[RegAffairs]Re: stability indicating method

[Malcolm Ross <generapharm@gmail.com>]

Analytical methods are devised for different purposes. If you intend 
to label your product USP then you must make sure that it complies 
with the USP monograph. The USP monograph is not stability 
indicating...it can't be because, for a finished dosage, it does not 
attempt to cover all the possibilities of formulation changes etc.

So the answer to your question is another question..."what is the 
purpose of the assay"


Malcolm Ross
Generapharm-Training and Consultancy
Basel-CH