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System suitability

Discussions about HPLC, CE, TLC, SFC, and other "liquid phase" separation techniques.

4 posts Page 1 of 1
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

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.
-- Tom Jupille
LC Resources / Separation Science Associates
tjupille@lcresources.com
+ 1 (925) 297-5374

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?

Yes, primarily for troubleshooting. Probably the initial pressure would be the easiest/most relevant as an indicator of column problems.
-- Tom Jupille
LC Resources / Separation Science Associates
tjupille@lcresources.com
+ 1 (925) 297-5374
4 posts Page 1 of 1

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