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Why forced Digradition Study is done
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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
| Is This Answer Correct ? | 36 Yes | 1 No |
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
| Is This Answer Correct ? | 9 Yes | 2 No |
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)
| Is This Answer Correct ? | 2 Yes | 0 No |
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
| Is This Answer Correct ? | 2 Yes | 0 No |
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