Therapeutic Goods (Standard for Tablets, Capsules and Pills) (TG0 101) Order 2019
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AUSTRALIA
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Therapeutic Goods (Standard for Tablets,
Capsules and Pills) (TG0 101) Order 2019
I, Jane Cook, as delegate of the Minister for Health, make the following order.
Dated 2I March 2019
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Jane Cook
First Assistant Secretary
Medicines Regulation Division
Health Products Regulation Group
Department of HealthContents
Part I-Preliminary I
I Name .I
2 Commencement .. I
3 Auniority
4 Intel'pretation.
5 SIandard . 4
6 Application. .. 4
7 Repeals 4
^
Part 2-Tablets and capsules .
Division I-Requii'ements foi. tablets and capsules 5
8 Gcneral requii'ements 5
Division 2-Requirements for tablets and capsules for which there is an
applicable monograph 6
9 Application of Division 6
10 Tablets o1' capsules containino folic acid 6
I I Dissolution 6
12 Unifoi'inityi'elating to dosageiiniis and \\, eiglii 7
Division 3-Australian Specific requirements 8
13 Application of Division .... 8
14 Assay oreacliaciiveingrcdient .. 8
15 Tabict o1' capsule containing folic acid 9
16 Elemental impuiities alldI'esidual solvenis .9
17 Dissolution. 9
18 Disintcgration 10
19 Finencss of dispersioii 10
20 Uniformity I'elating to dosage units and weiglit ... 10
Pal't 3-Pills 11
21 Application of Pail. . 11
22 General I'equii'einents 11
23 Appeal'an CG 11
24 Waici content. .. 11
25 Weight \, ariation 11
26 Disintcgration 11
27 Assay of each adjve ingredient 12
28 Eleiiiental impuiities 12
Schedule I-Tablets, capsules and pills: assay, disinteoration 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 vai. iation, disintegration and elemental
impurities 15
meldpeu/IC Goods is/dildoi'd/o1 Tub/e/s, CoysN/es andPi//s) (IGO IOU O, 'de, . 20/9Part I-Weight variation: dripping pills 15
Fart 2-Weight variation: sugar pills 15
Part 3-Weight variation: other pills 15
Part 4-Disinteoration 16
Part 5-Sieve pore diameter 16
Part 6-Elemental impurities 16
Schedule 4-Repeals 17
Therapeutic Goods Older No. 78 Sinnddrdfoi' Tob/CIS und GOPsu/es 17
11 7/7ei. opaliic Goods islandui. d/bi. Tableis, Capsules undPi//.$) (IGO IOU 01 del. 2019Part I-Preliminary
I Name
(1) TITis instrtimeiit is the TheI'dperilic Goods is/tiffdurd/or. Trrb/e/s, Capsules diid
Pills) (TG0 1011 01. ofei. 2019
(2) This instrument may also be cited as TG0 I 01.
2 Commencement
(1) Eaclipi'ovision of tills instrument specified ill column I of tile table commences,
or is taken to nave commenced, in accordance witlT column 2 of the table. Ally
other' statement in column 211as effect according to its tel'11Ts.
Commencement information
Column I Column 2 Column 3
Provisions Commencement Date/Details
I. Sections I to 15, and 31 March 20 19 31 Mai'clT 20 19
anything ill tllis instruinent not
elsewhere covei. ed by this
table
2. Sectioi} 16 31 March 2021. 31 March 2021
3. Sections 17 to 20 31March2019. 31 March 20 19
4. Pal't 3 31 March 2021. 31 Marclt 2021
5. Schedules I and 2 31 Marcli 20 19. 31 March 20 19
6. Schedule 3 31 March 2021 31 Mai. ch 2021
7. Schedule 4 31 March 20 19 31 March 2019
Note: This table I'elates only 10 the provisions of this insti'1/1nciit as o1'igiiially made. 11 \\, ill
not be ainended to deal willl any Iatci aincndmenis of this insti. uinent
(2) Ally inforinatioiiiii column 3 of tlieiable is not palt of tliis instrtiinent
Information Inay be illsei'led ill tliis column, or information in it Inay be edited, ill
ally published version of tliis instrtiiiieiit.
