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What is Nitrosamine Impurities in Pharmaceuticals about?

This document discusses nitrosamine impurities that have been detected in some drug substances and products. It provides a list of common nitrosamine impurities of concern, including NDMA and NDEA. The document outlines potential sources of nitrosamine formation, including during drug substance processing when secondary or tertiary amines are present with nitrites under acidic conditions. It recommends establishing controls to ensure elimination or reduction of nitrosamine levels and discusses analytical pr

Author

Javier Basoalto

Language

EN