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Dear all ,
Greetings, for a preclinical study we are working in addition of
fragments for quantitation in LCMSMS, is it acceptable by the
regulatory authorities? kindly give me a suggestion.
Thanks and Regards
R.Gopinath
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Not clear. Most quanititation is based on fragments not intact. Can
you state you goal more clearly?
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Dear R.Gopinath
This is very common in bioanalysis, make sure that validation has been
done with the same MS parameters (all fragments included in
quantitation).
regards,
Jignesh
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Do you mean deliberate addition of additional ions like Na , Ammonium
etc, so that you can get M+Na M+NH4 etc? It is one of the approach to
get good sensitivity or alternate MRM.
Regards,
Vinayak
Vinayak Nadiger
Manager , Bioanalytical Chemistry
11 Biopolis Way, Helios #08-05
Singapore 138667
E Mail: vnadiger.-a-.combinatorx.com
Website:www.combinatorx.com
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The following message was posted to: PharmPK
Addition of fragment ion for quantitation is possible as jignesh said.
But i am doubtful that such data will be acceptable by regulatory. i
am not come through such type of literature.
Before going to regulatory please check it out.
regards
laxman
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Do you mean "sum of multiple ions". If that is the case then any
regulatory authority will accept it as long as you can prove the
fragmentation patterns of all the ions used.
Dr. Mandar Mote
Sr. Manager Bio-analytical
Bio-equivalence Division
Macleods Pharmaceuticals Ltd.
Mumbai.
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Do you mean "sum of multiple ions". if that is the case then any
regulatory authority will accept it as long as you can prove the
fragmentation patterns of all the ions used.
Dr. Mandar Mote
Sr. Manager Bio-analytical
Bio-equivalence Division
Macleods Pharmaceuticals Ltd.
Mumbai.
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