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The following message was posted to: PharmPK
Dear all,
we are starting a 13 weeks toxicity program in beagle dogs of a test
article containing about 5000 ppm of Methyl Ethyl Ketone as residual
solvent, but we suspect this amount of Methyl Ethyl Ketone is not
safe enough and might generate potential toxic outcomes.
Have you already tested compounds containing this solvent as residue
and/or Methyl Ethyl Ketone by itself?
Have you some suggestion?
Best regards
Donda Palmiro
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Dear Donda,
Consult ICH Q3C for guidance (http://www.emea.eu.int/pdfs/human/ich/
028395en.pdf). MEK is a class 3 solvent so more latitude is given.
Hope this helps.
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Copyright 1995-2010 David W. A. Bourne (david@boomer.org)