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What are closely monitor parameters in stability study?
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Answer / manoj tiwari
At the time of ANDA submission stability protocol submit and in protocol we include test parameters which shall be performed at withdrawn point.
Generally critical test parameters like Appearance,Water,one Id test, Dissolution,Assay and RS test performed.
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If we get 100% assay of an Initial sample ,and the stability studies of the same sample got 90% dissolution result, and when the same stability sample was analyzed for RS studies no impurities was found . Where the 10% Active substance were gone during dissolution analysis.Please help me in getting the conclusion.
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