Section 28 - Therapeutic Goods (Standard for Tablets, Capsules and Pills) (TGO 101) Order 2019 - Elemental impurities

28 Elemental impurities

(1) The maximum concentration limits in relation to the following elements: (a) arsenic; (b) cadmium; (c) lead; and (d) mercury; are specified in the table in Part 6 of Schedule 3. (2) The total mass of each of the elements referred to in subsection (1) in the pill must be within the permitted daily exposure limit specified for that element in: (a) chapter <2232> Elemental Contaminants in Dietary Supplements of the United States Pharmacopeia-National Formulary; or (b) the ICH Q3D Guideline.

Schedule 1Tablets, capsules and pills: assay, disintegration and uniformity

Note: See Part 2.

Column 1Item	Column 2Property	Column 3Requirements
1	assay for each active ingredient	(a) for active ingredients in registered goods90.0 to110.0%(b) for active ingredients in listed goods90.0 to 120.0%
2	disintegration	European Pharmacopoeia (2.9.1) or United States Pharmacopoeia-National Formulary, chapter <701>
3	uniformity of dosage units	European Pharmacopoeia (2.9.40) or United States Pharmacopoeia-National Formulary, chapter <905>
4	uniformity of weight (mass)	European Pharmacopoeia (2.9.5) or United States Pharmacopoeia-National Formulary, chapter <711>

Schedule 2Tablets and capsules: assay limits for content of active ingredient or component in a tablet or capsule

Note: See section 14.

Column 1Item	Column 2Active ingredient	Column 3Not less than(percent)	Column 4Not more than(percent)
1	vitamin or provitamin:(a) water soluble;(b) oil soluble;(c) betacarotene, panthenol, pantothenic acid or salt of pantothenic acid	90.090.090.0	150.0165.0175.0
2	mineral or mineral compound:(a) generally;(b) when used as a source of boron, chromium, fluorine, iodine, molybdenum or selenium	90.090.0	125.0160.0
3	enzyme	90.0	200.0
4	probiotic	not less than stated content

28Elemental impurities

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28 Elemental impurities