1. INTRODUCTION

This document provides guidance for registration applications on the content and qualification of impurities in new drug products produced from chemically synthesised new drug substances not previously registered in a region or membe state .This guideline also does not apply to new drug products used during the clinical research stages of development .Also excluded from this document are : extraneous contaminants that should not occur in new drug products and are more appropriately addressed as good manufacturing practice(GMP)issues, polymorphic forms, and.