Bioequivalence and Bioavailability Forum

Hi Group,

This is query or concern regarding the usage of reference standard

1. what are the requirments of reference standard to be used as (analyte or internal standared) from the regulatory point of view. Any Guideline reference.

2. up to what % purity (40 or 50 or lower) of level can the regulatory can accept.

3. if any addtional compound is present in the reference standard, then whether the standard can be used or not without proving any assessement.
If yes please explain.

thanks in advance.


Regards.
Vajra