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change column, please help!
Posted: Fri Oct 01, 2010 7:54 am
by Kasiban
Dear all,
Which is a good practice to do if i want to change my old column to the new one, and the new column is same in column name, part number.
Can I change or need to qualified the new one before? and how? Which way is correct with USP method?
please suggest,
Best regards,
Watcharee
Posted: Fri Oct 01, 2010 11:42 am
by Gerhard Kratz
You can replace your old column by a new one, but you should do a performance check for the new column to see if everything is ok with the column. Easy check is to do the same test as used by the manufacturer to do the QC. The chromatographic conditions you can see on the certificate of Analysis which should be delivered with the column. You can also use your own standard reference solution if that is noticed in your method validation to see if resolution, symmetry etc. is within the range for your compounds. Have a nice weekend.
Posted: Fri Oct 01, 2010 12:39 pm
by danko
Both new and old one (as long as in use) should be checked before utilizing it/them for adequate performance with the SST sample that was found to be relevant under the method- development and/or the validation.
If you never checked the column you want to replace, in anyways, I’m curious to know what necessitated the need for exchanging it now
Best Regards
Posted: Sat Oct 02, 2010 11:36 pm
by tom jupille
As long as you meet the system suitability criteria, the new column is suitable.