3 Authority
TITis instruiiient is made under' section 10 of tlie Tilerdpezi/IC Goods, 4c/ 1989.
4 Interpretation
Note: A numbei of expiessions used in 1/1is instrument are defined in subsection 3(I) of the
Act, including Inc following:
(a) British Pharinacopoeia;
(b) default standard;
(c) Europeaii Pharmacopoeia;
(d) export only niedicine;
(e) label;
Tile! apeuiic Goods (S!d!Id"I'd/b!' rob/e/s, Cops!lies alld Pills) ITGO IOU 01'del' 20/9(1) listed goods;
(g) medicine;
(h) registered goods;
co standard;
O) United States Pharmacopeia-National Formulai'y.
(1) nitliis instrument:
ACi Ineans the Therape"/ic Goods ACi 1989.
,ICiive ingre, lieni ITas 111e same Ineaning as in the Regulations.
dipplic"ble 1/10"o8r, IPh, ill relation to therapeutic goods, means a default standard
specified witli reference to:
(a) a formulated preparation ill tlie Britisli PIiarmacopoeia;
(b) a pharmaceutical prepai. ation in the European PIiai'Inacopoeia; or
(c) all official product ill the United States PITarinacopeia-National Formulary;
whether or not those goods are labelled as collforining to that standard, and
coinprises:
(d) a specific monogi. aph;
(e) one o1' more applicable general 1110nographs; and
(f) one or more applicable general cliapters;
interpreted ill accordance \\, it 11 tile General Notices section of tile I elevaiit
pharmacopoeia
Notc I : Subsectioii 3(I) orilic I\ci 1110vides that the default standard 111usi 11c jiltcipieied in
accordancc \\illi 111c (1.11ci'"I Notices section of 1/1c IClevant phariiiacopocia.
Notc 2 SIIbscciioii 13(7) o1'111c ACi SPCcilies now to \Yolk out whethci' 1/1ci'riperItic goods
collroi'In willI a ticlaLilt 5/11/1111^I'd at a palticular Iiinc
'41/3ir"/i"11 specific req"ire, ,,'11/3' 11as tile Ineaniiig given by section 8
c, !PSW/e Ineans a solid preparation witli a liard or soft shell of various shapes and
capacities, containing one or more active ingredients.
chew(, ble, in relation to a tablet, Ineans a tablet willcli 11as been formulated to be
chewed rather tliaii swallowed wliole and for. WITicli the label includes a direction
to chew the tablet
of ispersible, ill relation to a tablet, means all uricoated or film-coated tablet
intended to be dispersed ill water before administration, giving a nomooeiieous
dispersion.
^ervesce"i, in relation to a tablet, Ineans all 11ncoated tablet generally
containing acid substances and cal'bonates or 11ydrogeii carbonates wliicli react
rapidly in the presence of water to release carbon dioxide, and that is intended to
be dissolved or dispersed ill water' before administration.
e, ,zy", e 11Teaiis a protein that acts as a catalyst for biocheinical reactions.
fro", oeop(, tl, ic prep"r"lion 11as tlie salne In Galling as in tlie Regtilations.
ICH g30 Gwiddi"e Ineans ICH Harmonised Guideline: G"Ide/^Ile/or
E/eii?enrol 11/1pui. illes 930, Current Stop 4 version, dated 16 December 2014.
2 The, .d'artic Goods ^/a, Ich, .d/o1. rob/at, Coysu/es o, Id P!7141 (IGO IOU Olde, 20/9Note: Tile IC}I Q30 Guideline is published by the International Council of Harmonisation at:
hitps://w\vw. icli. o1'g
Intr, errr/ means an in oroaiiic material of defined composition.
rim, errr/ coll!po""of Ineans a salt or otlier compound of one or more eleineiits that
11as a Recoininended Dietary Intake for' tliat element ill tlie publication Nun. ieiii
Refei'e, Ice I'd/ues/or Allsiin/itI rri?dNeIIJ Zed/and firc/udi, Ig Recoi, IIJieiided
Die/dry In/"kes endorsed by the Natioiial Healtli and Medical Researcli Council
o11 13 July 2017.
