When should I apply general chapter 2.9.40. Uniformity of dosage units?

Answer:

The following text is taken from the Q&A page for the European Medicines Agency’s Quality Working Party:

From a pharmaceutical quality perspective, the approach taken in the harmonised general chapter Uniformity of dosage units (2.9.40) is considered equivalent to the requirements in general chapters 2.9.5 and 2.9.6. It is left to the user to decide which approach to take. Either 2.9.40, or 2.9.5 and 2.9.6 may be applied to demonstrate compliance with the Ph. Eur. with regard to the uniformity of dosage units.

As stated in the respective dosage form monograph, where justified and authorised, the preparation complies with the test for uniformity of content or mass (2.9.6/2.9.5).