Bioequivalence and Bioavailability Forum

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.


Regards,
PSU