MFDS publishes a compilation of analytical methods to support drug manufacturers' efforts to control mutagenic impurities incuding nitrosamines.This document is intended to providepharmaceutical industry with the information about the analysis methods for the determination of mutagenicimpurities in ...

This document is intended to provide pharmaceutical industry with the information about the analysis methods for the determination of mutagenic impurities in drug substances or drug products. The analysis methods in this document were developed and validated in the research studies funded by MFDS. B...