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Elemental impurities testing and specification limits – ICH Q3D

The introduction of ICH Q3D (Guideline for Elemental Impurities)1 was an additional safety-based guidance for toxic impurities that complemented the existing ICH Q3C(R5) (Impurities: Guideline for residual solvents)2 and ICH M7(R1) (Assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk);3 as well as the existing guidelines for non-toxic impurities (ICH Q3A(R2) (Impurities in new drug substances)4 and non-toxic degradants (ICH Q3B(R2) (Impurities in new drug products).5

ICH Q3D allocated PDE (permitted daily exposure) limits for three routes of delivery, ie, oral, parenteral and pulmonary for 24 common elements. These elements were further classified into four categories:

  • Class I: known human toxicants with limited or no use in pharmaceutical manufacture;
  • Class IIa: route-dependent human toxicants with relatively high probability of occurrence in the drug product;
  • Class IIb: route-dependent human toxicants with reduced probability of occurrence that are only of concern if deliberately added, i.e. catalysts and;
  • Class III: elements with relatively low toxicities by the oral route of administration, PDEs >500μg/day, but which may require consideration for inhalation and parenteral routes.

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