Method Validation

Chromatography Forum: LC Archives: Method Validation
Top of pagePrevious messageNext messageBottom of pageLink to this message  By Anonymous on Monday, April 21, 2003 - 04:42 pm:

Does anyone know of any references that clearly outlines to the user what validation parameters need to be validated for the following types of method:

1)"In-house" & Compendial HPLC methods

2) Spectrophotometric methods such as UV-Vis, AA, ICP & NIR

3) TLC & Titration methods


Top of pagePrevious messageNext messageBottom of pageLink to this message  By Wanda on Thursday, April 24, 2003 - 10:54 am:

If the in-house methods are used to release product, this is a good reference: http://www.waters.com/WatersDivision/waters_website/Applications/validate/Vldt_top.asp

I believe for compendial methods, a method transfer/evaluation (described in the above article) is indicated. Or check the USP VALIDATION OF COMPENDIAL METHODS

ICH guideline Q2 deals with analytical validation: http://www.ich.org/ich5q.html


Top of pagePrevious messageNext messageBottom of pageLink to this message  By wanda on Thursday, April 24, 2003 - 10:54 am:

The USP section is 1225.


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