Can any body suggest me , how to approve a column by qualifying as per any standard procedure. Can we have any single method for all reverse phase columns. D any abody qualifying the new column after teh reciept.
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By Anonymous on Saturday, December 14, 2002 - 06:23 am:
Answer 1. Column can be approve by performing the test exactly given in test certificate by the manufacturer and analysing our required product on column and observing the system suitabilty criteria is acheviable.
Answer 2. It is very difficult to have single method for approval of all reverse phase column because column aprroval excersies have number of parameter which changes your acceptance criteria for example we select test mix like toulene and benzene mixture for 5micron particale size than your acceptance criteria for 10micron will change.
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By Anonymous on Wednesday, December 18, 2002 - 06:27 am:
My poor 2 cents worth,
I would qualify a column by the applications it will be used for. Validated methods usually include some sort of performance criteris, i.e. tailing, resoluton, etc. The best waqy to qualify a column ios to run the analysis it will be used for and make sure that it meets the method criteria for performance. It could be fairly simple such as a mix of the two most closely eluting components, make sure there is adequate resolution, or the worst tailing compound, make sure the tailing factor is acceptable.
Happy Holidays,
Mark