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Therapeutic Goods (Standard for Tablets, Capsules and Pills) (TGO 101) Order 2019
16Elemental impurities and residual solvents
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16 Elemental impurities and residual solvents
(1) The requirements for elemental impurities are those specified in either one of the following: (a) chapter <2232> Elemental Contaminants in Dietary Supplements of the United States Pharmacopeia-National Formulary; or (b) the ICH Q3D Guideline. (2) The limits for residual solvents are those specified in European Pharmacopoeia (5.4) for solvent impurities.