Ezetimibe BE [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2019-09-23 15:36  – Posting: # 20642
Views: 1,683

Hi Mutasim,

» Does it mean measuring each one alone? or the total as in FDA guidance?

The glucuronide is much more hydrophilic than the parent. No way to extract both together in sample preparation (not to speak about having them in the same chromatographic run – unless you apply an aggressive gradient elution). Hence, use glucuronidase. This gives you the total.

» CI be for each one alone or both unconjugated and total or only total?

Total.

Cheers,
Helmut Schütz
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