Chromatography Forum

Hi Guys,

I am doing Assay validation for byproduct of Raw material in my drug product. it is about 60% of active. Do i need to perform stress study of byproduct in my method validation? We are doing stress study af actives in drug product by different method. So my question is ICH or FDA asking for stress study of byproduct in method validation???

If you are stress testing the drug product, then you are stress testing whatever is in there (presumably, 60% byproduct and 40% API). Since the purpose of stress testing is to predict what you will find in stability testing, this is appropriate.

In other words, no, I see no point in stress testing the byproduct separately