3.2.S.4.5 - Justification of Specification

A justification for the API specification should be provided.

The justification of the API specification should be based, as applicable, on:

1. Non-clinical and clinical studies;
2. Impurity qualification studies;
3. Batch results;
4. Monographs of officially recognized compendia by ANVISA, according to RDC 37/2009;
5. In-process controls, control of intermediates and critical steps;
6. Carry-over studies for impurities; and
7. ICH guidelines listed on art. 11 of RDC 359/2020.