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System suitability

Posted: Fri Feb 18, 2005 11:21 am
by Basil
Which criteria do you use to define the system suitability test for intermediates in a synthetic route for an API ?.....

Should be the same as the product ?..

Thanks

Posted: Sat Feb 19, 2005 3:42 pm
by tom jupille
Same kind of specs (retention windows for compounds of interest, resolution between critical pairs, plus the usual repeatability, pressure, etc.) but appropriate to the compound for which you are analyzing.

Posted: Thu Feb 24, 2005 12:25 am
by JA
Tom,
do you record pressure only for potential troubleshooting? Also what in particular would you note when using a gradient - the initial pressure prior to an injection, maximum over an injection?

Posted: Fri Feb 25, 2005 1:03 am
by tom jupille
Yes, primarily for troubleshooting. Probably the initial pressure would be the easiest/most relevant as an indicator of column problems.