control treshold
- Guideline or reference source
- ICHQ3D Guideline for elemental impurities
- Definition
- A limit that is applied during the assessment of elemental impurities to determine if additional control elements may be required to ensure that the PDE is not exceeded in the drug product. The limit is defined as 30% of the PDE of the specific elemental impurity under consideration.
- Broader Term
- treshold
- Related Term
- impurity
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