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Monthly Archives: March 2015

Are Current Genotoxic Impurity (GTI) Regulations Too Weak?

Genotoxic impurities were around long before humans first began boiling bark.  Our attempts to quantify, understand and control GTI formation, however, is a much more recent phenomena. It’s also a…

Posted in analytical science, Chemistry, CMC, Contract Manufacturing, FDA, genotoxic impurities, method development, Neuland Labs, regulatory | Comments Off on Are Current Genotoxic Impurity (GTI) Regulations Too Weak?