1110(line(I-rele, ,se Ineans:
(a) in I'elation to a tablet, a coated or Lincoated tablet wliicli contains special
excipieiits or willcli is prepared by special procedures, or botli, designed to
Inodify the rate, the place o1' 111e time at \vliicli tlie active ingi'edieiit is, or
active ingredients are, released; or
(b) ill relation to a capsule, a liard or soft capsule ill whicli the contents or
shell, or botli, contain special excipieiits or ale piepai. ed by special
PI'ocedures designed to 1110dify the I'ate, tile place o1' tlie time at whicli the
active ingredient is, or active ingredients are, released.
pill Ineans a solid preparation in a SPITerical or ovoid shape, witli o1' witho11t a
coating, whicli is formed fi'o1n a pliable Inass tliat I'stains its shape during
storage, containing one or 11/01'e active ingi'edients, and is one of the following:
(a) a noneyed pill;
(b) a watei. -noneyed pill;
(c) a watei'ed pill;
(d) a pasted pill;
(e) a waxed pill;
(f) a concentrated pill;
(g) a dripping pill; or
(h) a sugar pill.
probiolic means viable, defined micro-organisms ill sufficient nullibei's to alter
the micronora (by implantation or colonisation) ill a coinpai'titleiit of tile nost.
provii",,, ill Ineans a cheiiiical prectirsor to a vitamin.
Regi, I"trolls 111eaii tile TheI'dpetriic Goods Regii/d/ions 1990.
siftte, I collie, ,i, in relation to tablets, capsules and pills, Ineans tile quantity of tile
active ingredient tliat is stated o11 tile label to be present in eacli tablet, capsule o1'
pill
t"blei means a solid preparation containing one or In ore active ingredients and
obtained by compressing 11nifoi'11T volumes of particles or by another suitable
manufacturing technique, sucli as exti'us ion, In o111ding o1' freeze-drying
(lyophilisation)
vii(,,,, ill Ineans a natLirally occurring organic substance or a synthetic equivalent,
o1' a salt or otlier compound, coinprising one of the following:
(a) vitamin A;
7/7ei'opeMiic Goods islandui. d/o1. Tnb/eis, Cnpsi!/es alldPi//.$) (IGO 10/1 Oldei. 2019 3(b) vitamin Bl;
(c) vitalnili B2;
(d) vitamiiT B3;
(e) vitalnili BS;
(f) vitamin B6;
(g) vitamin B12;
(11) vitamin C;
(i) vitalnili D;
(1) vitamin E;
(k) vitalnili K;
co biotin;
(in) choline; or
(11) folic acid
(2) Where the British Pharmacopoeia, EUi'opean Phai. macopoeia o1' United States
Pharmacopeia-National Foilnulary adopts a diffei'Grit naille o1' numbei' for' a test
o1' Insthod that is 16fereiiced ill tliis instrument, tliis instrument incoi'poi'ates that
renalned or Tenninbered test or In GIIiod.
5 Standard
This instrtimeiit coilstittites a standai'd for' tablets, capsLiles and pills
6 Application
(1) Subject to subscctioii(2), 1111s instillineiit applies to tilerapeutic goods that are
intended 101' o1'al adjiiiiiisli'ajion, and InaiiLifactured ill the followjno dosaoe
forms:
(a) tablet;
(b) capsule; and
(c) pill
Note: Pal'I3 and Schedule 3 of this insti'ument, \\, hich sets out requirements in relation to pills,
commences on 31 March 2021 iiT accordance with section 2
(2) This instrument does not apply to tlierapeutic goods that are:
(a) a radiopharinaceutical;
(b) all export only medicine;
(c) exempt under section 18 or 18A of the Act;
(d) the subject of allapproval or autliority under' section 19 of tile Act; or
(e) tlie subject of all approval under section 19A of the Act.
7 Repeals
Eacli instrument that is specified ill Scliedule 4 to 111is instruinent is repealed as
set o11t in the applicable items in tliat Scliedule.
