INTRODUCTION

This chapter covers requirements for controlling drug-related organic impurities in drug substances and drug products described in USP monographs. A threshold-based approach described in the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Q3A(R2) Impurities in New Drug Substances and Q3B(R2) Impurities in New Drug Products guidelines may be used for the control of organic impurities in drug substances or drug products generated during the manufacturing process and/or storage. (For additional information and definition of terms, see Impurities in Drug Substances and Drug Products 〈1086〉.)