Therapeutic Goods (Standard For Tablets, Capsules and Pills) (TGO 101) Order 2019

Therapeutic Goods (Standard for Tablets,
Capsules and Pills) (TGO 101) Order 2019

I, Jane Cook, as delegate of the Minister for Health, make the following order.
Dated 21 March 2019
Jane Cook
First Assistant Secretary
Medicines Regulation Division
Health Products Regulation Group
Department of Health
Authorised Version F2019L00369 registered 25/03/2019

Contents
Part 1—Preliminary 1
1 Name ...................................................................................................................................... 1
2 Commencement ..................................................................................................................... 1
3 Authority ................................................................................................................................ 1
4 Interpretation.......................................................................................................................... 1
5 Standard ................................................................................................................................. 4
6 Application ............................................................................................................................ 4
7 Repeals................................................................................................................................... 4
Part 2—Tablets and capsules 5

Division 1Requirements for tablets and capsules 5
8 General requirements ............................................................................................................. 5
Division 2Requirements for tablets and capsules for which there is an
applicable monograph 6
9 Application of Division.......................................................................................................... 6
10 Tablets or capsules containing folic acid ............................................................................. 6
11 Dissolution ........................................................................................................................... 6
12 Uniformity relating to dosage units and weight ................................................................... 7
Division 3Australian specific requirements 8
13 Application of Division........................................................................................................ 8
14 Assay of each active ingredient............................................................................................ 8
15 Tablet or capsule containing folic acid ................................................................................ 9
16 Elemental impurities and residual solvents .......................................................................... 9
17 Dissolution ........................................................................................................................... 9
18 Disintegration .....................................................................................................................10
19 Fineness of dispersion .........................................................................................................10
20 Uniformity relating to dosage units and weight ..................................................................10
Part 3—Pills 11
21 Application of Part ..............................................................................................................11
22 General requirements ..........................................................................................................11
23 Appearance .........................................................................................................................11
24 Water content ......................................................................................................................11
25 Weight variation .................................................................................................................11
26 Disintegration .....................................................................................................................11
27 Assay of each active ingredient...........................................................................................12
28 Elemental impurities ...........................................................................................................12
Schedule 1Tablets, capsules and pills: assay, disintegration and

uniformity 13
Schedule 2Tablets and capsules: assay limits for content of active
ingredient or component in a tablet or capsule 14
Schedule 3—Pills: weight variation, disintegration and elemental
impurities 15
Therapeutic Goods (Standard for Tablets, Capsules and Pills) (TGO 101) Order 2019 i

Part 1—Weight variation: dripping pills 15
Part 2—Weight variation: sugar pills 15
Part 3—Weight variation: other pills 15
Part 4—Disintegration 16
Part 5—Sieve pore diameter 16
Part 6—Elemental impurities 16
Schedule 4Repeals 17
Therapeutic Goods Order No.78 Standard for Tablets and Capsules 17
ii Therapeutic Goods (Standard for Tablets, Capsules and Pills) (TGO 101) Order 2019

Part 1—Preliminary
1 Name
(1) This instrument is the Therapeutic Goods (Standard for Tablets, Capsules and
Pills) (TGO 101) Order 2019.
(2) This instrument may also be cited as TGO 101.
2 Commencement
(1) Each provision of this instrument specified in column 1 of the table commences,
or is taken to have commenced, in accordance with column 2 of the table. Any
other statement in column 2 has effect according to its terms.
Commencement information
Column 1 Column 2 Column 3
Provisions Commencement Date/Details
1. Sections 1 to 15, and 31 March 2019. 31 March 2019
anything in this instrument not
elsewhere covered by this
table
2. Section 16 31 March 2021. 31 March 2021
3. Sections 17 to 20 31 March 2019. 31 March 2019
4. Part 3 31 March 2021. 31 March 2021
5. Schedules 1 and 2 31 March 2019. 31 March 2019
6. Schedule 3 31 March 2021. 31 March 2021
7. Schedule 4 31 March 2019. 31 March 2019
Note: This table relates only to the provisions of this instrument as originally made. It will
not be amended to deal with any later amendments of this instrument.
(2) Any information in column 3 of the table is not part of this instrument.
Information may be inserted in this column, or information in it may be edited, in
any published version of this instrument.
3 Authority
This instrument is made under section 10 of the Therapeutic Goods Act 1989.
4 Interpretation
Note: A number of expressions used in this instrument are defined in subsection 3(1) of the
Act, including the following:
(a) British Pharmacopoeia;
(b) default standard;
(c) European Pharmacopoeia;
(d) export only medicine;
(e) label;
Therapeutic Goods (Standard for Tablets, Capsules and Pills) (TGO 101) Order 2019 1

