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Articles by EAG Life Sciences

EAG Life Sciences

Robust Analytical Methods for Genotoxic Impurities
September 25, 2012

Genotoxic Impurities and Potential Genotoxic Impurities (GIs, PGIs) pose analytical method development and validation challenges for pharmaceutical development. This white paper illustrates overcoming specificity and low limits of detection difficulties for quantitative analysis of Genotoxic Impurities and Potential Genotoxic Impurities for methyl, ethyl and isopropyl camphor sulfonate esters in a drug substance.


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FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
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Reducing drug shortages
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Expedited reviews of drug submissions
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