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Nudelman ChemTox
Consulting
Qualification of Elemental Impurities
This service focuses on the evaluation and control of trace levels of elemental impurities in drug products to meet safety and quality standards. Key activities include:
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Conducting risk assessments to ensure elemental impurities remain below the PDEs specified in ICH Q3D.
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Qualify levels higher than the ICH Q3D PDEs taking into account other quality and safety considerations, including methods described in the ICH Q3D training modules.
This service helps manufacturers ensure product safety and meet global regulatory expectations.
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