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AMV Parameters for Related Substance and Assay

http://www.chromforum.org/viewtopic.php?t=21539

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AMV Parameters for Related Substance and Assay

Posted: Sun Dec 16, 2012 8:34 am
by mk_3249
Hello
I have a product Hydrochlorothiazide as per USP.
I would like to carry out Analytical Method Validation for this product.
There are two Tests in the USP.
1. Related substance and 2. Assay
Both of the tests are on HPLC and the chromatographic conditions are same for both.
Assay and related substance both are calculated from the same chromatogram.
So, Which parameters should I have to include while conducting AMV for Releted substance and also for Assay?

Thank You

Re: AMV Parameters for Related Substance and Assay

Posted: Mon Dec 17, 2012 7:30 am
by prepcolumn
Follow ICH Q2A for drug substance; Q2B for drug product. Linearity should be from LOQ to 120% of assay concentration.

Re: AMV Parameters for Related Substance and Assay

Posted: Thu Dec 20, 2012 11:36 am
by mk_3249
Follow ICH Q2A for drug substance; Q2B for drug product. Linearity should be from LOQ to 120% of assay concentration.

Thank You very much
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