ABSTRACT
This document is intended to provide guidance for registration applications on the content and qualification of impurities in new drug substances produced by chemical syntheses and not previously registered in a region or member state. It is not intended to apply to new drug substances used during the clinical research stage of development. The following types of drug substances are not covered in this guideline: biological/ biotechnological, peptide, oligonucleotide, radiopharmaceutical, fermentation product and semisynthetic products derived therefrom, herbal products, and crude products of animal or plant origin.
