Simultaneous analytical method [Bioanalytics]

posted by Obinoscopy  – USA, 2018-09-12 09:35 (1437 d 01:06 ago) – Posting: # 19268
Views: 3,386

Dear Giang

» It's a bioanalytical method for determination of 5 anti-TB drugs by LC-MS/MS. One just raise the question: Can we apply this method for just 2/3 APIs? Is there any infuence or differences? Do we need to revalidate the method, partial or full, and which criteria? Many thanks!

I don't think you need to revalidate as long as the 2/3 APIs were among the 5 APIs that were validated.

But if I may ask, did you include all the CCs and QCs for the entire 5 APIs in the same analytical run?

Scopy

Complete thread:

UA Flag
Activity
 Admin contact
22,305 posts in 4,668 threads, 1,587 registered users;
online 9 (0 registered, 9 guests [including 3 identified bots]).
Forum time: Friday 10:42 CEST (Europe/Vienna)

Doctors are men who prescribe medicines of which they know little,
to cure diseases of which they know less,
in human beings of whom they know nothing.    Voltaire

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