Stability of stock and working of stable-isotope labelled IS [Bioanalytics]

posted by PSU – Thailand, 2018-03-18 08:18 (2255 d 21:38 ago) – Posting: # 18566
Views: 1,718

Dear all,

Could you please share the experiment/how have you been doing to study the stability of stock and working of stable-isotope labelled IS to comply with EMA guideline which specific that "you don't need to study the stability of stable-isotoped IS if you demonstrate that no isotope exchange reaction occur under the same condition as the stability of the analyte was demonstrate".

In the present, our project which use stable isotope IS will be daily observed the conversion to analyte of the ZBK (IS sample undergone extraction process) and pure solution of IS. Are there showing peak of analyte in those samples.


Complete thread:

UA Flag
 Admin contact
23,033 posts in 4,835 threads, 1,647 registered users;
39 visitors (0 registered, 39 guests [including 4 identified bots]).
Forum time: 06:56 CEST (Europe/Vienna)

Give me a fruitful error any time, full of seeds, bursting with its own corrections.
You can keep your sterile truth for yourself.    Vilfredo Pareto

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