4 The, .apei!lie Goods Clandoi. d/b, . Tableis, Coysules a!?dpi7/s) (IGO 10/1 01 chi. 20/9Part 2-Tablets and capsules
Division I-Requirements for tablets and capsules
8 General requi, 'ements
(1) The reqtiireitieiits ill relation to a tablet or capsule for' whiclithei'e is an
applicable 1110nograpli are:
(a) tliose I'equireiiients specified in tliat In onogi'aph, subject to the mattei's
specified in Division 2; or
(b) tliose requirements specified in Division 3 (the Allsir, ,/in, , specific
req"if'ei, ,e, ,is) to getlier witlT the I'equireineiits I'elevaiit to tlie tablet or
capstile that are specified in one of the following:
co tlie genei'al In onographs in tile EUi'opean Phai'macopoeia;
(ii) tlie genei'al monographs ill tile Bittisli Pharinacopoeia;
(iii) tlie genei'al chapters of tlie United States Phai. macopeia-National
ForInulary.
(2) TITe reqtiirements in leiatioiito a tablet o1' capsule for' WITiclitliei'eis 110
applicable 11Tonograpli are:
(a) tile Allstralian specific requirements; and
(b) the reqtiireiiients relevaiit to the tablet o1' capsule that are specified in one
of tlie following:
(i) tlie general 1110nographs ill the E111'0peaii Pharinacopoeia;
(ii) the general monographs in 111e Britisli Pharinacopoeia;
(iii) tlie general cllapters of tlie United States PITarmacopeia-National
Formulai'y
The, .openiic Goods 61u, ,ofQ, d/o1. Tub/eis, Capst, /es und Ply/.$) (IGO IOU O, .de, . 2019 ,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) tliat are registered goods or listed goods; and
(b) for whicli there is all applicable In onograph.
10 Tablets or capsules containing folic acid
(1) If a tablet
(a) 11as a stated content of 100 1111crograins or 11Tore of folic acid; and
(b) is not a chewable, effervescent, dispersible or modified-release tablet;
then the following requireineiits are specified:
(c) if folic acid is tile single active ingredient- tile dissolution ^equiremeiits of
the Folic Acid Tablets 1110noorapli ill tlie United States Pharmacopeia-
National Formulary; or
(d) if tilere are multiple active ingredients- the dissolution requireitieiits for
folic acid in cliaptei' Disin/egrrr/10/7 alld Diss0/11noi? of Die/dry
SIIpp/eii?err/s or tlie United States Pharmacopeia-National FormLilai'y.
(2) If a capsule:
(a) 11as a stated collieiiioF 100 Inicrograins or 11/01'e of folic acid; and
(b) is not a soft capsiilc o1' a 1110dified-I'elease capsule;
then the following I'cqtiiiciiieiits are specified:
(c) the dissolution I'equircinents for' folic acid ill chapte^
Disiniegiu/10/1 till(/ Diss0/11noi? of Die/dry SIPp/enieii/s of the United States
PIiarmacopeia-Natioiial Formulai'y.
11 Dissolution
If
(a) a tablet or capsule is a registered good that:
(1) does not contain folic acid; or
(Ii) is not a Inodified-release tablet, cliewable tablet, effervescent tablet,
dispersible tablet or Inodified-release capstile; and
(b) tile applicable 1110nograpli that is applied to the tablet o1' capsule does not
specify a test foi. dissolution; and
(c) a default standard ill I'elation to any active ingredient contained ill that
tablet or capsule specifies a dissolLitioii test for the relevant dosage form;
tlieii the dissolution test specified for' the tablet or capsule is:
(d) tlie dissolution test specified ill the default standard mentioned in
paragrapli (1)(c); or
(e) anotlier dissoltition test that is SLiitable for tile tablet or capsule. .
Note I A dissolution test is specified foi' tablets and capsules that are reoistered goods or listed
goods, containing folic acid: see section 10
6 7/7ei'opeuiic Goods is/o17doi'd/bi' Table/s, Coys!Iles ond Ply/SI (IGO 1011 Oldei' 20/9Note 2: A dissolution test \\, ill al\\, ays be specified in an applicable monograpli for In odined-
release tablets and 1110dified-release capsules
12 Uniformity relating to dosage units and weight
If
(a) the tablet or capsule is a listed good; and
(b) tile applicable monograpli specifies a test for' 11niformity of dosage Linits;
tlieiitliat testinay be substitLited with the test foi' 11niforinity of weight (mass)
specified in Scliedule I.
