Which ICH guideline describes elemental impurities?

Question

Accepted Answer

Elemental impurities guidance

The guidance on elemental impurities is provided by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)
The specific guidance document is ICH Q3D: Guideline for Elemental Impurities
This guidance provides recommendations on the control of elemental impurities in drug products and ingredients
It outlines the permitted daily exposure limits for various elemental impurities and provides strategies for their assessment and control
The guidance helps ensure the safety and quality of pharmaceutical products

Accepted Answer

What is Q point and why is important?

Accepted Answer

ICH Q3D

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