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
Published13/07/2012
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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