Answer / umesh patel

the forced degradation study is carried out for

1. to determine recommonded storage conditions
2. to characterize possible impurities formed under various
stress conditions
3. to validate the stability indicating nature of the
method in place
4. to support stability data package submitted to
regulatory agencies

Answer / ganesh patil

the method is stability indicating method to prove in
forced degradation study.

In forced degradation method check impurity is well
separated or do not merge the impurity & drug will be pure

match factor limit above 950

Answer / asha latha

Forced degradation is a process of exposing a compound under severe stress conditions to evaluate the capacity of compound in all the conditions and to check given method is stability indicating ( whether a degradation products are coming in our methodology)

Answer / chaitanya

It was performed in order to ensure that any degradants generated during storage and shipment will not influence the assay of the method or the peak of interest. This is the reason why we are to acquire 10 to 30% degradation and peak purity should be passed

Answer / sandeep singh

for checking the specificity of Method .

Answer / pavan

force degradation method is the quantitative method this
test is used to determine the physical and chemical
properties of the drug product& substance

the acceptance criteria of the degradents less than 20%

how to qualify the impurity?

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