The, .on, "!ic G, ,d. , ('^,,, of, ,. d/,,. fob/,/,. Copy, /,., and P, 71, ) (IGO 10110, .der. 20/9 7Division 3-Australian specific requirements
13 Application of Division
This Division applies to tablets and capsules that ale reoistered o00ds or listed
goods.
14 Assay of each active inuredient
(1) Subject to this section, the assay limits for. the stated content of eacli active
ingi'edient of a tablet or a capsule are specified ill itein I of the table in Schedule
I.
(2) If tlie tablet or capsule contains all active ingredient that is mentioned ill all item
in the table ill Schedule 2, then tile assay limits for' tliat active inuredient are
specified in columns 3 and 4 of tliat itein.
(3) If
(a) a tablet or a capsule contains all active ingredient that is all antibiotic; and
(b) a Inicrobiologicalinethod is LISed ill relation to tlie assay of Inat active
ingredient;
then:
(c) the upper fiducial limit of ei'ro^ of the estiiiiated collteiit of active
ingredient ill eacli tabict o1' capstile (P = 0.95) Innst 1101 be less Inaii 97.0
pel' cent of the stated colliciit of active ingi'edieiit; and
(d) the lowei' lidticial limit o1' ci'Tor of tile estimated collteiit o1' active
ingi'edieiit in eacli tablci tii' capsule (P = 0.95) Innsiiiot be 11/01'eInaiT 115.0
per' cent of the SIaicd coniciit of active ingredient.
(4) For the purposes of tliis scctioii, Inc assay Innst be calculated LISing a pooled
salnple of not fewer than 20 tabicts or capsules
(5) If
(a) the tablet or capsule contains all active ingredient tliat coinprises two or
In ore components tliat are eacli qiiaiitified o11the label of tile Inedicine; and
(b) the proportions of these components vary independently of each other;
then the estimated average content of eacli component ill a pooled sailiple of not
fewer than 20 tablets or capsules Innst bellot less than 90.0 per cent of the stated
content of eacli coinponeiit.
(6) If tile tablet or capsule is a 1101noeopatliic preparation then there are 110 assay
requirements specified ill relation to that tablet or capsule.
(7) If
(a) tlie tablet or capsule contains all active ingredient that is a Inulti-component
ingredient; and
(b) 110 quantitative claim is Inade on tlie label of the goods for' ally component;
then the16 are no assay requirements specified ill relation to that active
ingi'edient.
8 melopei, /IC Goods ISIdndu, .d/0, . Tub/e/s, Capsules and Ply/.$) (IGO IOU Ode, . 20/915 Tablet or capsule containing folic acid
(1) If a tablet:
(a) 11as a stated content of 100 microgi'anIs o1' 11/01'e offo1ic acid; and
(b) is not a chewable, effervescent, dispel. sible or modified-release tablet;
then the following reqtiireinents are specified:
(c) iffolic acid is the single active illgredient^the dissolution I'equireinents of
tile Folic Acid Tablets monooraph of the United States Pharmacopeia-
National Formulary; or
(d) if there ai'e multiple active ingredients- the dissolution requireinents foi.
folic acid in cliapter Disiiiiegiu/ioii in?d Dissohi/10/1 of Die/my
Supplenieii/s of tile United States Phai'macopeia-National For1111/1ary.
(2) If a capsule:
(a) 11as a stated content of 100 Inici'ogi'ains or 11/01'e of folic acid; and
(b) is not a soft capsule or a In odined-release capsule;
111eii tile following reqtiireineiits are specified:
(c) tlie dissoltitioii requireineiits foi' folic acid in chaptei'
Disiiriegiwiion o17dDissoh!Iioi7 of DieimJiSi!PPIeiiie}IIS of tlie United States
Pharmacopeia-National FoilTiulai'y.
