Ezetimibe BE [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2019-09-23 15:36 (572 d 23:01 ago) – Posting: # 20642
Views: 3,345

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.

Dif-tor heh smusma 🖖
Helmut Schütz
[image]

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

Complete thread:

Activity
 Admin contact
21,419 posts in 4,475 threads, 1,509 registered users;
online 21 (0 registered, 21 guests [including 5 identified bots]).
Forum time: Sunday 14:37 CEST (Europe/Vienna)

Nothing fails like success because you do not learn anything from it.
The only thing we ever learn from is failure.
Success only confirms our superstitions.    Kenneth E. Boulding

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5