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Regulatory News

PDA's Regulatory News is a source of pertinent news from all over the globe. This section is set up by distinct parts of the world so you can read what is crucial to you and your company.

New Solvent Added to ICH Q3C(R6)

Jan 30, 2017, 06:46 AM
News Source Link:
http://www.ich.org/ichnews/newsroom/read/article/ich-q3cr6-guideline-reaches-step-4-of-the-ich-process.html
RegulatoryNewsDate:
Jan 27, 2017, 12:39 PM

ICH Q3C (R6), Impurities: Guideline for Residual Solvents, has entered the implementation period. The most recent update revises the Permissible Daily Exposure for Methyl isobutyl ketone (MIBK) and adds Triethylamine (TEA) as a new solvent.

regulatory-news-regions:
  • ICH