Chromatography Forum: LC Message Board: Cross-validation EP and USP


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By Margret on Tuesday, July 6, 2004 - 09:15 am:

Hi
If I already have a validated method in human plasma do I have to perform a full validation when I change the matrix to rat plasma. Can I rely on the stability data from human plasma?

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By Petra on Monday, April 7, 2003 - 03:44 am:

Hi,

Please, Could some one inform me about how to cross-validate methods from EP against methods from USP?

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By Anonymous on Tuesday, April 8, 2003 - 09:09 am:

Hi Petra,
Well, Why do you want to cross validate method from EP agianst methods from USP?
If method is official in any pharmacopiea no need to validate your method except specificity and recovery test.

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By Wanda on Thursday, April 17, 2003 - 07:32 am:

The point to doing a cross validation to to show equivalency. Additionally, if there is no LC method in the USP, you need to see if your in-house method compares. Essentially, you do an equivalency similiar to interlaboratory. I always do spike recoveries and LOD/LOQ just to see the applicability of the methods. USP used to accept 3 lots, but I've heard rumors of 5. I think EP will accept 3.
If you need more info, post your contact info, and I will help you offline. Needless to say, I do this all the time.

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By Anonymous on Wednesday, July 9, 2003 - 03:40 pm:

Don`t forget - performing equivalency is only part of the story. You need a national or supranational authority to approve the use of an alternative method to the PhEur or USP. In other words, your filing (NDA/MA etc) should reflect what you actually do. Also, in case of dispute, the official method rules.

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By komali on Thursday, January 8, 2004 - 04:43 am:

Hi

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By sonal on Thursday, April 15, 2004 - 10:16 pm:

Once we get a peak its area is reported along with it. How do we then determine the amount of the drug represented by that area?

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By tom jupille on Sunday, April 18, 2004 - 10:19 pm:

From a calibration plot relating peak area to mass injected.

This is a rather basic question. You might want to check out some of the free on-line courses and reference material available:
http://www.lcresources.com/resources/reslinks.html

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By sonal on Wednesday, April 21, 2004 - 07:46 am:

Thankyou Tom.