16 Elemental impurities and I. esidual solvents
(1) The requii'Gineiits foi' elemental impuiities ai'e tliose specified ill eitliei' o11e of the
following:
(a) cliaptei' E/gilleii/rr/ Co}11,111i}lull/s in Die/dry 8147p/ei}lei7/s of the
United States Pharinacopeia-National Formiilary; o1'
(b) the ICH Q30 Guideline.
(2) The Iiinits for' residiial solvents ale tliose specified ill European Phai'macopoeia
(54) for. solvent impurities.
17 Dissolution
(I) If
(a) a tablet or capsule is a registered good tliat:
(i) does not contain folic acid; or
(ii) is not a 1110dified-release tablet, cliewable tablet, effervescent tablet,
dispersible tablet or modified-release capsule; and
(b) a default standard ill relation to any active ingi'edieiit contained in that
tablet o1' capsule specifies a dissolution test foi' the relevant dosaoe form;
tlieii tlie dissolLitioii test specified foi' the tablet o1' capsule is:
(c) the dissolution test specified ill tlie default standard mentioned in
paragrapli (I )(b); or
(d) another' dissolution test that is suitable for. the tablet o1' capsule.
The!. apet, /IC Goods Ismndo, .d/0, . Tub/e/s, Caps!,/es o, IdPIT/s) (IGO 101) OldeJ. 20/9 9(2) If tlTe tablet or capsule is a 1110dified-release tablet or capsule, tlien a test for'
dissolution that delnonstrates tile appropriate release of eacli active ingredient
must be performed.
Note A dissolution test is specified for tablets and capsules Inat are legistered goods or listed
goods, containing folic acid: see section 15
18 Disintegration
(1) Subject to subsectioii (2), tlie test for' disintegration specified ill iteiii 2 of the
table ill Scliedule I applies in relation to tablets o1' capsules that are not chewable
tablets.
(2) If a test for' dissolution of active ingredients is perforined ill relation to the tablet
or' capsule in accordance witli section 15 or 17, then tlie tablet o1' capsule is not
requii. ed to comply witlitlie test for' disintegration specified in iteiii 2 of the table
ill Scliedtile I.
19 Fineness of dispersion
If the tablet is a dispersible tablet, then the test for' fineness of dispelsioii of tlTe
Britisli Pharinacopoeia, specified in the tienera1 1110nograpli entitled 'Tablets'
applies in relation to that tablet
20 Uniformity relating to dosage units and weight
The tests for' 11nifoi'inity ill I'elatioii to tablets and capsules ale:
(a) for' ^egistei'ed goods- specified ill iteiii 3 of tlie table in Scliedtile I; and
(b) for listed goods- specified in iteiii 4 of 11/6 table ill SchedLile I
10 The, .uponiic Goods ^Imidol'd/b!' rob/eis, Coyst, /es and Pi//SI (IGO IOU Olde, ' 20/9Part 3-Pills
21 Application of Part
This Part applies to pills that are registered goods or listed goods
22 General requirements
Tile requii'Gineiits of tliis Part are specified illi'elation to pills.
23 Appearance
Pills must be:
(a) 11/11foi'111 in appearance and colour; and
(b) witlioLit adliesion.
24 Water content
The following requirements are specified in relation to watei' content:
(a) lioneyed pills and concentrated noneyed pills must not contain 1110re than
15.0% water;
(b) water-honeyed pills and coliceiitrated water-noneyed pills 111ust not contain
1110reInaii 12.0% water; and
(c) watered pills, pasted pills alld concentrated \vatei'ed pills Innst not contain
1110re tliaii 9.0% water.
Note No determination or water content is requii'cd 101' waxcd pills.
25 Weight variation
(1) TITe weiglit vai'iatioii in relation to a di'ippiiig pill is specified in tlie table ill
Part I of Scliedtile 3
(2) The \\, eiglit vai'Iatioii ill relation to a sugar pill is specified in tlie table 111 Part 2 of
Schedtile 3.
(3) The weight variation for other pills, \vhicli are not di. ipping pills or sugar. pills, is
specified ill tlie table ill Part 3 of Schedule 3.
(4) The core weight vai'iatioiiof sugar-coated pills, whicli are not di'ipping pills o1'
sugar pills, In ust be exainined before coating.
