Ministry of Food and Drug Safety 국민 안심이 기준입니다 YOUR SAFETY IS OUR STANDARD

Ministry of Food and Drug Safety 국민 안심이 기준입니다 YOUR SAFETY IS OUR STANDARD

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Guideline

Analytical Methods for the Determination of Mutagenic Impurities in Drug Substances or Drug Products
  • Registration Date 2023-01-27
  • Hit 1865

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. Before adapting the analysis methods to the test site, verify or validate the methods with suitable 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.


* Notice ('23.8.11)

This document was updated, and old version ('23.1) was deleted.

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