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Therapeutic Goods (Standard for Tablets, Capsules and Pills) (TGO 101) Order 2019
17Dissolution
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17 Dissolution
(1) If:
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
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:
the dissolution test specified in the default standard mentioned in paragraph (1)(b); or
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.