how to validate the column, when it is validated.
Can u plz elaborate the Q.
How to carry out the column qualification?and what the qualification protocol contains?Could you have the information about this ? if have ,please reply or set a email to me (andy830701@126.com).Thanks a lot.
Hi,
Column validation is done when you recieve a new column at your end.
It can be done based on the column manufacturer performance report or you an have your own in house methods.
For C18 & c8 columns you can go for substances like acenapthane,uracil ,naphtalene dissloved in acetonitrile 90 %use the same solvent as mobile phase at wavelength 254 nm flow 1 ml/min .
Inject the 6 replicates see the response , for area , tailling factor (NMT 1.5) ,resolution,& theoritical plates the RSd should NMT 2.0 % include same in your 1 page protocol.
after certain usage to check your performance of column yu can refer to your any product analysis ,if the system suitabillity for the same meets the criteria ,that meen your column is good .
Dear Koleti,
Every manufacturer ofthe column, provides CoA, detailing worthful of information such as Silica lot used for Bonding, C18 lot used and etc.Column validation is a unneccesaty burden/ load. Kindly note every HPLC/GC is designed to meet customiized set of standards. If the column, what U have procurred, meets your system suitability parameters as per availbale methodology, then there is no requirement for performing validation study. Only you need to monitor performance of column after time to time.As far as our experience , we have not seen or faced any tough situations with Regulatory auditors, who is keen on COLUMN VALIDATION REPORTS.What they require is only the CoA and Usage log card of the particular column
Yes i fully aggree with Mr. T.Arun.
regards,
y.nagesh
Yes i agree with the Tarun comments
Rambabu
Kamud Drugs