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Therapeutic Goods (Standard for Tablets, Capsules and Pills) (TGO 101) Order 2019
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Administered by
Department of Health, Disability and Ageing
This item is authorised by the following title:
Therapeutic Goods Act 1989
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F2019L00369
25 March 2019
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27 November 2020
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Part 1—Preliminary
1 Name
2 Commencement
3 Authority
4 Interpretation
5 Standard
6 Application
7 Repeals
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Part 2—Tablets and capsules
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Division 1Requirements for tablets and capsules
8 General requirements
Division 2Requirements for tablets and capsules for which there is an applicable monograph
9 Application of Division
10 Tablets or capsules containing folic acid
11 Dissolution
12 Uniformity relating to dosage units and weight
Division 3Australian specific requirements
13 Application of Division
14 Assay of each active ingredient
15 Tablet or capsule containing folic acid
16 Elemental impurities and residual solvents
17 Dissolution
18 Disintegration
19 Fineness of dispersion
20 Uniformity relating to dosage units and weight
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Part 3—Pills
21 Application of Part
22 General requirements
23 Appearance
24 Water content
25 Weight variation
26 Disintegration
27 Assay of each active ingredient
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28 Elemental impurities
Schedule 1Tablets, capsules and pills: assay, disintegration and uniformity
Schedule 2Tablets and capsules: assay limits for content of active ingredient or component in a tablet or capsule
Schedule 3—Pills: weight variation, disintegration and elemental impurities
Part 1—Weight variation: dripping pills
Part 2—Weight variation: sugar pills
Part 3—Weight variation: other pills
Part 4—Disintegration
Part 5—Sieve pore diameter
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Part 6—Elemental impurities
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Schedule 4Repeals
Therapeutic Goods Order No.78 Standard for Tablets and Capsules
