Dear Members,
We are going to submit an ANDA of XXXX molecule for which TE code is rated as "AA". Below are some conditions that currently we are facing-
- RS (Reference Standard-Higher strength) was failing to meet the USP dissolution limit of NLT 75% in 60 min at single point dissolution.
- The product was developed in such a way that it shows the same dissolution behavior as the reference product.
As we need to claim biowaiver of the lower strength drug with the higher strength, we had to control the release profile of higher strength for which Q value of higher strength is not meeting as per USP specification.
Considering the above can anyone have any idea how we can fix the dissolution limit for the higher strength drug?
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Thanks & Best regards
Rajib Kumar Baishnab
Manager, Regulatory Affairs
The ACME Laboratories Ltd.
Dhamrai, Dhaka-1350, Bangladesh
Ph: +8801990-407587
Email:
rbaishnab.qo@acmeglobal.com------------------------------