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Why forced degradation studies are performed in hplc method
validation?
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Answer / sri krishna
1. based on the stability data packing material & storage
conditions can be designed.
2. forced degradation study is performed to know whether our
method is suitable to detect the maximum impurities formed
during the study.
| Is This Answer Correct ? | 53 Yes | 2 No |
is nothing but the study to assess specificity of the
analytical method by forcibly degrading the analyte
(Eg:exposure to temperauremore than accelerated conditions,
higher humidity and light, wide range of pH and oxidation)
Methodology :
Analyte should be exposed to the above said conditions and
analyse as per the testing methods.
Observatoin :
by applying the above stress conditions, new impurities and
degradants will be formed. the degradants should be well
seperated from the main analyte.
Scope and conculsion :
to prove the testing methods are good that can seperate all
the impurities from the analyte
(i.e stabilily indicating analytical methods) and
degradation path way can be established.
Note:we will come to know the impurities formation during
the stability storage for a period of time. if it is due to
storage, then it should be evaluated.
Best regards,
Bujji Kanchi.
| Is This Answer Correct ? | 30 Yes | 2 No |
Answer / sheetal
to develope a stability indicating method which in turn
help us to find likely degradants of the product
| Is This Answer Correct ? | 13 Yes | 5 No |
Answer / maulik
force degradation is the part of the one of the validation
parameter specificity, its indicate that your method is
specify no other peak is merged in it
| Is This Answer Correct ? | 11 Yes | 10 No |
Answer / deven bhatt
If you are doing forced degradation,it is nothing but fast forwording your development checking capability of your analytical method weather it is capable to resolve or not during stability study or weather some fine tuning requires for your analytical method
| Is This Answer Correct ? | 1 Yes | 1 No |
Answer / sridhara h s
Evaluate stability of sample solution by repeatability in
one day (short time) or over days (long time).
Solution of sample must be stable for purpose of routine
analysis under normal laboratory conditions. Stability of
sample is important when a sample is under different
storage conditions.
Stability of sample needs special attention for gradient
analysis, requiring even 100 min or so. Mobile phase should
be selected to avoid stability problem.
| Is This Answer Correct ? | 5 Yes | 24 No |
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