(f) listed goods;
(g) medicine;
(h) registered goods;
(i) standard;
(j) United States Pharmacopeia-National Formulary.
(1) In this instrument:

Act means the Therapeutic Goods Act 1989.
active ingredient has the same meaning as in the Regulations.
applicable monograph, in relation to therapeutic goods, means a default standard
specified with reference to:
(a) a formulated preparation in the British Pharmacopoeia;
(b) a pharmaceutical preparation in the European Pharmacopoeia; or
(c) an official product in the United States Pharmacopeia-National Formulary;
whether or not those goods are labelled as conforming to that standard, and
comprises:
(d) a specific monograph;
(e) one or more applicable general monographs; and
(f) one or more applicable general chapters;
interpreted in accordance with the General Notices section of the relevant
pharmacopoeia.
Note 1: Subsection 3(1) of the Act provides that the default standard must be interpreted in
accordance with the General Notices section of the relevant pharmacopoeia.
Note 2: Subsection 13(7) of the Act specifies how to work out whether therapeutic goods
conform with a default standard at a particular time.
Australian specific requirements has the meaning given by section 8.

capsule means a solid preparation with a hard or soft shell of various shapes and
capacities, containing one or more active ingredients.
chewable, in relation to a tablet, means a tablet which has been formulated to be
chewed rather than swallowed whole and for which the label includes a direction
to chew the tablet.
dispersible, in relation to a tablet, means an uncoated or film-coated tablet
intended to be dispersed in water before administration, giving a homogeneous
dispersion.
effervescent, in relation to a tablet, means an uncoated tablet generally
containing acid substances and carbonates or hydrogen carbonates which react
rapidly in the presence of water to release carbon dioxide, and that is intended to
be dissolved or dispersed in water before administration.
enzyme means a protein that acts as a catalyst for biochemical reactions.
homoeopathic preparation has the same meaning as in the Regulations.
ICH Q3D Guideline means ICH Harmonised Guideline: Guideline for
Elemental Impurities Q3D, Current Step 4 version, dated 16 December 2014.
2 Therapeutic Goods (Standard for Tablets, Capsules and Pills) (TGO 101) Order 2019

Note: The ICH Q3D Guideline is published by the International Council of Harmonisation at:
https://www.ich.org.
mineral means an inorganic material of defined composition.

mineral compound means a salt or other compound of one or more elements that
has a Recommended Dietary Intake for that element in the publication Nutrient
Reference Values for Australia and New Zealand Including Recommended
Dietary Intakes endorsed by the National Health and Medical Research Council
on 13 July 2017.
modified-release means:
(a) in relation to a tablet, a coated or uncoated tablet which contains special
excipients or which is prepared by special procedures, or both, designed to
modify the rate, the place or the time at which the active ingredient is, or
active ingredients are, released; or
(b) in relation to a capsule, a hard or soft capsule in which the contents or
shell, or both, contain special excipients or are prepared by special
procedures designed to modify the rate, the place or the time at which the
active ingredient is, or active ingredients are, released.
pill means a solid preparation in a spherical or ovoid shape, with or without a
coating, which is formed from a pliable mass that retains its shape during
storage, containing one or more active ingredients, and is one of the following:
(a) a honeyed pill;
(b) a water-honeyed pill;
(c) a watered pill;
(d) a pasted pill;
(e) a waxed pill;
(f) a concentrated pill;
(g) a dripping pill; or
(h) a sugar pill.
probiotic means viable, defined micro-organisms in sufficient numbers to alter
the microflora (by implantation or colonisation) in a compartment of the host.
provitamin means a chemical precursor to a vitamin.
Regulations mean the Therapeutic Goods Regulations 1990.
stated content, in relation to tablets, capsules and pills, means the quantity of the
active ingredient that is stated on the label to be present in each tablet, capsule or
pill.
tablet means a solid preparation containing one or more active ingredients and
obtained by compressing uniform volumes of particles or by another suitable
manufacturing technique, such as extrusion, moulding or freeze-drying
(lyophilisation).
vitamin means a naturally occurring organic substance or a synthetic equivalent,
or a salt or other compound, comprising one of the following:
(a) vitamin A;

