Module 3 - Strategic case studies in practice

ICH Q3D(R1) Guideline

excipients

Drug Substance

Pd, Ni

As

Ni

None None None None None None None None

MCC

None None None None None None None

As, Cd, Hg, Pb As, Cd, Hg, Pb As, Cd, Hg, Pb As, Cd, Hg, Pb As, Cd, Hg, Pb As, Cd, Hg, Pb As, Cd, Hg, Pb

None None V, Ni None

Lactose

Ca Phosphate Crospovidone Mg stearate

Ni

HPMC

None

Titanium Dioxide Iron Oxide

V

None

As, Cd, Hg, Pb

V, Ni

None

The assessment identified seven potential elemental impurities requiring additional evaluation. Three of the identified elements were found in multiple components. The applicant continued the risk assessment by collecting information from vendors, published literature and data. The individual component data in the risk assessment process is shown below in Table A.4.8. Total daily masses of elemental impurities are calculated as the daily intake of the component times the concentration.

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