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FDA Sets Recommendations For Predicting Dangerous Nitrosamine Impurities

FDA Sets Recommendations For Predicting Dangerous Nitrosamine Impurities
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Exponent : FDA Releases New Acceptable Intake Levels for Nitrosamine Drug Substance-Related Impurities

Including deriving acceptable intake limits - as well providing guidance on the implementation of the framework.


The 2023 guidance document provides further clarification and updates.
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