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Dear All
I was working on Eszopiclone, although the method was good (cc and qc
passes). i had problems in incurred sample analysis. During incurred
sample analysis around 20 % of concentration shows substantial
variation, mostly the % variation was within 10%, but some
concentrations had 30-60% difference. We initially thought its
proccesing problem but that's ruled out. We have LCMS method for
eszopiclone, the peaks are sharp and we get only one peak at RT, also
the anticoagulant in subject and cc/qc is K3EDTA.There has not been
any batch failures.
My query is what can be reason for incurred sample variation? How do
we solve this issue? Eszopiclone is S+ enantiomer of zopiclone can
that be the reason?
Regards
B.S
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Dear B.S,
Since you ruled out the bioanalytical related aspects, Yes It could be
due to conversion in to other form of enantiomer. If you see the
literature 10% of this drug is eliminated in its racemic mixture form,
through urine.
Other chance of variation could be Inter subject variability.
Hope it helps you
Regards
RajaReddy
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Dear B.S; Hi All,
Is your method capable to differentiating among enantiomers and is it
validated?
The most prabable causes of variation could be intra and /or Inter
subject variability
Hope it helps you.
Regards
KIM Al-khamis,Ph.D.
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