26Disintegration

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.