Note WeiglIt variation testing aftcr coaling is not I'equired for sugar-coatcd pills. but niusi be
undeiiaken for all o111ei. -coatcd pills.
26 Disinteoration
(1) The following I'eqiiireiiients are specified in I'elation to tliej, ills 111entioned in tile
table ill Palt 4 of Schedule 3 (the relev",, ipi/Is):
(a) a test for. disintegration (tlie rest) must be perfo^med, subject to the
remainder of this section, ill accordance witli the 111ethods specified in
either' one of tlte following:
Tin'open!IC Goods is/o11do! d/o1' Tub/eis. Capst!/es d, IdPi//s) (TGO IOU Oldei' 20/9 11(i) European Phai. macopoeia (291); or
(ii) chapter Distillegi. ajio}I of tlie United States Pharinacopoeia-
National ForInulary;
(b) subject to paragraphs (c) and (d), the test In ust be performed IISing six pills,
a disc, and a sieve witli the relevant pore diameter. specified in the table in
Part 5 of Schedtile 3;
(c) the test Inay be perforined, ill relation to dripping pills, witliout a disc;
(d) if, in the course of the test, one or Inore pills, or parts of tlie pills, adhere to
the disc, the test In ust be repeated without the disc, LISino anotlier six pills;
(e) tlie entirety of the pills used ill the test 111ust pass tlii'ougli tlie sieve within
the relevant tiine, if any, specified ill tlie table ill Part 4 of Scliedule 3.
(2) The relevant pills are taken to coinply witlitliis section ifthe onlyi'esidue
reinaining ill the test comprises softened Inasses witliout a 11ai'd coi'e.
Note No disintegiation test is specified in relation to big-honcyed pills. pills foi' grinding or
chewin0 o1' pills to be taken after being dispersed witli 1101 \\, atci' o1' ycllo\\, lice wine.
27 Assay of each active ingredient
(1) Subject to subsectioii(2), the assay limits for. eacli active ingi. edieiit of a pill are
those specified ill iteiii I of tile table ill Scliedule I.
(2) If
(a) a pill contains all active ingredient tliat is a 111ulti-component ingredient;
and
(b) 110 quantitative claiiii is Inade o11 tile label of 111e pill for' any individual
component;
then there are 110 assay ICquii'Gineiits specified ill relatioiT to tliat active
ingredient.
(3) For the purposes of tliis section, the assay Inust be calculated using a pooled
sample of not fewei' than 20 pills.
28 Elemental impurities
(1) The Inaxiinuin concentration limits ill relatioi} to the following eleinents:
(a) ai. seijic;
(b) cadmium;
(c) lead; and
(d) meI'Cury;
are specified jilthe table in Part 6 of Schedule 3.
(2) Tlie total Inass of eacli of the eleinents referred to in subsectioii (1) ill tlie pill
must be within the permitted daily exposure limit specified for that eleinent in
(a) chapter' Eienienia/ Con/o111inaii/s ill Dieidry Suppleii?enis of tile
United States Pharmacopeia-National ForInulary; or
(b) the ICH Q30 Guideline.
