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Answer:
As mentioned in general chapter 5.3. Statistical analysis of results= of biological assays and tests, the =E2=80=98stated potency=E2=80=99 = (or =E2=80=98labelled potency=E2=80=99) is the nominal (target) value estim= ated by the manufacturer for a bulk material or, in the case of formulated = products, a value assigned from the knowledge of the potency of the bulk ma= terial. For compliance with the monograph, the estimated potency (i.e. pote= ncy calculated from the assay data, usually expressed in International Unit= s per millilitre) must be within a specified range of the stated potency (e= .g. 80-120 per cent). Similarly, the substance has to fulfil the potency cr= iterion in International Units per milligram of protein (specific activity)= stated in the =E2=80=98Definition=E2=80=99 section of the monograph.