Setting specifications for related impurities in antibiotics - Scientific guideline
Table of contents
This guideline applies to human and veterinary medicines.
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.
Keywords: Antibiotics, specifications, related impurities
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Adopted guideline on setting specifications for related impurities in antibiotics (PDF/417.26 KB)
First published: 13/07/2012
Last updated: 13/07/2012
EMA/CHMP/CVMP/QWP/199250/2009 corr -
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Overview of comments received on setting specifications for related impurities in antibiotics (PDF/615.22 KB)
First published: 13/07/2012
Last updated: 13/07/2012
EMA/CHMP/CVMP/QWP/310350/2012 -
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Draft guideline on setting specifications for related impurities in antibiotics (PDF/205.08 KB)
Draft: consultation closed
First published: 30/07/2010
Last updated: 30/07/2010
Consultation dates: 24/06/2010 to 31/01/2011
EMA/CHMP/CVMP/QWP/199250/2009 -
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Concept paper on the development of a guideline on setting specifications for related impurities in antibiotics (PDF/50.3 KB)
First published: 09/07/2008
Last updated: 09/07/2008
CHMP/CVMP/QWP/136351/08