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

Document history - First version (current)

Topics

How useful was this page?

Add your rating
Average
1 rating