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Which dosage strength is the worst case for forced deg study

http://www.chromforum.org/viewtopic.php?t=23892

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Which dosage strength is the worst case for forced deg study

Posted: Wed Dec 04, 2013 12:33 am
by darasc0211
Hi, I am validating a stability indicating HPLC method that will quantitate both assay and impurities for 2mg/ml and 0.75mg/ml liquid drug product.

Which strength (2 mg/ml or 0.75mg/ml) shall I pick for forced degradation study? Why? I believe i only need to stress the worst worst case dosage instead of both.

Thanks in advance.

Re: Which dosage strength is the worst case for forced deg s

Posted: Wed Dec 04, 2013 3:03 pm
by DR
It can really go either way, so you will have to study both strengths initially. For solid dosage forms of several strengths, you can base your work on the extreme cases (highest & lowest % API formulations) but for 2 strengths, test both (IMHO).
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