Finished product assay limit

Regulatory
1

A. what will be Assay limit of doxylamine succinate 25 mg tablet for australia market?
note:

  1. it is not available in as Product in BP monograph
  2. it is present in USP monograph where assay is 92-108%.

B.how to set assay limit for finished product which are not in pharmacopoeia? refer guideline

2

First u will perform the analysis of three vendor samples. The samples received along with coas. U compare vendor results and your results based on that u fix the limit.

3

As per EMA
The maximum acceptable deviation in the active substance content of the finished products shall
not exceed ± 5% at the time of manufacture. On the basis of the stability tests the
manufacturer must propose and justify maximum acceptable tolerance limits in the active
substance content of the finished product up to the end of the proposed shelf life”.
– Release limits of ± 5% are acceptable without further justification.
– Release limits wider than ± 5% would need to be justified in the part “Development
Pharmaceutics” with experimental results which are normally based on a confidence
level of 95%. The wider limits also include both, the variation of the production and of
the test procedure for the assay.
– Use of inadequate manufacturing procedures or inadequate test procedures (low
precision) will not be accepted as a justification for wider release limits.

4

In general, for the finished dosage forms Assay limit can be set as 95% - 105% in the release specification and 90% - 110% in the shelf life specification.
Assay limit shall be set based on the degradative nature of the API during the shelf life.