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Column adjustemts allowed by USP

Posted: Fri Sep 03, 2021 10:36 pm
by ccharles
Hello

My laboratory works with HPLCs that have a maximum pressure of 44MPA so is ideal for 5 um columns.
We want to adapt methods that were developed in 3.5 um or 1.5 um.
Where in the USP can I find the allowed column adjustments ?

Re: Column adjustemts allowed by USP

Posted: Sat Sep 04, 2021 8:12 am
by Hollow
should be chapter 621 (I don't have access right now)

See also FAQ: https://www.usp.org/frequently-asked-qu ... matography


be aware to also check/optimize the extra column volume (bandspreading) of your HPLCs to keep your peaks small, otherwise the smaller particles won't show their full potential.
(e.g. use small(er) bore tubing between column and detector)

The rules for scaling/transfer of methods can be found on several locations within this forum as well as on column manufactures pages.

Also have a look at this Waters-blog article from 2015:
https://blog.waters.com/chapter-and-ver ... 21-and-you

Re: Column adjustemts allowed by USP

Posted: Sat Sep 04, 2021 1:50 pm
by Consumer Products Guy
USP <621> and FDA ORA-LAB.5.4.5

...unless you have a pointy-haired boss who learned 26 letters in kindergarten but refuses to believe official wording using those 26 letters.....ask me how I know this....