Impurites- Stability testing
Posted: Thu Mar 08, 2012 5:30 am
by samkarthik_1983
In Stability studies for Assay, the significant change is 5% from its initial value. Is there any specifications/limits/criteria for Related substances - Known and Unknown impurities?
Re: Impurites- Stability testing
Posted: Thu Mar 08, 2012 8:46 pm
by LC_labrat
The stability guidance states for a drug product a significant change is any degradation product's exceeding its acceptance criterion. I'm not sure if you are asking about drug substance or drug product.