(b) vitamin B1;
(c) vitamin B2;
(d) vitamin B3;
(e) vitamin B5;
(f) vitamin B6;
(g) vitamin B12;
(h) vitamin C;
(i) vitamin D;
(j) vitamin E;
(k) vitamin K;
(l) biotin;
(m) choline; or
(n) folic acid.
(2) Where the British Pharmacopoeia, European Pharmacopoeia or United States
Pharmacopeia-National Formulary adopts a different name or number for a test
or method that is referenced in this instrument, this instrument incorporates that
renamed or renumbered test or method.
5 Standard
This instrument constitutes a standard for tablets, capsules and pills.
6 Application
(1) Subject to subsection (2), this instrument applies to therapeutic goods that are
intended for oral administration, and manufactured in the following dosage
forms:
(a) tablet;
(b) capsule; and
(c) pill.
Note: Part 3 and Schedule 3 of this instrument, which sets out requirements in relation to pills,
commences on 31 March 2021 in accordance with section 2.
(2) This instrument does not apply to therapeutic goods that are:
(a) a radiopharmaceutical;
(b) an export only medicine;
(c) exempt under section 18 or 18A of the Act;
(d) the subject of an approval or authority under section 19 of the Act; or
(e) the subject of an approval under section 19A of the Act.
7 Repeals
Each instrument that is specified in Schedule 4 to this instrument is repealed as
set out in the applicable items in that Schedule.

Part 2—Tablets and capsules
Division 1Requirements for tablets and capsules
8 General requirements
(1) The requirements in relation to a tablet or capsule for which there is an
applicable monograph are:
(a) those requirements specified in that monograph, subject to the matters
specified in Division 2; or
(b) those requirements specified in Division 3 (the Australian specific
requirements) together with the requirements relevant to the tablet or
capsule that are specified in one of the following:
(i) the general monographs in the European Pharmacopoeia;
(ii) the general monographs in the British Pharmacopoeia;
(iii) the general chapters of the United States Pharmacopeia-National
Formulary.
(2) The requirements in relation to a tablet or capsule for which there is no
applicable monograph are:
(a) the Australian specific requirements; and
(b) the requirements relevant to the tablet or capsule that are specified in one
of the following:
(i) the general monographs in the European Pharmacopoeia;
(ii) the general monographs in the British Pharmacopoeia;
(iii) the general chapters of the United States Pharmacopeia-National
Formulary.

Division 2Requirements for tablets and capsules for which there is
an applicable monograph
9 Application of Division
This Division applies to tablets and capsules:
(a) that are registered goods or listed goods; and
(b) for which there is an applicable monograph.
10 Tablets or capsules containing folic acid

(1) If a tablet:
(a) has a stated content of 100 micrograms or more of folic acid; and
(b) is not a chewable, effervescent, dispersible or modified-release tablet;
then the following requirements are specified:
(c) if folic acid is the single active ingredient the dissolution requirements of
the Folic Acid Tablets monograph in the United States Pharmacopeia-
National Formulary; or
(d) if there are multiple active ingredients the dissolution requirements for
folic acid in chapter <2040> Disintegration and Dissolution of Dietary
Supplements of the United States Pharmacopeia-National Formulary.
(2) If a capsule:
(b) is not a soft capsule or a modified-release capsule;
(c) the dissolution requirements for folic acid in chapter <2040>
Disintegration and Dissolution of Dietary Supplements of the United States
Pharmacopeia-National Formulary.
11 Dissolution
If:
(a) a tablet or capsule is a registered good that:
(i) does not contain folic acid; or
(ii) is not a modified-release tablet, chewable tablet, effervescent tablet,
dispersible tablet or modified-release capsule; and
(b) the applicable monograph that is applied to the tablet or capsule does not
specify a test for dissolution; and
(c) a default standard in relation to any active ingredient contained in that
tablet or capsule specifies a dissolution test for the relevant dosage form;
then the dissolution test specified for the tablet or capsule is:
(d) the dissolution test specified in the default standard mentioned in
paragraph (1)(c); or
(e) another dissolution test that is suitable for the tablet or capsule..
Note 1: A dissolution test is specified for tablets and capsules that are registered goods or listed
goods, containing folic acid: see section 10.

Note 2: A dissolution test will always be specified in an applicable monograph for modified-
release tablets and modified-release capsules.
12 Uniformity relating to dosage units and weight

If:
(a) the tablet or capsule is a listed good; and
(b) the applicable monograph specifies a test for uniformity of dosage units;
then that test may be substituted with the test for uniformity of weight (mass)
specified in Schedule 1.

Division 3Australian specific requirements
13 Application of Division
This Division applies to tablets and capsules that are registered goods or listed
goods.
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.

