[RegAffairs]Re: Analytical method for unspecified & totalimpurities

["Malcolm Ross" <generapharm@gmail.com>]

It is necessary but the reasons differ depending on the jurisdiction 
that you are operating in. For example, outside of the US, the USP 
monograph has little relevance. Inside the US, you still need 
permission to sell and that comes from the FDA who will require that 
your product also complies with requirements for stability etc as 
described in the various ICH guidances. So the USP monograph becomes 
a relatively minor issue.

Malcolm Ross
Generapharm-TC
Basel-CH