Therapeutic Goods (Standard for Tablets, Capsules and Pills) (TGO 101) Order 2019
27Assay of each active ingredient
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27 Assay of each active ingredient
(1) Subject to subsection (2), the assay limits for each active ingredient of a pill are those specified in item 1 of the table in Schedule 1. (2) If: (a) a pill contains an active ingredient that is a multi-component ingredient; and (b) no quantitative claim is made on the label of the pill for any individual component; then there are no assay requirements specified in relation to that active ingredient. (3) For the purposes of this section, the assay must be calculated using a pooled sample of not fewer than 20 pills.