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Specifi optical rotation relation
Posted: Wed Dec 07, 2011 10:08 am
by ananthjkumar
Relationship between SOR & GC result.
Is there any correlation
Re: Specifi optical rotation relation
Posted: Thu Dec 08, 2011 3:59 pm
by krickos
Hi
Yes, in theory there is a relationsship between SOR and for instance a LC/GC chiral analysis.
Pratically as SOR is not that accurate and often not particular sensitive, you will not see the relationship unless on a larger scale. Observing a relationship for a substance with a SOR of for example 10-20° verus +/- 0,1% change in LC/GC results are in my experiance not possible.
Consequently at least for pharmaceutical drugs, it is preferble to use optical rotation (OR not SOR) to verify that racemates are racemates and chiral LC/GC/CE for identity of "pure" enantiomers and limit of the wrong enantiomer.
Re: Specifi optical rotation relation
Posted: Fri Dec 09, 2011 11:06 am
by achkata
HI
krickos,
if chiral LC/GC is more accurate, why do you prefer to test drug racemates with OR?
greetings,
Angelo
Re: Specifi optical rotation relation
Posted: Fri Dec 09, 2011 11:31 am
by ananthjkumar
but my clarification is whether we can able to get in GC analysis
Re: Specifi optical rotation relation
Posted: Fri Dec 09, 2011 1:46 pm
by krickos
HI
krickos,
if chiral LC/GC is more accurate, why do you prefer to test drug racemates with OR?
greetings,
Angelo
Hi Angelo.
Lets say there is a racemate drug substance avaible on the market as well as an enantiomer pure form. then it is sufficient for identity purposes to use OR to confirm identity for the racemate ie OR is +/- 0,10°.
Generally it is not value/quality/safety adding to add a chromatographic chiral analysis on top on OR for racemates, "simpler/cheaper" techniques can do a good enough work.
Re: Specifi optical rotation relation
Posted: Fri Dec 09, 2011 3:44 pm
by krickos
but my clarification is whether we can able to get in GC analysis
Ahh you mean like replacing SOR with chiral GC analysis?
Yes that it is possible regulatory wise, we also convinced USP/Ph Eur in a monograph to remove SOR as standard requirement as there was a chiral chromatographic requirement as well.
Re: Specifi optical rotation relation
Posted: Mon Dec 12, 2011 12:25 pm
by achkata
Hi, Krickos,
I agreed
thanks