Interested to Buy Any Domain ? << Click Here >> for more details...
Why forced degradation studies are performed in hplc method
validation?
- 6 Answers
- 25988 Views
- Apex, I also Faced
- E-Mail Answers
Answers were Sorted based on User's Feedback
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 |
what is the difference between loss on drying in ordinary oven technique and vacuum oven technique
4 Answers Divis Laboratories, Ranbaxy,
Why we select scan range from higer wavelength to lower wavelength in uv visible spectroscopy and ftir spectroscopy ? .
When you get Moisture content by KF higher than by LOD, what does this indicate?
Why do we use KMnO4 in the test of control of obsorbance ? and why do we take specific quantity i.e 57-63mg?
0 Answers Reddy Labs, Vimta Labs,
acceptance criteria for lod & loq by standard deviation of response and slope??
How do you show that equal quanitities of two isomers provide the same response using a PDA
Why do we use 0.005M h2so4 solution for preparation of k2cr2o7 solution for UV calibration?
3 Answers Jubilant, Medreich, Mylan,
pda detector mechanism?
1 Answers DKR, Teva Pharmaceuticals,
Ratio of Water and Acetonitrile(diluent) is not recommended to use in cleaning method validation,why?
0 Answers Aurobindo, Reddy Labs,
why xterra column require to use at higher ph?
What is difference between the working standard and reference standard?
Why are EDTA used to etimation of Ca,Mg etc, in Water analysis?
Organic Chemistry 