12 The, upon/I, G, ,d. , ('&,,, add/,,. rabid, , Cup. ,,,/,, ""of Pill, (IGO IOU O, .der. 20/9Schedule I-Tablets, capsules and pills: assay,
disintegration and uniformity
Note: See Part 2
Column I Column 2 Column 3
Item Pro ert Re uirements
assay for each active ingredient (a) for active ingredients in I'egistei'ed
o00ds-90.0 toll0.0%
(b) for. active ingredients in listed
o0ds--90.0 to 120.0V
2 disintegration European Phannacopoeia (291) or
United States PITarinacopoeia-National
Formulary, cha ter
3 11nifoi'inity of dosage units European PITai'macopoeia (2940) or
United States Phaimacopoeia-National
Formulary, cha tel
4 uniformity of weight (mass) EUi'opean PITarinacopoeia (295) or
UiTited States Pharinacopoeia-National
ForInulary, chapter
rindp, "Ii, G, ,ds ^lunch, .of/b, . rob/, I, , Copy, /,, 0"of P, 71$) (TG0 10/10, 'der' 20/9 13Schedule 2-Tablets and capsules: assay limits for
content of active ingredient or component in a
tablet or capsule
Note: See section 14
Column I Column 2 Column 3 Column 4
Item Active ingredient Not less than Not more than
(percenO (percent)
vitamin o1' provitaiiiin
(a) water soluble; 90.0 150.0
(by oil soluble; 90.0 165.0
(c) betacarotene, panthenol, 90.0 175.0
pantothenic acid or salt of
pantothenic acid
2 mineral or mineral coinpound
(a) generally; 90.0 125.0
(b) whei\ used as a source of 90.0 160.0
boron, chi'o1niLiin, fillorine,
iodine, 11/01ybdeiiuiii o1'
SGIeniuiii
~
, enzyine 90.0 200.0
4 PI objotic not less than stated
content
14 Thawe"/IC Good., ('&,,, da, 'd/b, Tab/,/,, Cup, "/co a, ,d P, IISl (IGO 10110, 'der' 2019Schedule 3-Pills: weight variation, disintegration and
elemental impurities
Note: See Part 3.
Part I-Weight variation: dripping pills
Column I Column 2 Column 3
Item Labelled or avera e wei ht Vai'iatioii ( ercent)
003 gains or less 15
,
more Inari 0.03 grains to 0.1 grams 12
3 more than O. I ams to 0.3 grams 10
4 mole Inari 0.3 ains 7.5
Part 2-Weight variation: sugar pills
Column I Column 2 Column 3
Item Labelled or avera e wei ht Variation ( ei'cent)
0,039'allis or less 15
2 more Inari 0.03 grants to 0.3 gi'anIs 10
3 1/10re than 0.3 gains 7.5
Part 3-Weight variation: other pills
Column I Column 2 Coluiiin 3
Item Labelled or averaoe weioht Variation ( ercent)
0.05 grains or less 12
?
more than 0.05 grains to O. I grams 11
3 more tlian O. I grains to 0.3 grains 10
4 more than 0.3 gains to 1.5 rains 9
5 more tlian 1.5 grains to 3 grains 8
6 more thaiT 3 granis to 6 grains 7
7 more than 6 ams to 9 grains 6
8 more tlian 9 grains 5
1/1ei'opeNiic Goods ,SIoiidoJ'd/o1. Table!s, Copsi!/es rilld Pills) (TG0 10/1 01'del' 20/9 15Part 4-Disintegration
Column I Column 2 Column 3
Item Pill t e Re ui, .ement
small honey pills, water-honeyed pills and the pill must completely
watered pills disintegrate within I hour
2 concentrated pills and pasted pills the pill 111ust completely
disintegrate within 2 hours
dripping pills (excluding coated dripping the pill 111ust completely
ills) disiiite, ,I'ate within 30 minutes
4 coated dripping pills the pill must completely
disintegi. ate within I hour
5 waxed pills the pill 111ust comply with a
SIIitable disintegration test
Part 5-Sieve pore diameter
Column I Column 2 Column 3
Item Pill diametei' Sieve pore dialmctCi'
less than 2.5 1111/1 0.42 11/1n
2 2.5 - 3.5 1111/1 1.0 mm
3 in o1'e than 3.5 min 2.0 Inin
Part 6-Elemental impurities
Column I Column 2 Column 3
Item Element Re uirement
arsenic a maximum concentration of 2 parts per million;
2 cadiniuin a maximum concentration of I part per. million;
3 lead a maximuin concentration of 5 arts er million
4 In errCury a maximum concentration of 0.2 parts per million
16 The, apeuiic Goods (SIunda, .d/0, . Tableis. Cups!Iles undPi//.$) (IGO IOU O, der. 20/9Schedule 4-Repeals
Note: See section 7
Therapeutic Goods Order No. 78 Sinn, fordfor nib/ets find C, IPs"/es
I The whole of the inst, .ument
Repeal the instruineiit.
The!. apeu/!'c Goods 61ai, dn, .d/b, . Tub/ats, Coysules and Pills) ITG0 10/10, .de, . 20/9 17You can also read
