Answer / phani
No observed effect level..
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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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i am preparing for Drug inspector exam.If u have previous questions please send me.
In Stability testing if significant change occur then what is the action plan?