Setting specifications for related impurities in antibiotics

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This guideline applies to human and veterinary medicines.

Current effective version

Adopted guideline

Reference numberCHMP/CVMP/QWP/199250
Effective from30/06/2013
KeywordsAntibiotics, specifications, related impurities
DescriptionThis document provides guidance for marketing authorisation applications on setting specifications for related impurities in antibiotics. It applies to antibacterial substances that are fermentation products or semisynthetic substances derived from fermentation products.

Document history

First version

Current version

Adopted guideline

Overview of comments

Draft guideline

Concept paper 

In operation: 30/06/2013–present

Published: 13/07/2012

Published: 30/07/2010

Published: 09/07/2008

Related content for human medicines

Related content for veterinary medicines

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