Ezetimibe BE [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2019-09-23 13:36  – Posting: # 20642
Views: 1,154

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
[image]

The quality of responses received is directly proportional to the quality of the question asked. ☼
Science Quotes

Complete thread:

Activity
 Mix view
Bioequivalence and Bioavailability Forum |  Admin contact
19,987 posts in 4,229 threads, 1,374 registered users;
online 11 (1 registered, 10 guests [including 3 identified bots]).
Forum time (Europe/Vienna): 19:06 UTC

To know the history of science is to recognize the mortality
of any claim to universal truth.    Evelyn Fox Keller

The BIOEQUIVALENCE / BIOAVAILABILITY FORUM is hosted by
BEBAC Ing. Helmut Schütz
HTML5