By Anonymous on Tuesday, June 11, 2002 - 11:35 pm:
Do we have to validate the USP Method II related with Heavy methals if we want to present a document to the FDA ?. Does anyone has a clue how to do it or where can I find this information?
Thanks
By Anonymous on Wednesday, June 12, 2002 - 05:24 am:
Methods in the USP are considered to be validated. You may consider doing some kind of suitability validation to show that it works for your compound. If I remember, method II has a control in it.
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