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How did you conclude that when stressing a compond, all
degradation products have eluted in chromatogram?
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Answer / s.elumalai
The main aim of degradation study is to separate know
impurities in the case when we do not have know impurities
or to generate impurities from the sample by degradation.
Obviously one should know the process related impurities or
the degradation pathways. From peak purity by PDA or Mass
analysis one can conclude the purity of each peak eluting,
beyond that mass balance also account for peaks.If mass is
not balanced then one can conclude that some of the compound
are not eluted or may not have UV absorption.
| Is This Answer Correct ? | 7 Yes | 0 No |
Answer / hemant
Method should be stability indicating & should give mass
balance
| Is This Answer Correct ? | 3 Yes | 0 No |
Answer / naga
in specificity,by mass balance study we can confirm all
impurities are eluted in specified run time.
Mass balance = Assay of main peak+total net degradation
from this we can conclude what r the degradants r there all
r eluted the desired runtime.
Mass balance limit NLT 95%
| Is This Answer Correct ? | 3 Yes | 0 No |
Answer / m.sivalingeswararao
By calculating mass balance.It should be equal to or nearer to 100%.%Decrease in mass balance indicates the % of Impurities not detected or not eluted. In some cases Degraded Impurities may not be eluted with in specified run time,in such cases they may elute in the next run ,hence it should be advisable to increase the run time.
| Is This Answer Correct ? | 1 Yes | 0 No |
Answer / pramod bhosale
In a dregradation process there should no effect of main
drug when degradant peak elutes in degradation.
| Is This Answer Correct ? | 0 Yes | 0 No |
Answer / babu.s
when we stressing a compound,all degradation products are may eluted or may not be eluted in chromatogrm.Due to stressing the form of drug my be changed to some extent. in that cases, the changed form is identified by pXRD/dsc.so better go TO UV/IR FOR BETTER RESULT.
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Answer / divya
degrading produts are considered as impurities and small in
size so they elute fast.
| Is This Answer Correct ? | 1 Yes | 13 No |
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