Setting specifications for related impurities in antibiotics

This guideline applies to human and veterinary medicines.

Current effective version

PDF iconAdopted guideline

Reference number CHMP/CVMP/QWP/199250
Published 13/07/2012
Effective from 30/06/2013
Keywords Antibiotics, specifications, related impurities
Description This 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

PDF iconAdopted guideline

 

PDF iconOverview of comments

 

PDF iconDraft guideline

 

PDF iconConcept paper

In operation: 30/06/2013–present

 

Published: 13/07/2012

 

Published: 30/07/2010

 

Published: 09/07/2008


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Related content for veterinary medicines


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