What is a ‘stated potency’?

Answer:

As mentioned in general chapter 5.3 Statistical analysis of results of biological assays and tests, the stated potency or labelled potency is the nominal (target) value estimated by the manufacturer for a bulk material or, in the case of formulated product, a value assigned from the knowledge of the potency of the bulk material. For compliance with the monograph, the estimated potency, i.e. potency calculated from the assay data (usually expressed in International Units per millilitre) must be within a specified range of the stated potency (e.g. 80-120 per cent). Simultaneously, the substance has to fulfil the criterion for the potency in International Units per milligram of protein (specific activity) stated in the Definition section of the monograph.