15 Tablet or capsule containing folic acid
(1) If a tablet:
(b) is not a chewable, effervescent, dispersible or modified-release tablet;
(c) if folic acid is the single active ingredient the dissolution requirements of
the Folic Acid Tablets monograph of the United States Pharmacopeia-
National Formulary; or
(d) if there are multiple active ingredients the dissolution requirements for
folic acid in chapter <2040> Disintegration and Dissolution of Dietary
Supplements of the United States Pharmacopeia-National Formulary.
(2) If a capsule:
(b) is not a soft capsule or a modified-release capsule;
(c) the dissolution requirements for folic acid in chapter <2040>
Disintegration and Dissolution of Dietary Supplements of the United States
Pharmacopeia-National Formulary.
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.
17 Dissolution
(1) If:
(a) a tablet or capsule is a registered good that:
(i) does not contain folic acid; or
(ii) is not a modified-release tablet, chewable tablet, effervescent tablet,
dispersible tablet or modified-release capsule; and
(b) a default standard in relation to any active ingredient contained in that
tablet or capsule specifies a dissolution test for the relevant dosage form;
then the dissolution test specified for the tablet or capsule is:
(c) the dissolution test specified in the default standard mentioned in
paragraph (1)(b); or
(d) another dissolution test that is suitable for the tablet or capsule.

(2) If the tablet or capsule is a modified-release tablet or capsule, then a test for
dissolution that demonstrates the appropriate release of each active ingredient
must be performed.
Note: A dissolution test is specified for tablets and capsules that are registered goods or listed
goods, containing folic acid: see section 15.
18 Disintegration
(1) Subject to subsection (2), the test for disintegration specified in item 2 of the
table in Schedule 1 applies in relation to tablets or capsules that are not chewable
tablets.
(2) If a test for dissolution of active ingredients is performed in relation to the tablet
or capsule in accordance with section 15 or 17, then the tablet or capsule is not
required to comply with the test for disintegration specified in item 2 of the table
in Schedule 1.
19 Fineness of dispersion
If the tablet is a dispersible tablet, then the test for fineness of dispersion of the
British Pharmacopoeia, specified in the general monograph entitled ‘Tablets’
applies in relation to that tablet.
20 Uniformity relating to dosage units and weight

The tests for uniformity in relation to tablets and capsules are:
(a) for registered goods specified in item 3 of the table in Schedule 1; and
(b) for listed goods specified in item 4 of the table in Schedule 1.

Part 3—Pills
21 Application of Part
This Part applies to pills that are registered goods or listed goods.
22 General requirements
The requirements of this Part are specified in relation to pills.
23 Appearance
Pills must be:
(a) uniform in appearance and colour; and
(b) without adhesion.
24 Water content
The following requirements are specified in relation to water content:
(a) honeyed pills and concentrated honeyed pills must not contain more than
15.0% water;
(b) water-honeyed pills and concentrated water-honeyed pills must not contain
more than 12.0% water; and
(c) watered pills, pasted pills and concentrated watered pills must not contain
more than 9.0% water.
Note: No determination of water content is required for waxed pills.
25 Weight variation
(1) The weight variation in relation to a dripping pill is specified in the table in
Part 1 of Schedule 3.
(2) The weight variation in relation to a sugar pill is specified in the table in Part 2 of
Schedule 3.
(3) The weight variation for other pills, which are not dripping pills or sugar pills, is
specified in the table in Part 3 of Schedule 3.
(4) The core weight variation of sugar-coated pills, which are not dripping pills or
sugar pills, must be examined before coating.
Note: Weight variation testing after coating is not required for sugar-coated pills, but must be
undertaken for all other-coated pills.
26 Disintegration
(1) The following requirements are specified in relation to the pills mentioned in the
table in Part 4 of Schedule 3 (the relevant pills):
(a) a test for disintegration (the test) must be performed, subject to the
remainder of this section, in accordance with the methods specified in
either one of the following:

(i) European Pharmacopoeia (2.9.1); or
(ii) chapter <701> Disintegration of the United States Pharmacopoeia-
National Formulary;
(b) subject to paragraphs (c) and (d), the test must be performed using six pills,
a disc, and a sieve with the relevant pore diameter specified in the table in
Part 5 of Schedule 3;
(c) the test may be performed, in relation to dripping pills, without a disc;
(d) if, in the course of the test, one or more pills, or parts of the pills, adhere to
the disc, the test must be repeated without the disc, using another six pills;
(e) the entirety of the pills used in the test must pass through the sieve within
the relevant time, if any, specified in the table in Part 4 of Schedule 3.
(2) The relevant pills are taken to comply with this section if the only residue
remaining in the test comprises softened masses without a hard core.
Note: No disintegration test is specified in relation to big-honeyed pills, pills for grinding or
chewing or pills to be taken after being dispersed with hot water or yellow rice wine.
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.
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.

