Is there any specific reason why we should look for 10-30% Degradation of active ingredient while conducting a forced degradation study during analytical method validation?
Mohamed, I only can refer you to the URL https://www.google.co.il/search?q=10-30%25+Degradation+of+active+ingredient&gws_rd=cr,ssl&ei=vWXTVKrdJ8rbapy3goAG where you should have a look to slide 53 where it is stated that one allows for 10-30% degradation of active ingredient.
More than this is not in my bag of basic knowledge. Cordially. Jan
One reason which i can share is since the shelf life of Active Pharmaceutical Ingredients is 90% as a result 10-20% degradation is considered practical to study Forced Degradation study and identify the degradation products.
Degradation more than that will not be considered practical since the formulation will not get subjected to such a harsh condition during its storage or transportation.
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