Pantoprazole Bioanalysis [Bioanalytics]

posted by Ohlbe – France, 2010-01-29 10:52 (5993 d 04:36 ago) – Posting: # 4657
Views: 3,359

Dear Kiran,

❝ Diethylamine is used as a

❝ stabilizer in bioanalytical method development.


(My emphasis)

❝ Is there any issue with the regulatory?


As long as you are using the same stabiliser for method validation as for the clinical phase, and demonstrate long term stability with that stabiliser, there should be no regulatory issue.

Regards
Ohlbe
—
Regards
Ohlbe

Complete thread:

UA Flag
Activity
 Admin contact
23,655 posts in 4,993 threads, 1,571 registered users;
355 visitors (0 registered, 355 guests [including 14 identified bots]).
Forum time: 16:29 CEST (Europe/Vienna)

Don’t compromise yourself.
You are all you’ve got.    Janis Joplin

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