May 30, 2008 · The impurity peak is compared with the active peak in (1) diluted 1 to 100. (2) eg if the peak area of impurity in (1) was 50% of the peak area of the active in (2) the impurity level would be estimated as 0.5%. This kind of method can be found in BP and USP. No Tswett.. "/>
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Calculation of impurities in drug products

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• Investigational drug substances and drug products, depending on the risk. • Associated enantiomeric impurities, where the active ingredient is a single enantiomer..