they put al liquids in special containers and I suppose they are burned by a contractor. As I have to borrow from them the I or II USP apparatus, many coworkers told about the item.
I think tihs is very odd, thinking in millions of peoiple that chroncally take some medication (including me like carvedilol and enalapril) and their/our wastes are not regulated!!!!!

Thank you

Fernando

Re: Dissolution Test Media Discarding

Posted: Thu Feb 11, 2016 8:58 pm
by DR
Welcome to the world of regulatory rule from a vacuum.

We frequently have to dispose of our disso media in a similar way because it has a low pH (but it's 0.1N or 0.01N HCl, our tap water pH >8, but NO, we are not allowed to run tap water and slowly pour the dissolution media down the sink because the pH is too low).

If your actives will foul the environment or cause cancer etc., some regulation is understandable, but we're in a "zero tolerance" world these days and there is zero tolerance for common sense.