Dissolution Test vs Assay
Posted: Tue Feb 23, 2016 1:48 pm
Hi All
This is the third post about new developments in the pharmaceutical industry I don't understand.
A colleage in QC informs me that if they obtain a vessel (Dissolution test) with for example 82 % liberated with Q= 75 % then the minimun is 80 % did not complain if the assay is 99 %. Wow!
Is this reasonable, is there in USP or FDA any mention at all?
Best regards
Fernando
Disclaimer: These are my doubts and opinions, not of my employer.
This is the third post about new developments in the pharmaceutical industry I don't understand.
A colleage in QC informs me that if they obtain a vessel (Dissolution test) with for example 82 % liberated with Q= 75 % then the minimun is 80 % did not complain if the assay is 99 %. Wow!
Is this reasonable, is there in USP or FDA any mention at all?
Best regards
Fernando
Disclaimer: These are my doubts and opinions, not of my employer.