14Assay of each active ingredient

14 Assay of each active ingredient

(1) Subject to this section, the assay limits for the stated content of each active ingredient of a tablet or a capsule are specified in item 1 of the table in Schedule 1. (2) If the tablet or capsule contains an active ingredient that is mentioned in an item in the table in Schedule 2, then the assay limits for that active ingredient are specified in columns 3 and 4 of that item. (3) If: (a) a tablet or a capsule contains an active ingredient that is an antibiotic; and (b) a microbiological method is used in relation to the assay of that active ingredient; then: (c) the upper fiducial limit of error of the estimated content of active ingredient in each tablet or capsule (P = 0.95) must not be less than 97.0 per cent of the stated content of active ingredient; and (d) the lower fiducial limit of error of the estimated content of active ingredient in each tablet or capsule (P = 0.95) must not be more than 115.0 per cent of the stated content of active ingredient. (4) For the purposes of this section, the assay must be calculated using a pooled sample of not fewer than 20 tablets or capsules. (5) If: (a) the tablet or capsule contains an active ingredient that comprises two or more components that are each quantified on the label of the medicine; and (b) the proportions of these components vary independently of each other; then the estimated average content of each component in a pooled sample of not fewer than 20 tablets or capsules must be not less than 90.0 per cent of the stated content of each component. (6) If the tablet or capsule is a homoeopathic preparation then there are no assay requirements specified in relation to that tablet or capsule. (7) If: (a) the tablet or capsule contains an active ingredient that is a multi-component ingredient; and (b) no quantitative claim is made on the label of the goods for any component; then there are no assay requirements specified in relation to that active ingredient.