Document ID: chunk:federal_register_of_legislation:F2020C01070:clause:3_28
Version: federal_register_of_legislation:F2020C01070
Segment Type: clause
Provision Reference: sch 3 cl 28
Character Range: 24546–25284

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.

Column 1  Column 2                          Column 3

Item      Property                          Requirements