Specification limits for residues of metal catalysts or metal reagents

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Current effective version

Adopted guideline

Reference numberCHMP/SWP/4446/2000
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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