Dear Regulatory community members.
Can someone please guide me on the issue I write below -
I am working on HPLC method development for 18F-Fluorodeoxyglucose (18F-FDG) injection via precolumn derivatization to enable UV detection.
As per EU and BP guidelines the HPLC analysis method requires quantification of impurities, namely Chlorodeoxyglucose (CDG) and Fluorodeoxymannose (FDM) in the assay.
The difficulty I am facing in my current method is derivatized FDM and FDG are relatively inseparable.
My question is how often is - Does anyone know how often do people analyze FDM in FDG injection and is it really important to get baseline separation of the 2 components?
Any help is greatly appretiated.
Kind regards.
Reji
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Reji Nair
Scientist, HPLC
Trace-Ability, Inc
Culver City, CA
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