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Regulation 8
Regulations 2(1) and 11(3)
The miscellaneous additives for which specific purity criteria are referred to below shall not contain–
(a)more than 2 milligrams per kilogram of arsenic;
(b)more than 10 milligrams per kilogram of lead;
(c)more than 50 milligrams per kilogram of copper, or 25 milligrams per kilogram of zinc or 50 milligrams per kilogram of any combination of copper and zinc.
The criteria in the monograph for heavy magnesium carbonate contained in the European Pharmacopoeia Vol. I, 1969 at page 322.
The criteria in the monograph for light magnesium carbonate contained in the European Pharmacopoeia Vol. I, 1969 at page 321.”
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