Specification limits for residues of metal catalysts or metal reagents

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Current effective version

Adopted guideline

Reference numberCHMP/SWP/4446/2000
Published21/02/2008
Effective from01/08/2008
KeywordsMetal catalysts, classification, concentration limits of metals, drug substance, excipients, permitted daily exposure (PDE), administration routes, testing strategies, reporting levels
DescriptionThis document recommends maximum acceptable concentration limits for the residues of metal catalysts or metal reagents that may be present in pharmaceutical substances or in drug products. It defines a pharmaceutical substance as a substance that is either an active pharmaceutical ingredient or an excipient. This guideline is valid until the ICH Q3D comes into force. For further details, please refer to the Elemental impurities in marketed products. Recommendations for implementation.


Document history

First version

Current version

Adopted guideline


Overview of comments


Draft guideline


Note for guidance

In operation: 01/08/2008–present


Published: 26/05/2009


Published: 01/01/2007


Published: 17/12/2002


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