Ezetimibe BE [Regulatives / Guidelines]
Hi Mutasim,
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.
Total.
❝ 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.
—
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Helmut Schütz
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Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Complete thread:
- Ezetimibe BE Mutasim 2019-09-23 14:40 [Regulatives / Guidelines]
- Ezetimibe BEHelmut 2019-09-23 15:36
- Confusing guidance Helmut 2019-09-25 11:52
- Confusing guidance nobody 2019-09-25 13:36
- Ezetimibe final guidance Helmut 2019-09-28 12:11
- Ezetimibe final guidance Ohlbe 2019-09-30 11:03
- Ezetimibe final guidance Helmut 2019-09-30 15:33
- Ezetimibe final guidance Ohlbe 2019-09-30 11:03
- Ezetimibe BE ElMaestro 2019-09-30 13:12
- Ezetimibe BE Helmut 2019-09-30 15:26