MFDS publishes a compilation of analytical methods to support drug manufacturers' efforts to control mutagenic impurities incuding nitrosamines. 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 verificated and validated in the research studies funded by MFDS. Before adapting the analysis methods to the test site, verify or validate the methods with suitable procedures. If the revised analysis methods being adapted, user should evaluate the methods with appropriate validation procedures.

※ The analysis methods could be changed according to the further research studies, and different from the policy of the MFDS.

※ This English document is a reference material to provide convenience for users. If there is some inconsistency between the Korean and this English document, the former shall prevail.

* Revision history

- Total of 24 analytical methods featured in the revised compilation.

- Subtitles and Content (e.g. system suitability, LOQ) of the methods were updated.

- Some typo errors in previous version ('23.1) were corrected.