ICH Guideline – Elemental Impurities

Elemental impurities in drug products may be present for various reasons, such as residual catalysts, contaminants coming from solvents, containers, closures, or by being present in components of the drug synthesis procedure.
Because elemental impurities do not provide any therapeutic benefit, their levels in the drug product should be controlled within acceptable limits.

The International Council created the ICH Guidelines for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH).

ICH guidelines aim to ensure safe, effective and high-quality medicines are developed and registered efficiently.

ICH Guideline – Elemental Impurities
10 componentsConcentration (mg/l)Matrix
Ag10HNO3 12%
As15
Cd2
Co5
Hg3
Ni20
Pb5
Se80
Tl8
V10

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