Item Property Requirements
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
4 uniformity of weight (mass) European Pharmacopoeia (2.9.5) or

Schedule 2Tablets and capsules: assay limits for
content of active ingredient or component in a
tablet or capsule
Note: See section 14.
Column 1 Column 2 Column 3 Column 4

Item Active ingredient Not less than Not more than
(percent) (percent)
1 vitamin or provitamin:
(a) water soluble; 90.0 150.0
(b) oil soluble; 90.0 165.0
(c) betacarotene, panthenol, 90.0 175.0
pantothenic acid or salt of
pantothenic acid
2 mineral or mineral compound:
(a) generally; 90.0 125.0
(b) when used as a source of 90.0 160.0
boron, chromium, fluorine,
iodine, molybdenum or
selenium
3 enzyme 90.0 200.0
4 probiotic not less than stated
content

Schedule 3—Pills: weight variation, disintegration and
elemental impurities
Note: See Part 3.
Part 1—Weight variation: dripping pills

Item Labelled or average weight Variation (percent)
1 0.03 grams or less 15
2 more than 0.03 grams to 0.1 grams 12
4 more than 0.3 grams 7.5
Part 2—Weight variation: sugar pills

1 0.03grams or less 15
3 more than 0.3 grams 7.5
Part 3—Weight variation: other pills

1 0.05 grams or less 12
5 more than 1.5 grams to 3 grams 8
6 more than 3 grams to 6 grams 7
7 more than 6 grams to 9 grams 6
8 more than 9 grams 5

Part 4—Disintegration
Item Pill type Requirement
1 small honey pills, water-honeyed pills and the pill must completely
watered pills disintegrate within 1 hour
2 concentrated pills and pasted pills the pill must completely
disintegrate within 2 hours
3 dripping pills (excluding coated dripping the pill must completely
pills) disintegrate within 30 minutes
4 coated dripping pills the pill must completely
disintegrate within 1 hour
5 waxed pills the pill must comply with a
suitable disintegration test
Part 5—Sieve pore diameter

Item Pill diameter Sieve pore diameter
1 less than 2.5 mm 0.42 mm
2 2.5 – 3.5 mm 1.0 mm
3 more than 3.5 mm 2.0 mm
Part 6—Elemental impurities

Item Element Requirement
1 arsenic a maximum concentration of 2 parts per million;
2 cadmium a maximum concentration of 1 part per million;
3 lead a maximum concentration of 5 parts per million
4 mercury a maximum concentration of 0.2 parts per million

Schedule 4Repeals
Note: See section 7.
Therapeutic Goods Order No.78 Standard for Tablets and Capsules

1 The whole of the instrument
Repeal the instrument.

Therapeutic Goods (Standard For Tablets, Capsules and Pills) (TGO 101) Order 2019

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Therapeutic Goods (Standard for Tablets,

Capsules and Pills) (TGO 101) Order 2019

Dated 21 March 2019

Authorised Version F2019L00369 registered 25/03/2019

Part 2—Tablets and capsules 5

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

Authorised Version F2019L00369 registered 25/03/2019

Authorised Version F2019L00369 registered 25/03/2019

Authorised Version F2019L00369 registered 25/03/2019

(1) In this instrument:

Australian specific requirements has the meaning given by section 8.

Authorised Version F2019L00369 registered 25/03/2019

mineral means an inorganic material of defined composition.

Authorised Version F2019L00369 registered 25/03/2019

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Authorised Version F2019L00369 registered 25/03/2019

10 Tablets or capsules containing folic acid

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12 Uniformity relating to dosage units and weight

Authorised Version F2019L00369 registered 25/03/2019

14 Assay of each active ingredient

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16 Elemental impurities and residual solvents

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20 Uniformity relating to dosage units and weight

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27 Assay of each active ingredient

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Column 1 Column 2 Column 3

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Column 1 Column 2 Column 3 Column 4

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Part 1—Weight variation: dripping pills

Part 2—Weight variation: sugar pills

Part 3—Weight variation: other pills

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Part 5—Sieve pore diameter

Part 6—Elemental impurities

Authorised Version F2019L00369 registered 25/03/2019

Therapeutic Goods Order No.78 Standard for Tablets and Capsules

Authorised Version F2019L00369 registered 25/03/2019

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