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.