Ashley Taylor

Elemental impurities testing and specification limits – ICH Q3D

The introduction of ICH Q3D (Guideline for Elemental Impurities)1 was…

22 December 2018 | By Dave Elder (JPAG Member and David P Elder Consultancy)

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…

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Ashley Taylor

Elemental impurities testing and specification limits – ICH Q3D