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How to validate a modified USP testing method

 
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Nov6-11, 12:19 PM   #1
 

How to validate a modified USP testing method


When you modify an analytical method outlined in the USP for a specific drug, how do you go about validating it? Is there a rule in the USP stating that the results obtained with the altered method have to come within a certain range of the results obtained with the original method or something?
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