Setting specifications for related impurities in antibiotics - Scientific guideline

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

Current effective version

Adopted guideline on setting specifications for related impurities in antibiotics

Reference Number: EMA/CHMP/CVMP/QWP/199250/2009 corr

Document history - First version (current)

Adopted guideline on setting specifications for related impurities in antibiotics

Reference Number: EMA/CHMP/CVMP/QWP/199250/2009 corr

Overview of comments received on setting specifications for related impurities in antibiotics

Reference Number: EMA/CHMP/CVMP/QWP/310350/2012

Draft guideline on setting specifications for related impurities in antibiotics

Consultation dates: 24/06/2010 to 31/01/2011Draft: consultation closedReference Number: EMA/CHMP/CVMP/QWP/199250/2009

Concept paper on the development of a guideline on setting specifications for related impurities in antibiotics

Reference Number: CHMP/CVMP/QWP/136351/08