Should we use stability indicative methods in Stability Analysis, even though official Pharmacopeia Method adopted

Quality Control
1

1). For an API - Assay by Titration method was adopted from USP 34.
2). Right now, the Assay by Titration USP 34 method is switchover to Assay by HPLC USP 41 method as per Official Pharmacopeia.
3). However USP 34 method too is in effective as per key customer requirement.
4). Should we use stability indicative methods in Stability Analysis, even though Official Pharmacopeia Method adopted.
5). Is it Article 47, Anvisa resolution RDC No. 318/2019 and Article 293, Anvisa resolution RDC No. 69/2014 requirement?
Please have your comments in GMP/Regulatory perspective to answer an inspection finding.

2

After successful of method verification of compendial method verification you are revised your moa and use hplc method.
Compared to titration method hplc is more accurate and stability indicating mrthod

3

Thank you for your feedback.

4

If you use USP as official compendia, you have to test ALL test parameters indicated in the USP article… Another method verification will be conducted when you switch from USP 34 to USP 41.