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EP HPLC method validation..what parameters do i need?

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EP HPLC method validation..what parameters do i need?

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seamoro
Just wondering if my Method is in the EP ...what parameters do i need to validate for?....System Suit...Specficity..Method Precision...Stability in Solution??? Im validating for Related Substances and Assay.

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Alex Buske
Ask your Q person.
Pharmacopoeial methods can be taken as validated. However, they often don't work well and need to be adjusted. So validation will be necessary again.

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krickos
Hi Seamoro

As Alex indicated, one typically have to do a "case by case" approach.

The links below from previous discussions may help:

viewtopic.php?p=49713&highlight=#49713

viewtopic.php?p=47849&highlight=#47849
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